New Delhi: The Ministry of Health plans to order the use of faster and more accurate methods for testing all imported blood products to maintain the highest safety standards and reduce the risk of transfusion infection.
The Ministry intends to introduce nucleic acid testing (NAT) to improve screening of imported blood products for antibodies of human immunodeficiency virus (HIV), Hepatitis B virus, Hepatitis C and other impurities, official, official.
The decision to the transition to NAT has already been adopted by the regulatory body, the CEO of the drug controller India (DCGI) and the matter was discussed at the Council for Technical Advisory Board of Drugs in April. The Board of Directors is the supreme legal body responsible for consulting the central and state governments in technical issues related to the administration of the 1940 drug and cosmetics law.
With the introduction of NAT, a conventional test method is known as Elisa or an enzyme -bound immunosorbent test. Elisa, while a powerful tool, has several disadvantages, including the potential of false positive and negative results, except for time -consuming.
The Ministry of Drugs and the National Institute of Biological Substances (NIB) in Noida issued a warning in October after NIB found out that three imported blood products-bar-p (used in rabies), hepabig (to prevent hepatitis b) and tetglob)-used for tetanus treatment).
When the BERAB-P and HEPABIG samples were re-tested at the National Institute of Virology in Pune using the advanced version of the polymerase chain reaction, which is more sensitive than Elisa, they have undergone test metrics. A set of tetglob samples sent to the private laboratory used by Elisa was unreactive.
Safety standards
Imported blood products are used to treat critically ill patients or those suffering from Thalassemia and other blood -related disorders. These products are tested in government laboratories to ensure that they meet safety and quality standards.
“They are tested using conventional methods, but now it is planned to change the rules to allow the advanced version of testing in accordance with international procedures,” the official said. “NIB also suggested that the change can be considered to test blood products from NAT.”
Questions sent to the Ministry of Health and the Ministry of Drugs remained unanswered until the press period.
“NAT testing provides accurate and quick results and is used highly nowadays. NAT testing is used for tuberculosis and NAT testing has been adapted to detect coronavirus during the COVID-19 pandemic,” said a scientist from the Indian Medical Research Council and demanded anonymity. “The ELISA test can sometimes provide false results if the viral load in the sample is low. However, PCR and NAT provide accurate results, even if the viral load is low.”
According to the evaluation of the National Council for Blood Transfusion, the APEX policy authority concerning blood and plasma issues, 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, production, distribution and sale of drugs, cosmetics and announced medical devices are regulated by the Act on Drugs and Cosmetics and the Rules of Drug and Cosmetics, 1945.
“When we have witnessed a decade of transformation into pharmaceutical and diagnostic perfection, we perceive the integration of NAT into testing and release of blood or products derived from plasma as a way forward. This change will bring harmonization with the recommendation of Indian pharmacopeia,” Bharat series and LTD vaccines in a statement. “Set sensitivity NAT over ELISA will allow the identification of viral antigen in the product if they exist. This will ensure the best quality of the product for patient safety.”
(Tagstotranslate) testing of nucleic acids
