On September 30, the Ministry of Health and Family Welfare published the Medical Devices (Fifth Amendment) Rules, 2022, through which it notified a new rule, 87A which deals with registration certificates to sell, stock, exhibit or offer for sale or distribute a medical device, including in vitro diagnostic medical devices. With the amendment coming into effect, all store owners selling thermometers, condoms, face masks, spectacles, or any other medical device will now have to get registered with the state licensing authority.
In exercise of the powers conferred by Sections 12 and 33 of the Drugs and Cosmetics Act, 1940, the central government, after consultation with the Drugs Technical Advisory Board, further amended the Medical Devices Rules, 2017. Under the new rules:
The state licensing authority shall appoint licensing authorities for the purpose of issuing registration certificates under this part for such areas as may be specified.
Any person who intends to sell, stock, exhibit or offer for sale or distribute a medical device, including in vitro diagnostic medical device, shall make an application in Form MD-41 to the state licensing authority for a grant of registration certificate to sell, stock, exhibit or offer for sale or distribution. The application needs to contain details of the applicant or firm, including its constitution, along with identification proof, such as, an Aadhaar card or PAN card, along with documentary evidence in respect of ownership or occupancy on rental of the premises. It also requires details of competent technical staff, under whose direction and supervision the sales activity of medical devices shall be undertaken, who shall possess the following educational qualification and experience, namely:
holds a degree from a recognized university/institution; or
is a registered pharmacist; or
has passed the intermediate examination or its equivalent examination from a recognised board with one-year of experience in dealing with the sale of medical devices.
Medical stores will now have to provide a brief description of other activities being carried out by the applicant, namely, storage of drugs, medical items, food products, stationeries, etc, or any other activities carried out by the applicant in the said premises, with an undertaking to the effect that the storage requirements to sell, stock, exhibit or offer for sale or distribute a medical device will be complied with.
The state licensing authority shall, after scrutiny of documents and on being satisfied that the requirements of these rules have been complied with, grant a registration certificate, or if not satisfied, reject the application for reasons to be recorded in writing, within ten days from the date the application is filed.
If the application for grant of registration certificate to sell, stock, exhibit or offer for sale or distribute a medical device is rejected, the aggrieved person may prefer an appeal before the state government within 45 days from the date of receipt of such rejection, which may, after such enquiry and after giving an opportunity of being heard to the appellant, dispose it within a period of sixty days from the date of receipt of such an appeal.
Other sub rules include the instruction that the registration certificate granted under rule 87A shall be displayed at a prominent place in the premises visible to the public and that the certificate holder shall provide adequate space and proper storage conditions for the storage of medical devices. This includes maintaining requisite temperature and lighting as per the requirements of such medical devices. Further, the medical devices shall be purchased only from an importer or licensed manufacturer or registered or licensed entity.
Separate records, in the form of invoice or register or electronic details, including software of purchases and sale of medical devices showing the names and quantities of such medical devices, names and addresses of the manufacturers or importers, batch number or lot number and expiry date (if applicable) shall also need to be maintained.
The records shall be open to inspection by a medical device officer who may, if necessary, make enquiries about purchases and sales of the medical devices and may also take samples for testing. All registers and records mentioned under these rules, shall be preserved for a period of not less than two years from the last entry. The registration certificate holder shall maintain an inspection book in Form MD-43 to enable the medical devices officer to record his observations and defects noticed.
The registration certificate issued shall remain valid in perpetuity, subject to payment of the registration certificate retention fee as specified in the Second Schedule, before completion of the period of five years from the date of its issue, unless, it is suspended or cancelled by the state licensing authority. If the registration certificate holder fails to pay the required registration certificate retention fee on or before the due date, the registration certificate holder shall, in addition to the registration certificate retention fee, be liable to pay a late fee calculated at the rate of two per cent of the registration certificate retention fee for every month or part thereof within six months.
If the registration certificate holder contravenes any provision of the rules, the state licensing authority, shall, after giving the registration certificate holder an opportunity to showcause as to why such an order should not be passed, by order and for reasons to be recorded in writing, suspend it for such period as it considers necessary either wholly or in respect of any of the medical device; or, as the case may be, cancel the registration certificate. The registration, unless suspended or cancelled by the state licensing authority, will be valid “in perpetuity” as long as the retention fee of Rs 3,000 is paid every five years.
Rajiv Nath, forum coordinator, the Association of Indian Medical Device Industry (AIMED) said that it is good to see that “most of our recommendations” have been accepted in the notification. He further said that it is good that the notification states that people who have experience in selling medical devices can continue to do so. He added that a foolproof record-keeping methodology might need to be devised.
Rajiv Singhal, general secretary, the All India Organisation of Chemists and Druggists (AIOCD), said that all medical stores already have a licence under Form 20, 21, 20B, or 21B under the current Act and they are not required to get registered again under the new regulations. Singhal further said that other than non-medical stores selling safe medical devices, such as spectacles, the big distributors of medical devices, such as X-ray machines will also need to be registered under the new regulations. So far, there was no regulation for the registration of these big distributors.
-By Adarsh Kumar and India Legal Bureau