Increase indigenous production of Active Pharmaceutical Ingredients; Report


With Indian companies heavily depending on other nations, especially China, for Active Pharmaceutical Ingredients (APIs), a report by the Technology Information Forecasting and Assessment Council (TIFAC) has recommended policies to address the requirement of APIs in short and medium term to make the country self-reliant.

In its report, TIFAC has called for increasing the indigenous production of Active Pharmaceutical Ingredients to a level where the production is economically viable.

Despite a very strong base, due to low-profit margins and non-lucrative industry, domestic pharmaceutical companies have gradually stopped manufacturing APIs and started importing APIs, which was a cheaper option with increased profit margins on drugs. With the availability of cheaper APIs from China, the pharmaceutical industry relies heavily on imports. The imports from China have been increasing steadily and now stand around 68%.

The report also said that the country has to develop mega drug manufacturing clusters with common infrastructure and technology platforms for reducing cost optimisation, according to a report by the Technology Information Forecasting and Assessment Council (TIFAC), an autonomous organisation under the Department of Science and Technology.

It has also called for focussing on engineering and scale aspect of technology development and also called for the need for Mission mode Chemical Engineering with defined targets for uninterrupted synthesis of molecules. The report also says that investment in fermentation sector of large capacity was needed and has asked to focus more on hazardous reactions, flow chemistry, cryogenic reactions, and membrane technology.

Union health Minister Harsh Vardhan released the report and also the white paper on ‘Focused Interventions for ‘Make in India’: Post COVID 19’.

The report further suggests chiral building blocks through biocatalysis for production of niche intermediates involving enzymatic reactions or fermentation as an area of potential exploitation for Indian API industry and focus on antiviral drugs, which require nucleic acid building blocks – Thymidine/ Cytosine Adenine/ Guanine none of which are manufactured in India because of lack of cyanation plants.

The report recommends for Government encouragement of Indian companies working in chemical segments such as steroids, amino acids, carbohydrates and nucleosides to collaborate for technology development or quick technology transfer as well as the need for closer academia-industry interaction for technology development and commercialization.

The white paper ‘Focused Interventions for ‘Make In India’ post-COVID 19’ has come up with the strengths, market trends, and opportunities in five Sectors, including Healthcare, which are critical from country’s perspective. The paper strongly brought out the import dependence for APIs, especially from China. In view of changing geo-political scenario and recalibrated trade alignments, it is imperative that India become self-reliant in production of APIs.

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. It has a strong network of 3,000 drug companies and about 10,500 manufacturing units with a domestic turnover of Rs 1.4 lakh crore (USD 20.03 billion) in 2019, with exports to more than 200 countries in the world.



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