NASSCOM Submits Comments to Ministry of Health and Family Welfare on the Draft Drugs, Medical Devices & Cosmetics Bill, 2022

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NASSCOM Submits Comments to Ministry of Health and Family Welfare on the Draft Drugs, Medical Devices & Cosmetics Bill, 2022

Devika Agarwal

@DevikaAgarwal

August 30, 2022

Public Policy

256

On 8^th July, 2022 the Ministry of Health and Family Welfare (MoHFW) released a draft of the Drugs, Medical Devices and Cosmetics Bill, 2022 (‘draft Bill’) for public consultation. The objective behind the draft Bill was to review obsolete laws and update existing laws to keep pace with changing needs, times and technology. NASSCOM submitted its feedback to the MoHFW on the draft Bill on 22^nd August, 2022.

The main recommendations made by NASSCOM are as follows:

Medical devices should be treated distinctly from drugs: The draft Bill defines ‘medical devices’ separately, instead of including them within the definition of ‘drug’. This is a welcome change to the existing law. However, there is a concern that medical devices may continue to be regulated in a manner similar to drugs in practice. We recommend certain measures to address this concern, such as the creation of a separate wing within the Central Drugs Standard Control Organisation (CDSCO) or a separate body for regulating medical devices. Further, the qualifications of Medical Device Officers may be prescribed as Bachelors in Engineering in any relevant field to avoid non-qualified Drug Inspectors from being appointed as Medical Device Officers.
Adoption of international best practices will promote the medical device industry: The government may adapt best practices prevalent in other jurisdictions for regulation of medical devices in India. For instance, ‘contract manufacturers’, should be excluded from the definition of ‘manufacturer’ in the context of medical devices. Currently, contract manufacturers of medical devices are assigned legal liability, which makes such manufacturers averse to entering into manufacturing contracts, thereby adversely impacting medical device start-ups which rely on such contract manufacturers. Further, the government should only prescribe standards related to the performance and safety of medical devices, instead of technical standards.
Post-market surveillance of medical devices should be mandated: The government should take measures to ensure post-market surveillance of medical devices in the interest of consumer safety. Similar to the Food and Drug Administration (FDA) in the US, the government could mandate user facilities (including hospitals and nursing homes) to report any adverse event involving medical devices. This information should be made publicly available, similar to the Manufacturer and User Facility Device Experience (MAUDE) database.
Public consultation should be held prior to making rules under the Draft Bill: The government should release the draft rules made inter alia under sections 83(2)(l) and 118(2)(r) (which empower the Central Government to make rules under Chapters IV and V of the draft Bill) for public consultation and provide sufficient time to the industry to implement the rules once they are finalised.
The draft Bill should be aligned with the existing Medical Devices Rules, 2017 (MDR): The standards prescribed for medical devices under section 126 of the draft Bill should link back to the provisions of the MDR which require medical devices to conform to the standards formulated by the Bureau of Indian Standards (BIS), or alternatively, the International Organisation for Standardisation (ISO)/ International Electro Technical Commission (IEC) standards. Similarly, the government may exempt medical devices from undergoing clinical investigation (in line with Rule 63 of the MDR).
As a general rule, the licensing authority should first issue an improvement notice in case of non-compliance: In cases of non-compliance in the first instance, the licensing authority should issue an improvement notice, except in certain specific circumstances.
Fines should not be recovered as arrear of land revenue: Section 64 of the draft Bill (power to recover certain amount as arrear of land revenue) should be deleted as it violates the principle of natural justice.
The draft Bill should provide certain definitions: The draft Bill should provide definitions for ‘registered medical practitioner’ in the context of allopathy and define ‘prescription’. This would bring about clarity for e-commerce marketplaces on who may prescribe allopathic drugs, and what constitutes a valid prescription.
The requirement to capture batch number of AYUSH drugs will facilitate recall of such drugs: The draft Bill should mandate that the batch number should be captured in the sales invoice for AYUSH drugs, to implement the recall process for AYUSH drugs. The draft Bill should also empower the Central Controlling Authority or the State Licensing Authority to recall an allopathic drug or medical device which is unsafe for use.
The records should be allowed to be maintained or furnished in electronic format: To facilitate the ease of doing business, records should be allowed to be maintained in electronic format (under section 43 of the draft Bill). Further, online pharmacies should be allowed to digitise the prescription and provide a digital copy in consumer accounts, for better traceability and record-keeping.

[The full-text of NASSCOM’s recommendations is appended. Kindly contact dagarwal@nasscom.in and sudipto@nasscom.in for further details].

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