The Drugs Controller General of India (DCGI) has asked the state drug authorities to take immediate steps to ensure the ban of serodiagnostic test kits for diagnosis of tuberculosis which was banned by the Centre in June.
“The Ministry of Health and Family Welfare, in exercise of powers conferred under Section 10A and Section 26A of the Drugs and Cosmetics Act, 1940 has issued a notification prohibiting the import, manufacture, sale, distribution and use of serodiagnostic test kits for diagnosis of tuberculosis with immediate effect in the country in public interest as the use of the kits are giving inconsistent and imprecise results leading to wrong diagnosis and their use is likely to involve risk to human beings whereas safer alternatives are available,” said a letter by DCGI Dr G N Singh to the state drug controllers.
“You are requested to ensure that the licences granted in your state for manufacture of serodiagnostic test kits for diagnosis of tuberculosis are cancelled with immediate effect and arrangements are made to recall the kits from the market on top priority. The chemists, druggists and manufacturers in your state should also be directed to stop the manufacture, import, sale, distribution, and use of these kits with immediate effect and return the unused stocks to the manufacturers,” the directive said, asking them to intimate the DCGI office on the actions taken thereof.
The Centre had banned the test kits following negative policy statement issued by the WHO over commercial serodiagnostic tests for tuberculosis stating that “commercial serological tests provide inconsistent and imprecise findings resulting in highly variable values for sensitivity and specificity”.
“There is no evidence that existing commercial serological assays improve patient-important outcomes, and high proportions of false-positive and false-negative results adversely impact patient safety. Overall data quality was graded as very low and it is strongly recommended that these tests not be used for the diagnosis of pulmonary and extra- pulmonary TB,” the WHO policy statement concluded.