Govt agencies conducting risk-based inspections of pharma units: Nadda

Over 400 drug manufacturing units, including MSMEs, inspected after high frequency of NQS reports

The Central Drugs Standard Control Organisation (CDSCO), in collaboration with state drug controllers (SDCs), has undertaken over 300 enforcement actions after carrying out risk-based inspections of 400 drug manufacturing facilities, Chemical and Fertilisers Minister Jagat Prakash Nadda said in the Lok Sabha.

These inspections also included checking many micro, small, and medium enterprises (MSMEs) to ensure compliance with national drug quality regulations.

“Facilities were selected for inspection based on the frequency of Not of Standard Quality (NQS) drug reports, lodged complaints, and the significance of their products. During these inspections, it was discovered that some drug samples did not meet the required quality standards,” Nadda said in his response in the Lok Sabha.

Enforcement actions taken by SDCs include issuing show cause notices, halting production, and suspending or cancelling licences and product licences under the Drugs Rules of 1945.

“These actions are part of a broader strategy to enforce strict adherence to drug manufacturing regulations,” Nadda added.

Nadda also discussed recent regulatory updates that support these measures. “Amendments to the Drugs and Cosmetics Act, including the Drugs and Cosmetics (Amendment) Act of 2008, have introduced stricter penalties for manufacturing counterfeit and adulterated drugs. Some offences under this Act are now cognisable and non-bailable, and special courts have been established across states and union territories for expedited trials,” he said.

This comes after various steps taken by the government to increase regulatory control over drug manufacturing.

Nadda noted that there has been an increase in sanctioned posts over the past decade, strengthening the CDSCO’s regulatory capacity. “Recent changes to the Drugs and Cosmetics Rules now require applicants for manufacturing licences to submit results of bioequivalence studies for certain oral dosage forms and evidence of the stability and safety of excipients,” Nadda said.

“The amended Drugs Rules of 1945 mandate joint inspections by central and state government drugs inspectors before issuing manufacturing licences. The revised Schedule M, effective from December 2023, introduces new Good Manufacturing Practices (GMP) standards and Quality Management System (QMS) requirements for pharmaceutical manufacturing facilities,” he added.