India’s drug regulator CDSCO has tightened rules for drug safety reporting. Pharma firms must file safety reports starting from the actual launch date of new drugs rather than the approval date. The regulator says this will better capture real-world safety signals. It also brings all forms and uses of a new drug under one consolidated safety report.
The Central Drugs Standard Control Organisation has warned that drug applications with unanswered queries will be rejected if applicants do not respond within 30 days. In a public notice dated May 4, CDSCO said several applications have remained pending at the applicant’s end since 2016, signalling stricter timelines for regulatory processing.
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India’s drug regulator, the Central Drugs Standard Control Organisation, has transferred about 95 officials across states as part of a structured policy. The stated goal is to strengthen compliance in the pharmaceutical sector and reduce the influence of long-serving officers. Officials say the reshuffle is intended to refresh oversight and improve how rules are enforced nationwide.
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