MUMBAI: India’s drug regulator has completed inspections of nearly 90 percent of the country’s cough syrup manufacturers, uncovering compliance issues in some firms, amid heightened scrutiny after contaminated syrups were linked to child deaths domestically and abroad.
The reviews follow the case of Sresan Pharmaceutical, a Tamil Nadu-based company whose Coldrif brand was found contaminated with diethylene glycol, causing 24 child fatalities in October 2025, according to Reuters.
Controller General of India
“We have taken serious actions against major non-compliances, and we aim to eliminate the issues in cough syrup manufacturing,” said Rajeev Raghuvanshi, Drugs Controller General of India, speaking at the IPA 11th Global Pharmaceutical Quality Summit in Mumbai.
He added that efforts are underway to resolve problems in production, though no timeline has been set.
India’s pharmaceutical industry, valued at USD 42 billion and largely composed of small manufacturers, has come under increasing pressure after India-made cough syrups were linked to more than 140 child deaths in Africa and Central Asia since 2022, affecting its reputation as the “pharmacy of the world.”
Regulators inspected about 1,100 cough syrup manufacturers, reporting violations such as breaches of good manufacturing practices, inadequate testing of raw materials, and use of invalid methods or processes. The number of non-compliant companies or their identities were not disclosed.
Additionally, since 2022, the regulator has carried out risk-based inspections of 1,250 other drug manufacturing units, though details on compliance issues or temporary operational suspensions were not shared.
