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Frequently Asked Questions on new registration requirement for medical devices in India

FAQs on Registration of Medical Devices

All medical devices that are manufactured in India or are imported into India have to either be licensed or registered by October 1, 2021. If a medical device is manufactured or imported after October 1, 2021 without registration or license, it will be deemed to have been manufactured or imported in violation of Indian law, thereby inviting penal action.

As a background, until 2020, the Indian Government regulated 37 categories of medical devices (scroll down for list) under the Drugs and Cosmetics Act, 1940 (DCA) and Medical Devices Rules, 2017 (MDR) for safety, quality and effectiveness. A license is presently required to manufacture or import these 37 categories of medical devices.

In 2020, the Indian Government brought about a change in law to the effect that manufacturers and importers of all medical devices other than the 37 categories of medical devices have to obtain registration ‘voluntarily’ before October 1, 2021. Those manufacturers and importers who are unable to obtain registration before October 1, 2021 would have to either stop business of said medical devices till they obtain the requisite registration, or risk facing penal consequences of violating DCA and MDR.

With an intent to help and support medical devices companies who wish to obtain a registration, we have put together a list of frequently asked questions (FAQs) with our responses in this article.

Please note that these FAQs are based on our understanding of the law, and under no circumstances should they be regarded as legal or professional advice or an endorsement of any industry practice.

What is this new requirement for obtaining registration for medical devices and equipment?

Owing to an amendment to Medical Devices Rules, 2017 in February of 2020 (said amendment hereinafter referred to as “Medica Devices (Amendment) Rules, 2020” or “MDR 2020”), manufacturers and importers of all medical devices and equipment (with the exception of those that have been notified by the government) in India are required to register their medical devices in India before October 1, 2021.

The list of devices notified by the government, to which the requirement of registration does not apply, is reproduced at the end of these FAQs.

Is the registration requirement voluntary or mandatory?

As per MDR 2020, the enforcement of registration requirementis to begin from October 1, 2021. The government has given time to the medical device industry to register ‘voluntarily’ by October 1, 2021. After that, manufacturers and importers will have to ‘mandatorily’ register their medical devices and equipment in order to be able to manufacture in India or import medical devices into India.

How to obtain registration?

In order to obtain registration, the manufacturer or importer of a medical device or equipment has to register itself, its medical device or equipment as well as the manufacturing site with the Central Drugs Standards Control Organization (CDSCO).

The registration is successful once the file number is generated.

What is the objective behind registration requirement?

The Indian government’s objective behind imposing registration requirement appears to be phase-wise regulation of all medical devices.

The pre-requisite for obtaining registration is just the existence of a ISO 13485 certificate (quality management system for medical devices) issued by a certification body accredited with National Accreditation Board for Certification Bodies (NABCB) or International Accreditation Forum (IAF) to the manufacturer of medical devices. No safety or effectiveness data is required to be submitted for obtaining registration. The intent of the Indian Government appears to be to ensure that by October 1, 2021, all medical devices sold in India must be manufactured at a facility whose quality management systems meet the standards specified in the ISO 13485, as certified by an accredited certifying body.

Is there a list of medical devices available to which the registration requirement is applicable?

 CDSCO has published a draft list of medical devices that may require registration. However, since this is only a draft list, there may be medical devices which are not part of the list but would still be subject to registration requirement.

 In order to evaluate whether a product qualifies as medical device or not (and consequently would be subject to registration requirement or not), one may refer to the following definition of medical devices under MDR:

All devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended function by such means for one or more of the specific purposes of ―

(i) diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder;

(ii) diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability;

(iii) investigation, replacement or modification or support of the anatomy or of a physiological process;

(iv) supporting or sustaining life;

(v) disinfection of medical devices; and

(vi) control of conception

If a device or equipment is covered by the definition of above, and it is not part of the list of devices specifically notified by the government (see bottom of the article for list), then such a device or equipment will be subject to registration requirement in India.

In certain cases, it may be helpful to avail expert advice in evaluating whether a product or equipment qualifies as a medical device under Indian law and is covered by registration requirement or not.

Whether components and accessories of medical devices are required to be registered?

Component and accessories of medical devices would be subject to registration requirement only if they qualify as medical device as per the definition of medical device i.e. if they are intended by their manufacturer to be used for medical purposes.

As per a recent clarification issued by CDSCO, components and accessories of medical devices imported as a system need not be registered separately. However, it is unclear what ‘separately’ implies, and why such an exemption should be given only to imported systems. It is our view that all components and accessories should be registered as part of the system because the official form for registration has fields under which details of components and accessories may be provided. In case components and accessories are not registered as part of the system for some reason, they should be registered separately, as components and accessories are ‘medical devices’ in their own right as per the definition of medical device.

In other words, components and accessories of medical devices may be registered alongside the system or independently, as long as they qualify as ‘medical device’ as per the definition of medical device.

What are the consequences of not obtaining registration before October 1, 2021?

A device to which registration requirement applies cannot be legally manufactured or imported into India without registration after October 1, 2021. The manufacturers and importers of such medical devices would have to obtain a registration for such devices in India before they can market these devices.

If a device is manufactured or imported after October 1, 2021 into India for marketing purposes without registration, then it would invite penal action under The Drugs and Cosmetics Act, 1940.

Who can make the application for registration?

An importer or manufacturer of the medical device or equipment can make the application for registration.

Can an importer obtain registration for imported medical device or equipment without whole sale drug license?

In order to create an account on the CDSCO’s registration portal as an importer, it is a pre-requisite to possess a whole sale drug license. However, for the time being, CDSCO is allowing registrations without a whole sale drug license as well.

What is the government fee payable for registration?

There is no government fee payable for registration.

What information is required to be provided for obtaining registration?

The following information has to be provided for obtaining registration:

  • Legal manufacturer’s name & address with Phone no., Fax & Email id, 
  • Actual Site Details (Name, Address, Email ID, Fax No. & Contact No.)
  • Nature of activity (import/export)
  • Category of Device (medical device / IVD)
  • Generic Name, Model No.,
  • Intended Use,
  • Product Description,
  • Class of Medical Device
  • Medical Device Category
  • Grouping Category
  • Material of Construction,
  • Dimension (If any)
  • Shelf Life
  • Storage Condition,
  • Package Size,
  • Sterile or Non-Sterile,
  • Brand Name (If registered under the Trade Marks Act, 1999)

What are the documents required to be submitted obtain registration?

In addition to the information, the following documents are required to be submitted for registering a medical device: (1) an ISO 13485 certificate; (2) a Certificate to Foreign Government or Free Sale Certificate (for imported medical devices); and (3) an undertaking stating that the information and documents supplied are true and authentic are required to be submitted.

What is ISO 13485?

ISO 13485 is a standard for quality management system for designing and manufacturing a medical device.

Who issues ISO 13485 certificate?

ISO 13485 certificate is issued by a certifying body. For the purposes of registration, the ISO 13485 certificate must be issued by a certifying body accredited by National Accreditation Board for Certification Bodies in India or the International Accreditation Forum.

What is Free Sale Certificate or Certificate to Foreign Government?

A Free Sale Certificate or Certificate to Foreign Government is issued by a Regulatory Authority / Ministry of the country in which the medical device is approved and marketed. It serves as proof that the medical devices manufactured in the country as freely sold in that country (or region).

Is there a prescribed format for the undertaking to be submitted along with the application?

There is no prescribed format for the undertaking.

What are the compliances to be done after obtaining registration?

The registration number (file number) has to be declared on the label of the medical device.

How long does it take for the registration to be received once the application has been submitted?

After the application for registration is submitted, a file number is generated instantaneously. The generation of the file number concludes the process of registration.

What is the registration number?

The file registration number is the registration number.

Is the registration number different for different medical devices and equipment?

The registration number differs as per the manufacturing site. Different medical device and equipment manufactured at the same site will receive the same registration number. Same medical devices manufactured at different manufacturing sites will receive different registration numbers.

What happens if the applicant submits incorrect information?

Once incorrect information has been submitted, it can only be rectified by CDSCO. The CDSCO requires applicants to submit an undertaking at the time of submission of the application for registration that information contained in the application is true and accurate. Therefore, it is paramount that the information submitted as part of the registration application is true and accurate.

What is the penalty for submitting false information or documents?

The CDSCO may cancel full or part of the registration, effectively making it impossible to sell medical devices in question in India.

Is it possible to sell medical devices and equipment manufactured in India or imported into India before October 1, 2021 without registration?

Given past precedents in similar matters, it is likely that medical devices imported or manufactured before October 1, 2021 may be permitted to be sold in India without registration. However, no medical device imported or manufactured in India after October 1, 2021 may be sold in India if it is not registered and labelled with the registration number.

It will be easy for enforcement authorities to check whether a medical device or equipment has been manufactured or imported into India on or after October 1, 2021 because the Legal Metrology (Packaged Commodities) Regulations, 2011 require the all packaged commodities to contain either date of manufacture or date of import.

Is it possible to sell unregistered medical devices in India which have been manufactured or imported after October 1, 2021?

No. It will be violation of DCA and MDR if a manufacturer, importer or trader sells an unregistered medical device which is manufactured or imported into India on or after October 1, 2021.

In other words, the concerned manufacturer or importer will have to register its medical devices in order to manufacture or import medical devices after October 1, 2021 for sale in India. In such cases, the registration will no longer be “voluntary” but mandatory. The registration number will have to displayed on the label of such medical devices.

Will the process for obtaining registration change after October 1, 2021 when obtaining registration for medical devices and equipment is no longer voluntary?

It is our understanding that it will not change.

For how long is the registration valid?

The registration is valid until appropriate manufacturing or import license is obtained by the concerned manufacturer or importer for those devices.

Before August 11, 2022, importers, manufacturers, distributors, whole sellers and retailers of Class A (low-risk) and Class B (low-medium risk) medical devices will have to compulsorily obtain a license. Before August 11, 2023, importers and manufacturers, distributors, whole sellers and retailers of Class C (medium-high risk) and Class D (high risk) medical devices will have to compulsorily obtain a license. The CDSCO is in the process of undertaking risk classification of all medical devices.

List of medical devices that are not covered by registration requirement

 The requirement to obtain registration does not apply to below categories of medical devices as these categories of medical devices are already regulated and require a license for manufacture, import, sale and distribution in India. In other words, if a manufacturer or importer has a license for manufacture or import of medical device, then registration requirement will not apply to such manufacturer or importer.

1. Disposable Hypodermic Syringes;2. Disposable Hypodermic Needles;3. Disposable Perfusion Sets;4. Substances used for in vitro diagnosis including Blood Grouping Sera;
5. Cardiac Stents;6. Drug Eluting Stents;7. Catheters;8. Intra Ocular Lenses;
9. I.V. Cannulae;10. Bone Cements;11. Heart Valves;12. Scalp Vein Set;
13. Orthopedic Implants;14. Internal Prosthetic Replacements;15. Ablation Devices;16. Ligatures, Sutures and Staplers;
17. Intra Uterine Devices (Cu-T)18. Condoms;19. Tubal Rings;20. Surgical Dressings;
21. Umbilical tapes;22. Blood/Blood Component Bags;23. Organ Preservative Solution;24. Nebulizer
25. Blood Pressure Monitoring Device26. Glucometer27. Digital Thermometer28. All implantable medical devices Equipment
29. CT Scan Equipment30. MRI Equipment31. Defibrillators32. PET Equipment
33. X-Ray Machine34. Dialysis Machine35. Bone marrow cell separator36. Disinfectants and insecticide specified in Medical Devices Rules, 2017;
37. Ultrasound equipment (effective November 1, 2021)   
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The Liability Conundrum for Telemedicine Platforms in India: Striking a Balance between Vicarious and Intermediary Liability

Telemedicine Vicarious Liability India

Introduction 

The COVID-19 pandemic, coupled with legitimisation of telemedicine in March 2020, has propelled the popularity of telemedicine manifold, with telemedicine platforms at the forefront. A question that arises is what the liability of these platforms is for any mishaps or complaints that patients may have about the consultations that they have with doctors through these platforms. The general perception is that, as technology providers, the platforms are intermediaries and are exempt from liability for consultations that take place on the platform. However, it is not quite that straightforward.

