The Division Bench of the High Court of Delhi, in the case of Union of India v Bharat Serums, has laid down how the overcharged amount should be calculated by India’s drug price control regulator, National Pharmaceutical Pricing Authority (“NPPA”). The judgement will have a significant impact on existing as well as future demands for overcharging which are raised on pharmaceutical and medical device companies in India.
Background
Under Para 20 of India’s drug price control law, the Drug (Prices Control) Order, 2013 [“DPCO”], all non-scheduled formulations are allowed to increase their price by 10% in 12 months. Non-scheduled formulations are non-essential drugs or medical devices that are not listed in the schedule of DPCO. Most pharmaceutical and medical device companies do not use the 10% price increase opportunity in the 12-month period and elect to increase the price after a number of years.
When the opportunity does arise to increase prices, the question that always arises is whether the company can increase the price by the ‘aggregate’ of permitted percentage increase, or by a maximum of 10% from its last published Maximum Retail Price (MRP). For instance, if the MRP of a drug or medical device was Rs. 100, and the company selling the product decides to increase the price of the drug or medical device after a period of 5 years, would it be entitled to increase the price of the product by Rs. 50 (10% increase allowed every 12 months period), or by Rs. 10 (10% increase from last MRP irrespective of the time gap).
The other question that arises is if a pharmaceutical or medical device company increases the MRP of its product by more than 10% in a 12-month period, then how should NPPA recover the overcharged amount? For instance, if the MRP of a drug or medical device was Rs. 100 earlier, and if the company revises the MRP of the product to Rs. 200 after 5 years, how should NPPA calculate the overcharged amount? Should NPPA assume that the company was only allowed to increase MRP by 10% and recover the remainder amount as an overcharged amount? In other words, should NPPA give a concession of Rs. 10 to the company and proceed to recover Rs. 90, or should NPPA ‘assume’ that the company would have increased its price by 10% each year, and proceed to recover only the balance amount, in this case Rs. 50 (or more accurately Rs. 39 since a 10% increase every year for 5 years would have resulted in MRP of Rs. 161).
The above questions were conclusively answered by the Delhi High Court and are discussed below.
Interpretation of 10% permissible price increase in 12-month period
The Delhi High Court has interpreted the 10% allowance to increase MRP as follows: the MRP of non-scheduled formulations can only be increased by 10% in a period of 12 months, at a time, but in case of overcharging, the NPPA will have to assume that the company would have taken the 10% MRP increase and will be permitted to recover the ‘net’ amount.
The above interpretation is explained using examples in the paragraphs below.
Examples
What is permissible MRP increase for a pharmaceutical or medical device company?
If the MRP of a non-scheduled drug or medical device was Rs. 100 in 2014, the permissible price increase on yearly basis would be as follows:
Years
01.01.2014
01.01.2015
01.01.2016
01.01.2017
01.01.2018
01.01.2019
01.01.2020
Actual MRP
100
110
121
133.1
146.41
161.05
177.15
If a pharmaceutical or medical device company wishes to take 10% increase after 5 years, how much can that be?
If the MRP of a non-scheduled drug or medical device was Rs. 100 in 2014, and the company decided to take a price increase in 2019, the maximum permissible price increase would be Rs. 110.
Years
01.01.2014
01.01.2015
01.01.2016
01.01.2017
01.01.2018
01.01.2019
01.01.2020
Actual MRP
100
100
100
100
100
110
121
How should the overcharged amount be calculated, in the event of default by a pharmaceutical or medical device company?
In a hypothetical scenario, where the MRP of a non-scheduled drug or medical device was Rs. 100 in 2014, and the company decided to increase it to Rs. 161.05 in 2015 and later to 177.15 in 2020, the overcharged amount will have to be calculated as follows:
Years
01.01.2014
01.01.2015
01.01.2016
01.01.2017
01.01.2018
01.01.2019
01.01.2020
Total ovecharged amount
Actual MRP
100/-
161.05
161.05
161.05
161.05
161.05
177.15
–
Permissible MRP (with 10% increase)
Not applicable
110
121
133.1
146.41
161.05
177.15
–
How NPPA calculated overcharging amount ? (Not legal)
Not applicable
51.05
51.05
51.05
51.05
0
0
204.2
Overcharged amount as per Delhi High Court
Not applicable
51.05
40.05
27.95
14.64
0
0
133.69
The above table is instructive because it illustrates the incorrect methodology applied by NPPA to calculate the overcharged amount that has been routinely demanded and recovered by NPPA so far from pharmaceutical and medical device companies.
