Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. we hope you enjoy reading it.
1. India’s Central pollution regulator has issued a Notification extending the deadline to 31st December 2024, for submitting quarterly filings for the FY 2023-24 for all entities registered under the Hazardous and Other Wastes (Management and Transboundary Movement) Amendment Rules, 2022.
Source: bit.ly/49ahqlK
2. A District Consumer forum in the State of Maharashtra has held that the refusal of returns by a e-commerce service provider, under a blanket “no-returns” policy constituted a “unfair trade practice” and awarded compensation to consumer whose return of sub-standard product had been rejected.
Source: bit.ly/417xJxQ
3. In a recently published response to a query received by it under the Right to Information Act, 2005, the Delhi Medical Council clarified that, since only medical practitioners registered with the council and having recognized qualifications in Allopathic medicine are permitted to practice medicine in Delhi: Dentists, who are registered with the Dental Council are not licensed to perform aesthetic and cosmetic treatment which is not medically necessary.
Source: bit.ly/3ZbT0Ur
4. After considerable negotiation, India has signed the final act of the Riyadh Design Law Treaty which aims to establish protections for Industrial Design patents, the treaty specifies procedural guardrails which member states can adopt into their own local design patent protection regulations.
Source: bit.ly/3CXRxcH Source: bit.ly/4f5AYJz
5. The United States Supreme Court has declined to hear petition by manufacturers of tobacco products, challenging the decision of the Federal Government of the United States to include graphic visual warnings on cigarette packets.
Source: bit.ly/415u1EU
Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.
1. Indian pharmaceutical manufacturers will have to prove compliance with revised Good Manufacturing Practices at the time of renewal of manufacturing license, as per media reports.
Source: bit.ly/3MAGjg9
2. A woman who has filed for divorce should be treated as a divorced woman for the purposes of medical termination of pregnancy, and therefore will have the right to terminate her pregnancy: High Court
Source: bit.ly/4fNDhT7
3. The Multidisciplinary Committee of Experts (MDC), which advises the National Pharmaceutical Pricing Authority (NPPA), will invite an officer not below the rank of Deputy Controller of Patents and Designs, to evaluate eligibility for exemption of patented drug from application of price control law.
Source: bit.ly/46Ya8jY
4. A new scheme to boost domestic medical device industry in India is under works and will reportedly be launched in a month.
Source: bit.ly/4fUqrSU
5. A new portal for reporting adverse events of drugs, vaccines and medical devices has been launched by Indian Pharmacopoeia Commission. The adverse event may be reported by consumers and medical practitioners.
Source: bit.ly/4dxeUXY
All Food Business Operators (FBOs) in India must maintain a record of annual medical examination of all food handler(s) engaged by the FBO. This is a mandatory condition of the food license. The Food Safety Officer checks the record of medical examination at the time of inspection, and any shortcoming in the record-keeping may result in suspension or cancellation of license.
In this article, we will discuss key considerations for ensuring full compliance with the requirement of maintaining records of medical examinations of food handlers.
Who is a food handler?
A food handler is any person who directly handles packaged or unpackaged food, food equipment, utensils, or food contact surfaces, and is therefore expected to comply with food hygiene requirements.
Personal hygiene and sanitary requirements applicable to FBOs
In addition to the requirement of a medical examination of food handlers, all FBOs have to ensure that no person, whether handling food or not, who may be suffering from any disease or illness that is likely to be transmitted through food is allowed to enter any area where the food is handled, i.e., where the food is packaged or unpackaged, where food equipment and utensils are stored, where food contact surfaces exist, or where food is cooked or manufactured.
In addition to the above general requirement, FBOs who are involved in high-risk food businesses such as meat and dairy have additional personal hygiene and cleanliness requirements, which are discussed below.
Meat
FBOs who deal in meat must ensure that any person who comes into contact with meat in the course of his or her work must be medically examined prior to such person being engaged. FBOs who run meat shops must ensure that any person who handles meat is medically examined annually, and the medical examination includes an examination of the sputum and chest X-ray for tuberculosis. The medical examination should also include stool tests for parasitic infections (protozoal and helminthic) transmitted through ingestion, as well as for enteropathogenic bacteria such as Escherichia coli, Salmonella, Shigella species, and Vibrio cholera.
Dairy
FBOs who manufacture, process, store, or sell milk and milk products are required to ensure that the persons employed for handling raw materials or dairy products have, before joining, submitted a medical certificate that states that there is no medical impediment to working in the specific capacity or role that the person is going to be employed by the FBO.
