Centre takes away state powers for issuing NOC for export of drugs
- Facing global scrutiny, Centre assumes sole authority to issue NOC to pharmaceutical companies for manufacturing of certain categories of drugs; takes away state drug regulators’ powers
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.
"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.
NOCs to be granted by the head of CDSCO zonal offices from 15 May
"Accordingly, power delegated to state/UT Licensing authority stands withdrawn with effect from 15 May 2024 and such NOCs shall be granted by the Head of respective CDSCO Zonal office with effect from 15 May," it added.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. All manufacturers may be informed that they are required to obtain NOC from respective zonal offices of CDSCO through online mode (SUGAM) w.e.f 15 May before issuing manufacturing license from SLA for manufacture of unapproved/banned/ new drugs for export purpose," it stated.
For handling the change, Ranga Chandrashekhar Rao, Joint Drugs Controller, will be the nodal and designated point person at CDSCO.
In 2018, the CDSCO had waived the provision of procuring NOC by pharmaceutical companies for exporting drugs, medical devices and cosmetics across ports in the country for ensuring ease of doing business. Before 2018, licensed manufacturers of drugs and medical devices could export them only to the US, Canada, Japan, Australia and the European Union. The change was then introduced saying that the NOC for licensed manufacturers will be waived if "shipping bills" submitted by the manufacturer include a copy of its "valid licence".
The CDSCO's latest decision comes in view of the Drug Consultative Committee's (DCC) advice who had found that the process of obtaining NOCs from various state drug regulators for pharmaceutical products is a time-consuming process. The DCC also pointed out that delays in obtaining NOCs could cause delays in the export consignment since applicants must obtain an export NOC and a manufacturing license from state licensing authorities for each purchase order.
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First Published:3 May 2024, 07:19 PM IST
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