Mumbai: Looking to bridge the resource and skill gap in India's regulatory ecosystem, the Central Drugs Standard Control Organization (CDSCO) is preparing to outsource GMP and GCP audits to agencies certified by the Quality Council of India (QCI) and bring on board over 1,500 experts to review new drug applications.

Speaking at the IPA's 11th Global Pharmaceutical Quality Summit, Dr. Rajeev Singh Raghuvanshi, Drugs Controller General of India (DCGI), said, “Until now, all audits were conducted by inspectors from the central and state licensing authorities. However, considering our limited capacity and workforce, we plan to include notified bodies in our audit system for assistance. These bodies will also carry out audits independently for certain categories of products.”

“Discussions with the Quality Council of India for identifying and certifying agencies for this task are already underway,” he added.

Speaking at a panel discussion at the Re-Pharma Summit earlier this month, Dr. Annam Visala, Joint Drugs Controller (India), CDSCO, also shared that authorities are considering a proposal to outsource GMP, GCP, and GxP audits of facilities to accredited agencies to bridge resource constraints while strengthening regulatory oversight.

Secondly, the apex regulator noted that “one of the major gaps identified at CDSCO is the absence of an internal scientific cadre. For various trial protocols, the organisation has been largely dependent on external professionals.”

“To address this issue, next month we will seek government approval to add around 1,500 experts to our internal review system, primarily for clinical trials,” he said.

Notably, under the Union Budget for FY 2026–27, Finance Minister Nirmala Sitharaman announced a dedicated scientific review cadre and specialists to meet global standards and approval timelines.

Source: ET Pharma - February 23,2026