Biopharma SHAKTI scheme

Why in News?

The Budget envisions the Biopharma SHAKTI scheme with an outlay of Rs. 10,000 crores over the next 5 years.

• Biopharma SHAKTI - Strategy for Healthcare Advancement through Knowledge, Technology and Innovation.
• Aim - To make India a global manufacturing hub for biopharma.
• Objectives - To build the ecosystem for domestic production of biologics, which are complex medicines derived from living organisms (cells, bacteria, or animals) or their components, such as proteins and genes.

Biological medications are used to treat severe conditions like cancers, autoimmune diseases (arthritis, IBD, psoriasis), and genetic disorders. These tend to be complicated to purify, process and manufacture.

• The scheme will also scale up the production of biosimilar medications, which are highly similar but not identical versions of biological drugs.
• Period - 5 years.
• Infrastructural support - Under the scheme, 3 new National Institutes of Pharmaceutical Education and Research (NIPER) will be launched, and 7 existing institutes will be upgraded as part of its Biopharma-focused network.
• Clinical Research - The scheme will also create a network of over 1,000 accredited sites for clinical trials in India.
• Regulatory Strengthening- It proposed strengthening the Central Drugs Standard Control Organisation to meet global standards and approval timeframes through a dedicated scientific review cadre and specialists.

India’s position in pharmaceuticals

• Disease Statistics - India’s shifting disease burden from communicable to non-communicable diseases (NCDs) like diabetes, cancer, and autoimmune disorders.
• According to a United Nations report, NCDs are responsible for 63% of all deaths in India, with cardiovascular diseases at 27% of overall mortality, followed by chronic respiratory diseases (11%), cancers (9%), and diabetes (3%).
• Turnover - In FY25, the sector’s annual turnover reached Rs. 4.72 lakh crore, with exports growing at a CAGR of 7% over the last decade (FY15 to FY 25).
• India’s medical devices sector has also become globally competitive, exporting to 187 countries in FY25.
• Among its exports are high-end equipment, including MRI and CT scanners, linear accelerators, cardiac stents, and ventilators, marking an expansion into sophisticated imaging and life-support technologies.

Reference

The Indian Express | Biopharma SHAKTI scheme