**Executive Summary**
The Ministry of Health and Family Welfare has issued a draft notification proposing amendments to the Drugs Rules, 1945, specifically concerning the testing norms for blood products. The primary objective is to align Indian regulatory requirements with global pharmacopoeial standards by removing duplicate viral testing for these products. Public comments on this draft amendment are invited within a prescribed timeline.
**Key Points / Main Content**
* **Objective of Amendment:** To align India's regulatory requirements for blood product testing with internationally accepted pharmacopoeial standards and eliminate unnecessary additional testing.
* **Harmonized Standards for Pooled Plasma:**
* The first homogeneous pool of plasma must be mandatorily tested for Hepatitis B surface antigen (HBsAg), Hepatitis C virus RNA, and antibodies to HIV.
* Pooled plasma must test negative for these viral markers to be approved for fractionation.
* Only plasma pools meeting these safety criteria can be used for manufacturing plasma-derived medicinal products.
* **Current Regulatory Issue:** The existing framework mandates re-testing of finished products manufactured from already tested and qualified plasma pools, leading to duplicated viral marker testing.
* **Alignment with International Practices:** The proposed amendment aims to eliminate this double testing, which is not consistent with international regulatory practices.
* **Benefits of Proposed Amendment:** The amendment is intended to promote regulatory harmonization, scientifically rationalize testing requirements, and reduce the compliance burden while maintaining high patient safety standards.
**Impact Analysis**
* **Manufacturers of Blood Products and Plasma-Derived Medicinal Products**
* **Impact:** Will benefit from a streamlined testing process, potentially reducing costs and time associated with regulatory compliance due to the elimination of redundant testing.
* **Action Required:** Review the draft notification and submit comments and suggestions within the specified timeline to influence the final rules.
* **Regulatory Bodies (Ministry of Health and Family Welfare)**
* **Impact:** Will be updating and harmonizing testing norms for blood products with international standards, ensuring scientific rationale and reducing unnecessary compliance burdens.
* **Action Required:** Review public comments received and finalize the amendment to the Drugs Rules, 1945.
* **Patients**
* **Impact:** Will continue to be protected by high safety standards as the amendment aims to uphold them while improving regulatory efficiency.
* **Action Required:** No direct action required, but may benefit from potentially improved availability or cost-effectiveness of plasma-derived products.
* **Public and Stakeholders**
* **Impact:** Given the opportunity to provide input on proposed changes to drug testing norms for blood products.
* **Action Required:** Review the draft notification and submit comments and suggestions within the prescribed timeline.
Key Entities Referenced
Drugs Rules, 1945: The foundational rules governing drugs, which are proposed to be amended.
Ministry of Health and Family Welfare (MoHFW): The government ministry issuing the draft notification and proposing the amendment.
Indian Pharmacopoeia (IP): A key pharmacopoeia whose standards are referenced for testing protocols.
British Pharmacopoeia (BP): A key pharmacopoeia whose standards are referenced for testing protocols.
United States Pharmacopeia (USP): A key pharmacopoeia whose standards are referenced for testing protocols.
Ministry of Health and Family Welfare
Ministry Invites Public Comments on Draft
Amendment to the Drugs Rules, 1945 to Update
Testing Norms for Blood Products
Proposed Amendment to Drugs Rules Seeks to Remove
Duplicate Viral Testing of Blood Products and Align with
Global Pharmacopoeial Standards
Posted On: 11 MAR 2026 9:37AM by PIB Delhi
The Ministry of Health and Family Welfare (MoHFW), Government of India, has issued a draft Gazette
Notification GSR 164(E) dated 9th March 2026, inviting public comments on a proposal to amend Para G
(Testing of Blood Products), Part XII C, Schedule F of the Drugs Rules 1945.
The proposed amendment seeks to align regulatory requirements for testing of blood products with
internationally accepted pharmacopoeial standards and to remove additional testing requirements on
products that are not warranted under global best practices.
As per the official monographs of Human Plasma for Fractionation in the Indian Pharmacopoeia (IP),
British Pharmacopoeia (BP), United States Pharmacopeia (USP), and European Pharmacopoeia (EP),
stringent testing protocols are prescribed for pooled human plasma.
Under these harmonized standards:
The first homogeneous pool of plasma is mandatorily tested for Hepatitis B surface antigen (HBsAg),
Hepatitis C virus RNA and antibodies to HIV.
The pooled plasma must test negative for these viral markers before it is permitted for fractionation.
Only plasma pools that meet these safety requirements are used for manufacturing plasma-derived
medicinal products.
Despite this, under the current regulatory framework, the final products manufactured from already tested
and qualified plasma pools are again tested.
This results in duplication of testing for the same viral markers at both the pooled plasma stage and the
finished product stage. Such double testing is not aligned with international regulatory practices.
The proposed amendment is a progressive step towards regulatory harmonization, scientific rationalization
of testing requirements, and reduction of avoidable compliance burden while continuing to uphold the
highest standards of patient safety.
Stakeholders are encouraged to review the draft notification and submit their comments and suggestions
within the prescribed timeline.
***SR
HFW–Public Comments Invited on Draft Amendment to Blood Product Testing Norms/11th March 2026/1
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