Until the Delhi High Court judgement, the NPPA demanded an amount which was excessive and incorrectly calculated (Rs. 204.2). However, after the Delhi High Court judgement, irrespective of the amount that has been calculated by the NPPA, the actual payable amount will be significantly lower than the amount demanded by NPPA (Rs. 133.69).
Impact
This particular Delhi High Court judgement on permissible price increase of drugs and medical devices will have a far-reaching impact on existing overcharging demands which have been raised by NPPA, and the demands that NPPA will raise in the future. All existing demands for overcharging raised by NPPA, which have been calculated using incorrect methodology due to incorrect interpretation of overcharging provisions of DPCO by NPPA, should be rolled back by the NPPA. A pharmaceutical or medical device company that has currently received such a demand should strongly object to the NPPA’s demand on the strength of the Delhi High Court judgement.
Pharmaceutical and medical device companies should also be careful in taking price increases for non-scheduled formulations in the future, and should not assume that they will be able to take an ‘aggregate’ price increase after a certain number of years if they haven’t availed the option to increase the price every 12 months.
The packaging and labelling of food items served in a food service establishment in India is regulated by The Food Safety and Standards (Packaging and Labelling) Regulations, 2011 (“Regulations”). The Regulations were amended in August 2020 to introduce the concept of menu labelling for the first time in India. Menu labelling means the process of declaring the nutritional information, calorific value per serving, information about allergens, and the logo exhibition for vegetarian or non-vegetarian, as applicable, on the menu cards/boards/booklets of restaurants and hotels. The menu labelling directives have been in force since January 01, 2022. However, the food regulator had relaxed its stringent implementation till June 30, 2022 in order to grant some additional time to the food business operators to adopt to the menu labelling mandates. In order to ensure compliance to the Regulations, the food regulator will commence verification of the declarations by sampling food items listed on the menu cards/boards/booklets of the food business operators from July 01, 2022 onwards. Since, the date is approaching, we have put together a list of frequently asked questions (FAQs) with our responses in this article to facilitate the food business operators to adopt the practice of menu labelling in a self-compliant manner.
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.
Q. What is the new menu labelling requirement?
A. Owing to an amendment to The Food Safety and Standards (Packaging and Labelling) Regulations, 2011 in August 2020, a new sub-regulation (2.4.6.), i.e., ‘Display of information in food service establishments’ was inserted to the existing regulation 2.4 enlisting specific requirements/restrictions on the manner of labelling. This sub-regulation mandates declaration of calorie information of food items amongst other specific labelling proclamations. This sub-regulation has introduced India to the concept of menu labelling in line with the emerging global trend towards reshaping the conventional food systems.
Q. Who does the menu labelling requirement apply to?
A. The menu labelling requirement is applicable to food service establishments either having central license or outlets at 10 or more locations. However, food service premises operating for a period of less than sixty days in a calendar year (consecutively or non-consecutively) are exempt from the menu labelling mandate irrespective of whether they possess a central license or have outlets at 10 or more locations.
Q. Which restaurants are covered by the menu labelling requirement?
A. Restaurants having a turnover of more than Rs. 20 Crores per annum or outlets at 10 or more locations have to ensure compliance with the menu labelling requirement.
Q. Do caterers also have to comply with the menu labelling requirement?
A. Yes. Caterers having a turnover of more than Rs. 20 Crores per annum or outlets at 10 or more locations have to comply with the menu labelling requirement. However, event caterers operating for a period of less than sixty days in a calendar year (consecutively or non-consecutively) are exempt from the labelling requirement.
Q. Do departmental canteens at the premises of central government institutions also have to declare information on their menu?
A. Yes. Departmental canteens at the premises of central government institutions having a turnover of more than Rs. 12 Lacs per annum are mandated to comply with the menu labelling requirement.
