Due to increased international scrutiny of medications created in India, the Union government has taken over as the only authority for granting manufacturing licenses for new drugs intended for export, removing the ability in state governments.
A copy of the order that Drug Controller General of India Dr. Rajeev Raghuvanshi issued on April 30 has been viewed by Mint. In it, the CDSCO requests that the industry submit new applications for no objection certificates (NOCs) starting on May 15.
In 2018, state drug controllers were granted full authority to grant NOC certificates.
The industry must now be enabled to submit new NOC applications for the manufacture of unapproved/approved new drugs/banned drugs solely for export purposes starting on May 15, 2024, online through CDSCO zonal offices, according to the order, which was approved by the Honorable Minister of Health and Family Welfare.
Effective on May 15, the head of the CDSCO zonal offices will issue NOCs.
"Accordingly, the power delegated to state/UT Licensing authority stands withdrawn with effect from 15 May 2024 and such NOCs shall be granted by the Head of respective CDSCO Zonal office with effect from 15 May," it said.
The NOC must be obtained by manufacturers from the appropriate CDSCO zonal office.
Ranga Chandrashekhar Rao, Joint Drugs Controller, would be the CDSCO nodal and designated point person for managing the change.
To facilitate commerce, the CDSCO eliminated in 2018 the requirement that pharmaceutical businesses obtain a notice of compliance (NOC) before exporting pharmaceuticals, medical equipment, and cosmetics across national ports. Until 2018, the only countries to which licensed producers of pharmaceuticals and medical equipment could export them were the US, Canada, Japan, Australia, and the EU. Next, a modification was proposed, stating that licensed manufacturers' "shipping bills" would not need to contain a copy of their "valid license" for the NOC to be waived.
(Input from various media sources)
(Rehash/Arpit Sharma/SB)
