Central Drugs Standard Control Organisation has announced plans to strengthen its regulatory framework by outsourcing Good Manufacturing Practice (GMP) audits to accredited third-party agencies and expanding its scientific workforce by approximately 1,500 experts. The move is aimed at enhancing inspection efficiency, improving technical capacity and accelerating regulatory decision-making.

Until now, GMP inspections have been conducted primarily by officials from central and state drug authorities. However, capacity constraints and increasing workload have prompted the regulator to explore collaboration with agencies certified by the Quality Council of India. These third-party bodies will support audits for specified product categories, helping to improve compliance monitoring across manufacturing facilities.

In parallel, CDSCO plans to create a dedicated scientific cadre comprising specialists in clinical research, biologics, regulatory science, statistics and related disciplines. The expansion is intended to strengthen the review of new drug applications, clinical trial proposals and complex regulatory submissions, while reducing reliance on external expertise.

The regulator also indicated its intent to leverage advanced technologies such as artificial intelligence to streamline review processes and modernize digital systems, including upgrades to the SUGAM portal for smoother handling of export No Objection Certificates, trial approvals and other regulatory workflows.

These initiatives reflect CDSCO’s broader effort to reinforce drug quality oversight, improve transparency and align India’s regulatory systems with global standards as the pharmaceutical sector continues to expand.