In an attempt to cut annual import of Chinese API to the tune of USD 2.5 Billion, India has come out with a plan to scale up indigenous API (Active Pharmaceutical Ingredients)

The API import in India is around USD 3.5 billion annually, out of which 70 % is imported from China alone. The government now intends to cut its import Bill on API mainly from China which alone stands at USD 2.5 Billion annually 

The pharmaceutical industry in India is the 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.

Despite a very strong manufacturing base, the domestic pharmaceutical industry prefers to import API instead of indigenous production because of  low-profit margins and non-lucrative industry. 

Import of API 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 its imports from China have been increasing steadily and now stand around 70 %.

To address this, TIFAC has recommended policies to address the requirement of APIs in short & medium term to make our country self-reliant. In a report published by the Technology Information Forecasting and Assessment Council (TIFAC), an autonomous organization under the Department of Science & Technology, Government of India, it has recommended the government to scale up indigenous production of API to a level where the production is economically viable.

The report titled ‘Active Pharmaceutical Ingredients- Status, Issues, Technology Readiness, and Challenges’, the TIFAC has given major recommendations including a focus on engineering and scale aspect of technology development, need for Mission mode Chemical Engineering with defined targets for uninterrupted synthesis of molecules.

The Report suggested 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 has 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 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.

 

TIFAC has also asked the government to encourage Indian companies working in chemical segments mainly steroids, amino acids, carbohydrates, nucleosides so as it could collaborate for technology development or quick technology transfer for closer academia-industry interaction for technology development and commercialization.

BY Vijay Thakur, Special Representative, The Statesman, vijaythakurx@gmail.com