The diagnostic kits, components and reagents used for pathological tests have been classified under the Schedule C1 of the Drugs and Cosmetics Act, which currently deals with biological products like sera and blood products. With a recent notification by Drug Controller General of India (DCGI) in this effect, the manufactures of all these products are required to have special license to make and market these products in the country as it is applied on biological products.

The diagnostics segment, which was hitherto not strictly monitored by the drug regulatory system as far as licensing for manufacturing and sales are concerned, would require the mandatory licensing by the state or central drug control department. The licensing of the manufacture and trade of the diagnostic kits and agents would require the Form 19 and 19A of the Drugs & Cosmetics Act.

Currently, there are 15 main diagnostic products in the Indian market. The test kits for HIV, hepatitis B and C, pregnancy and thyroid hormones are the first five in terms of current sales. At present, the total market for diagnostic kits in India is around Rs.500 crore, and the combined annual growth rate is pegged at 25-30 per cent. The diagnostic kits industry in India consists of 55 to 60 companies. Of this, more than 80 per cent are confining themselves to trading activities, that is, import and marketing of the finished products. There are a few companies who import bulk reagents and do repackaging, labeling and assembling in India.

The recent notification issued by the Drug Controller General of India (DCGI), in this regard would make it mandatory for all the manufacturing units of the test kits and diagnostic reagents to have manufacturing licences issued by the state drug control authority and the products should be duly approved by the central authority in case of a new and from the state authority for existing line of products.

The government had earlier laid down statutory control on the quality of four diagnostic kits used in the country for HIV, hepatitis B, hepatitis C and venereal diseases. The move is aimed to ensure that hospitals and blood banks strictly meet the critical blood safety requirements. However, the government has now extended it other major kits such as malaria, tuberculosis, pregnancy, thyroid hormones, reproductive hormones, toxoplasma, typhoid etc as well with the current notification.

Screening of blood for these pathogens is currently mandatory for the blood banks operating in the country. The government has noted that the objective of blood safety could be really achieved only if the quality specifications for diagnostic materials are invariably adhered to.

A notification would be issued in a few days under Section 3 H of the Drugs & Cosmetics Act, prescribing the quality parameters for the four in vitro kits. The specifications would be in terms of the National Institute of Biologicals' standards on the required levels of sensitivity and specificity for these products, Drug Controller General of India, Ashwini Kumar said. All kits used in the country, imported kits as well as kits manufactured domestically, will be under the purview of the mandatory quality control, he said.

The enforcement of the standards would be through the state drug control departments, which are implementing agencies for the D&C Act. The regulatory authorities would make use of NIB's recently commissioned facility for quality detection of vaccines and diagnostic kits for enforcement requirements. Issuance of new blood bank licenses would be subject to the satisfaction of the regulatory authorities on the quality of the diagnostic kits and systems.

Sources said that the National AIDS Control Organisation (NACO), which gives financial and operational support for blood banks, would be providing additional assistance to the blood banks under central and state governments in order to enable them meet the new quality requirements. The private blood banks have to meet the specifications with their own resources.

It may be recalled that the government had made it mandatory for blood banks to confirm absence of hepatitis C virus in the blood stored and supplied by them with effect from June 1, 2001. With this, there are five compulsory diagnostic tests for the blood banks to conduct namely malaria, HIV, hepatitis B, hepatitis C and venereal diseases.