On August 5, 2025, India’s Central Drugs Standard Control Organisation (CDSCO) issued its first formal rule that stipulates how Subject Expert Committees (SECs) must review and approve new drugs, medical devices, and biologics. This policy change aims to resolve long-standing concerns related to inconsistent approvals and the overall lack of transparency. These concerns have resulted in new product launch delays and a loss of trust from industry.
The guidelines detailed the composition, selection criteria, and responsibilities of SECs that guide the Drug Controller General of India (DCGI) in its decision-making process. This new guideline requires every SEC to have at least four experts to make decisions going forward. Furthermore, members of SECs must meet rigorous scientific and ethical standards. These reforms follow a World Health Organization’s regulatory review, which suggested that the Indian regulatory system lacked transparency, scientific rigor, and data integrity.
Drug applicants will benefit from quicker and more predictable drug review timelines once these measures are in place. In addition, the reforms include clearly defined criteria for clinical trial waivers, scientific justification of decisions, and stricter criteria for assessing product safety and efficacy.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.