India's drug pricing regulatory agency, the National Pharmaceutical Pricing Authority (NPPA), has extended the revised ceiling price of Heparin Injection up to September 2021. The rising costs of raw materials from China has pushed the NPPA to take this decision.
Earlier in the year, the NPPA had hiked the price of the essential blood thinner by 50% and extended the price hike till March 31, 2021. This has now been further extended.
The price revision was based on a Union Health Ministry committee report which noted a 211% increase in the price of heparin’s active pharmaceutical ingredient (API) as compared to the base year of September 2018.
Some of the brands of heparin are Hep and Hep-Lock by Gland Pharma, Lofh by Abbott Laboratories, and Celparin by Celon Laboratories. Other companies like Biological E, Samarth Lifesciences and Troikaa Pharmaceuticals also market heparin products in India.
Several drugmakers had reached out to the government early last year with a proposal to bring a law under which price hikes could be made possible due to unforeseen factors.
The NPPA had extended the ceiling prices of heparin injection 1000IU/ ml and heparin injection 5000IU/ ml fixed under Para 19 of the Drugs Prices Control Order (DPCO) and had invoked its extraordinary powers in the public interest to ensure consistent availability of the drug, in view of the increase in API costs from China in the COVID-19 scenario.
The Federation of Pharmaceutical Entrepreneurs, a lobbyist body, has been alleging that China is increasing the prices of some key raw materials. As an official pointed out, an organic compound used in making paracetamol, para-aminophenol, cost around $3.2 to $3.5 per kilogram last year. Its price now is around $7.3 to $7.5 per kg.
The regulator noted manufacturers’ concern that, over the years, the regulated price has decreased, while that of the API imported from China has consistently increased, which made production of the drug commercially unviable.
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