Stricter Drug Regulations: A New Era of Quality Control

In May 2026, 46 drug samples failed quality tests, and a spurious drug was discovered, prompting tightened regulations, including the amendment of the Drugs Rules. The amendment requires licensed pharmacies to sell cough syrups in small villages, heightening regulatory oversight to ensure public health and safety.

Stricter Drug Regulations: A New Era of Quality Control
CDSCO logo (Photo/CDSCO). Image Credit: ANI
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  • India

The Central Drugs Standard Control Organisation (CDSCO) has identified 46 drug samples as Not of Standard Quality (NSQ) for May 2026, heightening scrutiny over pharmaceutical products. This monthly routine aims at enhancing transparency in drug safety and maintains stringent checks to safeguard public health.

The State Drugs Testing Laboratories contributed to the findings, uncovering 113 NSQ drug samples during the same month. While these failures are specific to certain batches, one drug from Assam was flagged as spurious, being linked to unauthorized manufacturing. This discovery underscores ongoing efforts to curb counterfeit medication production.

Significantly tightening the regulatory framework, the Union Ministry of Health and Family Welfare introduced an amendment to the Drugs Rules, 1945. This measure, informed by Gazette Notification G.S.R. 927 (E), withdraws the licensing exemption for cough syrup sales in small rural communities, ensuring these products now require licensed dispensaries, hence bolstering public safety.

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