Liability exposure   

The principles of vicarious liability and intermediary liability, though derived from different laws, are closely linked and are both paramount factors for telemedicine platforms to take into consideration while structuring their business and governance policies. Both concepts define the liability of an entity – in this case the telemedicine platform – for the actions of another person. Vicarious liability arises when the platform had the right, ability or duty to control the activities of the violator i.e., the doctor.  Intermediary liability, on the other hand, arises because the platform facilitates the violator’s actions, and would cover violations by both the doctors and patients who use the platform. The former is largely dealt with by the Consumer Protection Act, 2019, while intermediary liability is derived from the Information Technology Act, 2000.

Vicarious liability

A common misconception is that platforms cannot be held vicariously liable since they do not employ the doctors that consult on the platform and there is no master-servant relationship between them; in fact, several platforms are structured as marketplaces, where anyone (subject to their credentials) can list themselves on the platform and offer their services. Further, telemedicine platforms typically make it clear that they are merely facilitating the interactions, not rendering medical advice themselves, so there is no doctor-patient relationship between the platform and patient, and the platform cannot be held liable for any deficiencies in service or negligence by the doctor.

However, these arguments would likely not pass the muster. A parallel may be drawn to hospitals, which typically raise the same defences in cases of medical negligence.

In the case of Smt. Savita Garg vs. The Director, National Heart Institute, the Supreme Court observed that when a patient goes to a private hospital/clinic, he goes by the reputation of the hospital and with the hope that proper care will be taken by the hospital authorities. Since these hospitals charge a fee for the services rendered by them, they are duty bound to bestow the best care, and if the hospital fails to discharge their duties through their doctors being employed on job basis or employed on contract basis, it is the hospital which has to justify.

In Smt. Rekha Gupta v. Bombay Hospital Trust & Anr., the National Consumer Disputes Redressal Commission held that a hospital cannot escape liability by taking the defence that it only provided infrastructural facilities and support staff, and did not perform or recommend any treatment itself. The NCDRC pointed out that the bills for doctor’s consultations are raised by the hospital and they charge a commission before remitting the fee to the consultant.

In Dr. Krishna Mohan Bhattacharjee vs. Bombay Hospital Medical Research Centre, the National Consumer Disputes Redressal Commission further stated that the terms under which a hospital employs the doctors is immaterial insofar as the hospital’s liability towards a patient is concerned, and that the defence that there is no master-servant relationship between the hospital and doctor cannot be taken in cases of established negligence, and held that  patients go and get themselves admitted in the hospital relying on the hospital to provide them the medical service for which they pay the necessary fee.

The same rationale that courts apply to hold hospitals vicariously liable would logically apply to telemedicine platforms as well, and it is thus unlikely that they would be eligible for a blanket exemption from liability for negligence or deficiencies in services offered through the platform by claiming that they are merely technology providers that do not play a role in the actual rendering of medical services.

That being said, there are safeguards that can be put in place to minimise the risk of prosecution.  Courts have recognised that a hospital – and therefore, by extension, a telemedicine platform – can mitigate their liability by showing that they had undertaken due diligence and adopted appropriate measures to prevent negligence or deficiencies in service. For a telemedicine platform, this would mean verifying the credentials of all doctors or healthcare professionals listed on the platform, ensuring that the doctors are: sufficiently well-versed with the practicalities, legalities and limitations of telemedicine; are aware of the functionalities of the platform; are following proper documentation processes, are compliant with the platform’s policies, etc.

The platform would also have to follow measures to mitigate their direct liability for medical negligence, such as ensuring that only qualified professionals are listed, the data protection systems are secure and compliant with the law, the technology supports smooth consultations.

It is also important to keep in mind the quality of care to be expected (and hence the liability for falling short of the expectations) of a medical establishment is directly proportional to its reputation. Thus, for a platform that makes claims of (facilitating) quality consultations, it is especially important to have stringent quality control measures in place, especially as they grow.

Dilemma of quality management vs. “control”: A threat to intermediary status

Implementing quality control measures to mitigate risk is essential for telemedicine platforms to mitigate risk of being held vicariously liable for negligence and deficiencies in service on the platform. However, it also poses a challenge to telemedicine platforms – it could potentially weaken their position as an intermediary that can avail of safe harbour protections under the Information Technology Act.

It is important to understand that telemedicine platforms are a kind of e-commerce entity. An e-commerce entity may either be set up as an inventory or a marketplace entity. An inventory e-commerce entity “owns” i.e. exercises control over the service provider doctors, whereas a marketplace entity merely provides the technological infrastructure to facilitate consultations. In case of the latter, the entity could be considered an internet intermediary that can avail of safe harbour protections, which is why most telemedicine platforms are structured as “aggregators”.

Essentially, the law recognises that an intermediary does not control what third-parties do on the platform and they cannot reasonably be expected to monitor every single transaction. Thus, provided that the intermediary complies with certain requirements, they are exempted from liability for wrongdoings done by third-parties on the platform without their knowledge.

In order to be eligible for the protection, the intermediary must follow the due diligence requirements stipulated in the Information Technology (Intermediary Guidelines and Digital Media Ethics Code) Rules, 2021, which include publishing and complying with a privacy policy and terms of service which specifies the types of content and activities that is prohibited on the website and/or mobile application, taking action against violators upon receiving knowledge of wrongdoings, cooperating with governmental authorities, etc, as well as certain compliances under the  Consumer Protection (E-Commerce) Rules, 2020  such as executing an undertaking with service providers to ensure that the descriptions and other contents pertaining to the services offered through the platform is accurate.

Thus, the law envisages a fairly “hands-off” and reactive approach to managing third-parties on the platform, and adopting more prescriptive policies and quality control measures could be viewed as the platform exercising control over the service providers, which would threaten their position as an intermediary.

Add-on services: changing dimension of intermediary status.

Most telemedicine platforms nowadays also offer value added services such as algorithmic matching of doctors/healthcare providers and patients, facilitating payments, electronic health record management, etc.

As per Section 79 of the Information Technology Act, the exemption from liability would also apply only if the intermediary is merely a passive conduit of the information, and is not involved in the initiation of the transmission, selecting the receiver of the transmission, and does not modify the information. Questions have been raised as to whether the value-added services dilute their role as a passive conduit, and result in the platform playing an active role in the transaction, which would mean that they cannot avail of the protection.

In the case of Amazon Sellers Services Private Limited vs. Modicare Limited & Ors. the Delhi High Court recognised that the FDI Press Note 2 of 2018 allows marketplace e-commerce entities to offer value added services to businesses, and held that Section 79 does not appear to differentiate between active and passive intermediaries. When an intermediary provides services in addition to access, it must comply with the requirements of Section 79 i.e. must remain a passive conduit in relation to the information. So long as that is complied with, the intermediary may avail of the protection.

It is important to note that the Intermediary Guidelines recognises not only human editorial control, but also automatic and algorithmic control. This means that a platform would not be able to take the defence that any service which dilutes their position as a passive conduit is entirely algorithmic and hence does not amount to active involvement.

Key Takeaway

If a telemedicine platform was to lose its status as an intermediary and the protections conferred by the law, they would be required to proactively monitor everything that takes place on the platform, since they would be liable for any non-compliances or wrongdoings. For platforms dealing with large volumes of consultations, this would be logistically challenging, if not impossible. The cost of operations and litigations that would arise would make it an untenable business.

Thus, it is essential that telemedicine platforms closely evaluate their structure, policies, features and service offerings to strike a balance between ensuring that high quality services are offered through the platform, while still minimising their liability.

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Legal requirements to manufacture drones (Unmanned Aircrafts) in India

Legal requirements to manufacture drone in India

Manufacturing drones [also referred to as Unmanned Aircraft System (UAS) or Remotely Piloted Aircraft System (RPAS)] in India is regulated by multiple laws including: Aircraft Act, 1934, Indian Wireless Telegraphy Act, 1933, Indian Telegraph Act, 1885 and Sea Customs Act, 1878 (as adopted by the Customs Act, 1962).

In this article, we have described the procedure that has to be followed for lawfully manufacturing drones in India.

Step 1- Obtaining Unique Authorization Number (UAN) for Manufacturer

Persons seeking to manufacture a drone have to first obtain a Unique Authorization Number (UAN) from the DGCA under the Unmanned Aircraft System Rules, 2021 (UAS Rules). It is important to note that only Indian citizens, enterprises (firms, partnerships etc.) and companies may seek authorization to manufacture drones.

Prior to making an application for authorization, the manufacturer has to first obtain security clearance from the Ministry of Civil Aviation (MCA) in consultation with Ministry of Home Affairs (MHA). The security clearance application may be made on the government portal https://e-sahaj.gov.in.

Upon receiving the security clearance, the manufacturer will have to submit an application to the DGCA in Form UA – 1 of UAS Rules along with the specified fee. The fee varies for each category of drone.

After the process of authorization is complete, the DGCA will provide a UAN for an authorized manufacturer. This UAN will be valid for a period of 10 years unless suspended, revoked or cancelled.

Any change thereafter to the credentials relevant to the eligibility criteria for obtaining the UAN has to be informed to the DGCA, and a fresh authorization will be issued thereafter if the eligibility conditions continue to be fulfilled.

Step 2 – Obtaining Equipment Type Approval for wireless system used in the Drone

An Equipment Type Approval (ETA) from the Wireless Planning & Coordination (WPC) Wing has to be obtained for every model and make of drone that is sought to be manufactured in India.

ETA can be obtained by making an application in the specified format to a Regional Licensing Officer (RLO) of the WPC Wing. The RLOs are located in Delhi, Mumbai, Kolkata, Chennai and Guwahati. An application form along with the technical literature, radio frequency reports from accredited labs and the requisite fees have to be submitted while applying for ETA.

An ETA issued for particular make and model of a prototype drone can be used by future users of the same make and model.

Step 3 – Obtaining Unique Prototype Identification Number

Any drone which has not been granted a Certificate Manufacture and Airworthiness (CMA) by DGCA cannot be used for sale and marketing purposes. In order to obtain a CMA, first a prototype of the drone has to be manufactured in India for testing at an approved laboratory.

In order to manufacture a prototype drone in India, the authorized manufacturer has to make an application for obtaining a Unique Prototype Identification Number, which is unique to the particular prototype drone and references the serial number. The application to obtain the Unique Prototype Identification Number has to be made as per Form UA – 2 of UAS Rules along with the specified fee.

The Unique Prototype Identification Number received from DCGA has to be affixed on the Prototype drone in an identifiable and visible manner.

