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India’s drug regulator has inspected practically 90% of India-made cough syrup producers and located non-compliance, the chief minister introduced on Monday (23 January 2026), as Indian syrups come beneath rising scrutiny as they’ve been linked to little one deaths at house and overseas.
The checks had been performed after a model of cough syrup was discovered to be contaminated with diethylene glycol, which was linked to the deaths of 24 youngsters final October. The product, named Coldrif, was manufactured by Tamil Nadu-based Sresan Pharmaceutical.
“We’ve got taken critical motion towards critical non-compliance and we consider corruption in cough syrup manufacturing can be eradicated,” India’s drug regulator Rajeev Raghuvanshi mentioned on the IPA eleventh World Pharmaceutical High quality Summit in Mumbai.
He mentioned regulators had been contemplating resolving points with cough syrup merchandise, however gave no timeline.
The company is beneath stress to tighten oversight of the $42 billion pharmaceutical trade, dominated by small producers, after Indian-made cough syrup has been linked to the deaths of greater than 140 youngsters in Africa and Central Asia since 2022, tarnishing its repute because the “pharmacy of the world.”
Raghuvanshi mentioned about 90% of all cough syrup producers (about 1,100 corporations) had been inspected, citing violations of fine manufacturing practices, failure to check incoming uncooked supplies, and use of invalid strategies and processes. He didn’t identify the businesses discovered to be in violation.
He mentioned regulators had been conducting protecting inspections of an extra 1,250 drug manufacturing amenities to evaluate danger, one thing that has been in place since 2022, however didn’t say what number of had compliance points or had been compelled to quickly droop operations.
Regulators are concentrating on FDA-level requirements
India’s drug regulator goals to deliver its operations on par with the US Meals and Drug Administration by addressing staffing shortages, dashing up approvals and rising sources, Raghuvanshi mentioned.
The company plans to create 1,500 positions, roughly 40% of which can be versatile contractual roles, with the potential to herald international trade consultants as advisors. Raghuvanshi mentioned the corporate can also be piloting using synthetic intelligence to evaluate purposes.
Individually, regulators are streamlining export customs clearance by eliminating the necessity for so-called “no-objection certificates” for medicines shipped to america, Europe, Australia, Japan, the UK and Canada, which is able to save time and sources, he mentioned.
