New Drugs Bill should ensure obligation from buyers to purchase only certified medical devices: AiMeD
The medical devices industry has urged the Centre to ensure obligation on the part of the buyer or users to purchase or use only those medical devices with required licenses and certifications under the New Drugs, Medical Devices and Cosmetics (NDMDC) Bill, 2022, the draft of which has been circulated by the Union Health Ministry for stakeholder’s feedback in July this year.
The industry has also pointed out certain responsibilities and provisions absent in the draft Bill and called for deletion of certain provisions which recommends one to seven years of imprisonment as penalty under the penal provisions of the Bill.
“The draft bill essentially makes it a criminal offence to import, manufacture or sale medical devices without the required licenses and certifications. The bill should also ensure there is an obligation on the part of the buyer/user to purchase or use only those medical devices that have the required licenses and certifications,” suggested the Association of Indian Medical Device Industry (AiMeD), the umbrella body of Indian medical devices manufacturers.
“Preferably to make it a criminal offence if anyone purchases/uses non-certified equipment. If this provision is not included, the victims will be those manufacturers who are committed to following the provisions of the bill, while its uninterrupted business as usual for the non-licensed manufacturer if they have willing buyers,” it added in a recent representation to the government.
It averred that there shall be provisions to facilitate clinical investigation and user feedback. Our experience is that users are generally not ready or eager to participate in any clinical investigation or evaluation studies or providing formal written feedback due to legal risks involved and a tedious process.
Besides, the Bill and the Medical Devices Regulation 2017 does not address imports of spares for medical devices. There should be provision for importing Spares without registering the main device.
For example, suppose an x-ray machine has been sold a few years ago, and if the Importer is no longer representing the original manufacturer but is still obligated to provide service support to the end user, the importer will not be able to clear spare parts at customs.
There are many Indian Companies that are only in the business of providing service support. Such companies are now forced to shut down because they are authorized by original manufacturers to service/repair their devices in India, but not to sell.
The Bill does not address Semi-Knocked Down manufacturing in India. In these cases, the original design ownership should rest with the original overseas manufacturer and the Indian manufacturer’s obligation should be limited to the quality of devices manufactured by them.
The Association also observed that, there is no provision made on the responsibility for Market Access Authorization Holder; responsibility of BIS (Bureau of Indian Standards); responsibility of Reseller – Hospital; responsibility of user; provision for Market Access Authorization Holder; provision for Grievance Handling, Tribunal etc.; provision for Advertising & Claiming Performance; provision for Restricting Reuse of Single Use Medical Devices; and a provision to Ban/Restrict Import of Preowned/Refurbished Medical Devices and address Medical Electronics generated E-Waste.
“We would suggest that appropriate provisions should be made on the above subjects either in the Law Book or the Rule Book,” added Rajiv Nath, forum coordinator, AiMeD in the representation.
The punitive and criminal judicial action may be maintained only for any non licensed or non registered manufacturing facility of medical devices and which has not even applied for registration or licensing compliance. The provision of imprisonment in certain sections should be deleted and appropriate administrative / penalty provisions.
This include Section 134 (5) where imprisonment upto one year for obstructing a Medical Device Officer; Section 146 which has provisions for imprisonment up to one year for failure to provide medical management and compensation; Section 152 (a) for imprisonment up to seven years for import or manufacture or adulterated or spurious; Section 153 for imprisonment up to 3 years for import or manufacture of device not of a standard quality; and Section 169 for imprisonment up to 2 years for submission of misleading or wrong information or refusal to furnish information. These provisions of imprisonment should be deleted, said the Association.
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