DCGI instructs SDCs to monitor supply and availability of paracetamol tablets, APIs

Manufacturers of paracetamol tablets need to supply the minimum quantity but not less than their average supply of the past three months (January, February and March) in the domestic market

In order to ensure the availability of paracetamol in the country during the nationwide lockdown, the Central Drugs Standard Control Organization (CDSCO) has instructed all the States and the Union Territories Drug Controllers (SDCs) to monitor the availability of their stocks.

On April 15, 2020, the Drug Controller General (India) (DCGI) received a letter from the National Pharmaceutical Pricing Authority (NPPA), Department of Pharmaceuticals (DoP), regarding recommendations for release of paracetamol APIs/ formulations exports. Post this development, the DCGI’s office has requested SDCs to ensure that manufacturers continue to supply paracetamol APIs/formulations as usual to the domestic market and continuously monitor the availability of these stocks.

The DCGI’s letter also informs that NPPA’s communication dated April 22, 2020, states that the manufacturers of paracetamol tablets shall supply a minimum quantity of paracetamol but not less than their average supply of the past three months (January, February and March) in the domestic market.

Commenting on the DCGI’s instructions to all SDCs, Narendra Ahooja, State Drug Controller, and Haryana said, “There is no shortage of either paracetamol APIs or tablets. Because this is not a time for fever or any other seasonal flu in the country. In fact, the consumption of paracetamol tablets has reduced since general OPDs in major hospitals are not functioning at their full strength and patients are also reluctant to visit hospitals during the lockdown due to fear of getting the COVID-19 infection.”

He elaborated, “This is an exercise by the government to increase preparedness and availability of stock in each state. The government always gets prepared for the worst situation and works hard so that the worst situation doesn’t arrive.”

“In Haryana, we have fewer manufacturers and higher consumption, still, we do not face or foresee a shortage of paracetamol APIs and finished formulations,’ informed Ahooja.

Dr Hemant Koshia, Commissioner, FDCA said, “There is no need to worry about shortages, we have surplus stock in the market. Last week itself, as requested by the DCGI, we carried out a complete market availability study and realised that the States has enough stock of both, COVID-19 related medicines as well as general category medicines.”

He also informed that Gujarat has a considerable number of pharma units. Even during the lockdown, following the stipulated guidelines of the Government, the state’s pharma production stood at around 60 – 70 per cent.

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