|
The Indian Pharmacopoeia 2026 (IP 2026), the 10th edition of India’s official book of drug standards, has introduced blood component monographs or quality standards in transfusion medicine for the first time, according to official sources.
These quality standards or monographs will prevent the occurrence of blood transfusion transmitted infections.
These monographs or quality standards are aligned with the Directorate General of Health Services (DGHS) manual and other international guidelines. A general requirement on irradiation of blood components has also been introduced.
The inclusion of 20 blood component monographs pertaining to transfusion medicine in the IP 2026, is in accordance with the provisions of the Drugs and Cosmetics (Second Amendment) Rules, 2020.
Union minister for health and family welfare and chemicals and Fertilizers J P Nadda, released the IP 2026 in New Delhi towards strengthening the quality, safety, and efficacy of medicines.
The IPC has developed general requirements and monographs or quality standards for blood and blood components from human source to ensure safe blood transfusion for patients in the country. Pan India experts from reputed institutions and blood centres have also contributed towards the development of these standards.
Publication of these quality standards in IP 2026 ensures the quality and safety of blood and blood components used in transfusion medicine.
Blood transfusion is a procedure in which whole blood or parts of blood are put into a patient's bloodstream through a vein. The blood may be donated by another person or it may have been taken from the patient and stored as per regulatory requirements. People need safe blood transfusions to replace lost blood or specific blood components due to injury, surgery, or illness. Transfusions are vital for conditions like severe anaemia, major surgery, accidents, cancer treatment, childbirth complications, and inherited blood disorders.
The newly developed monographs for blood and blood components and general requirements integrate harmonized testing into a public standard, maintaining quality throughout the shelf-life of the product. By promoting the use of quality drugs and mitigating the risk of sub-standard medicines and practices, these quality standards directly contribute to the reduction of adverse effects and are the most crucial measure to safeguard patient well-being against public health catastrophes.
IPC, an autonomous institution under the ministry of health and family welfare, Government of India (GoI), serves as the standard-setting organization for drugs and pharmaceuticals across the country. In compliance with the Drugs and Cosmetics Act, 1940 and the Rules 1945 thereunder, IPC is dedicated to ensuring the quality, safety, and efficacy of medicines by continuously updating and expanding the IP.
|