(Image source from: Financialexpress.com)
In a significant effort to shift from being the global supplier of generic drugs to a top player in advanced innovations, the Indian government has introduced the Biopharma Shakti initiative. Finance Minister Nirmala Sitharaman presented the initiative during the Union Budget 2026, with a budget of Rs 10,000 crores, aiming to transform how India produces medications. This five-year plan intends to capture 5 percent of the worldwide biopharmaceutical market by moving from standard chemical processes to the sophisticated area of cellular engineering. Most of the medications we use, like aspirin, are created through chemical processes, much like following a recipe where specific chemicals are mixed in a lab to create small molecules.
These small molecules are simple to duplicate and store. On the other hand, biologics are large molecules produced inside living systems like specially modified bacteria, yeast, or animal cells. Instead of using a test tube, the production happens in a living cell. This method of cellular engineering enables scientists to develop targeted treatments for complicated illnesses such as cancer and diabetes that traditional chemicals cannot effectively address. Scientists utilize bacteria or yeast cells as tiny living factories because these organisms can understand the genetic instructions humans provide. While standard chemicals are small and straightforward, cellular engineering results in large, complex proteins that function like precise keys. These proteins are crafted to ignore healthy cells and only interact with specific markers on cancer cells or malfunctioning areas of the body. Since these medicines are produced from living materials, they can effectively navigate biological systems and reach specific targets that simple chemicals would fail to engage with.
The Biopharma Shakti mission, which stands for Strategy for Healthcare Advancement through Knowledge, Technology and Innovation, is a comprehensive approach to create a local environment for biologics and biosimilars. Biosimilars are precise, biological alternatives to generic drugs, made to closely match the safety and effectiveness of original, costly medicines derived from living cells. Currently, India depends heavily on imports for the essential components needed to make these drugs. The mission plans to establish three new National Institutes of Pharmaceutical Education and Research (NIPERs) and enhance seven existing ones to develop a skilled workforce. To accelerate the process from research to pharmacy, the government will also set up a network of 1,000 certified clinical trial locations throughout the country.
A key emphasis is on biosimilars, which are high-quality and more affordable versions of costly branded biologics. By reinforcing the Central Drugs Standard Control Organisation (CDSCO) with a specialized scientific review team, the government seeks to align Indian regulatory timelines with international standards. This will ensure that life-saving biological therapies developed within the country reach patients more quickly, making the treatment of chronic diseases less expensive.
