Over 1,000 Cough Syrup Makers Audited Amid Pharma Quality Concerns
Over 1,000 manufacturers face scrutiny over cough syrup quality.
More than 1,040 drug manufacturing premises have undergone risk-based inspections since December 2022, with over 950 regulatory actions taken against non-compliant units, the Centre informed the Rajya Sabha on Tuesday. The inspections were carried out by the Central Drugs Standard Control Organisation (CDSCO) along with State Drugs Controllers.
Minister of State for Health and Family Welfare Anupriya Patel said more than 1,100 cough syrup manufacturers had also undergone intensive audits in coordination with state authorities. Regulators have simultaneously increased market surveillance and sampling of syrup formulations to strengthen monitoring of drug quality.
According to Patel, the inspections resulted in actions including show-cause notices, stop-production orders, suspension or cancellation of licences and product licences, as well as warning letters. The measures were taken by state licensing authorities based on findings from the inspections.
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The Centre explained that the manufacture, sale and distribution of medicines in India are primarily regulated under the Drugs and Cosmetics Act, 1940, and the rules framed under it. State Licensing Authorities are responsible for licensing and inspecting manufacturing units, while drug manufacturing premises are periodically checked for compliance with Good Manufacturing Practices prescribed under Schedule M of the Drugs Rules, 1945.
CDSCO zonal offices forward inspection reports and recommendations to the concerned State Licensing Authorities when violations or non-compliance are identified. These authorities have the legal power to order corrective measures, including stopping production, suspending or cancelling licences, issuing warnings and, where appropriate, initiating prosecution before a court.
The government's latest disclosure underlines the scale of regulatory surveillance of pharmaceutical manufacturing facilities, particularly cough syrup production. The Centre's figures indicate that inspections, market sampling and enforcement measures have been expanded to identify manufacturing deficiencies and ensure compliance with prescribed drug-quality and safety standards.
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