India to introduce more advanced testing for imported blood products to reduce infection risk

The ministry intends to introduce nucleic acid testing (NAT) to improve the screening of imported blood products for antigens or viral nucleic acids of the human immunodeficiency virus (HIV), the hepatitis B virus, the hepatitis C virus and other impurities, an official aware of the matter said.

The decision to shift to NAT has already been taken by the regulator, the Drug Controller General of India (DCGI), and the matter was discussed at the Drugs Technical Advisory Board meeting in April. The board is the highest statutory body responsible for advising the Central and state governments on technical matters related to the administration of the Drugs and Cosmetics Act, 1940.

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With the introduction of NAT, the conventional testing method known as ELISA, or enzyme-linked immunosorbent assay, will be done away with. ELISA, while a powerful tool, has several drawbacks, including the potential for false positive and negative results, apart from being time-consuming.

The Department of Pharmaceuticals and the National Institute of Biologicals (NIB) in Noida had issued an alert in October after the NIB found three imported blood products—Berirab-P (used in rabies injections), Hepabig (to prevent hepatitis B virus infection) and Tetglob (used for tetanus treatment)—to be of sub-standard quality.

When the Berirab-P and Hepabig samples were tested again at the National Institute of Virology in Pune using an advanced version of polymerase chain reaction, which is more sensitive than ELISA, they passed the test metrics. The set of Tetglob samples sent to a private laboratory that used ELISA were non-reactive.

Safety standards

Imported blood products are used for the treatment of critically ill patients or those who are suffering thalassemia and other blood-related disorders. These products are tested at government laboratories to ensure they meet safety and quality standards.

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“These are tested using conventional methods, but now the plan is to amend the rules to allow an advanced version of testing in line with international practices," the official said. “NIB also proposed that an amendment may be considered to test blood products by NAT."

Queries sent to the health ministry and the Department of Pharmaceuticals remained unanswered till press time.

“NAT testing gives accurate and quick results and nowadays it is highly used. NAT testing is used for tuberculosis and NAT testing was modified during the covid-19 pandemic to detect the coronavirus," a scientist from the Indian Council of Medical Research said, requesting anonymity. “The ELISA test may sometimes give false results if the viral load in the sample is low. However, PCR and NAT give accurate results even if the viral load is low."

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According to an assessment by the National Blood Transfusion Council, the apex policymaking body for issues pertaining to blood and plasma, the clinical requirement of blood in the country is about 14.5 million units per year. The volume of each unit of blood is about 450 ml.

In India, the import, manufacture, distribution and sale of drugs, cosmetics and notified medical devices are regulated by the Drugs and Cosmetics Act and the Drugs and Cosmetics Rules, 1945.

“Having witnessed decades of transformation in pharmaceutical and diagnostic excellence, we view inclusion of NAT in testing and releasing blood or plasma-derived products as a way forward. This change will bring alignment with the recommendation of Indian pharmacopeia," Bharat Serums and Vaccines Ltd said in a statement. “NAT’s superior sensitivity over ELISA will allow identification of viral antigen in the product, if they exist. This will ensure the best quality of product for the patients safety."