The Technology Information Forecasting and Assessment Council (TIFAC), an autonomous organization under India’s Department of Science & Technology, has recently released a report titled “Active Pharmaceutical Ingredients- Status, Issues, Technology Readiness, and Challenges.” This comprehensive report sheds light on the current status and potential growth areas of Active Pharmaceutical Ingredients (APIs) production in India.
Key Recommendations from TIFAC’s Report
According to TIFAC’s findings, increasing the indigenous production of APIs to an economically viable level is critical. The report emphasizes the need for Mission mode Chemical Engineering with clearly defined objectives for consistent API molecule synthesis.
Next, the report suggests creating mega drug-manufacturing clusters utilizing shared infrastructure within the country. Furthermore, it recommends developing a biocatalysis technology platform for cost optimization and investing more heavily in the large-capacity fermentation sector. Biocatalysis refers to the acceleration of chemical reactions using natural substances from biological sources, such as enzymes.
The report also stresses the importance of focusing on technologies like hazardous reactions, cryogenic reactions, and membrane technology. Cryogenic reactions are chemical processes performed at extremely low temperatures (below -150 °C). Membrane technology encompasses all engineering strategies for substance transport between two fractions through permeable membranes.
Focus on Antiviral Drugs and Government Role
In terms of specific pharmaceutical concerns, the report highlights the absence of nucleic acid building blocks – Thymine, Cytosine, Adenine, and Guanine – which are essential for antiviral drugs but currently not produced in India due to the lack of suitable manufacturing plants.
The government is encouraged to support Indian companies specializing in chemical segments such as steroids, amino acids, carbohydrates, and nucleosides. The aim is to foster collaboration for quicker technology development or transfer.
Moreover, the report underscores the need for a stronger bond between academia and industry, to expedite technology development and commercialization.
India’s Pharmaceutical Industry Overview
Currently, India’s pharmaceutical industry is the third-largest globally in terms of volume, trailing behind China and Italy, and ranks fourteenth in value. In 2019, it achieved a domestic turnover of Rs 1.4 lakh crore, supported by approximately 3,000 drug companies and 10,500 manufacturing units shipping products worldwide.
Recently, India has approved two schemes: the Scheme on Promotion of Bulk Drug Parks and the Production Linked Incentive (PLI) Scheme, aimed at bolstering domestic production of critical Key Starting Materials/Drug Intermediates and Active Pharmaceutical Ingredients.
Challenges Facing the Industry
The local pharmaceutical industry has been facing challenges due to low-profit margins, making the API production non-lucrative. Many domestic companies have opted to import APIs, as this has proven to be a cheaper option providing increased profit margins on drugs.
The availability of less expensive APIs from China makes the pharmaceutical industry heavily dependent on imports, which now constitute around 68% of total APIs used. The Hubei province in China predominates in API manufacturing.
Proposed Way Forward
If the recommendations of the TIFAC are implemented effectively, India can advance toward self-reliance in the pharmaceutical sector, thereby reducing its current import dependence. Furthermore, fostering indigenous manufacturing can stimulate growth in India’s pharma sector and create more job opportunities.