New Delhi, Feb 1 (PTI) Finance Minister Nirmala Sitharaman on Sunday proposed Rs 10,000 crore investment over the next five years to develop India as a biopharma manufacturing hub, set up 1,000 clinical trial sites and strengthen the Central Drugs Standard Control Organisation.

Biopharmaceuticals, or biologics, are complex medicines manufactured from living organisms, cells, or tissues rather than through chemical synthesis.

In the Union Budget 2026-27 speech, Sitharaman also announced plans to establish 1,000 accredited clinical trial sites in the country.

India's disease burden is observed to be shifting towards non-communicable diseases, like diabetes, cancer, and autoimmune disorders. Biologic medicines are key to longevity and quality of life at affordable costs, Sitharaman stated.

"To develop India as a global biopharma manufacturing hub, I propose the Biopharma SHAKTI with an outlay of Rs 10,000 crore over the next five years. This will build the ecosystem for domestic production of biologics and biosimilars," she added.

The strategy will include a biopharma-focused network with three new National Institutes of Pharmaceutical Education and Research (NIPER) and upgrading seven existing ones, the minister stated.

"It will also create a network of over 1000 accredited India Clinical Trials sites. We propose to strengthen the Central Drugs Standard Control Organisation to meet global standards and approval timeframes through a dedicated scientific review cadre and specialists," Sitharman noted.

Deloitte India Partner Antony Prashant said the next phase of growth for the pharma sector will be driven by quality, innovation, and resilience -- not just volume. In that context, the industry must shift significantly to innovation, which means more focus on biologics/biosimilars, enhance R&D capabilities, including reducing compliance friction for samples/clinical interactions, he added.

"In today's Budget, the announcement of the Rs 10,000-crore Biopharma Shakti puts the industry in the right trajectory -- focused on creating a bio-pharma hub, new NIPER facilities, 1,000 accredited clinical sites and enhancing CDSCO to meet global standards as well expediting approvals," Prashant said.

This not only boosts manufacturing but enables India be competitive in the end-to-end bio-pharma value chain, including drug discovering, clinical trials and market access, he said, adding that the industry is well-poised to reach USD 130 billion in the next 3-4 years.

The finance minister also proposed relief for cancer patients in the Budget.

"To provide relief to patients, particularly those suffering from cancer, I propose to exempt basic customs duty on 17 drugs or medicines," she said.

"I also propose to add 7 more rare diseases for the purposes of exempting import duties on personal imports of drugs, medicines and Food for Special Medical Purposes (FSMP) used in their treatment," she added.

India's pharmaceutical industry is shifting from a volume-driven to a value-driven approach, with greater emphasis on complex generics, biosimilars, and innovation, to move up the value chain. The Indian pharmaceutical industry is the world's third-largest by volume, meeting approximately 20 per cent of global generics demand, with exports to 191 countries in FY25, it stated.

In FY25, the sector's annual turnover reached Rs 4.72 lakh crore, with exports growing at a CAGR of 7 per cent over the last decade (FY15 to FY25). PTI MSS TRB

Biopharma SHAKTI proposes Rs 10,000 crore to build biologics manufacturing, clinical trial sites, and strengthen drug regulation. The Budget proposes Biopharma SHAKTI with Rs 10,000 crore over five years to build domestic biologics and biosimilars manufacturing capacity, expand NIPER education infrastructure, create 1,000 accredited clinical trial sites, and strengthen the Central Drugs Standard Control Organisation with a scientific review cadre to meet global approval timeframes; it also exempts basic customs duty on 17 drugs and extends import duty exemptions for personal imports related to seven additional rare diseases.