Govt tightens drug quality net, initiates 950 actions since 2022: Over 1,100 cough syrup makers are also facing intensive audits amid quality concerns

The government has initiated 950 enforcement actions against pharmaceutical companies since December 2022, as part of efforts to improve the quality of locally made medicines and prevent sales of spurious drugs.

The drug regulatory authority took actions such as issuing show cause notices and stop production orders, as well as suspension or cancellation of licences, where the manufacturing units were found to be failing in meeting quality standards, according to government data.

Significantly, more than 1,100 cough syrup manufacturers are facing intense audits in coordination with state authorities after instances of exported Indian drugs failing to meet quality standards in the export markets.

"The manufacture, sale, and distribution of drugs in India are regulated under the Drugs and Cosmetics Act, 1940, through a system of licensing and inspection by state licensing authorities," Anupriya Patel, minister of state for health and family welfare, told the Parliament Tuesday. "Drug manufacturing premises are inspected periodically to verify compliance with Good Manufacturing Practices prescribed under Schedule M of the Drugs Rules, 1945."

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She said beyond the routine inspections, CDSCO and state drug controllers have been conducting risk-based inspections, a more targeted approach that prioritises premises based on their risk profile rather than a fixed inspection calendar.

Cough syrup manufacturers are especially facing heightened scrutiny as more than 1,100 cough syrups were inspected, amid quality concerns that drew international attention in recent years. Increased market surveillance sampling of syrup formulations has also been carried out by both central and state regulators.

There are about 10,500 manufacturing units in India, producing drugs in various dosage forms and active pharmaceutical ingredients, per data from the Central Drugs Standard Control Organisation.

"The government has been carrying out raids in pharmaceutical companies in various states, and those which were found to be in violation of regulations were issued show cause notices," a senior official said on condition of anonymity.

Several drugmakers are under the scanner as the government continues with the inspections.

In a move to improve the quality of locally made drugs, the health ministry had notified Schedule M rules for good manufacturing practices. The rules call for implementing a prompt recall of products known or suspected to be defective.

India's drug regulator had earlier pointed to an urgent need to review the good manufacturing practice regulations and quality management systems being followed by pharmaceutical companies.