INTRODUCTION
This newsletter highlights the key developments and measures as well as other major developments in the Indian healthcare and pharma sector for the months of April-May 2023.
RECENT LEGAL & REGULATORY DEVELOPMENTS
Draft rules published to amend the New Drugs and Clinical Trials Rules, 2019
On May 11, 2023, the Government of India ("GOI") published draft amendment rules to amend the New Drugs and Clinical Trials Rules, 2019 ("Draft NDCT Rules").1 The Draft NDCT Rules intend to introduce provisions to govern registration and functioning of clinical research organisations ("CRO"). The proposed definition of CROs states that they are either commercial or academic bodies that can be delegated or transferred tasks, duties, or obligations by sponsors2 to conduct clinical trials. Currently, the Draft NDCT Rules are subject to ongoing public consultation.
Some of the noteworthy amendments proposed by the GOI, under the Draft NDCT Rules are as follows:
- CROs shall be required to obtain registration from the Central Licensing Authority ("CLA") to conduct any clinical trial or bioavailability or bioequivalence study of new drugs or investigational new drugs in human subjects;
- the registration granted to CROs will be valid for a period of 5 years from the date of its issuance; and
- CLA will have the power to take certain punitive actions against CROs such as: (i) to suspend or cancel the license granted to CROs; (ii) to issue written warning to CROs describing the deficiency or defect observed by CLA; (iii) to reject the results of the clinical trial or the bioavailability or bioequivalence study; or (iv) to debar the CRO from conducting any clinical trial study or bioavailability or bioequivalence study in future.
Draft rules published to amend the Cosmetics Rules, 2020
On May 15, 2023, the GOI published draft amendment to the Cosmetics Rules, 2020 ("Draft Amendment Rules").3 The Draft Amendment Rules propose to grant extensive powers upon the State Licensing Authority ("SLA") to cancel or suspend the license issued under the Cosmetics Rules, 2020. The SLA can take such action if the licensee fails to adhere to any of the conditions of the licence or fails to comply with any of the provisions of the Drugs and Cosmetics Act, 1940 or the Cosmetics Rules, 2020. Before the SLA passes an order of suspension or cancellation of the license, the licensee will be provided with an opportunity to present their case and show cause. Additionally, if the SLA does pass an order of suspension or cancellation, the licensee will have the opportunity to make an appeal to the appropriate state government against that order.
The Ministry of Chemical and Fertilizers published the National Medical Devices Policy, 2023
On May 2, 2023, the Ministry of Chemical and Fertilizers, Department of Pharmaceuticals ("DoP") released the National Medical Devices Policy, 2023 ("Policy").4 This Policy recognises the following areas of intervention for promoting the medical devices sector: (a) regulatory streamlining such as setting up a single window clearance system for licensing of medical devices; (b) enabling infrastructure such as establishment of large medical device parks and testing facilities; (c) facilitating research and development and innovation through collaboration between medical device industry and educational institutions, for the development of indigenous medical technology; (d) attracting investment in the domestic medical sector by encouraging public and private partnerships; (e) training and development of personnel skilled in MedTech; and (f) brand positioning and awareness creation by increasing global competitiveness of domestic companies.
Indian government successfully conducted a trial run of blood bag delivery using a drone
The Indian Council of Medical Research ("ICMR") has successfully conducted a trial run of blood bag delivery using a drone.5 This trial was carried out as part of the ICMR's Drone Response and Outreach for Northeast ("i-DRONE") program.6 The trial drone flight carried 10 units of whole blood samples, and the required temperature was maintained until reaching the destination. This trial conducted by the ICMR aims to reduce the time required for lastmile delivery of essential medicines and blood bags.
The ICMR had previously used drones for distributing Covid-19 vaccines in remote areas of India.7 The ICMR will further conduct studies and trials to assess the quality of red blood cells, fresh frozen plasma, and platelets delivered using drones vis-à-vis standard methods of transportation.
Draft cabinet note on the new scheme of Promotion of Research and Innovation in the Pharmaceuticals MedTech Sector
The DoP has submitted a proposal to the Economic Finance Committee ("EFC") for a new scheme, namely, the Promotion of Research and Innovation in Pharma MedTech Sector ("PRIP"). The PRIP scheme had an outlay of INR 7,150 crores and was in line with the announcements made in the union budget for the financial year 2023-24.8 However, in its meeting held on March 15, 2023, the EFC approved the PRIP scheme with an overall outlay of INR 5,000 crores for a period of 5 years (i.e., from 2023-24 to 2027-28).9 Following this, a draft cabinet note on the PRIP scheme has been prepared and sent to the empowered technology group for approval.
The PRIP scheme consists of two components. The first component focuses on strengthening the research infrastructure by establishing 7 centres of excellence at different National Institutes of Pharmaceuticals Education and Research. The second component aims to promote research in the pharmaceutical sector by encouraging research in 6 areas, including new chemical entities, complex generics (including biosimilars), medical devices, stem cell therapy, orphan drugs, and antimicrobial resistance. Financial assistance will be provided to companies working with government institutes and for in-house research and development.
Amendment to the operational guidelines of the Scheme for Promotion of Medical Device Parks
The GOI has amended the operational guidelines of the Scheme for Promotion of Medical Device Parks ("Medical Device Scheme") through a corrigendum dated May 19, 2023 ("Amended Scheme").10 These amendments have been introduced in response to an office memorandum dated March 9, 2022, issued by the GOI. The memorandum advised that funds disbursed by the central government under central schemes should be released in a 'just-in-time' manner.11
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Footnotes
2. As per section 2(hh) of the Draft NDCT Rules, a 'sponsor' includes a person, a company or an institution or an organisation responsible for initiation and management of a clinical trial.
3. https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/ elements/download_file_division.jsp?num_id=MTAxNTU=
5. https://pib.gov.in/PressReleaseIframePage. aspx?PRID=1923159#:~:text=The%20drone%2Dbased%20delivery%20 of,distributing%20vaccines%20to%20unreachable%20areas
6. https://www.icmr.gov.in/idrone.html
8. Report on Demands for Grants, Department of Pharmaceuticals, 42nd Report, Standing Committee on Chemicals and Fertilizers (2023-24) (https:// loksabhadocs.nic.in/lsscommittee/Chemicals%20&%20Fertilizers/17_Chemicals_And_Fertilizers_42.pdf)
11. https://cga.nic.in//writereaddata/file/GuidelinesCentralSectorSchemesDt09032022.pdf
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