Report on Active Pharmaceutical Ingredients: TIFAC
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Recently, the Technology Information Forecasting and Assessment Council (TIFAC) has brought a report titled ‘Active Pharmaceutical Ingredients- Status, Issues, Technology Readiness, and Challenges’.
- TIFAC is an autonomous organization under the Department of Science Technology, Government of India.
Key Points-RAS Online Classes
- Recommendations from the Report:
- Indigenous production of Active Pharmaceutical Ingredients (APIs) needs to be scaled up to a level where the production is economically viable.
- Need for Mission mode Chemical Engineering with defined targets for uninterrupted synthesis of API molecules.
- To create mega drug manufacturing clusters with common infrastructure in India.
- Developing a Technology platform for biocatalysis for cost optimization and investing in the fermentation sector of large capacity.
- Biocatalysis refers to the use of natural substances from biological sources (such as enzymes) to speed up (catalyze) chemical reactions.
- Attention to technologies like hazardous reactions, cryogenic reactions, and membrane technology.
- Cryogenic reactions are chemical reactions performed at very low temperatures (below −150 °C).
- Membrane technology covers all engineering approaches for the transport of substances between two fractions with the help of permeable membranes.
- Focus on antiviral drugs, which require nucleic acid building blocks - Thymine, Cytosine, Adenine and Guanine - none of which are manufactured in India because of lack of manufacturing plants.
- Government encouragement for Indian companies working in chemical segments such as steroids, amino acids, carbohydrates, nucleosides, etc., to collaborate for technology development or quick technology transfer.
- Need for closer academia-industry interaction for technology development and commercialization.
- India’s Pharmaceutical Industry:
- It 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 around 3,000 drug companies and about 10,500 manufacturing units with a domestic turnover of Rs 1.4 lakh crore in 2019, with exports across the world.
- Recently, India has approved two schemes, namely the Scheme on Promotion of Bulk Drug Parks and Production Linked Incentive (PLI) and Scheme to promote domestic manufacturing of critical Key Starting Materials/Drug Intermediates and Active Pharmaceutical Ingredients in the country.
- Issues Involved:
- Low-profit margins and non-lucrative industry forced domestic pharmaceutical companies to stop manufacturing APIs and start importing, which is 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%.
Note: Active Pharmaceutical Ingredients (APIs), also called bulk drugs, are significant ingredients in the manufacture of drugs. The Hubei province of China is the hub of the API manufacturing industry.
- Implementing the recommendations of TIFAC will help India to become self-reliant (Atmanirbhar) in the Pharmaceutical sector by reducing its import dependence.
- Indigenous manufacturing will boost India’s pharma sector and will help generate jobs.