New Delhi, Aug. 2 -- India has issued its first formal playbook for how expert panels should vet new drugs, biologics and medical devices-a move aimed at fixing long-standing concerns about inconsistent and opaque approvals that have delayed critical drug launches and eroded industry 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, how members are selected, and how they must evaluate applicat...