DCGI Plans Cough Syrup Plant Inspections Across India, Sets Stage for Licence Suspensions

Speaking at the Indian Pharmaceutical Alliance’s (IPA) virtual Advanced GMP Workshop, Drugs Controller General of India (DCGI) Dr Rajeev Raghuvanshi stated that Central regulatory authorities, in coordination with State drug authorities, would soon conduct focused audits of cough syrup manufacturing facilities across the country. The exercise is aimed at strengthening quality compliance and increasing regulatory oversight ahead of the approaching winter season.

The DCGI added that stringent action would be taken against manufacturing facilities that fail to meet the required standards. He also expressed concern over the broader state of current Good Manufacturing Practices (cGMP) compliance, particularly among smaller manufacturing facilities. According to him, although companies were upgrading their facilities, findings from risk-based inspections remained unsatisfactory and did not indicate the expected improvement.

Raghuvanshi also highlighted the regulatory action taken through Corrective and Preventive Action (CAPA) measures. More than 1,000 CAPA enforcement letters have reportedly been issued during the past four years, but none of the notices has been adequately addressed so far. Going forward, 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. He emphasised that the industry must either improve compliance or move out of the sector.

Safety and quality concerns surrounding cough syrups have remained a major issue in India. Past incidents involving child deaths in countries including Uzbekistan and Cameroon, linked to Indian-made products, have also resulted in international scrutiny of pharmaceutical manufacturing standards in the country.

The issue gained fresh urgency following last year’s tragedy in Madhya Pradesh, where 24 children died after consuming Coldrif cough syrup. The product was subsequently found to be adulterated with diethylene glycol (DEG).

According to CDSCO records, around 1,100 cough syrup manufacturing facilities have been inspected since December 2022, accounting for nearly 90 per cent of the total facilities in the country. The audit exercise has also covered 960 other manufacturing units and 380 blood centres.

Similar to cough syrups, the DCGI highlighted that State and Central agencies have undertaken focused audits of sterile drug manufacturing facilities. The CDSCO is also exploring various routes to bring the licensing of this drug class under its ambit to strengthen regulatory oversight following multiple cases of contamination.

The regulator is also planning an analysis of Not of Standard Quality (NSQ) cases reported over the past five years in view of recurring quality concerns reflected in monthly NSQ reports. The analysis will be undertaken in collaboration with the MSME representative body FOPE and is intended to identify the underlying root causes and address gaps contributing to quality failures.

Economic Times Pharm reports that data disclosed in Parliament showed that during FY26, around 1.4 lakh drug samples were tested by Central and State laboratories. Of these, 3,012 samples were found to be Not of Standard Quality, while another 283 were declared spurious or adulterated.

Enforcement action has been taken against firms found to be violating quality requirements, including suspension and cancellation of manufacturing licences. Prosecution proceedings were also initiated in 779 cases, according to the latest data.