Biopharma Shakti mission announced to promote India as manufacturing hub for complex biological drugs

“The Biopharma Shakti programme reflects India’s intent to scale biologics and biosimilars manufacturing with long-term policy certainty, at a time of rising global demand and patent expiry… For India’s USD 50 billion-pharmaceutical industry, which contributes nearly 2.5% to the country’s GDP, this budget reinforces the shift from volume-led growth to value and innovation-driven leadership,” said Rajiv Nath, forum coordinator of Association of Indian Medical Device Industry (AiMeD).

“Complementing this, weighted R&D deduction up to 200% and expansion of Production Linked Incentive support to advanced modalities such as APIs, biosimilars, and complex generics would further accelerate domestic manufacturing, reduce import dependence, and position India as a trusted global supplier of high-quality, affordable biopharmaceutical solutions,” he added.

Satish Reddy, Chairman of Dr Reddy’s Laboratories Limited, said the fact that the pharmaceutical sector was the first to be highlighted in the Finance Minister’s presentation signals its strategic importance. “The emphasis on biologics and biosimilars is particularly timely, as India is at the cusp of taking a global lead in this space,” he added.

Sitharaman said that the mission will also create a network of 1,000 accredited clinical trial sites — essential for testing before taking these medicines to the market. According to an expert, who wished to remain anonymous, this will not only help in bringing manufacturing to the country but also a share of the global clinical trial market.

They said: “There are around 200 community and hospital-based clinical trial sites in the country, funded by bodies such as the Indian Council of Medical Research and Department of Biotechnology. This is a very important announcement because no new biological drug — even biosimilars of existing drugs — can be brought to the country without clinical trials.”

They added, “Importantly, global clinical trial market is USD 10 billion. Having these clinical trial sites at ready would mean that India will be able to carve out a chunk in this global market.”
To support the aim of creating a biopharma hub, Sitharaman said that the government will work to strengthen the Central Drugs Standard Control Organisation (CDSCO) to meet global standards. The government also plans to create a dedicated scientific review cadre and specialists to ensure that the drug regulator can follow the global approval timeframes. “This is also a much-needed move to ensure that it is subject experts who approve various drugs and in a timely manner,” the expert added.

Winselow Tucker, president and general manager of Eli Lilly and Company (India), said: “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, improve timely patient access to new therapies, and reinforce India’s position as a trusted global life-sciences hub.”