Against the backdrop of India’s bid to become ‘atmanirbhar’ (self-reliant), one of the Government’s own bodies has maintained that reducing dependency on the import of the Active Pharmaceutical Ingredients (API) from China is not going to be an easy affair. API is a chemical compound that is the most important raw material to produce a finished medicine. At present, 68 per cent of India’s API need is fulfilled by China.
It pointed out that indigenously-manufactured drugs would be 20 per cent costlier than those available from the neighbouring country.
The Technology, Information Forecasting and Assessment Council (TIFAC), an autonomous body under the Union Science and Technology Ministry, in its report has now called for preparing a national stockpile of generic medicines for critical illness and ensure API security in view of changed global norms due to Covid-19 pandemic and border tiff with China.
The report also suggested that while India has the technology for production of many APIs, the production cost needs to be optimised to match the global norms largely by scaling up of operations. “Towards this, common facilities such as solvent recovery plant, distillation plant, power and steam units etc. should be established in bulk drug parks,†said the report “Active Pharmaceutical Ingredients: Status, Issues, Technology “Readiness and Challenges†as it dwelt in detail on the strength and limitation as well as emerging market scenario in the sector.
In 2019, India imported APIs worth Rs 249 billion of which around Rs 169 billion were from China itself, with the imports increasing steadily from just 0.3 per cent in 1991 to the current 68 per cent.
“Two-thirds of the total imports of APIs and drug Intermediates were from China. Out of the 373 drugs in the National List of Essential Medicines (NLEM), around 200 are imported as APIS, that too mostly from China. The import value of bulk drugs and drug intermediates from China to India increased around 23 per cent from 2016-17 to 2018-19,†said the report.
Despite a very strong base, due to low-profit margins and non-lucrative industry, domestic pharmaceutical firms gradually stopped manufacturing APIs and started importing, finding it a cheaper option with increased profit margins on drugs,
Dependence of India on China for the imports of critical key starting materials KSMs, intermediates and APIS has increased over the period. India also imports common raw materials, solvents etc, required for the production of drugs, said the report.
All the drug Intermediates are imported to India, of which 58 molecules are exclusively imported from China
The global pharmaceutical market is USD 12 trillion with API market of USD 1,822 billion.
The pharmaceutical industry in India is third largest in the world, in terms of volume, behind China and Italy and fourteenth largest in terms of value.
The Indian industry has a network of 3,000 drug companies and about 10,500 manufacturing units with Indian domestic turnover reaching Rs 1.4 lakh crore (USD 20.03 billion in 2019, with exports to more than 200 countries in the world:
Identifying a list of APIs which need to be taken up for prioritized manufacturing, the report compiled by scientists and pharma experts said that India needs a Mission mode Chemical Engineering with defined targets for uninterrupted synthesis of molecules and to create mega drug manufacturing clusters with common infrastructure.
“For those few APIS, for which we don’t have technology, early stage research and development support should be provided for pilot development of APIs.
“At the same time, issues related to land acquisition, ease of doing business. environmental clearance, taxation, and R&D need to be resolved while a single window clearance system and priority license renewal system for companies manufacturing APIS need to be established,†said the report.
