Central Drug Controller Aims to Overhaul Cough Syrup Manufacturing Practices by Next Production Season

India Undertakes Extensive Quality Crackdown on Cough Syrup Manufacturers

February 23, 2026

The Drug Controller General of India (DCGI), Rajeev Singh Raghuvanshi, has announced a comprehensive quality crackdown on cough syrup manufacturers in the country. The regulator has audited over 90% of the country's cough syrup-making plants, inspecting 1,150 facilities and taking enforcement action against serious lapses.

The intensified oversight aims to "clean up" a sector that has come under global scrutiny. The regulator expects to "remove the rot of cough-syrup manufacturing" by the next production season, with additional initiatives to ensure higher-quality syrups for both domestic use and exports.

Read also: Treasury Yields Experience Largest Increase in Two Weeks Following Release of Labor Market Data

Key Initiatives

• The regulator is conducting risk-based inspections based on Revised Schedule M of India's Drugs and Cosmetics Rules, covering facilities of all sizes, including MSMEs and bigger pharma companies.
• The extension deadline for MSMEs with an annual turnover of less than Rs 250 crore to comply with GMP norms has ended on December 31, 2025.
• The Corrective and Preventive Action (CAPA) system was introduced in April 2025 for all Not of Standard Quality (NSQ) drug samples. Under this system, manufacturers are issued a formal CAPA notice and their product's manufacturing licence is suspended until a satisfactory response is submitted.
• As of February 23, 2026, 850 CAPA notices have been issued in the past 10 months, but no manufacturer has yet submitted an acceptable response.

The CAPA system is expected to "weed out all the issues with quality manufacturing" by forcing non-compliant companies to either improve or exit the market. The regulator believes these initiatives will permanently strengthen manufacturing standards in the sector.