Bio Spectrum - September 2024

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Can India Reclaim API Throne from China?
Despite having the third-largest pharmaceutical industry by volume in the world and being the largest manufacturer of generic medicines globally, India is heavily dependent on China for imports of raw materials, Key Starting Materials (KSMs), and Active Pharmaceutical Ingredients (APIs). India is the source of around 60,000 generic brands across 60 therapeutic categories and manufactures more than 500 different APIs. However, India imports about 70 per cent of its APIs from China as it’s a cheaper option than manufacturing them domestically. There were 58 APIs in which India was heavily dependent on China. In the case of 45 APIs, India was dependent on China for 100 per cent of imports. Out of these 58 APIs, 29 APIs are manufactured through fermentation and 29 APIs are manufactured through chemical synthesis. The Department of Pharmaceuticals has drawn up a list of 56 APIs to prioritise them for the Make-in-India initiative. These include APIs or bulk drugs that go into the making of essential drugs, such as antibiotics, anti-HIV medicines, and the humble but indispensable paracetamol. The plan to make APIs in India has been in the works for some time but the Council of Scientific and Industrial Research (CSIR ) was engaged only recently. Let’s see how these steps taken by the government help to promote the production of KSMs and APIs in India in the coming years.