CDSCO to rope in third-party bodies to check pharma units

TO ENSURE THE drug regulation compliance within the facilities of pharma companies, the central drug regulator has decided to engage third-party certification bodies approved by the Quality Council of India (QCI).

- MANU KAUSHIK

A senior official told FE that the move to strengthen the auditing capacity of Central Drugs Standard Control Organisation (CDSCO) has been made to make the regulatory system more robust, to address the shortage of manpower and plug the structural gaps in compliance monitoring.

“With the expanding size of the pharma sector coupled with the need to ensure strict compliance with the WHO’s good manufacturing practices (GMP), a proposal to engage third-party competent bodies is being finalised,” the official said.