Mandatory vaccination of workers working in food factory
If the FBO is a manufacturer, processor, and packer who operates a factory, then all workers working in the factory ought to be compulsorily vaccinated against an enteric group of diseases as per the recommended schedule of vaccination. Enteric groups of disease are infections caused by viruses and bacteria that enter the body through the mouth or intestinal system, primarily as a result of eating, drinking, and digesting contaminated food or liquids. Cholera, typhoid fever, Salmonella, or E. coli are some common enteric diseases. A record of the vaccination of all factory workers is required to be maintained, which may be inspected at the time of inspection. The decision regarding the scope of vaccination, i.e., which enteric diseases are to be covered by vaccination, is taken by the registered medical practitioner according to the list declared by the concerned municipal corporation of the area.
Format of Medical Fitness Certificate
After the medical examination of food handlers, a medical fitness certificate in the prescribed format must be issued by a registered medical practitioner. It must contain the signature and seal of the registered medical practitioner. The medical fitness certificate should indicate that the registered medical practitioner has undertaken a physical examination, an eye test, and a skin examination, as well as any other tests required to confirm any communicable or infectious disease that the person is suspected to be suffering as observed during the clinical examination, if applicable. It should also indicate that “based on the medical examination, he/she is found free from any infectious or communicable diseases, and the person is fit to work in the food establishment.”
Discretionary Powers of Food Safety Officer vis-à-vis ordering medical examination of workers
If a Food Safety Officer, during an inspection, believes that the food handler is suffering from any infectious disease, he may ask for a medical examination of that person, and on such examination, if he finds out that person is suffering from an infectious disease, he has the authority to prohibit employees suffering from infectious diseases from participating in food handling activities and ensure strict adherence to health and safety.
Penalty for non-compliance
Failure to comply with these regulations can result in penalties of up to two lakh rupees and potential license cancellation under Section 58 of the Food Safety and Standards Act, 2006.
Conclusion
All FBOs should sensitize themselves to the legal requirements of annual medical examination of staff, mandatory vaccination of workers working in food factories, and general hygiene and sanitary requirements applicable to all persons handling food or operating in an area where food is handled. Failure to meet these requirements of food laws may result in a heavy monetary fine and suspension or cancellation of the license.
India’s Central Pollution Control Board has issued final warning to all Producers, Importers, Brand Owners and Plastic Waste Processors, to complete Extended Producer Responsibility (EPR) registration on dedicated EPR portal latest by June 30, 2024, or face punishment. Source:bit.ly/4cgRsxK
India’s Health Ministry has published Guidelines for Ethical Use of Leftover De-identified/ Anonymous Samples for commercial purposes. Source:bit.ly/3RIc0XE
The Committee on Energy and Commerce in Congress of the United States of America has sought reply from US Food and Drugs Administration (US FDA) about institutional weaknesses in US FDA’s foreign inspection program over variations in inspection outcomes from India and China. Source:bit.ly/3RF3xEH
India’s Karnataka High Court has formed a sub-committee to draft rules for establishing Intellectual Property Division (IPD) in Karnataka High Court. IPD benches are established with specialised judges to cater to Intellectual Property Disputes. Source:bit.ly/4bmOVR8
India’s Kerala High Court, in a recent case, has framed guidelines for prosecuting guardian of a minor, or the owner of a vehicle driven by a minor, for offences involving vehicle driven by the minor. Source:bit.ly/3RHALDn
India’s Department of Pharmaceuticals (DoP) has published The Uniform Code For Pharmaceutical Marketing Practices, 2024 (UCPMP 2024). The UCPMP is a code that governs the interaction between the industry and healthcare practitioners (HCPs/doctors) in India. The UCPMP 2024 replaces the UCPMP 2015, and is applicable to both pharma and medical device companies.
In the paragraphs below, we have summarized the business-critical changes between UCPMP 2024 and UCPMP 2015. The expression ‘company’ refers to both pharma and medical device companies, unless the context suggests otherwise.
Enforceability: The UCPMP 2024 is ‘kind of’ ‘somewhat’ mandatory. The text of UCPMP 2024 does not carry the word ‘voluntary’ as UCPMP 2015 did, but at the same time, it also does not have any statutory backing. It appears that the DoP is planning to enforce it through ‘audit’ mechanism. Under UCPMP 2024, DoP has the power to order an audit of any company upon receipt of a complaint of violation of UCPMP 2024 against the company. In case the audit proves a breach, the DoP may ‘recommend’ appropriate government agencies (such as the Income Tax Department and the National Pharmaceutical Pricing Authority) to take action against the company. An appellate body, which is headed by the Secretary, DoP, also has the power to ‘prescribe’ penalties to defaulting companies. Separately, the CEO of the company has to give an undertaking that the company shall abide by UCPMP 2024 will extend all assistance to ‘authorities’ for its enforcement.
Medical Education and Training: Companies can sponsor or organize conferences, workshops and trainings for doctors by themselves without having to necessarily collaborate with another entity, such as an association of doctors. Such conferences, workshops and trainings cannot be held outside India. The details of such events and expenses incurred by the company will have to be published on the company’s website. The record of these expenses may be audited by auditors appointed by the DoP. If the DoP auditors find discrepancies in the records, they will bring them to the attention of appropriate government agencies and authorities.
