India tightens drug safety net, brings blood components under uniform standards | India News

NEW DELHI: In a major move to strengthen patient safety, India has, for the first time, brought blood components used in transfusions under uniform pharmacopoeial standards, tightening regulatory oversight of blood banks and transfusion services nationwide. The step is accompanied by stricter quality specifications for widely used medicines—from tuberculosis and diabetes drugs to cancer therapies—aimed at curbing risks from unsafe blood products and substandard medicines.Blood transfusion involves giving whole blood or specific blood components into a patient’s vein to replace blood lost due to injury, surgery or illness, and is essential for treating conditions such as severe anaemia, major surgery, trauma, cancer care, childbirth complications and inherited blood disorders.The measures were formalised with the release of Indian Pharmacopoeia 2026, India’s official book of drug standards, by Union health and family welfare and chemicals and fertilisers minister JP Nadda at the Dr Ambedkar International Centre on Friday.Indian Pharmacopoeia (IP) standards are legally enforceable in India and accepted in courts, with regulators using them to ensure drug quality. The Indian Pharmacopoeia Commission (IPC), an autonomous body under the Ministry of Health and Family Welfare, sets and regularly updates these standards under the Drugs and Cosmetics Act, 1940 and Rules, 1945.Published by the Indian Pharmacopoeia Commission on behalf of the Ministry of health and family welfare, the Pharmacopoeia lays down authoritative and legally enforceable standards under the Drugs and Cosmetics Act, 1940. These standards form the basis for licensing, inspection and distribution of medicines across the country.A major regulatory expansion in the 10th edition is the first-time inclusion of 20 monographs for blood components used in transfusion medicine, bringing blood banks and hospital transfusion services under clearer and more consistent oversight—an important safeguard for surgeries, trauma care and maternal health.The monographs cover standards for whole blood and blood components, including whole blood (standard and irradiated); a wide range of red cell products (packed, additive solution, leucodepleted, buffy coat removed, cryopreserved and washed RBCs); plasma components such as fresh frozen plasma (from whole blood and apheresis), cryoprecipitate and cryo-poor plasma; platelet products including PRP, pooled and random donor platelets, buffy coat and apheresis-derived platelets (including additive solution and double units); and granulocyte components obtained through apheresis or buffy coat pooling.The edition also tightens the country’s drug safety framework by adding 121 new drug standards, taking the total number of monographs to 3,340. Each monograph specifies how a medicine must be manufactured, tested, stored and labelled, strengthening regulators’ ability to act against sub-standard or unsafe products.A key public-interest gain is the expanded and sharper coverage of medicines used under national health programmes. Drugs for tuberculosis, diabetes and cancer—relied upon by millions for long-term treatment—will now be subject to more uniform quality checks, a critical safeguard for patients dependent on public healthcare systems.Officials said the revised standards will also strengthen safety surveillance. Highlighting the progress of the Pharmacovigilance Programme of India (PvPI) under the IPC, Nadda said India—ranked 123rd globally during 2009–2014 in contributions to the World Health Organization’s pharmacovigilance database—has now climbed to 8th position worldwide in 2025, reflecting faster reporting of adverse drug reactions and stronger regulatory action.With public healthcare bearing the bulk of the country’s disease burden, Indian Pharmacopoeia 2026 is expected to directly strengthen blood safety, improve medicine quality and enhance patient protection across the healthcare system.