India considers allowing import of API for mfg crude heparin

Heparin and its related derivative, the low molecular weight heparin, also known as enoxaparin, is an anticoagulant

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New Delhi: India is considering allowing import of raw material for manufacturing crude heparin, an anticoagulant being used for treatment of Covid-19 patients, a move aimed at reducing dependence on China.

With an aim to promote indigenous manufacturing of heparin, the Department of Pharmaceuticals (DoP) held a meeting with other ministries including commerce and industry, and animal husbandry, dairying and fisheries on Tuesday to facilitate the import of the waste raw materials.

Heparin and its related derivative, the low molecular weight heparin, also known as enoxaparin, is an anticoagulant that has demonstrated its effectiveness in treatment of patients infected with Covid-19 virus during the ongoing pandemic.

Derived from porcine intestinal mucosa, heparin has been declared an essential drug by the World Health Organization and also figures in the National List of Essential Medicines.

So far India has been importing crude heparin from China, which accounts for nearly 60% of the pig production in the world. India is almost entirely dependent on China for the supply of this porcine-derived mucosal end product.

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The IMS 2019-20 data shows that the annual market for this product is reported to be about Rs 50 crore for heparin (about 6.3 million units) and Rs 504 crore (about 15 million units) for enoxaparin. This estimates the product imported into India at 2,500-3,000 kg heparin, from which about 1,000 kg of enoxaparin is being processed. This doesn’t account for the product that is imported directly as the finished product.

India is eyeing import of crude heparin from countries including those in South America, where the porcine mucosa that lines the porcine intestine is discarded or converted into very inexpensive pet food due to the lack of collection and processing plants closer to the site of pig production.

“Given the size of the production of China, any challenge to the production can affect the availability of this product globally and this has been expressed by multiple sources. However, some developed countries around the world have established alternative sources for porcine mucosa,” said a government official, who did not wish to be identified.

The government is of the view that by allowing the import of the raw material India’s pharmaceutical industry, with extensive expertise for processing such raw materials, can convert the porcine extract into active pharmaceutical ingredients such as heparin and enoxaparin and help India realise the goal of “atmanirbhar Bharat (self-reliant India)”.

The DOP, under the chemicals and fertilizers ministry, recently announced the production-linked incentive scheme for manufacture of active pharmaceutical ingredients (APIs), key starting materials and intermediates in India so as to reduce the country’s dependence on China.

In addition to the 53 APIs primarily identified under the scheme, the DOP has also taken various product specific initiatives to encourage self-reliance in manufacturing. “Heparin is one such product,” said the official cited earlier. Industry experts said the move will also bring down the price of the drug.

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