The Karnataka drugs control department has initiated an internal audit of the drugs tested in the laboratory. An external auditor would verify ten per cent of all the samples tested at the department's drug testing laboratory.
"The decision to verify tests of samples will help us to provide quality reports and avoid unnecessary errors," said Dr Suresh K Muhammed, drugs controller.
As a part of a modernisation plan, the department has also approached the Drugs Controller General of India (DCGI) for funds to open a world-class resource centre in the drug testing laboratory library.
In a bid to increase the speed of file clearance, the department recently received a central government grant, which allowed it to install 12 new computers. Plans are underway to introduce online acceptance of manufacturing license applications once the web site of the department is ready by the National Informatics Centre (NIC).
The department's enforcement wing represented by drug inspectors are now kept under surveillance by an external body to ensure that they undertake routine inspection of all manufacturing units besides the mandatory evaluation for GMP certification or renewal of licenses or export clearances. The drug inspectors have to now pick up drug samples at random to ensure that the units are maintaining standard quality parameters for both the domestic and international markets. The number of prosecutions launched by the enforcement wing has increased manifold. "At the same time we are becoming extremely customer-friendly and we are playing proactive role to improve the pharma trade and manufacturing business in the state," said Dr Muhammed.
The drugs controller wants the drugs testing laboratory to become the first accredited lab approved by the National Accreditation Board for Testing and Calibration of Laboratories (NABL) set up a Lab Consultative Committee which has laid down the standard operating procedures (SOPs) related to glassware, washing, storing chemicals etc. The staff's training needs are being identified. The department has been selected for an intensive month-long training programme by the National Institute of Pharmaceutical Education and Research (NIPER), Chandigarh under a World Bank project from January 2004. In addition, AstraZeneca and Biocon have agreed to train the chemists from the drug testing laboratory on quality, maintenance and use of equipment, so that good laboratory practises (GLP) are followed.
A team represented by officials from the drugs control department and pharmacy trade would submit a status report on the distribution of medical shops in the state. The objective is to prevent the mushrooming of medical shops in areas where already enough number of shops exist. Then we can prevent the unethical practises in the pharma trade, said Dr Muhammed.