Random quality testing of pharmaceutical products picked up from the market is a routine practice followed by most of the state drug authorities in the country for several years. In most of the states, drug inspectors are given monthly targets for drawing samples from the market, for testing them and for initiating prosecutions. The objective of this exercise is to ensure quality of pharmaceutical products circulating in the market. The question of maintaining the quality of licensed pharmaceutical products continues to be a disturbing issue in India as the system of product licensing is not ideal. Once a drug is approved for marketing in India by the DCGI, manufacturing license for its formulations can be issued by state drug authorities. But, before product licenses are issued by state drug authorities for the manufacture and sale, these local authorities do not insist on bioavailability or efficacy studies of the product. There is also no guarantee that product contains the quantum of ingredient claimed on the label. In the case of fixed dose combinations containing the new drug with any other drug, product licenses are issued without conducting clinical trials. Fixed dose combinations of a new drug are also considered to be new drugs and the statutory three phase clinical trials have to be completed before allowing them for marketing. This not done by state authorities today. In short, the quality question of a pharmaceutical product begins right from here.
And the random testing of samples from the market has become just a routine for some or a means to extract bribes for others in the state drug authorities. First of all, most of the state government drug testing laboratories numbering about 20 are not well equipped to test certain formulations. The testing equipments in these laboratories are not of uniform standards and the reagents and other inputs used are not of high quality. The test results of the product samples could therefore be quite inaccurate or wrong. Variation of test results in state government laboratories is a serious problem faced by drug companies with not much of an option for appeal. Haryana government's recent decision allowing drug companies to test their products in a private laboratory in cases of disputes relating to the quality and efficacy, in this regard, is, thus, a reformist move. The drug companies are thus free to challenge any test result with that of a result from a private lab of their choice. Haryana government still has the option of verifying the result provided by the drug company with a central government laboratory. Such an option of drug testing for quality should be available to drug companies in other states too until a system of annual auditing of testing laboratories is introduced in the country. DCGI had already constituted an expert group to draw up an elaborate checklist for auditing of drug testing laboratories.