CDSCO lifted export restrictions on paracetamol APIs

A letter has been issued by the Central Drugs Standard Control Organisation (CDSCO to all the State and Union Territories Drug Controllers with a recommendations to revoke export restrictions on major manufacturers of paracetamol APIs.

The DCGI has communicated to Drug Controllers of all the States and Union Territories to make sure that domestic requirements have been fuflilled during the COVID-19 pandemic, condititions has been laid down for six major manufacturers of paracetamol APIs and these are Farmson Pharmaceutical, Meghmani LLP, Sri Krishna Pharmaceuticals, Granules India, and Bharat Chemicals. The six major manufacturers are able to export up to 50 per cent of their monthly operational capacity in a given month subject to release of a similar quantity for domestic purpose.

Manufacturers shall be required to submit an undertaking to the Directorate General of Foreign Trade Directorate (DGFT) at the time of export as per recommendations.
State/UT offices have been asked to ensure that the quality equal to the export is reserved/released for the domestic requirement for indigenous use, to ensure public interest during the COVID-19 situation.

“On a monthly basis, we have the capacity to manufacture paracetamol APIs of 1800 tonnes and 22000 tonnes annually. There is not much demand for paracetamol in the domestic market and we believe that nearly 20 to 25 per cent of the country’s capacity can fulfil the domestic demand. If the Government wants the industry to ensure that 50 per cent of our monthly operational capacity is given to the domestic market, we will abide by the given instructions.” said Krishna Prasad Chigurupati, Chairman and Managing Director, Granules informed.

The NPPA has allowed six manufacturers this month to export 2000 metric tonnes of paracetamol APIs. This is as per the recommendations by the Ministry of Home Affairs.

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