What are Key Starting Materials (KSMs)?

The basic raw materials to produce critical bulk drugs are called Key Starting Materials (KSMs). KSMs are the “building blocks” of Active Pharmaceutical Ingredients (APIs). These are often sourced by generic pharma companies through third party companies who develop and manufacture them.

  • The Indian pharmaceutical industry is the 3rd largest in the world by volume. However, despite this achievement, India is significantly dependent on import of basic raw materials, viz., Bulk Drugs that are used to produce medicines.
  • In some specific bulk drugs the import dependence is 80 to 100%.
  • To reduce import dependence, approvals have been accorded to 16 applicants under Production Linked Incentive (PLI) Scheme for Promotion of Domestic Manufacturing of critical Key Starting Materials (KSMs)/ Drug Intermediates and Active Pharmaceutical Ingredients (APIs) in the country.

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