Kirti BalasubramanianPartner
Paarth SamdaniAssociate
Rimjhim MishraAssociate
Key Developments
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New Biological Diversity Rules, 2024 define procedures for foreign entities to access Indian biological resources for research and commercial utilisation
The Ministry of Environment, Forest and Climate Change (MoE&FCC) notified the Biological Diversity Rules, 2024 (Rules) on 25 October 2024 to define procedures for certain provisions of the Biological Diversity (Amendment) Act, 2023 (Amendment Act), particularly concerning the use of Indian biological resources by foreign entities. The Rules could impact varied businesses, including research institutions, laboratories or companies involved in the development of drugs, cosmetics or food, and entities involved in the biotechnology or agricultural industries, among others.
The primary objective of the Rules is to streamline the process for foreign individuals and entities looking to gain access to biological resources in India for the purposes of bio-survey, bio-utilisation, and commercial utilisation of the biological resources. This has been achieved by providing separate application forms depending on the purpose for which such access is being sought.1 Effective 25 December 2024, the Rules require that all foreign entities (i.e., entities not incorporated in India or companies incorporated in jurisdictions outside India having control of entities incorporated in India) must obtain approval from the National Biodiversity Authority (NBA) to access such resources by filing the specific forms designated for their respective purpose. The Rules also allow foreign entities already possessing such resources to apply for retrospective approval to rectify any potential non-compliance.
Foreign entities must now seek prior approval of the NBA before granting any intellectual property rights (in India or abroad), based on an Indian biological resource, including digital sequence information. They must also notify the NBA within 45 days of a patent application being granted for inventions using any Indian biological resource.
The Amendment Act had previously decriminalised certain offences, replacing them with fines of up to INR 50 lakh. The Rules are expected to prompt many foreign entities to seek NBA approval to avoid the substantive monetary penalties. The extent of the enforcement remains to be seen, although the Rules outline a detailed procedure for adjudicating penalties for non-compliance with the Amendment Act.
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Medical device adverse event reporting form updated to enhance monitoring of medical device safety in India
The Materiovigilance Programme of India (MvPI), under the Indian Pharmacopoeia Commission, has released an updated medical device adverse event (MDAE) reporting form. This move aims to encourage MDAE reporting to MvPI by manufacturers, importers, distributors, and healthcare professionals with direct or indirect knowledge of MDAEs.
The MDAE reporting form requires inputs such as:
- the medical device and its category,
- description of the event, including whether it can be considered serious or not,
- whether the device was implanted,
- whether the device is still in use, and
- current location of the device.
The report and reporter’s identity are treated as strictly confidential.
The latest iteration of the MDAE reporting form also includes a helpful disclaimer clarifying that MDAE reports will not constitute an admission of wrongdoing or contribution towards the MDAE. The report will not have any legal implications for the reporter.
In recent years, post-market surveillance (PMS) of medical devices has emerged as a critical indicator of device safety and performance. However, under-reporting of MDAEs (and even drug adverse events) is a growing concern. Indian regulators expect the new MDAE reporting form, and its disclaimer, to encourage more complete and timely reporting of MDAEs, thereby enhancing PMS.
In 2024, the Drugs Technical Advisory Board (DTAB) conducted formal deliberations on the Medical Devices Rules, 2017 (MDR) and agreed to propose certain amendments, including (a) compliance with Quality Management System (QMS) for Class A non-sterile and non-measuring medical devices, such as gauzes, scalpels, scissors, knives, etc. (Class A Medical Devices), and (b) reduction in timelines for audit of manufacturing sites. While the amendments are awaited, the first proposed amendment implies that small-scale businesses entering the low-risk medical device segment will need to align with more stringent rules from the outset, resulting in increased compliance costs for manufacturers and importers of Class A Medical Devices. Manufacturers, importers and distributors of Class A Medical Devices must closely follow the forthcoming developments in MDR and realign their practices to ensure compliance. The second proposed amendment streamlines license procurement for other devices, which will expedite commercialisation and market entry for compliant businesses.
[1]Form 1 relates to applications for research, bio-survey and bio-utilisation of Indian biological resources. Form 2 pertains to applications for commercial utilisation of Indian biological resources. Bio-survey and bio-utilisation refer to survey or collection of biological resources for any purpose, including characterisation and inventorisation, and commercial utilisation refers to ends use of biological resource in drugs, industrial enzymes, food flavouring, cosmetics, etc.
