Current Affairs Brain Booster for UPSC & State PCS Examination (Topic: Report on Active Pharmaceutical Ingredients)

Current Affairs Brain Booster for UPSC & State PCS Examination

Report on Active Pharmaceutical Ingredients

Technology Information Forecasting and Assessment Council (TIFAC), an autonomous organisation under the Department of Science & Technology has brought out a report titled, ‘Active Pharmaceutical Ingredients- Status, Issues, Technology Readiness, and Challenges.
It was released along with a white paper on ‘Focused Interventions for ‘Make in India’: Post COVID 19’ which brought out the strengths, market trends, and opportunities in five sectors, including healthcare.

Focus on engineering and scale aspect of technology development.
Need for mission mode chemical engineering with defined targets for uninterrupted synthesis of molecules and to create mega drug manufacturing clusters with common infrastructure in India and the technology platform to be developed for biocatalysis towards reducing process steps for cost optimization and for fluorination
Investment on priority in fermentation sector of large capacity and scale supporting techno-economic feasibility, attention to technologies like hazardous reactions, flow chemistry, cryogenic reactions, and membrane technology.
The report further suggested chiral building blocks through biocatalysis for production of niche intermediates involving enzymatic reactions or fermentation as an area of potential exploitation for Indian Active Pharmaceutical Ingredients (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.
Government encouragement of Indian companies working in chemical segments such as steroids, amino acids, carbohydrates, nucleosides, etc., to collaborate for technology development or quick technology transfer as well as the need for closer academiaindustry interaction for technology development and commercialization.

API means the active ingredient which is contained in medicine.
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.
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:
The imports from China works out to be cheaper and cost effective for the pharmaceutical companies.
Uncertainty of price fluctuations of APIs from other producers like US, Italy, Singapore etc.
Lack of suitable policies and incentives to boost indigenous development and production of essential APIs in the country.
Lack of time consuming environmental clearance norms in the country.
The major groups of products (either as active ingredient, or intermediate chemicals) that are imported are antibiotics, steroids & hormones (key starting materials (KSM), vitamins, statins, enzymes and other fermentation-based intermediates and APIs.

India, the world’s third-largest drug producer by volume, imports 70% of the APIs, used by its drug makers, from China. For some APIs, especially antibiotics, the dependence is more than 90%.
Indian firms including Lupin, Sun Pharmaceuticals, Glenmark, Mankind, Dr Reddy’s and Torrent are dependent on imports from China. According to data from Pharmexcil, India imported Rs. 17,400 crore worth of APIs from China in 2018-19.
China has experienced rapid growth in the pharmaceutical market, moving from the 9th largest market in the world in 2007 to the second largest at present, next only to the US.
China is predicted to overcome the US as the number one pharmaceutical market by 2020. In 2018, Chinese pharmaceutical market was USD 137.0 and this is estimated to grow to USD161.8 billion by 2023, with 30% share of global market.