Kirti BalasubramanianPartner
Paarth SamdaniAssociate
Yashaswini HareeshAssociate
Key Developments
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Significant regulatory changes for Clinical Research Organisations
On 19 September 2024, the Ministry of Health and Family Welfare notified the New Drug and Clinical Trials (Amendment) Rules, 2024 (Amendment Rules) to regulate Clinical Research Organisations (CRO). The Amendment Rules, in line with the Medical Devices Rules, 2017, define CROs to include commercial and academic bodies involved in clinical trials, bioavailability or bioequivalence studies. Effective from 1 April 2025, the Amendment Rules require all CROs conducting such studies on humans to register with the Central Licencing Authority (CLA) using Form CT-07B (with the exception of study centres that are already registered).
The Amendment Rules also introduce an inspection mechanism for the premises of a CRO, without prior notice, by any officer authorised by the CLA accompanied by an officer authorised by the State Licensing Authority. Violations can result in warnings, rejection of trial results, or cancellation of registration.
This move aims to enhance the structure, quality, and transparency of clinical trials and related studies in India. All organisations falling within the definition of CROs should register before 1 April 2025 to continue operations and avoid regulatory scrutiny.
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Uniform Code for Marketing Practices in Medical Devices issued to ensure ethical practices in the industry
The Department of Pharmaceuticals published the Uniform Code for Marketing Practices in Medical Devices (Code). The Code aims to establish an ethical structure for governing the marketing and promotion of medical devices as well as the interactions of the medical devices industry with healthcare practitioners in India. The Code also provides for an ethics committee to deal with complaints of unethical marketing practices under the Code. Unlike the 2014 iteration of the Code which explicitly mentioned that adherence to the Code is voluntary, the 2024 iteration is silent in this regard.
The key highlights of the Code are:
- Restriction on unqualified safety claims: The Code restricts the use of certain terms like ‘safe’ and ‘safety’ without qualification. Companies cannot categorically state that a medical device has no adverse consequences.
- Marketing only after approval: The Code prohibits companies from promoting medical devices before they have been approved under the Medical Devices Rules, 2017.
- Restriction on free samples: The Code restricts companies from providing free samples to healthcare practitioners. The Code prescribes that the number of free evaluation samples (single use products) provided to practitioners must not exceed the quantity that is reasonably necessary for evaluating the product.
- Prohibition on offering benefits to healthcare professionals: The Code prohibits companies and their representatives from offering excessive hospitality, monetary grants, travel benefits or gifts to healthcare practitioners, similar to the Uniform Code for Pharmaceutical Marketing Practices released earlier this year.
The Code relating to medical devices closely follows the marketing code for pharmaceutical products and is largely similar in comparison. The medical device industry has the opportunity and unrestricted timeline to apply the Code to its business practices, as the Code is yet to be made strictly applicable.
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Certain new drugs exempted from local clinical trial requirement if already approved by specified countries
The Drugs Controller General of India has exempted new drugs in certain categories from the local clinical trial requirement for their approval, if such drugs have already been approved in the United States, United Kingdom, Japan, Australia, Canada or the European Union. These categories are:
- orphan drugs for rare diseases;
- gene and cellular therapy products;
- drugs used in pandemic situation;
- drugs used for special defense purposes; and
- drugs having significant therapeutic advancement over the current standard care.
This exemption is anticipated to benefit patients and pharmaceutical companies alike by enhancing accessibility and affordability of essential drugs. Additionally, both domestic and international drug manufacturers with prior approvals in the specified countries will now bypass the lengthy registration process, expediting the availability of a broader range of medicines in the Indian market.
