India’s top drug regulator, the Drugs Controller General of India (DCGI), will conduct inspections of cough syrup manufacturers nationwide this month, with plans to penalize non-compliant facilities, including license cancellations. The move aims to enhance quality standards and oversight ahead of winter, following recent safety concerns and incidents linked to contaminated products.
Dr Rajeev Raghuvanshi of DCGI stated that central regulatory authorities, working with state drug agencies, will soon execute focused audits of cough syrup production sites nationwide. This initiative seeks to enhance quality adherence and boost regulatory oversight before the upcoming winter season.
The DCGI expressed apprehension regarding current Good Manufacturing Practices compliance levels, especially in smaller production units. Despite companies upgrading their infrastructure, risk-based inspection outcomes remain unsatisfactory and fail to show the anticipated progress.
The DCGI showed regulatory actions taken via Corrective and Preventive Action (CAPA) protocols. Over 1,000 CAPA enforcement letters have been dispatched in the last four years, yet none have received adequate responses.
The regulator plans to introduce a defined timeline for companies to respond to CAPA notices, with failure to respond within the prescribed period potentially resulting in suspension of manufacturing licences. The DCGI stressed that India has a greater role to play in the global healthcare ecosystem and that companies need to take the necessary steps to improve their quality standards.
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CDSCO records indicate that approximately 1,100 cough syrup manufacturing units were inspected since December 2022, representing nearly 90 per cent of national facilities. The review process also encompassed 960 additional production sites and 380 blood centers.
The DCGI noted that state and central agencies have conducted targeted audits of sterile drug manufacturing facilities. The CDSCO is evaluating multiple strategies to integrate licensing for this drug category under its authority to reinforce oversight following contamination incidents.
The regulator plans to analyze Not of Standard Quality (NSQ) cases reported over the previous five years, given recurring quality issues highlighted in monthly NSQ reports. This assessment, in partnership with the MSME body FOPE, aims to uncover root causes and address deficiencies driving quality failures.
Parliamentary disclosures revealed that during FY26, about 1.4 lakh drug samples underwent testing by Central and State laboratories. Among these, 3,012 samples were classified as Not of Standard Quality, while 283 were marked as spurious or adulterated.
Authorities have implemented enforcement measures against entities breaching quality norms, including license suspensions and cancellations. Prosecution proceedings were also initiated in 779 instances, according to recent data.
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