Spurious drugs fallout: Centre NOC must to export unapproved medicines from May 15

The central drug regulator will soon be the sole authority to grant no-objection-certificates (NOCs) to pharmaceutical companies that manufacture drugs that are unapproved, new or banned for the sole purpose of exports in India.

In a communication to the drug controllers of all states and Union Territories on April 30, the Central Drugs Standard Control Organisation (CDSCO) has said that the powers delegated to the state and UT authorities to grant such NOCs will stand withdrawn from May 15, 2024.

The pharmaceutical companies will now have to get their NOCs from the zonal offices of CDSCO through online mode before applying for manufacturing licenses from their respective state/UT drug regulators.

The Drugs Controller General of India, Rajeev Singh Raghuvanshi, stated that the decision was taken to facilitate the application process for the industry.

In August 2018, the CDSCO had relaxed the requirement of Central NOCs and permitted state and UT drug licensing authorities to grant permissions to export some specific drugs that are not allowed to be used in India. The state/UT regulators will now have to handover the details of all the approvals they have given during the August 2018-May 2024 period to the central drug regulators.

The Drug Consultative Committee (DCC), the body that advises central and state regulators on technical matters for uniform implementation of drug laws, had in its January 2024 meeting observed that the process of obtaining NOCs from various state drug regulators for pharmaceutical products is a time-consuming process. The DCC also noted that delays in securing NOCs may result in delays in the export consignment since for each purchase order (for repetitive export purchase orders), applicants need to obtain export NOC (specific to quantity, country & buyer) & manufacturing license from state licensing authorities.

In the case of export permission for biological products that are not approved in India, the time taken for approvals could be anywhere between 8 to 10 months and the entire process is very cumbersome and time consuming to approach every time to apply for repetitive export orders, the DCC had noted.

The DCC had proposed the grant of one-time export NOC for certain categories of drugs like approved/ unapproved new drugs, and not for the banned drugs. However, the committee opined that due to misuse potential, the current practice for issuance of NOCs for export of drugs should continue. It recommended the constitution of a sub-committee to examine the pros and cons involved for taking further decisions in the matter.