Written by Rishika Saddam and Kashish Tandon
MUMBAI (Reuters) – India’s drug regulator has inspected nearly 90% of the country’s cough syrup makers and found compliance gaps in some, the head of India’s medicines regulator said on Monday, amid growing scrutiny after an Indian-made syrup was linked to child deaths in the country and abroad.
The inspections come in the wake of the discovery of a type of cough syrup contaminated with diethylene glycol, which was linked to the deaths of 24 children in October last year. The product, called Coldrif, is manufactured by Sresan Pharmaceutical, based in Tamil Nadu.
“We have taken serious action on serious cases of non-compliance and believe that the rot of cough syrup manufacturing will be removed,” India’s Drugs Controller General Rajiv Raghuvanshi said at the 11th IPA Global Pharmaceuticals Quality Summit in Mumbai.
He said the regulator was looking to fix the issues with cough syrup products, without providing a timeline.
The agency is under pressure to tighten oversight of the $42 billion pharmaceutical industry, dominated by small manufacturers, after an Indian-made cough syrup was linked to the deaths of more than 140 children in Africa and Central Asia since 2022, damaging its reputation as the “pharmacy of the world.”
Raghuvanshi said about 90% of all cough syrup makers, about 1,100 factories, were inspected and cited violations of good manufacturing practices, failure to test incoming raw materials and use of invalid methods or processes. He did not mention the number of companies found to be non-compliant or name them.
He said the regulator also preventively inspected an additional 1,250 drug manufacturing units to assess risks, a practice that began in 2022, but he declined to say how many units faced compliance issues or had to temporarily halt operations.
The regulator targets FDA level standards
Raghuvanshi said India’s drug regulator aims to bring its operations on par with the US Food and Drug Administration by addressing staff shortages, speeding up approvals and enhancing resources.
The agency plans to create 1,500 jobs, about 40% of which will be in flexible and contractual roles, and may use global industry experts as consultants. It is also experimenting with using artificial intelligence to review applications, according to Raghuvanshi.
Separately, the regulator simplified export permits by eliminating the need for so-called no-objection certificates for drugs shipped to the United States, Europe, Australia, Japan, the United Kingdom and Canada, a move it said would save time and resources.
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