To strengthen the technical evaluation process that supports regulatory decisions and to bring formal structure to the functioning of Subject Expert Committees (SECs), the Central Drugs Standard Control Organization (CDSCO) has released a first-of-its-kind guidance document. These committees play a key advisory role in evaluating applications related to clinical trials, marketing authorization, and post-marketing regulatory actions for new drugs, biological products, vaccines, investigational medical devices (IMDs), and more. While CDSCO retains final decision-making authority under applicable regulations, SEC recommendations are also highly influential.
The guidance formalizes SEC roles under a framework, detailing composition, qualifications, independence, and responsibilities of committee members. It institutionalizes the SEC system, previously functioning without formal codification, thereby enhancing transparency, consistency, and scientific rigor. The guidance applies to applications involving Investigational New Drugs (INDs), Subsequent New Drugs, rDNA-derived products, fixed-dose combinations, Global Clinical Trials (GCTs), BA/BE studies, and clinical studies on IMDs.
Notably, the document identifies categories exempt from SEC review, including routine post-approval changes, minor administrative or protocol amendments, and certain trial withdrawals without patient safety concerns. It also affirms the possibility of local clinical trial waivers under Rule 101 of the NDCT Rules, 2019, for drugs already approved in specific countries (e.g., USA, UK, EU, Japan, Australia, Canada), especially for orphan drugs or those with significant therapeutic advantage.
Applicants are required to submit focused briefing materials, one-page summaries, and concise presentations. SECs are expected to complete their evaluations within seven working days. A CDSCO moderator oversees each meeting to ensure order, equal participation, and adherence to agenda. Voting mechanisms have been introduced for structured decision-making, and a sample set of regulatory questions has been annexed to guide discussions. An appeal mechanism via the Technical Committee is available for rejected/aggrieved applicants.
This SEC Guidance Document establishes clear procedures and strengthens scientific accountability. It is expected to streamline regulatory decision-making, safeguard public health, and foster innovation in India's healthcare sector.
Disclaimer: LexCounsel provides this e-update on a complimentary basis solely for informational purposes. It is not intended to constitute, and should not be taken as, legal advice, or a communication intended to solicit or establish any attorney-client relationship between LexCounsel and the reader(s). LexCounsel shall not have any obligations or liabilities towards any acts or omission of any reader(s) consequent to any information contained in this e-newsletter. The readers are advised to consult competent professionals in their own judgment before acting on the basis of any information provided hereby.
