India, with a population of more than 1.2 billion, currently has a healthcare sector of approximately US$50 billion, which is expected to rise at the rate of about 2% per year as per the Fitch Rating agency report released in January 2011. Currently there are 336 teaching hospitals in India with diagnostic laboratory facilities and over 12,000 private hospitals of various sizes and more than 100,000 private clinical laboratories. Test volumes serviced by Indian laboratories vary from a few hundred tests a day for regional and hospital laboratories to a few thousand per day for larger laboratories. India’s diagnostic laboratory sector is forecasted to grow at about 25% over the next 3 years and estimated to be about US$2 billion in the near future.
India, like the rest of the world, has from the early 1990s witnessed a flooding of the market with commercial microbiological kits, particularly in the field of immunodiagnostics. At the beginning these were primarily imported kits from the United States or Europe, but gradually indigenous kits as well as those from various Asian countries like Korea, Malaysia, and China have made their presence felt. These later kits in many instances have performed equally well as the Western manufactured ones and are substantially economical.
Analogous to the US Food and Drug Administration (FDA), the apex Government institution in India is the Central Drugs Standards Control Organization (CDSCO). This office is part of the Directorate General of Health and Family Welfare, Government of India. The CDSCO also has offices at the capitals of various states. The office of the CDSCO is the central licensing authority for all drugs, medical devices, and diagnostic kits. Licensing is a two-part procedure for select imported items (such as pharmaceutical products and medicines, and medical devices such as catheters and heart valves): the company interested in marketing a particular product manufactured abroad first has to obtain the license to import that item to India. Once the license is obtained, testing of the product by a Central Government approved laboratory needs to be completed and if it passes the test, then the second license to market the drug or product is issued. The microbiology products in this select category, requiring a two-part licensing procedure, include the immunodiagnostic kits and nucleic acid testing systems for HIV, HCV, and HBV. For all other imported items related to diagnostic microbiology products, a single licensing procedure to import the particular test or reagent is required. For various items manufactured in India, the manufacturer has the items tested by Central Government approved laboratories, followed by application to the licensing authority along with the test reports so as to market the product in the country.
The CDSCO has the following responsibilities:
- It implements policy and guidelines for quality assurance of diagnostic kits.
- It establishes the standards for assuring quality, safety, and efficacy of the kits.
- It ensures good manufacturing practice on the part of the manufacturers. To this end inspectors carry out visits to laboratories of the manufacturers from time to time without giving prior notice.
- It issues the license for importation of diagnostic kits and maintains a registry of licensed manufacturers. It also issues the license to the kit manufactured in India after receiving a satisfactory report from the reference laboratory.
- It carries out post-marketing surveillance to evaluate and monitor commercial kits that have been released into the market. It instructs the state laboratories to send representative kits being used to the reference laboratory for testing.
- It can recall the kits from the market in the event of any deviation in the kit quality after marketing.
The organogram of the test license section (used for products imported and for those manufactured in India) is as follows [2]:
The manufacturer first has to apply for the license of the product, addressed to the Drugs Controller General of India office. This application goes through the successive offices of the Deputy Drugs Controller, followed by the Assistant Drugs Controller and finally to the diagnostic cell or wing. All applications for licensing of products will be ultimately directed to this section (the diagnostic cell or wing), which then gives instructions to the state-level drugs controller office to send the test kits to an approved laboratory for evaluation. Once a satisfactory report is obtained from the state-level office, the diagnostic cell forwards the report to the Drugs Controller General, who is the final signatory for grant of license; and the manufacturer receives a license to market the product after completing the relevant documentary procedures. The test-licensing procedure is governed by the Drugs and Cosmetics Act of 1940 and rules of 1945, as amended from time to time. The validity of a manufacturer’s license is for a period of 3 years.
The apex testing laboratory in India is the National Institute of Biologicals (NIB) situated in the National Capital region of Delhi at Noida. It was established as an autonomous organization under the Ministry of Health and Family Welfare, Government of India registered in 1992. The overall objective of the institute is to ensure the quality of the biological products (which include diagnostic kits) and also to strengthen the regulation of biologicals in India. The institute assures and reviews the quality of biological products available through domestic manufacturer or imports. The operations are carried out in a state-of-the-art facility of the institute and in close collaboration with the Government of India’s regulatory authority, i.e., office of CDSCO. The NIB plays the following roles in India:
- Examination of in vitro