Q. Do food service establishments involved in preparation and serving of food at airports/seaports also have to comply with the menu labelling requirement?
A. Yes. Food service establishments involved in preparation and serving of food at airports/seaports have to comply with the menu labelling requirement.
Q. Do Restaurants/Caterers/Canteens at the premises of Railway Stations also have to comply with the menu labelling requirement?
A. Yes. Restaurants/Caterers/Canteens at the premises of Railway Stations serving food items through a menu card/board/booklet and having a turnover of more than Rs. 12 Lacs per annum have to comply with the menu labelling requirement.
Q. Are the food delivery platforms also required to comply with the menu labelling requirement?
A. Yes. The menu labelling requirement is applicable to all e-commerce food business operators to the extent it is applicable to physical food establishments, i.e., e-commerce food business operators have to display the mandated declarations on their website/platform only for food items from those establishments which have a central license or outlets at 10 or more locations. The e-commerce food business operator can either get this information directly from the respective food business operators and update it on their online platforms or implement a feature on their web and/mobile applications that allows such restaurant chains to upload and exhibit the same information for every food that is offered for sale by the restaurant on the platform of the e-commerce food business operator.
Q. Is the menu labelling requirement also applicable to food items not listed on the menu of the food service establishment?
A. No. The menu labelling mandate is not applicable to special-order items or modified meals not listed on the menu of the food service establishments. The menu labelling mandate is also not applicable to self-serve condiments that are free of charge and not listed on the menu. In addition, the menu items prepared as per the request of the customer will also not attract a menu label irrespective of the mode and manner of sale.
Q. What declarations have to be mentioned against the food items on the menu card as per the menu labelling requirement?
A. The following information has to be declared against the food items displayed on the menu cards/boards/booklets of the food service establishments in a manner compliant to the provisions of the Regulations:
Calorific value (in kcal per serving and serving size) including the reference information on calorie requirements to be specified verbatim as “an average active adult requires 2,000 kcal energy per day, however, calorie needs may vary”
Information relating to allergens
Logo for vegetarian or non-vegetarian
Nutritional information
Information relating to organic food or ingredients, if claimed
Specific labelling requirements mandated under the Regulations relating to food products containing added monosodium glutamate, artificial sweeteners, caffeine, polyols, polydextrose, and plant stanol esters
Q. How can a food business operator determine the nutritive value of the food items displayed on their menu?
A. The calorie and nutrition information for food items can be determined by the food service establishments either by a laboratory testing and a nutrient analysis method or by manual calculation using the nutritive/calorific values of each of the ingredients provided by a credible scientifically-backed source. In the latter case, the food business operator will be required to retain physical or soft copy documentation/records of all such sources relied by him for determining the nutritive value of food items for the purposes of verification by the food safety officers, as and when required. On the other hand, the laboratory testing and nutrient analysis method is usually adopted by restaurant chains preparing standardized food items with standardized ingredients and recipes across their outlets.
Q. What if the nutritive value determined by a food business operator is not entirely accurate?
A. A deviation of up to twenty-five per cent is allowed by the regulator.
Q. What is the objective behind mandating the menu labelling requirement?
A. The objective behind introduction of the menu labelling mandate is to enable the consumers to make informed choices about their food purchases and promote public health.
Q. Is there any penalty for non-compliance with the menu labelling requirement?
A. Yes. Any non-compliance with the menu labelling requirement may initially attract an improvement notice from the designated officer under Section 32 of The Food Safety and Standards Act, 2006 directing compliance. If the food business operator fails to comply with an improvement notice, his licence may be suspended and even cancelled if the non-compliance with the improvement notice continues.
Starting April 22, 2022, all fertility clinics, gamete banks and surrogacy clinics across India will have to commence the process of applying for registration with the National ART and Surrogacy Registry.
A National ART and Surrogacy Registry has been constituted and operationalised under the new laws, which will serve as a central database of all clinics and banks in the country. All clinics are mandatorily required to make an application for registration on the Registry website and submit it to the relevant appropriate authority for the state by June 21, 2022. It should be noted that as of today, the appropriate authority for each state has not been notified, but it is expected to be notified within the next few days.