Step 4 – Manufacturing a Prototype UAS

An authorized manufacturer can manufacture a prototype drone after obtaining the Unique Prototype Identification Number. The prototype drone is essential for the receiving the CMA.

Step 5 – Obtaining Certificate of Manufacture and Airworthiness (CMA)

Once the prototype drone has been manufactured in India, the authorized manufacturer is required to prove that the prototype drone is ‘airworthy’ i.e. it is capable of airborne operations as per the requirements stipulated by Indian law. A drone is considered to be airworthy only when it receives a Certificate of Manufacture and Airworthiness (CMA) from DGCA.

An authorized manufacturer can obtain a CMA by making an application under Form UA – 3 of UAS Rules to the DGCA with the specified fee. Please note that unmanned aircraft flight manual and maintenance manual should also be prepared and submitted along with Form UA – 3. On receipt of duly filled application, the DGCA allots an approved laboratory for testing of drones. Upon allotment, the authorized manufacturer has to submit the prototype drone which was manufactured in India along with design documents to the testing laboratory. The testing laboratory will test the prototype drone for its design, build and airworthiness. Once the testing laboratory validates the prototype drone and issues a test report, the DGCA will issue a CMA for specific type and class of a drone after being satisfied with the test report.

A drone can be lawfully manufactured in India after ensuring that the requirements stipulated in the steps mentioned above are complied with.

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GUIDE TO MANDATORY LABELLING REQUIREMENTS FOR COSMETICS IN INDIA

Mandatory Labelling Requirements for Cosmetics in India

Regulatory declarations usually do not receive the same importance as cosmetic product claims and design, but they are essential nonetheless and may invite liability if they are found to be missing from a product package.

The above statement may apply to cosmetics sold all around the word, but is especially true for cosmetics products sold in India because the Indian cosmetics regulator (the State Licensing Authority i.e.  SLA for domestically manufactured cosmetics, and the Central Drugs Standards Control Organization i.e. CDSCO for imported cosmetics) does not approve labels at the time of granting marketing authorization (even though it is mandatory to submit a copy of the label at the time of application). It is up to the importers and manufactures of cosmetics products to ensure that mandatory declarations laid down under the Cosmetics Rules, 2020 (“Cosmetics Rules”) and other laws appear on the product’s label.

Omitting any of the compulsory declarations would render the product ‘misbranded’ under the Drugs and Cosmetics Act, 1940 and may have consequences for the manufacturer or importer, ranging from suspension or cancelation of manufacturing license or import registration to criminal prosecution. It may even have consequences for the whole sellers and retailers, as misbranded products are bound to be confiscated without compensation.

In this article, we have described mandatory labelling requirements for sale of cosmetics in India.

Understanding inner label and outer label

Typically, a cosmetic product would have labels on the container (“inner label”), an outer wrapper or box (“outer label”), and sometimes a leaflet containing instructions or additional information.

The Cosmetics Rules not only prescribe the declarations but also stipulate the label on which those declarations should appear.

As per the Cosmetics Rules the following declarations must appear on the label or labels specified. If the product has only a single label, all declarations must appear on that label.

Mandatory declarations for cosmetics manufactured in India under Cosmetics Rules, 2020

Inner and Outer labels

The following information needs to appear on label on the container as well as any external packaging.

  • Name of the cosmetic
  • Name of legal manufacturer
  • Complete address of the premises where the cosmetic has been manufactured
  • Use before date/date of expiry.
  • List of ingredients, present in concentration of more than one percent, shall be listed in the descending order of weight or volume at the time they are added, followed by those in concentration of less than or equal to one percent, in any order, and preceded by the words “INGREDIENTS”

Inner or Outer labels

The following information needs to appear on either the inner or outer label.

  • Distinctive batch/lot code* [preceded by “Batch No.”, “B. No”, “Batch”, “Lot No.” or “Lot”]
  • Manufacturing License Number* [preceded by “M”, “M.L. No.”, or “Mfg. Lic. No.”]

It is advisable to include the license number and batch code on the both outer and inner label, as most regulatory authorities check the external label for compliance, but most consumers discard the secondary package upon unboxing.

Only on Outer label:

The following information only needs to appear on the outer label:

  • Net contents (weight for solids, fluid measure for liquids, and either for semi-solids)*
  • Number of items, if more than one

Only on Inner Label(s):

If there are any hazards linked to a cosmetic, the following should appear:

  • Adequate directions for use
  • Any warning, caution or special directions
  • Names and quantities of ingredients that are hazardous or poisonous

If not, only the declarations that need to appear on both the inner and outer label must be mentioned on the container.

Mandatory declarations for cosmetics imported into India under Cosmetics Rules, 2020

The Cosmetics Rules stipulate the labelling requirements for all products that are sold in the Indian market, which includes imported cosmetics. All the information that must appear on the domestically produced cosmetics must also appear on imported cosmetics (except to the extent mentioned below). In addition, details of the importer must also be mentioned, so that consumers and the regulators have access to a domestic entity in relation to the imported products. Note that the modifications to the labelling may be effected at a customs bonded warehouse i.e. before clearing Indian customs before after importing into India.

The following additional declarations must appear:

  • Import registration certificate number [preceded by “RC”, “RC No.”, “Reg. Cert. No.”]
  • Name of importer
  • Address of importer
  • If the importer does not wisht to declare the manufacturing site, –then a declaration of country of manufacture as would suffice [“Made in (Country)”].
  • If the cosmetic is imported from a country that does not require that the manufacturing license number be mentioned, manufacturing license number need not be mentioned.

Exemptions for small-size cosmetic packages under Cosmetics Rules, 2020:

Small containers of cosmetics are subject to certain relaxations.

  • Address of manufacturer may be shortened to only principal place of manufacture and the pin code where the cosmetic’s container is less than or equal to 60 ml of liquid and 30g of solids and semi-solids.
  • Batch code need not be mentioned on any cosmetic that are up to 10 grams if in the solid or semi-solid state or 25 ml if in the liquid state.
  • The declaration of net contents need not appear in case of a package of perfume, toilet water or the like, the net content of which does not exceed 60 ml or any package of solid or semi-solid cosmetic the net content of which does not exceed 30 grams
  • The list of ingredients need not appear for cosmetics that are less than or equal to 60 ml of liquid and 30g of solids and semi-solids.

These relaxations have likely been granted to ensure that the vital declarations are still present and readable, while avoiding unnecessary packaging and inserts.

Requirements for Hair Dyes containing dyes, colours and pigments under Cosmetics Rules, 2020:

Hair dyes must contain additional declarations due to their strong chemical composition, and the likelihood of reactions occurring.

The following statements must appear on both the inner and outer labels in English and in local languages:

  • “Caution.﹘ This product contains ingredients which may cause skin irritation in certain cases and so a preliminary test according to the accompanying directions should first be made. This product should not be used for dyeing the eyelashes or eyebrows; as such a use may cause blindness.”
  • “This preparation may cause serious inflammation of the skin in some cases and so a preliminary test should always be carried out to determine whether or not special sensitivity exists. To make the test, cleanse a small area of skin behind the ear or upon the inner surface of the forearm, using either soap and water or alcohol. Apply a small quantity of the hair dye as prepared for use to the area and allow it to dry. After twenty-four hours, wash the area gently with soap and water. If no irritation or inflammation is apparent, it may be assumed that no hypersensitivity to the dye exists. The test should, however, be carried out before each and every application. This preparation should on no account be used for dyeing eyebrows or eyelashes as severe inflammation of the eye or even blindness may result.”

Cosmetics that are subject to any Bureau of Indian Standards (BIS):

The Ninth Schedule to the Cosmetics Rules specifies the BIS Standards that are applicable to a total of 37 categories of cosmetics including skin powders, skin creams, hair oils, shampoos, soaps, lipsticks, foundations, etc. Further, if any new BIS standards are introduced for cosmetics, those would become mandatory after six months from the date of publication.

If any of the standards specify labelling requirements, they must mandatorily be complied with. This requirement applies to both domestically manufactured and imported cosmetics.

Animal Testing Declaration

While most products do include a statement or symbol to signify that the cosmetic product was not tested on animals, the Cosmetics Rules do not require that the declaration be made since animal testing has been outrightly banned for cosmetic products. Should the brand choose to include the declaration, however, care should be taken that they do not use any of the symbols associated with certifications such as the PETA’s ‘Beauty without Bunnies’ or the Cruelty-Free International’s ‘Leaping Bunny’ unless the certification has actually been obtained.

Mandatory declarations for cosmetics imported or manufactured into India under Legal Metrology (Packaged Commodities) Rules, 2011

In addition to the Cosmetics Rules, the label must also contain the declarations required under the Legal Metrology (Packaged Commodities) Rules, 2011 (“Packaged Commodity Rules”).

The additional declarations that would be required are:

  • Generic name of the product
  • Maximum retail price
  • Contact details for customer care
  • Date of import, if applicable

Alteration of Mandatory Declaration on Cosmetics Product Labels:

Caution should be taken while finalising the labels for a cosmetic product, since making any modifications to the label once the product leaves the manufacturing factory premise (in case of manufactured cosmetics) or the Indian customs (in case of imported cosmetics), would require prior approval from the office of Drugs Controller General of India (India), who heads the CDSCO, and, if the modification relates to a mandatory declaration under the Packaged Commodity Rules, the authority thereunder as well.

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Legal requirements to import drones (Unmanned Aircrafts) into India

Drone Flying In India Regulations

The import of drones [also referred to as Unmanned Aircraft System (UAS) or Remotely Piloted Aircraft System (RPAS)] into India is governed by multiple laws, including: Aircraft Act, 1934, Indian Wireless Telegraphy Act, 1933, Indian Telegraph Act, 1885, Sea Customs Act, 1878 (as adopted by the Customs Act, 1962), and the Foreign Trade (Development and Regulation) Act, 1992.

The key permission required to secure an import clearance for a drone is the Certificate of Manufacture and Airworthiness from Director General of Civil Aviation (DGCA). However, there are many steps involved in the process of obtaining the said certificate.

In this article, we have described the procedure that has to be adopted before importing drones into India in a step-by-step manner.

Step 1- Obtaining Unique Authorization Number (UAN) for Importer

Persons seeking to import a drone have to first obtain a unique authorization number from the DGCA under the Unmanned Aircraft System Rules, 2021 (UAS Rules). It is important to note that only Indian citizens, enterprises (firms, partnerships etc.) and companies may seek authorization to import drones.

Prior to making an application for authorization, the importer first has to obtain security clearance from the Ministry of Civil Aviation (MCA) in consultation with Ministry of Home Affairs (MHA). The security clearance application may be made on the government portal https://e-sahaj.gov.in.

Upon receiving the security clearance, the importer will have to submit an application to the DGCA in Form UA – 1 of UAS Rules along with the specified fee. The fee varies for each category of drone.

After the process of authorization is complete, the DGCA will provide a Unique Authorization Number (UAN) for an authorized importer. This UAN will be valid for a period of 10 years unless suspended, revoked or cancelled.

Any change thereafter to the credentials relevant to the eligibility criteria for obtaining the UAN has to be informed to the DGCA, and a fresh authorization will be issued thereafter if the eligibility conditions continue to be fulfilled.

Step 2 – Obtaining Equipment Type Approval for wireless system used in the Drone

An Equipment Type Approval (ETA) from the Wireless Planning & Coordination (WPC) Wing has to be obtained for every model and make of drone that is sought to be imported into India. 

