CDSCO issues recommendations to lift export restrictions on paracetamol APIs

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

Through the letter, the DCGI has communicated to Drug Controllers of all the States and Union Territories that in order to fulfil domestic requirements during the COVID-19 pandemic, certain conditions have been put into place with respect to six major manufacturers of paracetamol APIs, namely Farmson Pharmaceutical, Meghmani LLP,  Sri Krishna Pharmaceuticals, Granules India, and Bharat Chemicals. These six major manufacturers can 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.

The recommendations also include that these manufacturers are required to submit an undertaking to the Directorate General of Foreign Trade Directorate (DGFT) at the time of export.

Further, State/UT offices have been requested 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.  The DCGI has requested Drug Controllers of States/UTs to ensure compliance to said direction of the NPPA by seeking and verifying regularly domestic and export supply data from these manufacturers.

The details of the action taken and a report of compliance by the manufacturer, along with data in this regard, needs to be communicated to the CDSCO office on fortnightly basis i.e; on 15th and 30th of every month by concerned State Drugs Controllers via an email to div@cdsco.nic.in and dci@nic.in  until NPPA’s order remains operational.

Krishna Prasad Chigurupati, Chairman and Managing Director, Granules informed, “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. Nevertheless, 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.”

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