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TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Reader, 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.

Draft Guidance on Vaccine Approval and Quality Monitoring at port of Import published by Central Drug Regulator for Public Commect
The Central Government has recently published a draft of guidance on (1) regulatory framework for conducting vaccine related clinical trials, marketing approval, manufacture, import/ export and post marketing assessment and (2) Risk Based Approach for monitoring quality of imported drugs, medical devices and IVDs at customs ports. Public Comment is sought on these above Guidance Notes, within 30 days of publication i.e. by 10th May 2024.
Source: bit.ly/3xIoiIv
Source: bit.ly/4cVOpvL

Merchants Association Request Central Government Intervention to Stabilize trade of Medicines and Medical Devices with Africa
The Federation of Pharmaceutical and Allied Products Merchant Exporters, an industry association of small and medium sized importers and exporters, has advocated for fiscal and trade policy intervention including continued efforts to stabilize Rupee value, by the Government to stabilize the export of Medicine and Medical Products to Africa, which has seen a sharp decline due to rising shipping tariffs caused by ongoing geopolitical conflicts.
Source: bit.ly/3Q8qlvT

Threefold Increase in FDI in Healthcare and Medical Device Sector in India during latter half of FY 2023-2024
Foreign Direct Investment (FDI) into the Hospital and Diagnostic Sectors in the country has increased by about 90% in the last quarter of 2023-24, as compared to the same quarter the previous year. Moreover, the Medical and Surgical Implements Sector has also seen a nearly 1/3rd growth by proportion during the same time. The total FDI received in hospital and medical devices sector stood at USD 462 Million.
Source: bit.ly/3U6Km70

Modern medicine Doctor body Expresses Concerns regarding Introduction of Integraded School of Medicine as Treatment
The Indian Medical Association, a professional representative body of Doctors, has expressed its concerns regarding the proposal of the Central Government to institute Integrated Medicine, which would offer treatments which are a mix of allopathic, homeopathic and traditional medicine. The Council expressed concern that due to the vast gulf in the manner of training, specialization and expertise between the various schools of medicine means that integration and cross practice treatment may pose severe risk to patient.
Source: bit.ly/3U6yi5E

EU and Japan harmonize Pharmacopoeia for ease of doing Business and regulatory Burden
The European Directorate for the Quality of Medicine and Healthcare, and the Japanese Ministry of Health, Labour and Welfare have entered into a Memorandum of Cooperation and Confidentiality, to coordinate efforts to harmonize the European and Japanese Pharmacopoeia, a move that would reduce the regulatory burden on manufacturers operating in the twin jurisdictions, with respect to carrying out compendial tests and IP approval.
Source: bit.ly/3UmRBJo

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New portal for medical devices registration in India (NSWS)

On January 01, 2024, India’s medical device regulator, Central Drugs Standard Control Organization (CDSCO) issued a notice that applications for certain medical device related regulatory approvals will not be accepted on the current medical devices CDSCO portal (CDSCO MD-Online portal) after January 15, 2024. Instead, they will be accepted through the National Single Window System (NSWS) portal only.

This transition is being implemented in stages. In the first phase, medical device related regulatory applications which are described below in this article will be accepted through NSWS portal. In future all medical device related regulatory applications will be accepted and filed through the NSWS portal only.

What is NSWS portal?

The NSWS portal is a digital platform established by the Indian Government with the aim to act as a single window for all the approvals. The portal enables the investors (manufacturers, importers, traders etc.) to obtain registrations and approvals according to their business requirements.

Which medical devices approvals could have been obtained through NSWS portal prior to January 01, 2024?

Importers and manufacturers of medical devices were previously able to use NSWS portal to make application for legal metrology registration, wireless planning and coordination wing’s (WPC) equipment type approval (ETA), import export code (IEC), etc.

Going forward, which medical devices related regulatory applications will be accepted through NSWS portal only?

From January 15, 2024, the list of medical device applications which will be accepted through NSWS portal are as follows:

  • Application for license to import medical devices for the purposes of clinical investigations or test or evaluation or demonstration or training (Form MD-16).
  • Application for license to manufacture medical device for purpose of clinical investigations, test, evaluation, examination, demonstration, or training (Form MD-12).
  • Application for grant of certificate of registration of a Notified Body (Form MD-01).

Is there any guidance for the filing of applications for approvals on NSWS?

There is a user manual for the submission of the applications through the NSWS portal which has been made available by the Indian Government.

What happens to the applications that have been filed before January 01, 2024?

The medical device regulatory applications which were filed before January 01, 2024, through CDSCO MD-Online portal will be processed on the same portal. The medical device regulatory applications that are identified above should not have been filed after January 01, 2024, on CDSCO MD-Online portal. Importers and manufacturers of medical devices will not be able to use CDSCO MD-Online portal for filing regulatory application identified above after January 15, 2024.

Which medical device regulatory applications will be accepted through CDSCO MD-Online portal?

All applications excepting those described above, including applications for import and manufacture of medical devices will be accepted through CDSCO MD-Online portal until further notice.

Conclusion

The transition of certain medical device regulatory applications from CDSCO MD-Online portal to NSWS portal is a welcome development for the importers and manufacturers of medical devices because they will now be able to determine licences/approvals applicable to their business, apply for those approvals and track the status of their applications under one roof i.e. NSWS portal.