ETA can be obtained by making an application in the specified format to a Regional Licensing Officer (RLO) of the WPC Wing. The RLOs are located in Delhi, Mumbai, Kolkata, Chennai and Guwahati. An application form along with the technical literature, radio frequency reports from accredited labs and the requisite fees have to be submitted while applying for ETA.

An ETA issued for particular make and model of a prototype drone can be used by future users of the same make and model.

Step 3 – Obtaining Unique Prototype Identification Number

Only a drone which has been granted a Certificate Manufacture and Airworthiness (CMA) by DGCA may be imported into India for sale and marketing. In order to obtain a CMA, first a prototype of the drone has to be imported into India for testing at an approved laboratory.

In order to import a prototype drone into India, the authorized importer has to make an application for obtaining a Unique Prototype Identification Number, which is unique to the particular prototype drone and references the serial number. The application to obtain the Unique Prototype Identification Number has to be made as per Form UA – 2 of UAS Rules along with the specified fee.

The Unique Prototype Identification Number received from DCGA has to be affixed on the Prototype drone in an identifiable and visible manner.

Step 4 – Obtaining Import Clearance for Import of Prototype UAS

Once the Unique Prototype Identification Number has been obtained, the next step is to make an application for prototype import clearance from DGCA. For seeking import clearance, an authorized importer has to make an application in Form UA – 6 along with the specified fee to the DGCA. Once the import clearance is received, the authorized importer may import the drone after obtaining import authorization from Director General of Foreign Trade (DGFT).

Step 5 – Obtaining IEC and Restricted Imports Authorization for Prototype UAS from DGFT

As per the Foreign Trade Policy, 2015 – 20 (FTP), notified under the Foreign Trade (Development and Regulation) Act, 1992, every person or entity who wishes to import any article into India for commercial purposes is required to obtain an Import – Export Code (IEC) from DGFT.

Furthermore, as per the FTP, articles whose import is ‘restricted’ under the Export and Import (EXIM) policy of India would also require an import authorization from Directorate General of Foreign Trade (DGFT) prior to import into India. The import of drones is restricted under India’s EXIM Policy (with the exception of nano drones). Therefore, import of a prototype drone will also require prior import authorization from DGFT.

An authorized importer can apply for restricted imports authorization on the government portal: https://www.dgft.gov.in/CP/

Step 6 – Obtaining Certificate of Manufacture and Airworthiness (CMA)

Once the prototype drone has been imported into India, the authorized importer is required to prove that the prototype drone is ‘airworthy’ i.e. it is capable of airborne operations as per the requirements stipulated by Indian law. A drone is considered to be airworthy only when it receives a Certificate of Manufacture and Airworthiness (CMA) from DGCA.

An authorized importer can obtain a CMA by making an application under Form UA – 3 of UAS Rules to the DGCA with the specified fee. Please note that unmanned aircraft flight manual and maintenance manual should also be prepared and submitted along with Form UA – 3. On receipt of duly filled application, the DGCA allots an approved laboratory for testing of drones. Upon allotment, the authorized importer has to submit the prototype drone which was imported into India along with design documents to the testing laboratory. The testing laboratory will test the prototype drone for its design, build and airworthiness. Once the testing laboratory validates the prototype drone and issues a test report, the DGCA will issue a CMA for specific type and class of a drone after being satisfied with the test report.

Step 7 – Obtaining Import Clearance for Compliant UAS

Once DGCA issues a CMA for a specific type and class of the drone, the authorized importer is required to make an application for its import clearance. Unlike import clearance for prototype, an import clearance of a compliant drone (i.e. a drone which has received a CMA) will allow the authorized importer to import drones in large quantity and for the purpose of sale and marketing in India. For obtaining import clearance for compliant drone, an application in Form UA – 7 of UAS Rules has to be made to DGCA with the specified fee.

Components or parts of drones which are intended to be imported also have to be approved by the DGCA in advance. An application in Form UA – 8 has to be made to seek import clearance of parts and components. The necessary documents to be submitted will vary depending on the purpose of import. For manufacturing purposes, the applicant needs to submit the manufacturer authorization and CMA. If the purpose of import is for R&D purposes, the R&D authorization and Unique Prototype Identification Number will have to be submitted. If the components or parts are being imported for maintenance, the owner’s authorization and CMA have to be submitted by the applicant.

Step 8 – Obtaining Restricted Imports Authorization for Complaint UAS from DGFT

Note that the restricted imports authorization obtained from the DGFT for prototype drone will not work for compliant drones. Therefore, a fresh restricted import authorization will have to obtained for compliant drones. Please refer to Step 5 in terms of applying for restricted imports authorization in context of importing Compliant UAS.

Exemption for Nano Drone

As of May 2021, Steps 5 and 8, insofar as they relate to obtaining restricted import authorization from DGFT, are not applicable for nano drones i.e. drones which are up to 250 grams in weight, with maximum speed up to 15 meters/second, having maximum attainable height up to 15 meters and range limited to 100 meters from remote pilot, which do not fly beyond visual line of sight and cannot carry a payload. However, this exemption may be revised or removed by DGFT in near future.

Once the requirements stipulated under Step 1 to Step 8 are in place, a drone may be lawfully imported into India.

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The use of cannabis leaves in Indian ayurvedic medicine – legalities and limitations

In India, the use of cannabis and cannabis leaves in medicines has caught public imagination. Contrary to popular perception, the use and consumption of cannabis and cannabis leaves is not entirely prohibited in India. It is permitted for medical and scientific purposes, subject to compliance with applicable laws. In this article, we have discussed the legality of use of cannabis leaves in pharmaceutical and ayurvedic medicines.

What are the laws that regulate use of cannabis leaves in medicines in India?

There are two sets of laws that regulate the use of cannabis leaves in medicines – The first set of laws treat cannabis leaves as a potential narcotic drug, and the second set of laws treat cannabis leaves as an intoxicant and a taxable item, i.e. as a source of revenue for the Government.

Narcotic drugs

The Narcotic Drugs and Psychotropic Substances Act, 1985 (NDPS Act) regulates the use of narcotic drugs in medicines India. In context of cannabis, it identifies three things as narcotic drugs: 1. The cannabis plant as a whole, including its parts such as leaves; 2. Cannabis, i.e. the flowering or fruiting top of cannabis plant when separated or not from the cannabis plant; and 3. Resin of the cannabis plant, when separated from the cannabis plant (popularly known as Charas or Hashish).

The NDPS Act treats cannabis leaves as ‘narcotic drug’ only when: 1. They are attached to the cannabis plant; 2. When they are separated from the cannabis plant but are not separated from its flowering or fruiting tops; and 3. If they contain resin from the cannabis plant.

So, leaves of cannabis plant are not regulated as narcotic drugs in India under the NDPS Act. They are regulated as narcotic drug only when they are associated with a narcotic drug, i.e. when they are attached to the cannabis plant or its flowering or fruiting tops or when they contain resin from the cannabis plant. This legal position has been upheld by Indian courts and accepted by the Indian Government.

Intoxicant

Each State in India has an excise law, for example, the Madhya Pradesh Excise Act, 1915. These laws are also sometimes referred to as prohibition laws, for example, the Maharashtra Prohibition Act, 1949. The purpose of these laws is to control access to intoxicants, and to give powers to the State Government to charge a duty on the manufacture and supply of intoxicants.

Almost all state laws in India identify cannabis leaves as an intoxicant, like they identify alcohol as an intoxicant. This means that cannabis leaves cannot be produced (i.e. separated from the cannabis plant) or used for commercial purposes without a license. For example, if a manufacturer of medicine wishes to use cannabis leaves in its medicines, it ought to have an appropriate license to procure cannabis leaves and to use it for medicinal purposes. Needless to say, the manufacturer will also have to pay a ‘duty’ (or tax) for procurement of cannabis leaves.

Why is the use of cannabis leaves more prevalent in ayurvedic medicines than in pharmaceutical medicines?

The marketing of medicines in India is regulated by Drugs and Cosmetics Act, 1940 (DCA). At present, there is no pharmaceutical medicine containing cannabis or cannabis leaf (or cannabinoids) that is approved under DCA for sale in India. If any pharmaceutical manufacturer were to introduce a cannabis or cannabis leaf based medicine in India, it would have to first undertake clinical trial of such medicine and establish its safety and efficacy.  Undertaking clinical trials is an expensive and time-consuming process. To add to that, cannabis is hardly cultivated officially in India. So, it is difficult to procure standard quality cannabis or cannabis leaf that may be required in the manufacture of pharmaceuticals containing cannabis or cannabis leaf or their extracts.

However, Ayurveda as a branch of medicine explicitly recognizes use of cannabis and cannabis leaves in manufacture of ayurvedic medicines. This means that if a standard ayurvedic medicine is to be manufactured which contains cannabis or cannabis leaves, then no clinical trials have to be undertaken prior to its commercial launch. This makes ayurvedic system of medicines an obvious choice to manufacture and sell cannabis and cannabis based medicines.

Why manufacturers choose to use cannabis leaves over cannabis in ayurvedic medicines?

There are chemicals in cannabis that have medical properties. These chemicals are commonly referred to as cannabinoids. Of the many cannabinoids, cannabidiol (CBD) and tetrahydrocannabinol (THC) are the most sought after for their medicinal properties.

Both CBD and THC are found in significant quantity in the flower and the bud of the cannabis plant. Their percentage in leaves of the cannabis plant is relatively insignificant.

However, the use of cannabis leaves in medicines is preferable to cannabis in general. There are two reasons for it. First, it is relatively easy to procure cannabis leaves as they are not regulated as ‘narcotic drugs’. Second, cannabis leaf-based medicines do not require license to sell in each state under the NDPS Act as cannabis-based medicines do.

Are there any specific labelling declarations that are applicable to manufacturers of ayurvedic medicines made out of cannabis leaves?

Manufacturers of ayurvedic medicines containing cannabis leaves or extracts must put the following declaration “Caution: to be used taken medical supervision” in English and Hindi on the label of the medicine, if the medicine is for internal use. As per an advisory issued by Ministry of AYUSH, these medicines should be sold under a prescription of a registered medical practitioner. They are not required to be labelled as “NRx”, however, since these medicines are not narcotic drugs.

What is the limitations of use of cannabis leaves in ayurvedic medicines?

The manufacturers of ayurvedic medicines containing cannabis leaves or its extracts must be careful to not use resin that may be deposited on the leaves of the cannabis plant for preparation of medicines. The resin found on any part of the cannabis plant (including leaves) is considered narcotic, and its use in ayurvedic medicine will make the ayurvedic medicine a narcotic drug, which in-turn will invite several additional compliances such as manufacturing quota, mandatory sale license and record-keeping.

The manufacturers should also be careful to not disturb the natural balance of cannabinoids as found in leaves of cannabis plant, while using cannabis leaves or its extract in the medicine. One of the cannabinoids, THC, is known for its psychoactive properties and is regulated as a psychotropic substance under NDPS Act. If the cannabis leaves are used specifically to extract THC out of cannabis leaves for subsequent use in ayurvedic medicines, then there is a risk that the ayurvedic medicine may be regulated as a psychotropic substance under NDPS Act, thereby inviting additional compliances.

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New Consumer Protection law in India: A Simple Overview (Seller Beware!)

