Licensing power for export of medicines taken away from state governments

Amid increasing scrutiny of Indian-made drugs globally, the central government has taken away the power to license new drugs to be exported from state governments and has now taken complete power into its own hands. Now CDSCO i.e. Central Drugs Standard Control Organization will be the sole licensing authority for the manufacturing of such medicines.

In an order issued by the country's Drug Controller General Dr Rajeev Raghuvanshi on April 30, CDSCO has invited online applications from May 15 onwards for obtaining fresh no objection certificate from manufacturers in the pharmaceutical industry. From 2018, it was made mandatory for state drug controllers to grant such NOC to such cleared sectors. As per the order, it has now been decided that the industrialists will have to apply afresh through the zonal office of CDSCO for all new or restricted drugs approved or invalid for export purpose from May 15, 2024.

NOC will be issued by the zonal office of CDSCO. In view of this, the power to grant licenses to States and Union Territories has been withdrawn with effect from May 15, 2024, and such NOCs will be issued through the regional offices of CDSCO. Further, all NOCs issued from August 20, 2018 to May 14, 2024 will have to be surrendered back to the zonal office of CDSCO. All manufacturers will now have to obtain such certificates through online mode. Joint Director of Drugs Chandrashekhar Rao will be the designated officer in CDSCO to implement such changes. In 2018, licensed pharmaceutical and medical device manufacturers could only export to the US, Canada, Japan, Australia, and the European Union. Subsequently, if the shipping bill also includes a copy of the valid license of the company, there is no need to issue NOC. The Advisory Committee on Drugs had suggested this as it believed that drug manufacturers should seek NOC from the authorities for each purchase order and this would waste more time.

Some special aspects of drug regulation

In the year 2018, the State Drug Directorate was given full power to grant NOC.

From now onwards NOC will be issued only from the zonal office of CDSCO.

The power to give NOC to State Drug Controllers was withdrawn.

Any NOC issued between 2018 and 2024 will now have to be submitted to CDSCO.