India’s pharmaceutical regulatory authority has completed sweeping inspections of approximately 90% of the nation’s cough syrup manufacturers, revealing significant compliance failures across multiple facilities. The comprehensive audit comes in response to a series of international tragedies linking Indian-made syrups to the deaths of over 140 children across Africa and Central Asia since 2022.
Drugs Controller General of India Rajeev Raghuvanshi announced the findings at the IPA 11th Global Pharmaceutical Quality Summit in Mumbai, confirming that nearly 1,100 manufacturers had undergone rigorous evaluation. The inspections identified critical violations including breaches of good manufacturing practices, failure to test incoming raw materials, and implementation of invalid methods and processes.
The regulatory crackdown follows the October discovery of diethylene glycol contamination in Coldrif cough syrup manufactured by Sresan Pharmaceutical, which resulted in 24 pediatric fatalities. This incident has placed unprecedented pressure on India’s $42 billion pharmaceutical industry, challenging its reputation as the ‘pharmacy of the world’.
Raghuvanshi stated, ‘We took serious actions on serious non-compliances, and our belief is that the rot of cough syrup manufacturing will be removed.’ While declining to specify the exact number of non-compliant companies or identify them publicly, the regulator confirmed additional protective inspections of 1,250 drug manufacturing units to evaluate potential risks.
Concurrently, India’s drug regulatory agency is undertaking transformative reforms to achieve parity with US Food and Drug Administration standards. The modernization initiative includes creating 1,500 new positions—40% through flexible contract roles—and potentially engaging global industry experts as advisors. The regulator is also piloting artificial intelligence applications to streamline application reviews and has eliminated redundant export clearance requirements for shipments to the US, Europe, Australia, Japan, the UK and Canada.