Consumer Protection Act 2019

On July 20th, 2020, the new Consumer Protection Act, 2019 came into force in India, replacing the previous enactment of 1986. The new Act overhauls the administration and settlement of consumer disputes in India. It provides for strict penalties, including jail terms for adulteration and for misleading advertisements. More importantly, it now prescribes rules for the sale of goods through e-commerce. The consumer is now truly the king!

Here are some of the highlights:

  • An aggrieved consumer can file complaints about a defect in goods or deficiency in services from where she lives, instead of the place of business or residence of the seller or service provider. The new law provides for e-filing of consumer complaint as well.
  • No fees are required to be paid if the claim is within Rupees 5 lakhs (approximately 3500 USD).
  • A consumer can conduct her own case via video conferencing. Engaging a lawyer is optional.
  • A concept of product liability has been introduced by the new law, thereby allowing aggrieved consumers to claim significant compensation as a relief due to the negligence of the manufacturer or service provider.
  • A group of aggrieved consumers can join hands and file a class action suit (like in the US) to reduce costs and improve chances of redressal or settlement.
  • Producers of spurious goods may be punished with imprisonment.
  • Misleading advertisements may be punished with imprisonment. Celebrities endorsing a product may not be punished but can be barred from endorsing if the advertisement is misleading.
  • E-commerce is now tightly regulated, and e-commerce companies are now expected to disclose all relevant product information, including country of origin, and respond to the grievance of consumers withing prescribed timelines.
  • Settlement of consumer disputes through mediation i.e. with the help of a neutral intermediary outside the consumer court is encouraged under the new law, thus saving time and resources of disputing parties which would otherwise have been spent on dispute resolution through a formal mechanism.
  • Consumers now have several protected rights, including the right to safety, information, choice, redressal as well as right to be heard, to be educated as a consumer, and to a mediated settlement.

Corporates entities that cater to consumers will have to exercise greater care and caution in terms of quality, quantity, and product safety. The boards of corporates that manufacture or trade consumer goods must create a Consumer Affairs Committee to periodically review consumer complaints and address the need to proactively offer mediated settlements by holding online mediation and save themselves the expenses of defending a matter in Consumer Courts, in some remote part of India besides incurring the collateral damage to reputation.

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Alcohol-Based Hand Rubs and Sanitizers – Regulatory requirements, uncertainties and important considerations for doing businesses in India

Alcohol Based Hand Rubs India Legal Requirements Issues

Summary: Due to the sudden spurt of demand for hygiene products due to COVID-19 virus pandemic,   several manufacturers and marketers in India are now selling hand sanitizers containing ethanol or isopropyl alcohol as an active ingredient.  However, regulatory uncertainties, especially surrounding requirement of drug license for stock and sale and scope of price control are becoming roadblocks for businesses from scaling-up operations. Manufacturers and marketers of hand sanitizers are thus forced to explore alternate options such as manufacturing hand sanitizers as a cosmetic or ayurvedic formulation (Indian medicine) to overcome some of these regulatory challenges. However, these alternatives have their own limitation.

Background

The World Health Organization (WHO) has said that hand hygiene is extremely important to prevent the spread of COVID-19 virus. As part of hand hygiene guidelines, WHO  has recommended the use of an alcohol-based hand rub for 20-30 seconds using appropriate technique when hands are not visibly dirty. In line with these guidelines, various governments around the world have promoted the use of ethyl alcohol or isopropyl alcohol-based hand rubs for hand hygiene. India is no exception.

The WHO endorsement and government recommendations for alcohol-based hand sanitizers have resulted in high public demand for these products in India. Due to the heightened public demand, there is a race to manufacture and market alcohol-based hand sanitizers (gel) and hand rubs (liquid) (together referred to as “ABHRs”). The Drug Licensing Authorities have also started granting a license to manufacture ABHRs in a record time of three (3) days to drug manufacturers, even to alcohol distilleries and cosmetic manufacturers to ensure steady and sufficient supply of hand sanitizers and hand rubs.

However, manufacturers and marketers of ABHRs are now faced with some legal and regulatory challenges, which they must overcome in order to scale the business of ABHRs. In this article, we have discussed these challenges in detail.

Stock and sale drug license

The Drugs and Cosmetics Act, 1940 (DCA) mandates that every drug stocked or sold in India must be sold under a license unless the drug, or the person stocking or selling the drug, is exempt by law from this requirement.

There is no such exemption for ABHRs. Therefore, the entire supply chain, including retailers of ABHRs, are required to sell them under a stock and sale license under DCA.

However, due to COVID-19 (Corona) virus, it is not possible to meet the current demand for ABHRs through existing distribution and retail channels that have stock and sell license for drugs. Therefore, there is a widespread expectation that ABHRs should be sold through general FMCG distribution and retail channels.

The only way to legally do so is by positioning ABHRs as disinfectants. There is an exemption under DCA for disinfectants that allows disinfectants to be stocked and sold without a drug license. Such an exemption from stock and sale drug license is not unique to disinfectants. Several other drugs presently enjoy such exemptions as well, for example, oral rehydration salts, medicated dressings, condoms etc.

Some courts in India have, in the past, recognized the disinfectant properties of specific formulations of antiseptic liquids containing alcohol and validated their ability to avail exemption from drug stock and sale license otherwise available only to disinfectants. However, the courts are yet to specifically opine on exemption of ABHRs in general from the requirement of stock and sale license.

The industry is awaiting an official clarification on this issue. The central drug regulator, the Drugs Controller General of India (DCGI), is currently reviewing the regulatory positioning of hand sanitizers, including ABHRs, as ‘disinfectants’ and availability of exemption from drug stock and sale license to them. Until DCGI takes a final position, some State-level Drug Licensing Authorities may accept ABHR’s claim of disinfectants and allow them to be stocked and sold by the distributors and retailers without drug license. But Some State-level Drug Licensing Authorities some may not do the same, and the overall objective to scale ABHRs business to meet demand may not be met.

It is our view that such an exemption should be available to ABHRs, especially since the US Pharmacopeia, which is one of the pharmacopoeias recognized under Indian law for drug quality standards, explicitly acknowledges disinfectant properties of ABHRs.

Meanwhile, with a view to improve access to ABHRs, the Government has notified them as an essential commodity (discussed in next paragraph in detail). However, notification of ABHRs as an essential commodity does not automatically exempt them from the requirement to be sold under a stock and sale drug license either at distributor or retail level. All drugs sold in India are, in fact, essential commodities.

To overcome the limitation imposed by requirement of drug stock and sale license on distribution of ABHRs, some manufacturers and marketers are manufacturing ABHRs under as an ayurvedic drug that is made under an ayurvedic drug manufacturing license, or as cosmetic that is made under a cosmetic manufacturing license. Both ayurvedic drugs and cosmetics do not require any regulatory license for stock and sale and therefore may be distributed via a supply chain that does not have a drug stock and sale license.

However, there are significant challenges in selling ABHRs as ayurvedic drugs or cosmetics. For example, ayurvedic drugs containing alcohol have a long history of litigations with excise department for their potential to be abused as intoxicating liquor. Some State Governments in India have prescribed a limit on alcohol content, stating that alcohol used in the manufacture of antiseptic solutions should not contain alcohol in excess than is necessary for the preservation of (ayurvedic) ingredients. As ABHRs typically have 60%+ alcohol content, manufacturers and marketers of ABHRs must ensure that their product passes the above test.

When ABHRs are sold as cosmetics, it is not possible to make any ‘drug’ claim on it. For example, it is not possible to claim on the label that the ABHR ‘kills’ germs, as it would mean that the product is not for cosmetic application but for medicinal application. The definition of ‘drug’ under DCA is broad and covers all substances that are intended to be used in the prevention of disease in human beings. If any such ‘drug’ claim is made on the label of a cosmetic, then it may invite strict regulatory action under DCA.

Status as new drugs in India

The two ABHR formulations recommended by WHO are: Ethanol 80% (v/v) or Isopropyl alcohol 75% (v/v), Glycerol 1.45% (v/v) and Hydrogen peroxide 0.125% (v/v). As per the records released by central drug regulator, DCGI, both these formulations were first approved for sale in India in 2017. These formulations now preferred by most manufacturers and marketers due to the WHO endorsement and constitute the bulk of new ABHRs being launched in India.

Under New Drugs and Clinical Trial Rules, 2019 (NDCTR), a formulation is deemed to be a “new drug” for four years from the date of its first approval. Therefore, both WHO recommended formulations are to be currently treated as ‘new drugs’ for regulatory purposes in India until 2021.

When any drug is classified as a ‘new drug’, it has two consequences for the manufacturer of the drug. Firstly, a prior permission from the central drug regulator, DCGI, is required to be obtained in addition to a manufacturing license. Secondly, after the manufacturing license is granted, the manufacturer is supposed to undertake post marketing surveillance and submit periodic safety update reports (PSURs) to DCGI.

The manufacturers of ABHRs as per WHO recommended formula must ensure that DCGI permission is in place for their products, in addition to the manufacturing license, and must make periodic submissions of PSURs to DCGI as per the format specified under NDCTR.

Price control of hand sanitizers

ABHRs manufactured under a drug manufacturing license have always been under some or the other form of price control. The Drug (Prices Control) Order, 2013 (“DPCO”) regulates the prices and distribution of ABHRs containing ethyl alcohol 70% (v/v) since 2013. The current price ceiling on 70% ethyl alcohol solution is 0.56 Rupees per ml, which translates into 112 Rupees for 200 ml. All other ABHRs are restricted from increasing their maximum retail price by more than 10% in between twelve months.

However, as described earlier, it is possible to manufacture “hand sanitizers” as an Indian medicine (ayurvedic drug) or cosmetic as well. Ayurvedic formulations are not regulated for price by DPCO to a great extent and cosmetics are not regulated for price at all. Thus, the price cap of 112 Rupees for 200 ml will not apply to ayurvedic or cosmetic hand sanitizers. Furthermore, DPCO does not regulate cost of raw materials of drugs, in this case methylated industrial alcohol / denatured ethyl alcohol / isopropyl alcohol. The DPCO also does not empower State Governments to direct manufacturers of drugs to enhance production capacity and increase their availability. This power is vested only with the Central Government.

In order to overcome these challenges, the Indian Government has notified The Essential Commodities Order, 2020, thereby classifying “hand sanitizers” as essential commodity until June 30th, 2020. Due to this, all hand sanitizers (drug, ayuvedic medicine, cosmetic) and the raw material used in them have come under the purview of price control and have become amenable to jurisdiction of respective State Governments. The Indian Government has also notified The Fixation of Prices of Masks (2 ply and 3 ply), Melt Brown Non-Woven Fabric and Hand Sanitizers Order, 2020 (“Hand Sanitizer Price Control Order”). As a consequence, all hand sanitizers (drug, ayurvedic, cosmetic) cannot be sold for price higher than 100 Rupees for 200 ml until June 30, 2020. Needless to say, after expiry of the aforesaid order, hand sanitizers will be regulated as per DPCO (to the extent applicable to them).

There has been a collateral impact of the Hand Sanitizer Price Control Order on non-alcohol based hand sanitizers. There are currently at least twenty-four (24) formulations of hand sanitizers approved for sale in India, some of which are not alcohol-based. The Hand Sanitizer Price Control Order does not clarify whether it applies only to alcohol-based hand sanitizers or other hand sanitizers as well. The expression “hand sanitizer” is not defined under law, and has been interpreted loosely by the central drugs regulator, DCGI. The DCGI has in fact put out a list of all hand sanitizers approved by it which includes both alcohol-based and non-alcohol based hand sanitizers. Therefore, there is a risk that the Hand Sanitizer Price Control Order may be interpreted broadly and cover non-alcohol based hand sanitizers as well.

