Draft Drugs (Amendment) Rules, 2026: Aligning Blood Product Testing with International Standards

On 9 March 2026, the Ministry of Health and Family Welfare issued the draft of the Drugs (Amendment) Rules, 2026, for public consultation.

Key Highlights of the draft Drugs (Amendment) Rules:

1. This Draft proposes revisions to the Drugs Rules, 1945 to bring India’s regulatory framework for blood product testing in line with internationally accepted pharmacopoeial standards.

2. The official monographs for Human Plasma for Fractionation in the Indian Pharmacopoeia (IP), British Pharmacopoeia (BP), United States Pharmacopeia (USP), and European Pharmacopoeia (EP), prescribe strict, harmonized testing protocols for pooled human plasma.

3. As per these monographs:

   • The first homogeneous plasma pool must be tested for Hepatitis B surface antigen, Hepatitis C virus RNA, and HIV antibodies.

   • The plasma pool must test negative for all these markers before it can proceed to fractionation.

   • Only plasma pools that meet these safety criteria, can be used for manufacturing plasma derived medicinal products.

4. Despite these extensive controls, the existing regulatory requirements also mandate testing of final finished products, although these products are manufactured from plasma that has already undergone and cleared the prescribed viral marker testing.

5. This results in unnecessary duplication, as the same viral markers are tested both at the plasma pool stage and at the finished product stage, a practice not aligned with international regulatory norms.

6. Thus, the proposed amendment addresses this gap by omitting the following requirement from Schedule F, Part XII C, Para G:

   “The final products shall be tested for freedom from HIV I and HIV II antibodies, Hepatitis B surface antigen and Hepatitis C virus antibody.”

7. This amendment marks a meaningful step toward harmonizing blood testing rules with global best practices, ensuring scientifically justified testing, and reducing avoidable compliance burden, while maintaining high levels of patient safety through validated plasma‑pool testing.

8. Stakeholders will review the draft and submit their feedback within 30 days of its publication.