Govt Unveils Rules on How Panels Should Vet New Drugs

The move aims to fix concerns about opaque approvals that have delayed key drug launches

- Priyanka Sharma

India has issued its first formal playbook for how expert panels should vet new drugs, biologics and medical devices—a move aimed at fixing chronic concerns about inconsistent and opaque approvals that have delayed critical drug launches and eroded trust in the regulatory system.

The guidelines, issued by the Central Drugs Standard Control Organization (CDSCO), represent a major overhaul of India's drug approval process and aim to make regulatory decisions faster, more predictable and transparent, according to two government officials and documents reviewed by Mint.

The guidelines standardize how Subject Expert Committees (SECs) are formed, members are selected and how they must evaluate applications, including the scientific benchmarks and disclosure norms they must follow.

The SECs advise the Drugs Controller General of India (DCGI) on whether to clear new drugs, and their decisions have long shaped the trajectory of India's pharmaceutical industry.

The CDSCO finalized the norms about two weeks ago and circulated them to SEC members for immediate implementation, the officials said, asking not to be named.

The overhaul follows recommendations from the World Health Organization (WHO), which last year conducted a regulatory review of CDSCO and the office of the DCGI, who heads the organization.