Hospitality and travel: During conferences and workshops, all doctors including delegates may be served modest meals. However, delegates cannot be offered travel facilities. Speakers may be offered both hospitality and travel facility.
Brand reminders: A company may supply doctors with informational and educational materials such as e-journals and dummy device models as brand reminders, provided that the total worth of each item does not exceed Rs. 1000. There is no cap on how many brand reminders can be given to the doctor. However, a brand reminder should not have an independent commercial value for the doctor.
Engagement of HCPs as a Consultant: Companies can continue to engage doctors as consultants for research, but the research has to be ‘bona fide’. The DoP is expected to provide more clarity on this issue.
Monetary grants: Companies cannot offer monetary grants under any pretext now, including for educational purposes to doctors who are pursuing training, residency, or fellowship.
Sample packs: A company may offer a doctor up to 12 sample packs of medicines each year. However, these sample packages should be properly marked as ‘not for sale.’ The monetary value of samples distributed by a company should not exceed 2% of its domestic sales.
Further changes to UCPMP 2024: The DoP has reserved powers to modify or limit the scope of UCPMP by issuing standing orders from time to time.
It is important that industry takes cognizance of the changes because any non-compliance with UCPMP 2024 may negatively impact a company’s industry standing and perception amongst doctors. India’s tax department has also been disallowing any expenses which have been incurred in contravention of UCPMP, so a mistake may prove very expensive.
The import of medical devices including in-vitro medical devices (hereinafter referred to as “medical devices”) in India is regulated by India’s central medical device regulator, the Central Drugs Standard Control Organization (CDSCO). In order to import a medical device into India, the importer has to make an application for import license Form MD-14 of Medical Devices Rules,2017 (MDR, 2017) before CDSCO. Once the application is processed successfully, the CDSCO grants an import license to the importer in Form MD-15 of MDR, 2017.
For Class A and Class B medical devices: 1st October 2022
For Class C and Class D medical devices: 1st October 2023
In the paragraphs below, we have answered some of the common questions regarding timelines for obtaining import license for medical devices on the basis of our working knowledge of the law and prevailing practice.
1. What is the usual time within which an import licence may be granted by CDSCO?
The prescribed timeline for issuance of import license is nine (09) months from the date of application. However, the timeline is suspended if a query on the application is raised by CDSCO.
2. What is the approximate timeline for receiving query from CDSCO on the import license application?
As per current estimate, a query is typically received within a span of 3-4 months from the date of import license application. Please note that CDSCO may raise multiple rounds of queries.
3. How much time does an applicant of import license gets to reply to the queries?
The general expectation of CDSCO is that the queries should be responded within forty-five days from the date of receipt of queries.
4. What happens if a query cannot be responded within 45 days?
If the applicant is facing a difficulty in replying to the query, an intimation may be sent to CDSCO justifying the reason for delay and providing appropriate undertaking.
5. What is the maximum time within which queries have to be responded?
There is no official time limit for responding to the queries which has been stipulated by CDSCO. However, the expectation is to respond to the queries within the reasonable time frame.
6. What is the timeline by which the response to the queries is processed by CSDCO?
There is no prescribed timeline for processing the queries by CDSCO. However, the timeline for grant of import licence is nine (09) months from the date of filing of the application.
7. Is the time taken by the authorities to grant an import licence includes the time taken by the importer to respond to the queries?
No. The total timeline of nine months prescribed for grant of import license is not inclusive of the time taken by the importer to respond to the queries.
8. What is the time limit in which the importer can appeal to the Central Government in case the application is rejected by CSDCO?
If the application is rejected by CDSCO, the applicant may appeal to the Secretary, Ministry of Health and Family Welfare within a period of forty-five days. The Secretary or another officer designated by the Secretary may, after conducting an enquiry into the matter as considered necessary, pass orders in relation to the appeal within a period of ninety days from the date of appeal.
9. What is the validity of import license granted in Form MD-15?
The licence granted by CDSCO under Form MD-15 is valid in perpetuity unless cancelled or surrendered. The validity of the license so granted is subject to the payment of the retention fee by the importer.
10. When is importer license retention fee due to be paid?
The retention fee to retain import license has to be paid by the importer every 5 years.
11. What if the importer of medical device fails to pay the retention fee within the prescribed time period?
If the import licence holder fails to pay the required retention fee on or before the prescribed due date, the license holder is required to pay a late fee in addition to the retention fee.
The late fee will be calculated at the rate of two per cent (2%) of the import license retention fee for every month or part thereof within ninety days. Non-payment of fee until expiry of ninety days will result in cancellation of the import license.
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)
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.
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.
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.
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