Biopharma SHAKTI to Cut Import Dependence, Open New Growth Path for Indian Pharma, Executives Say

Pharma industry executives have said the Union Budget 2026 has laid the groundwork for a major shift in India's pharmaceutical sector, with the Biopharma SHAKTI initiative expected to reduce reliance on imported biologic medicines while opening new growth opportunities for domestic pharma companies, particularly MSMEs.

Finance Minister Nirmala Sitharaman, while presenting the Budget announced Biopharma SHAKTI, a ₹10,000-crore initiative spread over five years. The programme is aimed at pushing India beyond its traditional strength in generic medicines and preparing the industry for advanced therapies such as biologics and biosimilars.

Explaining the policy intent, Sitharaman said India’s disease burden is rapidly shifting towards non-communicable diseases such as diabetes, cancer and autoimmune disorders. These conditions increasingly rely on biologic medicines, which are complex, costly and often imported. "Biologic medicines are key to longevity and quality of life at affordable costs," she said, underlining the need to build strong domestic capabilities.

Under Biopharma SHAKTI (Strategy for Healthcare Advancement through Knowledge, Technology and Innovation), the government plans to set up three new specialised National Institutes of Pharmaceutical Education and Research (NIPERs) and upgrade seven existing ones to create a skilled talent pool. It also aims to establish a network of over 1,000 accredited clinical trial sites across the country and strengthen the Central Drugs Standard Control Organisation (CDSCO) to ensure faster approvals in line with global standards.

Industry leaders believe these measures will directly address long-standing gaps in India’s biologics ecosystem. Namit Joshi, Chairman of Pharmexcil, said the Budget reinforces the "kartavya" of India's pharmaceutical exporters to sustain the country’s leadership as the "pharmacy of the world."

"Pharma exports today are a critical contributor to India’s trade balance, foreign exchange earnings and global health security, and this is driven largely by MSMEs that form the backbone of the export ecosystem," Joshi said.

He added that the Biopharma SHAKTI project marks a historic and strategic shift in India’s pharmaceutical journey. "From being a global leader in generics, India is now moving towards emerging as a global bio-pharma manufacturing powerhouse. With a committed outlay of ₹10,000 crore, the initiative is designed to build an end-to-end ecosystem for MSMEs to develop and manufacture biologics and biosimilar drugs, the fastest-growing segment of the global pharmaceutical market," Joshi said.

He further noted that by strengthening research infrastructure, clinical trial capacity, regulatory capability, skilled manpower and advanced manufacturing facilities, Biopharma SHAKTI aims to significantly reduce India’s dependence on imports for complex biologic therapies.

Echoing this view, Biocon Biologics CEO and Managing Director Shreehas Tambe said the emphasis on academic research, training and clinical infrastructure is transformative. "These steps reinforce Atmanirbhar Bharat while positioning India as a credible global biopharma hub delivering affordable, high-quality complex therapies at scale," he said.

The push comes at a time when India’s pharmaceutical industry remains largely dominated by generic drug manufacturers, with most firms yet to enter biologics due to high capital requirements, advanced technology needs and specialised talent constraints.

Currently, India is the world’s third-largest pharmaceutical producer by volume, meeting around 20% of global generics demand and exporting to 191 countries in FY25, according to government data. More than 50% of exports go to highly regulated markets such as the US and Europe. Beyond generics, India is also a global leader in low-cost vaccine supply, providing a majority of the world's DPT, BCG and measles vaccines.

In FY25, the sector’s annual turnover stood at ₹4.72 lakh crore, with exports growing at a 7% CAGR over the last decade (FY15–FY25). India ranks 11th globally in pharmaceutical exports by value, with a 3% share, while medical devices exports rose sharply from $2.5 billion in FY21 to $4.1 billion in FY25.

Globally, the biosimilars opportunity is expanding rapidly. The global biosimilars market, valued at $28 billion in 2025, is projected to reach $130.1 billion by 2035, growing at a CAGR of 16.7%, according to Roots Analysis. Europe accounts for over 50% of the global biosimilars market, driven by ageing populations and rising chronic disease burden.

Meanwhile, India's biosimilars market is projected to grow at a CAGR of 19.89% between FY26 and FY33, expanding from $1.51 billion in FY25 to $6.44 billion in FY33, according to Markets & Data.

Industry experts say Biopharma SHAKTI does not replace India's successful generic-drug model, but adds a critical new growth path. Large pharma companies may invest directly in biologics and biosimilars, mid-sized firms could partner with global players or focus on contract manufacturing, while smaller generic players may benefit indirectly through ancillary services, supply chains and clinical research.

"A significant proportion of patients with non-communicable diseases remain inadequately treated, and the push for biosimilars can help bridge this gap," said Dr H Sudarshan Ballal, Chairman of Manipal Hospitals.

At the post-Budget press conference, Sitharaman said biopharma is one of the government’s identified "strategic and frontier sectors", expected to attract fresh investments and help India build global healthcare brands. By backing Biopharma SHAKTI with ₹10,000 crore, the government is signalling its intent to keep India's pharmaceutical leadership intact while expanding into next-generation medicines that directly impact human health.