BackDCGI asks these state labs to give ‘top priority’ to testing cough syrup samples
The decision to implement quality checks before export was introduced after India-made syrups were linked to dozens of deaths in Gambia and Uzbekistan in 2002.
PremiumAfter making testing mandatory before the export of Indian cough syrups, the Drugs Controller General of India (DCGI) has now asked some specified state laboratories to examine such samples from manufacturers on ‘top priority and issue the test report at the earliest’.
In a notification, the Directorate General of Foreign Trade (DGFT) stated that cough syrup exporters will have to produce a certificate of analysis issued by a government laboratory before the product is exported, effective June 1.
"The export of cough syrup shall be permitted to be exported subject to export samples being tested and production of a certificate of analysis issued by any of the laboratories..., with effect from June 1, 2023," the notification read as quoted by news agency PTI.
This came amid instances of quality concerns being raised abroad on cough syrups exported by Indian firms.
The country's top drug regulator on Wednesday wrote to state drug controllers of Gujarat, Karnataka, Kerala, Madhya Pradesh, Maharashtra, Jammu and Kashmir, and Uttarakhand and central laboratories and referred to the notification issued by the Ministry of Commerce and Industries regarding the export policy of cough syrups.
"State Drug Controllers are hereby requested to give instructions to your state-owned NABL accredited laboratories to analyze the samples received from the manufacturers of cough syrups for export purposes on top priority and issue the test report at the earliest," the letter read.
It also requested all central laboratories to prioritize the analysis of samples received from the manufacturers and issue the report immediately in order to avoid delays, PTI reported.
"It is requested to all state licensing authorities to forward the e-mail Ids of their NABL accredited laboratories of their state to this office by return mail," the letter stated.
The specified central government labs include Indian Pharmacopoeia Commission, regional drug testing lab (RDTL - Chandigarh), central drugs lab (CDL - Kolkata), central drug testing lab (CDTL - Chennai Hyderabad, Mumbai), RDTL (Guwahati) and the NABL (National Accreditation Board for Testing and Calibration Laboratories) accredited drug testing labs of state governments.
India is the largest provider of generic drugs globally, supplying over 50% of the global demand for various vaccines, about 40% of generic demand in the US, and about 25% of all medicine in the UK.
India-made cough syrups were allegedly linked to the deaths of 66 and 18 children in Gambia and Uzbekistan, respectively, last year. India exported cough syrups worth USD 17.6 billion in 2022-23 as against USD 17 billion in 2021-22.
(With PTI inputs)
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