India’s drug regulator inspected 90% of cough syrup makers, found lapses, official says

MUMBAI: India’s drug regulator has inspected nearly 90% of the country’s cough syrup makers and found compliance lapses, its chief said on Monday, amid heightened scrutiny after India-made syrups were linked to the deaths of children in the country and abroad.

The inspections follow the discovery of a brand of cough syrup contaminated with diethylene glycol that was linked to the deaths of 24 children in October last year. The product, named Coldrif, was made by Sresan Pharmaceutical, based in Tamil Nadu.

“We took serious actions on serious non-compliances, and our belief is that the rot of cough syrup manufacturing will be removed,” Drugs Controller General of India Rajeev Raghuvanshi said at the IPA 11th Global Pharmaceutical Quality Summit in Mumbai.

The regulator is looking to fix issues around cough syrup products, he said, without providing a timeline.

The agency is under pressure to tighten oversight of the $42 billion pharma industry, dominated by small manufacturers, after India-made cough syrups have been tied to the deaths of more than 140 children in Africa and Central Asia since 2022, denting its reputation as the “pharmacy of the world”.

Safety lapses, weak oversight - How children die from Indian cough syrup

About 90% of all cough syrup makers, around 1,100, had been inspected, Raghuvanshi said, and pointed to breaches of good manufacturing practices, failure to test incoming raw materials and use of invalid methods or processes. He did not name the companies found non-compliant.

The regulator has also inspected an additional 1,250 drug manufacturing units protectively to evaluate risks, a practice begun in 2022, he said, but declined to say how many had compliance issues or were forced to halt operations temporarily.

Regulator targets FDA-level standards

India’s drug regulator aims to bring its operations on par with the U.S. Food and Drug Administration by addressing staffing shortages, speeding up approvals, and boosting resources, Raghuvanshi said.

The agency plans to create 1,500 positions, with about 40% of them flexible, contract roles, and may bring in global industry experts as advisers. It is also piloting the use of artificial intelligence to review applications, according to Raghuvanshi.

Separately, the regulator has streamlined export clearances by removing the need for so-called no-objection certificates for drugs shipped to the U.S., Europe, Australia, Japan, the UK and Canada, a move he said will save time and resources.