DGFT lifts export restrictions on paracetamol APIs

The Directorate General of Foreign Trade (DGFT), an arm of the Ministry of Commerce and Industry, has completely lifted export restrictions on paracetamol active pharmaceutical ingredients (API).

As per notification no of 07/2015-2020 by the DGFT, in the exercise of powers conferred by Section 3 of the Foreign Trade (Development and Regulation) Act 1992 (No 22 of 1922) as amended with para 1.02 and 2.01 of the Foreign Trade Policy 2015-2020, the Central Government has made an amendment in Chapter 29 of the Schedule 2 of the ITCHS Export policy. It has amended the previous notification no 50/2015-2020 dated March 3, 2020, related to the export policy of paracetamol API and removed the restriction on the export of paracetamol API, making its export free with immediate effect.

Sahil Munjal, Vice Chairman, Pharmexcil said, “We welcome the announcement of lifting the complete export restriction of paracetamol API. And it is good news for paracetamol exporters as well as manufacturers. Certainly, it will give a boost to all the paracetamol formulator at this critical juncture, wherein all the manufacturers will be able to sell their paracetamol and paracetamol combination products directly to their customers across the globe without any delay.”

Nipun Jain, Chairman, Small and Medium Pharma Manufacturers Association said, “It was long-awaited from the Government. We welcome this wholeheartedly. This move will not only benefit paracetamol manufacturers, but also merchant exporters. India will once again stand in competition with Chinese companies with respect to paracetamol APIs and cater to the whole world.”

Sudarshan Jain, Secretary-General,  Indian Pharmaceutical Alliance (IPA) said, “It is a welcome step by the government and the industry appreciate it. It will further boost our commitment towards ensuring domestic as well as global demands of pharma products.”

BR Sikri, Chairman FOPE, and Vice President BDMA, said “We welcome the move of the Government in releasing paracetamol from ‘restricted’ to ‘free’ category for export purpose. It is mainly because of our API manufacturers have sufficient stock of Para in their inventory and sufficient quantity of raw material in the pipeline. Similarly, now approximately 90 per cent units of the API and formulations are operational and slowly and gradually our industry is becoming self sufficient as we were three months ago. The Government keeps on observing the availability of all the products and monitors it minutely and that is the reason the Government has taken immediate action. The proactive approach of the government is much appreciable, as they keep an eye on each and every essential APIs and formulations.”

Recently, the Central Drugs Standard Control Organisation (CDSCO) had issued a letter to all the State and Union Territories Drug Controllers regarding recommendations to revoke export restriction of paracetamol active pharmaceutical ingredients (API). In its communication, it had mentioned that to fulfil domestic requirements, certain conditions are being put into place. It had allowed six major manufacturers, namely with respect to six major, manufacturers namely Farmson Pharmaceutical, Meghmani LLP,  Sri Krishna Pharmaceuticals, Granules India, and Bharat Chemicals, to export up to 50 per cent of their monthly operational capacity subject to a release of similar quantity for domestic purposes.