On a separate note, manufacturers who have been selling formulation of ethyl alcohol 70% (v/v) will have to obtain a prior price approval from central price regulator, National Pharmaceutical Pricing Authority (NPPA), before manufacturing ABHR containing ethyl alcohol as per the procedure prescribed under DPCO.

Making Corona related Claim

There is scientific laboratory data now in place to support the claim that WHO recommended formulae for ABHRs, or ethyl alcohol or isopropyl alcohol in concentration of more than 30% v/v, can inactivate COVID-19 virus in thirty (30) seconds.

However, such scientific laboratory data has not been endorsed by India’s central drug regulator, DCGI, and is very specific to WHO formulations when used under laboratory conditions. If any manufacturer or marketer wishes to put a generic COVID-19 virus related claim on its label, it may need to first obtain prior permission from DCGI who may decide to treat the ABHR as a untested ‘new drug’ and require the manufacturer to submit supporting laboratory data for its own formulation before it is permitted to make any COVID-19 virus related claim.

Needless to say, in absence of the permission from DCGI, any such claim may make the manufacturer liable for prosecution under DCA.

Making “WHO recommended formula” claim

There is an expectation in some quarters of the industry that the if an ABHR is manufactured as per the WHO recommended formulae (described in earlier paragraphs), then it should be launched with a supporting claim of ‘WHO recommended formula’ on its label. However, it may not be ethical to commercially exploit the WHO brand name since the WHO formulae were originally recommended as an alternative when suitable commercial products were either unavailable or too costly. The actual recommendation from WHO for ABHRs is, in fact, for any effective alcohol-based hand rub product that contains between 60% and 80% of alcohol.

For context, the WHO recommended formula even today is intended for local production by pharmacies and WHO has permitted use of its brand name by them in order to (most likely) lend credibility to the end product.

On the same note, it is an offence in India to put the name of World Health Organization or its abbreviation (WHO) without prior permission of the Central Government under the Emblems and Names (Prevention of Improper Use) Act, 1950. Therefore, even if a manufacturer is able to manufacture the exact formulation as recommended by WHO, it should not claim that it is manufactured “as per WHO recommended formula” without prior permission of the Central Government.

Putting Government Logo for endorsement in fight against Covid-19 virus

Like World Health Organization, putting the name or official seal or emblem of the Government of India or of any State or of a Department of any Government without prior permission of the Central Government is an offence under the Emblems and Names (Prevention of Improper Use) Act, 1950.

Getting the labelling right

Apart from alcohol, there may be other active ingredients in ABHRs such as hydrogen peroxide which kill or limit the growth of harmful microorganisms. Such ABHRs with more than one active ingredients fall in the category of ‘fixed dose combinations’ (“FDCs”). Every FDC is required by law to state the composition on the label first, followed by its brand name. For instance, in case of the WHO recommended formulae described earlier, the name of the active ingredients must appear prominently on the label and simply writing “hand sanitizer” or “hand rub“ may not be enough.

Further, due to the high alcohol content in the ABHRs, there are specific declarations that ought to appear on their label. Each label must specify that ABHR contains denatured alcohol (in case of use of methylated spirit) and that it is for external use only. If the ABHR is making a disinfectant claim, then it must specify the mode of use. The content of the alcohol in the ABHR must be stated in terms of average percentage of absolute alcohol.

It is also advisable to write about storage conditions and appropriate warnings, in view of the high concentration of alcohol in ABHRs.

Same brand name, different drug

Some marketers of ABHRs are selling two or more formulations of ABHRs under the common / umbrella branding of ‘Hand Sanitizer’. This strategy should be revisited, since different formulations of ABHRs are different drugs, and selling different drugs under a common / umbrella branding of ‘Hand Sanitizer’ may be misleading.

If a marketer is selling ABHRs manufactured under pharmaceutical drug license and ayurvedic drug license under a common / umbrella branding such as ‘Hand Sanitizer’, then the regulatory risk identified above may increase since pharmaceutical drug and ayurvedic drug are two very different products though with the same end-application.

The law does not want consumers to be misled while buying drugs. Therefore, every manufacturer who wishes to sell ABHR under a brand name is required to file a declaration at the time of applying for drug manufacturing license. The declaration states that the brand name under which the drug is proposed to be sold is not used by  any other manufacturer. This declaration should be submitted by manufacturers of ABHRs before obtaining the manufacturing license for ABHR.

Getting quality aspects right

The manufacturers of ABHRs is obligated by law to ensure that its products are of standard quality. The WHO has recommended that the efficacy of any ABHR should be proven according to European (EN 1500) or American (ASTM E-1174) standards. Considering these are foreign standards and may not be enforceable in India, manufacturers of ABHRs must ensure that the hand sanitizers at least satisfy requirements of quality and efficacy as per applicable Indian standards.

As of date, in case a drug is found to be not of standard quality (NSQ), the liability lies with the manufacturer and not the marketer. However, this will change in future. From March 1, 2021, the marketers of drugs themselves will be responsible for the quality of the drug and the agreement between marketers and manufacturers will play an important role in the determination of liability. Therefore, the meeting of applicable Indian quality standards by ABHRs will be important for both the marketer and the manufacturer.

Conclusion

Hand Sanitizers, specifically ABHRs, are more relevant and in-demand in India than ever before. However, manufacturers and marketers of ABHRs should be careful about compliance with laws and regulations, because any oversight today may invite strict regulatory action in future.

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India’s new price regulation for medical devices and equipment – impact on price and supply chain due to Drugs (Prices Control) Order, 2013

Summary

On February 11, 2020, the Indian Government had gazetted a notification that brought all medical devices and medical equipment sold in India under existing quality and safety regulatory framework by declaring them as “drugs”.  However, this notification has exposed all medical devices to India’s drug price control regulation that was put in place to make drugs affordable and accessible as well. So, from April 1, 2020 (i.e. the effective date of the notification), all manufacturers and importers of medical devices and medical equipment sold in India will have to be careful to not increase the maximum retail price of their products by more than 10% within 12 months. They will have to make periodic trade-related filings with the Government in which they will have to submit price information such as price to distributors, price to stockist, price to hospital and price to retailer. And, on top of all this, they will have to operate under constant risk of price fixation at the hands of the Government, like was done in the case of coronary stents and knee implant systems in 2017.  

Background

The quality and safety of drugs sold in India is regulated by the Drugs and Cosmetics Act, 1940 (“DCA”). There is no equivalent legislation for medical devices. Therefore, the Indian Government notifies those medical devices whose quality and safety it intends to regulate as ‘drugs’ from time to time.

Prior to February 11, 2020, the Indian Government used to regulate the quality and safety of medical devices in a piecemeal  manner. There were only 37 categories of medical devices and  medical equipments that had been notified as drugs under DCA (see annexure for this list). However, on February 11, 2020, the Government declared all medical device and medical equipment to be drugs in order to bring them under the fold of quality and safety regulation under DCA, effective April 1, 2020. We have written extensively about it here.

There was a collateral impact of this decision of the Government on price and supply chain of medical devices and medical equipment. India regulates production, control and supply of all essential commodities through a law called the Essential Commodities Act, 1955 (“ECA”). ‘Drugs’ are regulated as an essential commodity under ECA. Therefore, the Government has power to regulate product control and supply of all drugs under ECA. In furtherance of the provision of ECA, the Government has notified a price control order for drugs called the Drugs (Prices Control) Order, 2013 (“DPCO”).

On February 11, 2020, when the Government decided to regulate all medical devices and medical equipment by notifying them as drugs, it automatically subjected them to the provision of DPCO. The authority responsible for the administration of DPCO, the National Pharmaceutical Pricing Authority (NPPA), has already brought out a clarificatory order stating that the provision of DPCO will squarely apply to all medical devices and medical equipment.

Impact on price and supply of medical devices after April 1, 2020

From April 1, 2020, all medical devices and medical equipment manufacturers and importers will have to comply with the provisions of DPCO. The obligations imposed by DPCO on all manufactures and importers of medical devices and medical equipment are as follows:

Retail sale price to be mentioned on all medical devices, including ones for institutional use: The DPCO requires that every SKU of medical device and medical equipment must be labelled with its maximum retail price (“MRP”) that is to be set by the importer/manufacturer/marketer. The said price must be prefixed by the words “Maximum Retail Price” and suffixed by the words “inclusive of all taxes”.

Before April 1, 2020, there was an exemption available for medical devices and medical equipment that weighed more than 25 kg or that were intended for institutional use,  from declaration of MRP under the Legal Metrology (Packaged Commodity) Rules, 2011. However, from April 1, 2020, all medical devices and medical equipment, irrespective of their weight and intended use, will have to declare MRP on the label of each SKU in the manner specified above.

% cap on variation of retail sale price: The importers, manufactures and marketers of medical devices will have to be cognizant about variation of the MRP declared on the label of their medical devices. The MRP of the product should not be varied by more than 10% in any 12 month period, else the variation in excess of 10% will be recovered as ‘overcharging’ from the business concerned. For example, if an importer of medical device decides to reduce the MRP by 20%, but after a single quarter decides to return to the original retail price (i.e. increase by around 20%), then it won’t be permitted to do so. It can, at best, increase its MRP by 10% of the reduced price. If it starts selling the product at the original MRP, then the 10% excess will be recovered from the importer on MRP basis i.e. by multiplying the number of units sold with the 10% excess, along with intrest and penalty.

Price related filings to be done from time to time: All importers, manufacturers and marketers of medical devices and medical equipment will have to submit price to distributors/stockists, price to retailers/hospitals and retails sale price in format prescribed under Form V of Schedule II of DPCO (with appropriate modifications) in the event of revision of MRP. The aforesaid information is to be submitted on an online platform called Integrated Pharmaceutical DataBase Management System operated by NPPA.

Risk of price fixation: The NPPA has the powers to fix ceiling prices of any drug under extra-ordinary circumstances and in public interest. Now, from April 1, 2020, this power will extend to all medical devices and medical equipment. Once a price is fixed, the importer, manufacturer and marketer of said medical device has to set its MRP either equal to or below the ceiling price. Most of the times, NPPA also fixes the margins that may be offered to the supply chain and makes the concerned importer/manufacturer/marketer liable for any breach of margin by the supply chain.

In the past, the NPPA has used this power to fix prices of coronary stents and knee implant systems (both devices were notified as drugs in 2005). In the aftermath of the price fixation, many advanced coronary stents were sought to be withdrawn from India by the manufacturers on the grounds of unviability. A prior permission from NPPA is required to withdraw or to reduce production / import of medical device whose prices have been fixed by NPPA in public interest.

Risk of being subject to market based pricing: The Ministry of Health and Family welfare brings about a National List of Essential Medicines (“NLEM”) every few years. Medical devices are also included in the said list from time (e.g. coronary stent). The consequence of being included in NLEM from pricing perspective is that the medical device in question automatically becomes subject to a market price based price control i.e. the MRP of the said device must not exceed the average MRP of all importers, manufacturers and marketers who sell the same device and who have more than 1% market share in that particular device market. The said average MRP (referred to as “Ceiling Price”) is decided and set by NPPA. The Ceiling Price may go up or down every year, depending on the wholesale price index of the Government. The MRP of the medical device will have to be adjusted accordingly.  A prior permission from NPPA is required to withdraw or to reduce production / import of medical device which are recognized as ‘essential’ by the Government.