At present, the application for registration involves declaration qualified staff, equipment and nature of procedure undertaken.
In future, clinics and banks may have to demonstrate that they meet the minimum standards of physical infrastructure, facilities, laboratory and diagnostic equipment, and specialised manpower for clinics and banks, that may be prescribed by The National Reproductive Technology and Surrogacy Board (“Board”). If clinics and banks fail to do so, the application for registration may be rejected. As on date, the Board has not yet been set up, so the minimum standards are yet to be prescribed.
Therefore, it may be pragmatic for fertility clinics, gamete banks and surrogacy clinics to make application for registration on the Registry website without delay to avoid any interruption in business and operations in future.
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 Device
26. Glucometer
27. Digital Thermometer
28. All implantable medical devices Equipment
29. CT Scan Equipment
30. MRI Equipment
31. Defibrillators
32. PET Equipment
33. X-Ray Machine
34. Dialysis Machine
35. Bone marrow cell separator
36. Disinfectants and insecticide specified in Medical Devices Rules, 2017;
37. Ultrasound equipment (effective November 1, 2021)
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.
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.
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.
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.
India’s medical device price regulator has issued a direction to importers and manufacturers of 24 categories of medical device to submit price-related information, including the price at which they sell medical devices to distributors and hospitals in India, by March 10, 2021.
Background
In India, medical devices are regulated not just for quality, but also for price. The Drug (Price Control) Order 2013 (“DPCO”) regulates prices of all medical devices that are marketed in India. Some medical devices such as coronary stents, drug eluting stents, condoms and intra-uterine devices that are listed in the schedule of DPCO have their ceiling price fixed by the National Pharmaceutical Pricing Authority (“NPPA”), while all other medical devices (i.e. the non-scheduled medical devices) have to abide by a restriction whereby their maximum retail price cannot increase by more than 10 per cent in any given 12-month period.
Direction
In order to ensure that medical device manufacturers and importers are complying with the requirements of DPCO, the NPPA has been given powers under DPCO to issue directions to manufacturers and importers to submit price related information. It is in furtherance of this power that NPPA has directed that the following information be submitted to it:
Medical device category as per risk classification published by DCGI
Product name or specifications
Brand name or description
Date of launch in India
Minimal unit of sale/retail pack size
Price per unit to distributor / stockist
Price per unit to hospital
Price per unit to retailer
Applicable GST percentage
Moving Annual Turnover
Maximum retail price for unit as on January 1 of the years 2018, 2019, 2020 and 2021 (for a few categories, only the MRP as on January 1, 2021 needs to be submitted)
A copy of the said direction is available at this link.
24 Categories of Medical Devices covered by the Direction
Disposable Hypodermic Syringes
Disposable Hypodermic Needles
Disposable Perfusion Sets
IVD devices of HIV, HBsAg and HCV
Catheters
Intra Ocular Lenses
I.V. Cannulae
Bone Cements
Heart Valves
Scalp Vein Set
Orthopedic Implants
Internal Prosthetic Replacements
Ablation Devices
Organ Preservative Solution
Blood Grouping Sera
Ligatures, Sutures and Staplers
Tubal Rings
Surgical Dressings
Umbilical tapes
Blood/Blood Component Bags
Nebulizer
Blood Pressure Monitoring Device
Digital Thermometer
Glucometer
Challenges with submitting price for retailer
There may be certain fields for which information has been requested by NPPA, but the information may not be available with the importers or manufacturers. For example, the details of price to retailer sought by NPPA may not be available since importers and manufactures typically sell to a distributor or hospital, and not directly to a retailer. In such cases where the information is not available due to the nature of the manufacturer’s or importer’s business model, the importer or manufacturer may simply submit to NPPA that the information is not available with them. The importer or manufacturer is not expected to retrieve this information from its supply chain and submit to NPPA. Being in possession of such information may in fact result in breach of anti-trust laws, as an attempt to undertake resale price maintenance.
