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Drug Safety
India's drug regulator has directed manufacturers and importers to submit Periodic Safety Update Reports (PSURs) for new drugs from the date of actual marketing of the product rather than from the date of regulatory approval, in a move aimed at strengthening post-marketing safety surveillance. In an advisory issued by the Central Drugs Standard Control Organisation (CDSCO) on April 21, the regulator said it has observed instances where companies obtained approval for a new drug but launched the product in the market much later while submitting PSUR data from the approval date instead of the launch date. The CDSCO said such a practice results in the loss of "valuable safety insights" that are critical for monitoring adverse effects and ensuring patient safety after commercial roll out of medicines. Under the Fifth Schedule of the New Drugs and Clinical Trials Rules, 2019, manufacturers and importers are required to submit PSURs as part of post-marketing drug safety monitoring. "In v
A PIL has been filed in the Supreme Court seeking inquiry and systemic reform in drug safety mechanisms in the wake of deaths of children in Madhya Pradesh and Rajasthan allegedly due to consumption of toxic cough syrups. The PIL, filed by advocate Vishal Tiwari, seeks a court-monitored probe into the incidents and urges the constitution of a National Judicial Commission or Expert Committee headed by a retired Supreme Court judge. The PIL requests that all pending FIRs and investigations concerning the deaths of children caused by toxic cough syrups across states be transferred to the CBI. It seeks a probe under the supervision of a retired Supreme Court judge to ensure fairness and uniformity. The petition contends that separate state-level investigations have led to fragmented accountability, enabling repeated lapses that allow hazardous formulations to reach the market. The petition comes amid reports from Madhya Pradesh and Rajasthan, where several children allegedly died afte
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
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