Consequences of non-compliance

There are different consequences associated with different violations. Any violation of DPCO is serious because its parent legislation, the Essential Commodities Act, 1955, stipulates that any breach of DPCO may result in imprisonment and fine for the company and person(s) in-charge of the company for conduct of its business. However, undoubtedly, the most draconian provision of DPCO is the liability to deposit any amount ‘overcharged’ by the importer or manufacturer in breach of DPCO in addition to the interest and penalty.

Final comments

It is extremely important for medical devices and medical equipment companies doing business in India to be aware of the compliance requirements and obligation under India’s price control law (i.e. EC Act and DPCO). Since all medical devices and medical equipment are now regulated as drugs, and all drugs are treated as essential commodities, an inadvertent violation of India’s price control laws may have serious consequences for the business of these companies.

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India’s new Telemedicine Practice Guidelines – Analysis and Do’s and Don’ts for Doctors offering teleconsultation

Summary: The Indian Government has published Telemedicine Practice Guidelines (“Telemedicine Guidelines”) on March 25, 2020. These guidelines finally clarify India’s position on the legality of teleconsultation. It is now perfectly legal to provide teleconsultation by registered medical practitioners (M.B.B.S and above) in line with the requirements of the Telemedicine Guidelines. It has been clarified that the first consultation between doctor and patient need not be an in-person consultation, and doctors in India can provide the first consultation to patients located in any State remotely through teleconsultation. However, going forward, all doctors who provide teleconsultation will have to display their registration number in all communications exchanged with the patient – for example, in emails or WhatsApp messages, on prescriptions and on fee receipts. Doctors will also have to be careful while issuing a prescription during teleconsultation. As a thumb rule, prescribing medicines for chronic diseases (such as asthma, diabetes or hypertension) should be avoided during teleconsultation, unless it is an add-on or refill of an earlier prescription obtained during an in-person consultation less than six months ago. If a prescription for chronic diseases is to be issued, then the teleconsultation should be done strictly via video. A prescription can be sent through any electronic medium such as email, WhatsApp etc. as a photo/scan / digital copy of a signed prescription or an e-prescription.

What is the new development?

On March 25, 2020, the Board of Governors (“BoG”) entasked by the Health Ministry to regulate practice and practitioners of modern medicine, published an amendment to the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 (“Code of Conduct”) that gave statutory support and basis for the practice of telemedicine in India.

The relevant part of the amendment is as follows:

3.8.1. Consultation through Telemedicine by the Registered Medical Practitioner under the Indian Medical Council Act, 1956 shall be permissible in accordance with the Telemedicine Practice Guidelines contained in Appendix 5 (of Code of Conduct).

A registered medical practitioner under Indian Medical Council Act, 1956 is a person who is enrolled in the State Medical Register or the Indian Medical Register under the Indian Medical Council Act, 1956 (or National Medical Commission Act, 2019 as and when it comes into full force and replaces the Indian Medical Council Act, 1956). Every practising doctor in India today is required by law to be enrolled in the State Medical Register or Indian Medical Register before the start of his or her medical practice. Therefore, the amendment does not add any new requirement of registration for doctors who want to practice telemedicine and provide teleconsultation to his or her patients.

Telemedicine is defined under the Telemedicine Guidelines as:

 “The delivery of health care services, where distance is a critical factor, by all health care professionals using information and communication technologies for the exchange of valid information for diagnosis, treatment and prevention of disease and injuries, research and evaluation, and for the continuing education of health care providers, all in the interests of advancing the health of individuals and their communities”

What does the amendment mean for Doctors?

Telemedicine consultation (or “teleconsultation”) has been offered by doctors in India since the year 2000. However, in the absence of statutory basis and support, it was not clear whether it was legal or not. In fact, there have been news reports that State Medical Councils had banned the practice of teleconsultation. For example, the Karnataka State Medical Council had reportedly warned doctors in the State of Karnataka against offering online consultations and threatened them with dire consequences if they did (including cancellation of registration). Despite such reports, the practice of telemedicine and teleconsultation flourished, and several major companies currently provide online teleconsultation services for a fee in India.

Now, doctors who are providing teleconsultation independently or through such companies can rest assured that such practice is lawful as long as it is done in compliance with Telemedicine Guidelines. Doctors can also provide teleconsultations to patients from any part of India.

In fact, the Telemedicine Guidelines specifically permit Doctors to provide teleconsultation for prescribing medicines, providing counselling (e.g. food restrictions, do’s and don’t’s for a patient on anticancer drugs, proper use of a hearing aid etc.) and imparting health education (e.g. advice on contagious infections, immunizations, exercises, hygiene practices, mosquito control etc.).

What does the amendment mean for patients?

India does not have a great doctor to patient ratio. This, coupled with the fact that India is a huge country and that the density of doctors is far higher in cities than in rural areas where the bulk of India’s population resides, is the reason why teleconsultation has great demand and potential in India.

Unfortunately, there were hardly any standards for doctors to follow and patients to expect during a teleconsultation. For example, Indian patients sometimes felt short-changed when a doctor was not clear or audible, or the doctor refused to issue a prescription or did not provide a report of the consultation after the consultation ended. Some patients feared whether the person on the other end was, in fact, a doctor or not. A few worried about their privacy, as electronic communications over mobile application or email, can leave a trail.

Indian patients now will be able to hold doctors accountable to provide teleconsultation as per the Telemedicine Guidelines, which provide a clear set of do’s and don’ts for doctors. A violation of the Telemedicine Guidelines will give patients avenue to complain against the doctor before appropriate State Medical Council for ‘misconduct’.

Telemedicine Guidelines – Salient features

Doctor can choose the medium of teleconsultation: A doctor may use any medium for patient consultation, e.g. telephone, mobile or landline phones, chat platforms like WhatsApp, Facebook Messenger etc., other mobile apps or internet-based digital platforms for telemedicine or data transmission systems like Skype/ email/ fax etc. However, before proceeding with the teleconsultation, the doctor should exercise professional judgement to decide whether the teleconsultation is, in fact, appropriate and in the interest of the patient. If the answer is yes, then the doctor should evaluate which medium would be preferred for the teleconsultation. For example, a complaint of appendicitis may require a physical examination and teleconsultation may not be preferred. On the other hand, some common complaints may not require physical examination or even consultation in real-time. For example, a complaint of headache or fever may not always require the doctor to examine the patient physically or audio-visually through a mobile or computer application. However, in certain cases, for example, on presentation of allergy or inflammation (e.g. Conjunctivitis), the doctor may choose to examine the patient in-person or through an audio-visual teleconsultation. Thus, the decision to examine the patient physically or remotely i.e. through teleconsultation, and the medium of teleconsultation, is to be taken by the doctor himself or herself on case to case basis.

Doctor has to maintain the same standard of care during teleconsultation as during in-person consultation: The Telemedicine Guidelines require doctors to maintain the same standard of care towards a patient during a teleconsultation as they would during an in-person consultation. In other words, the fact that the teleconsultation took place over a mobile app or email or telephone cannot be taken as a defence by a doctor against an allegation of medical negligence. Every doctor is expected to know the limitation of teleconsultation and advise or prescribe accordingly.

Patient is responsible for the accuracy of information: During the course of teleconsultation, if the doctor inquires for relevant information from the patient, then the patient is supposed to disclose the right information. The Telemedicine Guidelines have clarified that is the patient who will be responsible for accuracy for the information shared with the doctor, and not the doctor. However, since the standard of care is as high in the case of teleconsultation as in-person consultation, the doctor must make all efforts to gather sufficient medical information about the patient’s condition before deciding on a diagnosis or a treatment. If a patient provides any contradictory information, or if the doctor is not convinced with the information at hand to make a professional decision, he may ask patient to provide such documents or undertake such tests as he/she may feel proper in his/her professional judgement without fear of liability. 

Caregiver is deemed to be authorized on behalf of minor or incapacitated patients: If the age of the patient is 16 years or less, or if the patient is incapacitated (due to mental conditions like dementia or physical disability due to an accident), then the caregiver is deemed to be authorized to consult on behalf of the patient. The Telemedicine Guidelines clarify that in such cases, the teleconsultation can take place with the caregiver without the presence of the patient.

No fixed Format for issuing a prescription: There is no fixed format for issuing a prescription in a teleconsultation. The Telemedicine Guidelines has recommended a format, but following it is not mandatory. However, the doctor must provide photo/scan /digital copy of a signed prescription or e-Prescription to the patient via email or any messaging platform. Please note that a doctor can transfer the prescription to a pharmacy only if he/ she has the explicit consent of the patient.

Invoice for fees: Doctors can charge appropriate fees for teleconsultation. A receipt or invoice should be given to the patient against the fees.

Do’s and Don’t’s for Doctors

Patient identification is mandatory during first consultation: If the teleconsultation is, in fact, the first consultation of the patient with the doctor, then doctor should confirm the patient’s identity to his/her satisfaction by asking patient’s name or age or address or email I.D. or phone number or any other identification that may be reasonable.

Patient identity confirmation is not mandatory during follow-up consultation, but may be carried out on need basis: It is not mandatory to identify the patient during a follow-up teleconsultation with a known patient, especially if the doctor is communicating through the registered user id, email id or phone number. However, in case of doubt, the doctor should confirm patient identity as during the first consultation.

Caregiver identity and authorization should be checked: If the patient is not a minor or is not incapacitated, then a caregiver cannot consult on behalf of the patient unless he or she has a formal authorization such as a signed authority letter by the patient or his/her legal representatives (family members) or, where the caregiver is a family member himself or herself, if he or she has a document that verifies his or her relationship with the patient such as a government identity proof. The caregiver’s identity and authorization should be checked by the doctor before offering teleconsultation. In the case of minors, the identity of the caregiver should be confirmed.

Doctor should identify himself/herself to the patient before start of every teleconsultation: A doctor should begin any teleconsultation by informing the patient about his/her name and qualification. This may be uncomfortable to be done every time, especially to a known patient. However, this is the requirement of Telemedicine Guidelines at present.

Doctor should display his/her registration number at every touch-point with patient: A doctor who provides teleconsultation is required to display his/her registration number provided by respective State Medical Council on his/her prescription, website, electronic communications (WhatsApp/Message/Email etc.) and fee receipts given to his/her patients.

Doctor should not continue with teleconsultation if it not appropriate: the doctor is not satisfied with the information provided by the patient to provide specific treatment, i.e. prescription or health advice, then he/she should provide limited consultation as appropriate and refer the patient for an in-person consultation.

Doctor should maintain patient records of teleconsultation: For in-person O.P.D. consultations in India, the doctors, in general, do not maintain patient records. Appropriate patient history, observations and findings are recorded on the prescription and it is handed over to the patient. However, for teleconsultation, it is mandatory for doctors to prepare, maintain and preserve the patient’s records (e.g. case history, investigation reports, images, etc.), copy of prescription issued and proof of teleconsultation (e.g. phone call history, email records, chat/ text record, video interaction logs etc.). While no time period is prescribed for how long such records are required to be preserved, it is generally recommended to maintain these records for three years.

