As India aims to shift API dependence from China to country-made ingredients, the Department of pharmaceuticals (DoP) will increase this list by including APIs for essential drug -- Heparin.
According to sources, the ministry is in talks with department of commerce and animal husbandry to ensure that India can import waste raw materials which can then be processed to make APIs for Heparin.
Heparin is an essential anti-blood coagulant drug used in thinning of blood or to avoid blood clotting. Heparin is listed under the national list of essential medicines (NLEM) and WHO’s essential drug list. Heparin is also being widely used in COVID-19 treatment.
The Department of Pharmaceuticals has already announced a production-linked incentive scheme to manufacture 53 critical API/KSM/Intermediates in India and to reduce the dependence on imports of such products from countries like China. But, it could not include 5 other APIs as the government realised that it can’t manufacture these 5 in the country.
Working on this task now, DoP first identified APIs for Heparin and its related derivative to see whether indigenous manufacturing can be done.
“Heparin and its related derivative, the low molecular weight heparin also known as -- Enoxaparin is an age-old anticoagulant that has demonstrated its effectiveness even in treatment of patients infected with COVID-19 virus. Heparin is derived from porcine intestinal mucosa and is considered as an essential drug by the WHO. China accounts for nearly 60% of the pig production in the World. Given the size of the production of China any challenge to the production can affect the availability of this product globally and the same has been expressed by multiple sources,” sources said.
“However, some developed Countries around the World have established alternative sources for porcine mucosa. In general, especially in various South American countries, 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,” they added.
Currently, since India is entirely dependent on China for supply of this porcine derived mucosal for manufacturing of Heparin, but now, India has initiated a smooth import process for porcine intestinal mucosa from Ukraine, Brazil, USA, etc, sources added.
“Department of Pharmaceuticals believes that by allowing the import of this raw material the pharmaceutical industry within India with extensive expertise for processing such raw materials can convert the porcine extract into active pharmaceutical ingredients like Heparin and Enoxaparin and help India realise the goal of ‘atmanirbhar Bharat’.”
According to government data, the annual market for Heparin is about Rs 50 crore for almost 63 lakh units and Rs 504 crores for Enoxaparin, which is for about 150 lakh units.
These estimates are of the product imported into India, which is about 2,500-3,000 kilos for Heparin from which about 1,000 Kgs of Enoxaparin is processed in India. This doesn’t account for the product that is imported directly as the finished product.
First Published: IST