Sale of imported medical devices marketed by marketer
Some importers import and sell directly to a marketer in India. In that case, it is the marketer who is supposed to provide this information as price related information is not available with the importer. However, the importer should ideally endorse and countersign the information submitted by marketer because the primary obligation to submit this information is with the importer. Alternatively, the importer may submit whatever information that it has and give a written undertaking along with the submission that the remainder of the information will be submitted by the marketer because the remaining information is unavailable with the importer.
Requirement of license
The direction also contains a note which states that manufacturers and importers must attach a copy of the licence obtained from the DCGI for each medical device. It may be difficult to furnish the manufacturing licence for Class A and Class B medical devices (such as Glucometer). The said licence is actually issued by State Licencing Authority of the state where the medical device is manufactured. In order to comply with the requirement of the direction, a copy of the licence issued by State Licencing Authority should be annexed in place of copy of license from DCGI.
Format for submission
All the above information has to be certified by a qualified chartered accountant or cost accountant in a physical format, and the same information is also required to be sent in form of an Excel Sheet to the NPPA at the following email ID medicaldevices-nppa@gov.in
What should manufacturers and importers of medical device take this direction very seriously?
Any non-compliance with the direction of NPPA to submit price information may result in criminal prosecution under provisions of Essential Commodities Act of 1955.
The information will also be used to ascertain whether any manufacturer, importer or marketer has fixed the MRP of the medical device in excess of ceiling price or has increased the MRP over the permissible 10 per cent limit in a 12-month period. In both these cases, the NPPA has the power to recover the excess price paid by the end-consumer from the importer or manufacturer, and to levy a penalty for overcharging in certain cases.
That apart, the information will most likely be used by NPPA to track or validate the market share of various medical devices and medical device manufacturers in terms of moving annual turnover (MAT) of said medical device under the submitted medical device category. If, at any time in future, a medical device is inserted in the schedule of DPCO on the grounds of essentiality to the Indian population, then the market share in terms of MAT will become an important consideration before NPPA in fixing the ceiling price that medical device.
Therefore, manufacturers and importers of the 24 categories of medical devices listed above must take this exercise seriously and submit the requisite data to the NPPA in prescribed form within timelines, both in physical and electronic format.
Across the world, December 3 is observed as the International Day of Disabled Persons. The United Nations has designated it as a day that “aims to promote the rights and well-being of persons with disabilities in all spheres of society and development, and to increase awareness of the situation of persons with disabilities in every aspect of political, social, economic and cultural life.” The United Nations Convention on the Rights of Persons with Disabilities (CRPD), which was signed and ratified by India, charts out a tangible path for realising this goal.
India enacted the Rights of Persons with Disabilities Act in the year 2016 pursuant to its obligations under the CRPD. The Act defines person with disability as “a person with long term physical, mental, intellectual or sensory impairment which, in interaction with barriers, hinders his full and effective participation in society equally with others” and specifies a total of 21 physical, intellectual and mental disabilities as well as disabilities due to chronic neurological conditions and blood disorders.
Amongst other things, the law calls for greater public awareness in a bid to break the stigma, discrimination and ostracization faced by people with disabilities. In recent years, there has been a spurt in campaigns – largely digital – aimed at a establishing a more inclusive society. While these should, without a doubt, be encouraged, there are certain legal considerations that should be kept in mind.
Web Accessibility
While this requirement is not yet embedded in the law, it seems counterintuitive to have campaigns that the primary beneficiaries do not have access to. Nonetheless, web accessibility is still in its formative stages in India. The Rights of Persons with Disabilities Rules, 2017 requires that every establishment (government and private) maintains a website that is accessible to the disabled. This mandate was scheduled to come into effect on June 15, 2019, but as of date, the Government has only released the standards for government websites, and it yet to notify the standards applicable to private entities’ websites. In addition to complying with the standards, the documents on the website must be in a text-to-speech compatible Electronic Publisher or Optical Character Reader based PDF format.
As a matter of good practice, businesses should move towards accessible websites. There are plenty of resources online, most notably the Web Content Accessibility Guidelines. If not entirely, businesses may choose to incorporate at least a few of the tools and tactics to make their websites more accessible.