Patient’s personal data should not be disclosed or transferred without written consent of the patient: Since teleconsultation happens on an electronic medium, the Indian law that protects personal information, including medical and health-related information of patients, squarely applies to doctors who provide teleconsultation and receive such information from patients. This is in addition to the ethical obligation to protect patient privacy that is recognized in the Code of Conduct. The most important thing to note here is that Doctors who provide teleconsultation should not disclose or transfer any information that may identify the patient without the prior written consent of the patient.

Doctor should not deny emergency teleconsultation, but limit it for immediate assistance or first aid: Emergency teleconsultation should not be provided remotely except when it is the only way to provide timely care.Even then, such emergency teleconsultation should be limited to first aid, life-saving measures, counselling and advice on referral. Every emergency teleconsultation must end with an advise to the patient or his/her carer for in-person interaction with a Doctor at the earliest.

Limitation on prescribing medicines to patients: This is, perhaps, the most significant limitation imposed by Telemedicine Guidelines on the practice of telemedicine in India. Going forward, doctors will not be able to prescribe medicines over teleconsultation freely.

In order to prevent abuse, the Telemedicine Guidelines require every doctor to “prescribe medicines via telemedicine ONLY when (the doctor) is satisfied that he/ she has gathered adequate and relevant information about the patient’s medical condition and prescribed medicines are in the best interest of the patient.” Prescribing Medicines without an appropriate diagnosis/provisional diagnosis will amount to professional misconduct.

Before issuing a prescription through teleconsultation, every doctor is supposed to inquire about the age of the patient. If there is any doubt about the age of the patient, then the doctor should seek age proof. If the patient turns out to be a minor, then further teleconsultation should be done and prescription should be issued only in the presence of an adult, whose identity should also be ascertained by the doctor.

If the teleconsultation with the patient does not take place over video, then the concerned doctor cannot prescribe drugs to the patient other than common over-the-counter (“O.T.C.”) medications such as paracetamol, O.R.S. solutions, cough lozenges etc. Such patient also cannot be prescribed medication for which diagnosis is possible only by video consultation such as antifungal medications for Tinea Cruris, Ciprofloxacillin eye drops for Conjunctivitis etc. The doctor may, however, prescribe ‘add-on’ medication to such patient to optimize the existing treatment through drugs if such existing treatment was prescribed in an in-person consultation less than six months ago. Please note that there is no bar in prescribing emergency medications, even if they are not O.T.C. medicines, as and when notified by the government, through any form of teleconsultation, whether video or not.

A list of common O.T.C. medications that can be prescribed without video teleconsultation is described in List O, Appendix 5 of the Code of Conduct. A list of ‘add-on’ medications to optimize existing treatment is described in List B, Appendix 5 of the Code of Conduct. For the purpose of this list, emergency medications would be included in the list of O.T.C. medications, i.e. List O.

If the patient is examined through video, then the doctor may prescribe medications other than O.T.C. medicines described in List A of Appendix 5 of Code of Conduct. Some examples of such medicines are:

  • Ointments/Lotion for skin ailments: Ointments Clotrimazole, Mupirocin, Calamine Lotion, Benzyl Benzoate Lotion etc.
  • Local Ophthalmological drops such as: Ciprofloxacillin for Conjunctivitis, etc
  • Local Ear Drops such as: Clotrimazole ear drops, drops for ear wax etc.

The doctor may also prescribe a ‘refill’ of medication already prescribed during an in-person consultation for chronic illnesses (hypertension, diabetes, asthma etc.) or an ‘add-on’ medication to optimize the existing treatment (like in the case of non-video consultation).

Please note, however, that no doctor is permitted to prescribe habit forming drugs (i.e. drugs in Schedule X of Drugs and Cosmetics Rules, 1945) or narcotic or psychotropic drug (i.e. drugs regulated by Narcotic Drugs and Psychotropic Substances Act, 1985) through any medium of teleconsultation.

For details on restrictions on the ability of doctors to issue prescriptions during teleconsultation, please refer to the table below:

Type I (Non-video consultation)

Prior in-person consultation Scope and limitation of prescription List of drugs that may be prescribed
No prior in-person consultation + Can prescribe only O.T.C. medication e.g. Paracetamol, Oral Rehydration Solution (O.R.S.) packets, Antacids

– Cannot prescribed medications for which diagnosis is possible only by video consultation such as antifungal medications for Tinea Cruris, Ciprofloxacillin eye drops for Conjunctivitis etc.  

– Cannot prescribe ‘add-on’ medication which are used to optimize an existing condition

– Cannot prescribe ‘refill’ medications for chronic diseases such as Diabetes, Hypertension, Asthma etc.

– Cannot prescribe habit forming, narcotic or psychotropic drug 		As provided in List O, Appendix V of Code of Conduct
Prior in-person consultation for same health condition in last six months + Can prescribe O.T.C. medication e.g. Paracetamol, Oral Rehydration Solution (O.R.S.) packets, Antacids

+ Can prescribe ‘add-on’ medications which are used to optimize an existing condition – e.g. if the patient is already on Atenolol for hypertension and the blood pressure is not controlled, an A.C.E. inhibitor such as Enalapril may be prescribed as an add-on.

– Cannot prescribed medications for which diagnosis is possible only by video consultation such as antifungal medications for Tinea Cruris, Ciprofloxacillin eye drops for Conjunctivitis etc.

– Cannot prescribe ‘refill’ medications for chronic diseases such as Diabetes, Hypertension, Asthma etc

– Cannot prescribe habit forming, narcotic or psychotropic drug 		As provided in List O & List B of Appendix V of Code of Conduct

Type II (Video consultation)

Prior in-person consultation Scope and limitation of prescription List of drugs that may be prescribed
No prior in-person consultation + Can prescribe O.T.C. medication e.g. Paracetamol, Oral Rehydration Solution (O.R.S.) packets, Antacids

+ Can prescribed medications for which diagnosis is possible only by video consultation such as antifungal medications for Tinea Cruris, Ciprofloxacillin eye drops for Conjunctivitis etc.

– Cannot prescribe ‘add-on’ medication which are used to optimize an existing condition

– Cannot prescribe ‘refill’ medications for chronic diseases such as Diabetes, Hypertension, Asthma etc   – Cannot prescribe habit forming, narcotic or psychotropic drug 		As provided in List O & List A of Appendix V of Code of Conduct
Prior in-person consultation for same health condition in last six months + Can prescribe O.T.C. medication e.g. Paracetamol, Oral Rehydration Solution (O.R.S.) packets, Antacids

+ Can prescribe ‘add-on’ medications which are used to optimize an existing condition – e.g. if the patient is already on Atenolol for hypertension and the blood pressure is not controlled, an A.C.E. inhibitor such as Enalapril may be prescribed as an add-on.

+ Can prescribed medications for which diagnosis is possible only by video consultation such as antifungal medications for Tinea Cruris, Ciprofloxacillin eye drops for Conjunctivitis etc.

+ Can prescribe ‘refill’ medications for chronic diseases such as Diabetes, Hypertension, Asthma etc

– Cannot prescribe habit forming, narcotic or psychotropic drug   		As provided in List O, List A & List B of Appendix V of Code of Conduct

Mandatory training in telemedicine

At some point of time in future, the Board of Governors in supersession of Medical Council or National Medical Commission would introduce training programs in telemedicine. It will be mandatory to participate in those training programs for all doctors who intend to offer teleconsultations to patients. However, until those training programs are developed, there is no restriction in terms of prior training or qualification for registered doctors to engage in teleconsultation.

Do Telemedicine Practice Guidelines apply to doctors who are practising Indian medicine?

The Telemedicine Guidelines do not apply to practitioners of Ayurveda, Yoga, Homeopathy, Unani or Siddha.

What happens to the Telemedicine Guidelines when the National Medical Commission is set-up?

The Board of Governors in supersession of Medical Council of India will soon make way for the National Medical Commission. However, this transition will not impact the Telemedicine Guidelines and the practice of telemedicine in India.  The National Medical Commission Act, 2019 has a savings clause, which will allow the Code of Conduct and Telemedicine Guidelines to survive and remain enforceable until new regulations are made.

Impact of 2018 judgement of Deepa Sanjeev Pawaskar and Anr. v. State of Maharashtra on Telemedicine Practice Guidelines

In 2018, a judgement of High Court of Bombay caused panic amongst doctors who offered teleconsultation. In that case, two gynaecologists were denied anticipatory bail on the grounds that, prima facie, they were criminally negligent towards their patient who unfortunately died while under their care. The material facts of the case are that the deceased patient had presented herself with a complaint of fever and severe vomiting. She was admitted to the nursing home of the accused doctors by the hospital staff without examination, as the doctors were out of town. One of the doctors started treatment for the patient telephonically, by instructing the on duty nurse. Unfortunately, the patient died. The Court held that the patient died because, amongst other things, she was prescribed treatment over telephone without appropriate diagnosis, and found such practice to be an act of criminal negligence. The application of the doctors for bail in anticipation of arrest was rejected. However, the doctors were successful in receiving the bail in appeal and were not arrested.

This judgement was interpreted by some doctors as deeming the practice of telemedicine and teleconsultation itself illegal. However, such an interpretation is without basis and incorrect. The Court was only concerned failure of the doctor to diagnose the patient. The fact that the drugs for treatment of patient were communicated by the doctor through telephone is only incidental to the outcome of the judgement. It is not the basis of the judgement. In other words, had the doctor communicated the same drugs to the nurse orally while being physically present but without examining the patient, and then patient would have died, the Court would have come to the same conclusion. Thus, the judgement should not be extrapolated to state that the practice of telemedicine and teleconsultation itself is illegal.

Therefore, the above judgement of Bombay High Court does not interfere with the Telemedicine Guidelines at all. In fact, it supports it. The Telemedicine Guidelines require doctors who provide teleconsultation to start patient treatment only if the doctor is satisfied that he/ she has gathered adequate and relevant information about the patient’s medical condition and prescription of medicines which are in the best interest of the patient.  Else, the doctor should not prescribe medication to the patient. If the doctor prescribes patient in violation of the Telemedicine Guidelines, he/she risks losing his/her registration with respective State Medical Council i.e. the license to practice medicine on grounds of professional misconduct.

Enforcement of the Telemedicine Guidelines

The Telemedicine Guidelines have been published in form of an amendment to the Code of Conduct. Therefore, any violation of the Telemedicine Guidelines will be looked at as a ‘misconduct’ at hands of the concerned doctor under the Code of Conduct. A patient, who suffers due to misconduct, has the right to complain to the respective State Medical Council with whom the doctor is registered about the misconduct. If the doctor is found guilty of the misconduct, he or she may be reprimanded, or his/her registration may be suspended or cancelled. A suspension or cancellation of registration would effectively stop the doctor from carrying on his/her medical practice.

Conclusion

The notification of the Telemedicine Guidelines marks the dawn of a new era in the practice of modern medicine. The law has finally caught up with the reality and necessity of modern times.

The Telemedicine Guidelines enable doctors to confidently provide teleconsultation via any medium (such as email, phone call, message, fax, WhatsApp, other mobile and computer applications such as Skype, Google Hangouts etc.) to the patients.

At the same time, they protect patient interest by mandating doctors to identify themselves before consultations, disclose their registration number, offer the same standard of care to patients as during in-person consultation and limit medicines that can be prescribed through a teleconsultation.

Indians will now be able to enjoy access to quality healthcare remotely, and doctors will be able to extend their services to many more needy patients.