Government News

In a regulatory update aimed at streamlining drug export processes, the Central Drugs Standard Control Organization (CDSCO) has announced the implementation of a Prior Intimation System for Form CT-05 applications. The new system will come into force from April 21, 2026, following amendments introduced under Gazette Notification G.S.R. 50(E).

In a significant step toward easing the regulatory burden on India's retail pharmacy sector, the Drugs Consultative Committee (DCC) at its 68th meeting on 20 March 2026 directed a sub-committee to examine four landmark deregulation proposals. The sub-committee's findings will be placed before the DCC for final deliberation before any rule amendments are made.

In a significant development for India’s pharmaceutical regulatory landscape, the Drugs Technical Advisory Board (DTAB) has reaffirmed its position to include all antimicrobial drugs under the definition of “New Drugs” as per the New Drugs and Clinical Trials Rules, 2019.

The decision was taken during the 93rd meeting of DTAB held on February 16, 2026, at FDA Bhawan, New Delhi, conducted in a hybrid format. The board reviewed and approved the Action Taken Report (ATR) from its previous (92nd) meeting held on April 24, 2025.

India’s drug regulator has issued a public advisory after a consignment of insulin pens manufactured by Sanofi India Limited was reported stolen during transportation, raising concerns about potential risks if the products enter the market through unauthorized channels.