NEW DELHI : The Union government has become the sole authority for issuing manufacturing licences for new drugs meant for exports, withdrawing the power from state governments amid heightened global scrutiny of Indian made drugs. The sole licensing authority from now on will be the Central Drugs Standard Control Organisation (CDSCO), India's apex drug regulatory body.
In an order issued by Drug Controller General India Dr Rajeev Raghuvanshi on 30 April, a copy of which has been seen by Mint, the CDSCO has asked the industry to submit fresh only applications for no objection certificates (NOCs) from 15 May onwards. State drug controllers were given complete jurisdiction to issue NOC certificates from 2018.
Also Read: Uniform rates in pvt hospitals across all states an uphill task, as majority do not implement CEA: Health ministry "Now it has been decided with the approval of the honourable Health and Family Welfare Minister that industry must be facilitated to file fresh applications for NOC for manufacture of unapproved/approved new drug/banned drugs solely for export purpose from 15 May 2024 on online mode through CDSCO zonal offices," the order stated. "Accordingly, power delegated to state/UT Licensing authority stands withdrawn with effect from 15 May 2024 and such NOCs shall be granted by the Head of respective CDSCO Zonal office with effect from 15 May," it added.
Manufacturers will need to obtain the NOC from the respective zonal office of the CDSCO. "Further all state/UT drugs Controllers are required to handover all NOC's issued from 20 August 2018 to 14 May 2024 to respective Zonal offices of CDSCO.
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