Drug Safety

New rules ease testing for drug imports from US, EU, Australia, and Japan

Under new guidelines, testing will be reduced to one sample every two years or one sample from 20 consecutive consignments, whichever comes first

Eli Lilly's popular drug Mounjaro stuck at Indian regulators' counter

Eli Lilly's Mounjaro, a blockbuster diabetes medication and a highly popular obesity treatment is still awaiting approval from CDSCO despite a SEC clearance

Health ministry plans drug licensing changes to ensure drug safety

Proposals aim to standardise drug manufacturing practices after a few Indian medicines were flagged as 'substandard' by the WHO

DGCI asks labs to priortise mandatory testing of cough syrup before exports

With India making testing of cough syrups before export mandatory from June 1, the Drugs Controller General of India (DCGI) has asked specified state laboratories to examine such samples from manufacturers on "top priority and issue the test report at the earliest". 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 Directorate General of Foreign Trade (DGFT) said in a notification on Monday. The move came amid instances of quality concerns being raised abroad on cough syrups exported by Indian firms. "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 stated. On Wednesday, the country's top drug regulator, DCGI, wrote to state drug controllers of Gujarat, Karnataka, Kerala, Madhya Pradesh, Maharashtr

Letters: Drug safety assurance

Apropos Bhupesh Bhandari's article, "Listen to Dinesh Thakur" (May 6), it is correct that the Indian pharmaceutical sector makes the finest medicines in the world