Permissions have been granted to Farmson Pharmaceuticals, Meghmani LLP, Sri Krishna Pharmaceutical, Granules India, Bharat Chemicals and Para Products based on DoPs assessment of the availability of paracetamol APIs and KSMs
The National Pharmaceutical Pricing Authority (NPPA) has allowed six major manufacturers of paracetamol active pharmaceutical ingredients (APIs) to export 2000 metric tonnes of paracetamol API. This is as per the recommendations by the Ministry of Home and Affairs.
This move is based on the assessment of the availability of paracetamol API and KSMs by Department of Pharmaceuticals.
The below-mentioned manufacturers are allowed to export Paracetamol API, as they have a surplus available:
- Farmson Pharmaceutical -456 MT
- Meghmani LLP- 209 MT
- Sri Krishna Pharmaceuticals – 474 MT
- Granules India- 655 MT
- Bharat Chemicals- 91 MT
- Para Products- 115 MT
Mahesh Doshi, President, Indian Drugs Manufacturers Association (IDMA) said, “This is a progressive step initiated by the government by allowing the large manufacturers of paracetamol to begin the export. Since the Ministry of External Affairs is monitoring the activities of paracetamol and hydroxychloroquine (HCQ) in a licensed category and their demand position would be continuously monitored by them based on the stock position, companies would be allowed to fulfil the export commitments. The permission to export paracetamol raw materials for six large manufacturers is an encouraging step by the government. It also indicates that there will be smooth functioning of pharma exports. We look forward to permissions for other merchant exporters as well in the coming days.”
B R Sikri, Chairman, Federation of Pharma Entrepreneurs (FOPE) said, “FOPE appreciates the move of the government of increasing the quantity of export of paracetamol APIs. The earlier quantity was almost 50 per cent of the current allocation, which is now 2000 metric tonnes. It shows how seriously the government is monitoring production, stock, materials in the pipeline as well as the demand-supply scenario. This is what is needed. This efficient way of working by the government will bring more such positive decisions in days to come so that neither our own people suffer for want of API or finished dosages nor the world markets which look towards India.”
However, an industry insider also questions the NPPA’s move and states that there needs to be some disclosure about the parameters considered. “Respective authorities must clarify on which basis this quota is given. The initiated move seems to be biased. There should have been either blanket approval for everyone or a blanket ban or equal quantity permission to all,” the insider opines. Secondly, what about the merchant exporters who have orders of paracetamol APIs and were hoping similar kind of relief from the government. The authorities should reconsider the initiated move, the insider stated.
The NPPA has requested the DCGI to ensure that manufacturers continue to supply the quantity of paracetamol APIs as usual to the domestic market and continuously monitor the availability of stock of paracetamol in the domestic market.
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we have requirement of Paracetamol caplets 500mg(100s) -100,000 units and also Metformin tablets 500mg(28s)-100,000 units as these will be sample order and same or more will repeated on monthly basis for two years the manufacturer should have UK -MHRA registration as these are to be exported in United Kingdom.
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