India Pharma Outlook Team | Saturday, 14 March 2026
The centre has suggested reforms in the Indian drug regulations, hoping that the process of testing drugs that are produced using human plasma would be made smoother. This involves the elimination of frequent virus testing on the completed plasma-derived products, which include albumins, intravenous immunoglobulin (IVIG), and clotting factors, including Factor IX and Factor VIII.
These products play a crucial role in the treatment of immune disorders, serious infections, and such conditions as haemophilia.
The move is meant to make the drug regulations in India meet international standards. According to existing laws, the plasma used to obtain these medicines is screened against virus diseases such as HIV, hepatitis B and C. However, once a fractionation procedure is performed to produce medicines, the final products are again tested for viruses. This is a redundant step that is being proposed to be removed by the government.
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Dr. Aseem Kumar Tiwari, Senior Director, Department of Transfusion Medicine, Medanta, Gurugram, described how excess plasma from blood donations is usually utilized in the production of life-saving plasma-derived medicinal products. These medicines are carefully screened for safety, including checking for HIV, hepatitis B, and hepatitis C and viral inactivation of these medicines during the manufacturing process.
Dr. Tiwari has stressed that these products are not associated with the spread of the infection, as the safety measures are highly implemented. The change suggested is designed to streamline the process of testing and still ensure high safety levels that safeguard the health of the people.
A draft notification concerning the amendment of the Drugs Rules, 1945, has been published by the Ministry of Health seeking the opinion of the population. The finalization of the amendment requires 30 days within which the stakeholders can send feedback.
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