India is moving toward an extensive revision of its legal drug-quality measures, which will be aligned with the various drug standards of the US, EU, and Japan. The Indian Pharmacopoeia Commission (IPC) will include new drug quality measures for 123 products and revise approximately 200 existing monographs, which define a drug’s identity, strength, and purity.
The revisions extend to different therapies, such as anticancer (Dactinomycin, Pomalidomide), antidiabetics (Dapagliflozin, Vildagliptin), antiretrovirals (Etravirine), antibiotics (Cefprozil, Cefuroxime), and therapies used for tuberculosis (Bedaquiline). The newer monographs will also add advanced methods of testing, along with dissolution specifications and impurity controls.
The updated monographs will be included in the new 2026 edition of the Indian Pharmacopoeia for use not only in India but 14 other countries, such as Nepal, Ghana, and Sri Lanka. The overhaul is part of India’s continuous efforts to enhance trust in its growing 50 billion dollar pharmaceutical sector.
In parallel, the IPC is trying to achieve global harmonization through its participation in the Pharmacopoeial Discussion Group with the US, Japan, and the EU.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.