It should also be noted that all organisations are required to have an Equal Opportunity Policy, which outlines the measures that the organisation has taken to implement the provisions under this law. It should, inter alia, contain a statement verifying that it has the requisite barrier-free accessibility, facilities, amenities and assistive devices that are required for a person with disability to be able to discharge their duties, thereby making it an inclusive organisation. This policy should be displayed on the business’ website, or, if they do not have a website, in a conspicuous location within the premises.
Data Protection
The extent to which data protection is an applicable varies largely depending on the nature of the campaign. If it’s an entirely social- or programmatic-based campaign, the entity organising the campaign gets access to only aggregated and anonymised data, which does not demand a high level of compliance. If the campaign directs the user to a website where they need to register, however, it is far more onerous. The website must contain a detailed privacy policy – ideally optimised to be accessible for persons with disabilities – outlining the data that is being collected, the purpose of its collection, who it will be shared with and why, how it will be protected, and how the person may withdraw their consent for the collection, processing and storage of such data. Given the sensitive nature of the data, strong security systems should be implemented.
Community Guidelines
Social media has come to be synonymous with the freedom of speech and expression, which has made it a catalyst for change. In the last few years alone, a number of movements have been waged and amplified over the internet. However, most platforms have strict policies which specify the type of content that is permitted and prohibited on the platform. Most policies unequivocally prevent any type of content that can be viewed as or that promotes bullying and harassment, hate speech, or discrimination against protected classes, which includes persons with disabilities. Content that can be considered triggering is also generally discouraged. We recommend going through the relevant platform’s community guidelines and tailoring the content to ensure that it does not violate or promote violations, since that may diminish the reach of the post.
Targeting Content
While targeting a campaign specifically at relevant stakeholders is one of the biggest USPs of digital campaigns, there are certain restrictions in place that would hamper a campaign with persons with disabilities as their target group.
Google’s (and YouTube’s) policy states that “Advertisers can’t use personal hardship categories to target ads to users or to promote advertisers’ products or services” and clarifies that this includes disabilities, even when content is oriented toward the user’s primary caretaker.
Similarly, Facebook’s policy states that “Ads must not contain content that asserts or implies personal attributes. This includes direct or indirect assertions or implications about a person’s race, ethnic origin, religion, beliefs, age, sexual orientation or practices, gender identity, disability, medical condition (including physical or mental health), financial status, voting status, membership in a trade union, criminal record, or name.”
Unintended Consequences of the Comment Section
The comment section for posts about social justice issues like disability are often filled with an overwhelming amount of compassion, with complete strangers bonding over their struggles and experiences. While fostering a strong sense of community is aspirational, it is not without risk. The most obvious is the strong likelihood of hate speech erupting: which is not only undesirable on a humane level, but also a violation of platform policies and the law. Secondly, it results in the somewhat inadvertent collection and sharing of highly sensitive personal data, that can be misused by absolutely anyone to discriminate against persons with disabilities. While these issues may not have direct legal ramifications for the campaign organiser or poster specifically, they are highly undesirable. We would recommend seriously considering the pros and cons of keeping the comments section disabled (no pun intended whatsoever).
Testimonials
A great deal of caution must be used while using testimonials from persons with disabilities, their family, friends or caretakers, or medical and allied healthcare professions. Waivers should be obtained, in writing, prior to using such content. Personal information of persons with disabilities should not be disclosed unless explicitly consented to, and even then, should be avoided. While collaborating with medical or allied healthcare professionals, ensure that the content is not positioned as medical advice, a diagnosis or a tool for self-diagnosis. Encourage viewers to seek professional help if required. Most importantly, ensure that persons with disabilities are not shown in a bad light.
Conclusion
To conclude, it would be unpragmatic to not use the platforms that we have access to today to spread awareness about the many issues that plague society, and to work towards a better tomorrow. However, exercise caution while doing so to avoid inadvertently violating the law.
Stay updated about latest legal and regulatory
developments in the area of health by subscribing to our newsletter
If you wish to receive more such legal guides and
latest updates in your inbox, you can subscribe
to our newsletter.
First telephonic consultation is FREE! Call 022 48900222 / (+91) 22 48900222 or fill-in the form below to hear back from us.
