Start as a marketing company, not a manufacturer: you own the brands and sales force, a licensed contract manufacturer makes the products, and you need a wholesale drug licence from your state drug controller rather than a factory. Manufacturing is heavily regulated and capital-heavy: a plant needs a manufacturing licence from the state licensing authority under the Drugs and Cosmetics Act and Rules, and must meet the revised Schedule M good manufacturing practices, which applied to small makers (Rs 250 crore turnover or less) from 31 December 2025 with risk-based inspections from January 2026; only about 26% of an estimated 6,500 such makers had even filed upgrade plans. New drugs, imports and devices go to CDSCO itself. Choose your contract manufacturer by its Schedule M compliance, not its price. What kills most new pharma companies is the field: doctors prescribe through relationships your representatives take years to build, so fund the sales team for the long haul.
India's national drug regulator under the Drugs and Cosmetics Act 1940 and Rules 1945. It sets the rules; state licensing authorities issue most manufacturing and sale licences.
December 2025 report that the revised Schedule M good manufacturing practice deadline for MSME drug makers (turnover of Rs 250 crore or less) stayed at 31 December 2025, with risk-based inspections from January 2026, when only about 26% of an estimated 6,500 MSME manufacturers had filed upgrade plans.
The January 2025 report of the one-year extension for drug makers under Rs 250 crore turnover, and the conditions attached: a gap analysis and a compliance plan filed with the regulator.
SUGAM, the drug regulator's e-governance system for applications to CDSCO, which also links to the national drug licensing system used for state manufacturing and sale licences.
The government's only portal for registering a micro, small or medium enterprise. It states registration is free and lists the revised limits: a micro enterprise has investment up to ₹2.5 crore and turnover up to ₹10 crore, a small one up to ₹25 crore and ₹100 crore.
