CDSCO, SDCs Enforce Drug Quality with 300+ Actions After 400 Inspections

Following risk-based inspections of 400 drug manufacturing facilities, the Central Drugs Standard Control Organisation (CDSCO) and state drug controllers (SDCs) have carried out over 300 enforcement actions, including examining micro, small, and medium-sized enterprises (MSMEs) to verify compliance with national drug quality regulations. Based on the number of Not of Standard Quality (NQS) medicine reports, complaints filed, and the importance of their goods, the inspections were conducted. During the inspections, certain medicine samples did not match the necessary quality criteria. Under the Drugs Rules of 1945, SDCs have taken enforcement actions include stopping production, issuing show cause notices, and suspending or revoking licenses and product licenses.

These steps are a part of a larger plan to ensure that medication production laws are strictly followed. Stricter penalties for producing fake and contaminated pharmaceuticals have been established by recent regulatory changes, such as the pharmaceuticals and Cosmetics Act of 2008, which also made some offences cognisable and non-bailable. Additionally, the government has tightened its regulatory oversight of the drug manufacturing industry. Over the last ten years, the number of sanctioned roles has grown, bolstering CDSCO's regulatory authority.