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.
India’s drug regulator has accelerated pharma innovation by cutting approval timelines by more than half. Clinical trial approvals will now take about 120-135 days, while marketing authorisations are cleared in under 150 days. The reforms also remove certain pre-clinical approval requirements, aiming to strengthen ease of doing business and speed product delivery.
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