Regulator tightens cough syrup test norms
NEW DELHI : The drug regulator has warned cough syrup manufacturers not to send samples of the same batch to multiple government-accredited testing laboratories at the same time. In the event of a drug maker found violating the rules, government labs will not test any of their samples, Drug Controller General of India (DCGI) Rajeev Raghuvanshi warned.
The warning follows several incidents of drugmakers sending the same samples to multiple labs accredited with the National Accreditation Board for Testing and Calibration Laboratories (NABL) for early testing which in turn would help them fast-track exports. Although India is the world’s largest supplier of generic drugs, Indian-made cough syrups have been linked to the deaths of children in several developing countries, including 66 in the Gambia.
“It is noticed that cough syrup samples of the same batch number, manufactured by the same manufacturer (for export purpose) are being received by two different laboratories for testing purposes which is highly objectionable and not acceptable," Raghuvanshi said in a communication to all exports and drug manufacturing association. In addition the DCGI has told exporters not to send samples to two overloaded labs--Indian Pharmacopoeia Commission, Ghaziabad, and Central Drug Testing Laboratory, Maharashtra--until they have analyzed existing samples.
India exported cough syrups worth $17.6 billion in 2022-23 as against $17 billion in 2021-22. Queries sent to the health ministry did not elicit answers.
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