The central government has included four critical diagnostic kits for blood testing namely those for HIV 1 and 2, hepatitis B and C in the Schedule C (1) of Drugs & Cosmetics Rules, to bring stricter regulatory control on import as well as domestic manufacture of these kits. Schedule C (1) contains sensitive biological products for healthcare and manufacture of all items listed therein are subject to specified conditions including licensing under the more exacting Form 28. The amendment has come in force since September 1, 2002.
According to a recent notification issued by the Ministry of Health, in vitro blood grouping sera and in-vitro diagnostic devices for HIV (1 &2), hepatitis B surface antigen (HbsAg), and hepatitis C antibody (HCV) are being included in the said Schedule. The notification says that the decision was taken after consultation with the Drugs Technical Advisory Board (DTAB).
All the four diagnostic tests are currently mandatory for blood banks, along with the tests for malaria and syphilis. The government had included hepatitis C test as the fifth compulsory test for donor blood in June last year. There are about a dozen domestic manufactures of these diagnostic kits in the country at present, including Dr Reddy''s, Cadila Pharmaceuticals, Lupin Laboratories, Delhi-based J Mitra and Bangalore-based XyCton.
The regulatory control on the manufacture of these products will now be strengthened as per the conditions stipulated in the Schedule C (1). The existing manufacturers are likely to be asked to renew their licences under Form 23, while all new licence applications will be subject to the stringent conditions applicable for Schedule C (1) products.
Imported diagnostic kits are already under regulatory control commensurate to the Schedule C (1) prescriptions, with these devices being included in the import registration rules notified by the government the previous year.