Biopharmaceuticals, or biologics, are complex medicines manufactured from living organisms, cells, or tissues rather than through chemical synthesis. File
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Union Budget 2026-27 has proposed a biopharma strategy for healthcare advancement through knowledge, technology and innovation with an outlay of ₹10,000 crore over the next five years to develop India as a global biopharma manufacturing hub.
“Biopharma SHAKTI will build the ecosystem for domestic production of biologics and biosimilars,” Finance Minister Nirmala Sitharaman said in the Budget speech on Sunday (February 1, 2026). Biopharma is part of the seven strategic and frontier sectors identified for scaling up by the government.
Watch | FM Sitharaman launches ₹10,000 cr outlay for biopharma sector
The decision to facilitate innovation and ramp up production of biopharmaceuticals comes in the backdrop of India’s disease burden shifting towards non-communicable diseases such as diabetes, cancer and autoimmune disorders. “Biologic medicines are key to longevity and quality of life at affordable costs,” the Finance Minister said.
Setting up three new National Institutes of Pharmaceutical Education and Research (NIPER) and upgrading existing seven facilities and creation of a network of over 1,000 accredited India clinical trials sites forms part of the strategy on biopharma.
“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,” Ms. Sitharaman said.
Biopharmaceuticals are complex molecules and unlike other medicines not manufactured through chemical synthesis. According to U.S. Food and Drug Administration, biological products are generally large, complex molecules and produced through biotechnology in a living system such as a microorganism, plant cell or animal cell and often more difficult to characterise than small molecule drugs.
Pharma industry on Budget
Pharma industry leaders hailed the Budget announcement. Dr. Reddy’s Laboratories chairman Satish Reddy said the ₹10,000-crore programme will be a key enabler for India’s journey from volume to value leadership, helping the country move from being a global supplier of quality medicines to becoming a global innovator. Alongside the expansion of the national clinical trials network and strengthening of the CDSCO with specialised scientific review and globally aligned timelines, these initiatives will enhance India’s capacity to develop complex, high-value therapies, he said.
The decision on new NIPERs and upgrading the existing facilities will build the talent pipeline essential for innovation-led growth, Mr.Reddy said.
“The Budget’s focus on health and biopharma is a welcome step… we also appreciate the government’s emphasis on strengthening CDSCO and advancing a more predictable, science-led regulatory framework. Aligning regulatory processes with global standards, while expanding India’s clinical research capabilities, will help bring medical innovation to India faster,” President and General Manager of Eli Lilly and Company (India) Winselow Tucker said.
Senior Director at Crisil Ratings Anuj Sethi said India’s pharmaceutical sector has long been a leader in low-cost, small-molecule generics. The Biopharma Shakti initiative will enable domestic companies expand into more complex products such as biosimilars.
The support is crucial as biosimilars require significant investments in clinical studies and capital. The initiative will help reduce gestation periods and regulatory hurdles for U.S. FDA and EMA approvals, positioning India to capitalise on the $100-110 billion opportunity arising from the patent expiries for blockbuster biologics over the next decade, he said.
Published – February 01, 2026 11:42 am IST
