Lack of adequate number of modern drug testing laboratories at the Centre and in most of the states continues to be a serious handicap of Indian drug regulatory machinery even today. Thousands of drug samples, collected by the drug inspectors from all over the country are not being tested on time and are lying with the labs for several months. Probably this inadequacy of testing facilities is what is hampering the detection of substandard and spurious drugs in the country. Currently there are only 6 central drug testing laboratories with a capacity to test 8,000 samples per annum. The Central Drug Testing Laboratory, Hyderabad is yet to be equipped and the other five Central Drug Testing Laboratories at Kolkata, Mumbai, Chennai, Guwahati, and Chandigarh are not fully equipped and requires urgent upgradation with the state-of-the-art facilities for testing and analyzing complex formulations. Then there are 160 drug testing laboratories in the approved private and government sectors in various states. Most of these state drugs testing laboratories are also not fully equipped with adequate manpower and infrastructure. Considering the current global status of Indian pharmaceutical industry, the drug testing laboratories in the country need to conform to international norms. Just upgradation of the existing facilities will not be enough. It is in this context, the Drugs Technical Advisory Board suggested in 2004 that Good Laboratory Practices (GLP) should be made mandatory for all drug laboratories in the country. A draft in this regard was then prepared on the basis of the recommendations of the Mashelkar Committee on Drug Regulation. The committee called for mandatory GLP norms for all approved testing laboratories and also in-house testing laboratories of drug manufacturers. This would make India one more step closer to the international practices in most of the stringent drug regulations followed by developed nations.
Union ministry of health had thus notified the Schedule L-I of Rules 74, 78 and 150 E under Drugs & Cosmetics Third Amendment Rules 2008 giving the pharmaceutical industry time till November 1, 2010 for compliance of GLP. With Schedule L-I of Rules 74, 78 and 150 E, all pharmaceutical companies have to comply with the GLP and make the necessary requirements of premises and equipments. As per the GLP norms, all laboratories and organizations carrying out testing, calibration, validation, etc have to adhere to Schedule L-I. The management of the labs should have a team of qualified personnel to carry out all technical activities for the implementation of documented quality system. Now, although GLP norms are mandatory for all the labs from 2010, most of the laboratories are yet to comply with the norms. The Union health ministry has thus decided to do an audit of state drug testing laboratories in collaboration with the State drug authorities with respect to their GLP compliance. This exercise is in view of a proposal for capacity building of the laboratories with a massive investment which is under the consideration of the Planning Commission for implementation during the current Five Year Plan. It would be desirable therefore, the health ministry take the initiative to modernize the Central and state government labs without any delay so that private labs are motivated to do the same without much pressure.