Usha Sharma – Mumbai
Post the ban on import, manufacture, sale, distribution and use of the Serodiagnostic test kits, the Drug Controller General (India) (DCGI) has requested zonal, sub zonal, port offices of Central Drugs Standard Control Organisation (CDSCO), to follow up with State Drugs Controllers on its effective implementation. The DCGI has circulated the letter to all State Drugs Controllers to stop the use of Serodiagnostic test kits for diagnosing tuberculosis.
Dr Hemant Koshia, Commissioner, Gujarat Food and Drug Control Administration (FDCA) said, “Today nobody is manufacturing the Serodiagnostic test kits in Gujarat. We had immediately circulated the notification to all chemists and druggists, stockists, retailers and doctors. We conduct regular check ups to ensure that the ban is effectively enforced.”
The Government of India, 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 Gazette Notification GSR432(E) and GSR433(E) dated June 7, 2012 prohibiting the import, manufacture, sale, distribution and use of ‘Serodiagnostic test kits for diagnosis of tuberculosis with immediate effect in the country. The Serodiagnostic test kits for diagnosis of tuberculosis are giving inconsistent and imprecise results leading to wrong diagnosis and their use is likely to involve risk to human being whereas safer alternatives are available.
The letter issued by Dr GN Singh, DCGI to all State Drugs Controllers mentions, “You are requested to ensure that the licenses granted in your state for the manufacture of ‘Serodiagnostic test kits for diagnosis of tuberculosis’ are cancelled with immediate effect and arrangement has been made to recall the kits from the market on a priority basis. 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.”