Drug Safety

111 drug samples tested in November found 'not of standard quality': CDSCO

Central Drugs Standard Control Organisation (CDSCO) has found 41 drug samples tested in the central drug laboratories in November as 'not of standard quality' (NSQ), official sources said. Besides, 70 drug samples tested by the state drugs testing laboratories have also been identified as NSQ in November, they said. Identification of drug samples as NSQ is done based on failure of the drug sample in one or the other specified quality parameters. "The failure is specific to the drug products of the batch tested by the government laboratory and it does not warrant any concerns on the other drug products available in the market," an official said. Two drug samples were identified as spurious drugs in November. Out of the two samples, one was picked by Bihar Drugs Control Authority and the other by CDSCO, Ghaziabad, the sources said. The drugs were made by unauthorised and unknown manufacturers, using brand names of other companies. Action to identify NSQ and spurious medicines is ta

USFDA restricts imports of certain Viatris drugs made at India facility

The FDA has issued a warning letter to Viatris related to its drug manufacturing facility in Indore in the central Indian state of Madhya Pradesh

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