India has introduced uniform pharmacopoeial standards for blood components used in transfusions for the first time, marking a significant step to strengthen patient safety and regulatory oversight of blood banks and hospital transfusion services nationwide. The move, formalised with the release of Indian Pharmacopoeia (IP) 2026, also includes stricter quality specifications for widely used medicines, covering treatments for tuberculosis, diabetes, and cancer, aimed at reducing risks from unsafe blood products and substandard drugs.
Blood transfusions, which involve administering whole blood or specific components to replace lost blood, are critical in treating severe anaemia, trauma, surgery, cancer care, childbirth complications, and inherited blood disorders. The 10th edition of IP introduces 20 monographs for blood components, including whole blood (standard and irradiated), various red blood cell products (packed, additive solution, leucodepleted, buffy coat removed, cryopreserved, and washed), plasma components (fresh frozen plasma, cryoprecipitate, cryo-poor plasma), platelet products (PRP, pooled, random donor, buffy coat and apheresis-derived), and granulocyte components obtained via apheresis or buffy coat pooling.
The IP, published by the Indian Pharmacopoeia Commission under the Ministry of Health and Family Welfare, provides legally enforceable drug standards under the Drugs and Cosmetics Act, 1940. These standards form the basis for licensing, inspection, and distribution of medicines across India.
The 2026 edition also adds 121 new drug standards, taking the total number of monographs to 3,340. Each monograph details manufacturing, testing, storage, and labelling requirements, enabling regulators to act decisively against unsafe or substandard products. Expanded coverage of medicines used in national health programmes ensures that treatments for tuberculosis, diabetes, and cancer meet consistent quality benchmarks, safeguarding millions of patients relying on public healthcare.
The updated standards are expected to strengthen safety surveillance across India. The Pharmacovigilance Programme of India (PvPI) has contributed to a significant rise in adverse drug reaction reporting, helping India move from 123rd globally in 2009–2014 to 8th position worldwide in 2025.
With the introduction of these measures, Indian Pharmacopoeia 2026 is poised to enhance blood safety, improve medicine quality, and reinforce patient protection across the country’s healthcare system.
