Abstract

The present review lays emphasis on the history, regulations, and processes involved in the approval of In vitro Diagnostic (IVD) kits in the Indian Market. Diagnostic system or apparatus used for diagnosis are called diagnostic kits. Some important types of kits, based on their mechanism of actions, are (i) Immunoassay diagnostic kits; (ii) Polymerase chain reaction diagnostic kits; (iii) Displacement polynucleotide assay employing polyether and diagnostic kits; (iv)Diagnostic kit as well as a diagnostic method utilizing carbohydrate receptors; (v) One-step detection of matrix metalloproteinase activity using a fluorogenic peptide probe-immobilized diagnostic kits. Previously, as per the Drugs and Cosmetics Act 1940, IVD kits were classified into notified and non-notified category. Notified category IVDs includes in vitro Diagnostic Devices for HIV; in vitro Diagnostic Devices for HBV; in vitro Diagnostic Devices for HCV and in vitro Blood grouping sera. Recently, on November 1, 2017, Central Drug Standard Control Organization (CDSCO) published risk-based classification of medical devices and IVD kits on the origin of their intended use. The guideline has been implemented with effect from January 1, 2018. As per the new guidelines, the IVD kits have been categorized into four categories based on their level of risk, such as Class A (low risk); Class B (low moderate risk); Class C (moderate high risk), and Class D (high risk). Class A and B are processed and regulated through the State Licensing Authority, while C and D are processed and regulated by the Central Licensing Authority. The new guideline is not only limited to IVDs but also regulates the in-vivo diagnostics. New guidelines are very well aligned in terms of regulations of western countries and are a significant and revolutionary step in regulations of IVDs in the Indian market.

Keywords: In vitro diagnostic kits, Central Drug Standard Control Organization (CDSCO), approval process, medical device, HIV, HCV.

Graphical Abstract