Small Drugmakers Supplying Medicines In Rural Areas Under Scrutiny; Centre Calls For Crackdown
Small pharmaceutical companies, especially those supplying medicines in rural areas, have come under regulatory scrutiny, with the Drug Controller General of India (DCGI) directing state officials to closely monitor their activities and ensure accountability. The DCGI has asked states, via state licensing authorities (SLAs) to take strict action against any such marketers found violating quality standards under the Drugs and Cosmetics Rules, 1945.
The move comes amid growing concerns over the quality and compliance practices of certain small-scale players in the drug distribution chain.
The apex drug regulatory agency has also called for stricter action against the repeated manufacture of spurious and Not of Standard Quality (NSQ) drugs and asked states to keep CDSCO informed of any regulatory actions taken.
'We are still awaiting response on Schedule M compliance and most small players are unable to cope up with quality scrutiny. The government is convinced that without proper oversight, these companies pose a risk to medicine safety in under-served regions," a senior government official privy to the development told News18.
The official added that the apex regulatory authority, Central Drugs Standard Control Organisation (CDSCO) has conducted over 1,000 Risk-Based Inspections (RBIs) across the country. 'These inspections have been key in identifying non-compliance among drug manufacturers and strengthening the surveillance framework."
The first is adoption of revised Schedule M. The DCGI has asked state officials to begin enforcing updated Good Manufacturing Practice norms for drug production units.
Also, it has asked to fix new drug licensing gaps as state licensing officials have been asked to refrain from issuing product licences without proper permissions from DCGI.
The officials have also been instructed 'Post risk based inspections action." The states and UTs have been urged to act on the findings and recommendations that emerge from inspections.
CDSCO has informed officials to comply with '84AB" in which details of all drug makers and product details must be uploaded and verified on the central online portal to ensure traceability.
Also, the state officials will work on building testing lab capacity which has been flagged as a 'critical need."
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