Unveiling a roadmap to strengthen the drugs control administration (DCA) in Kerala and to improve the quality control mechanism, the experts in the health department have recommended setting up of Peripheral Drugs Testing Laboratories (PDTL) in selected districts on a private-public partnership model between the DCA and the pharmacy colleges.
The action plan was drawn up to tackle the mounting number of issues faced by the DCA like insufficient quality control measures, uncontrolled and unethical marketing of drugs, delay in withdrawal of not-of-standard-quality drugs, etc. These issues are like impediments affecting the operations of the drug regulatory mechanism in the state, said a senior officer in the health department.
“The quality control mechanism of the state is in real doldrums. As per available statistics, only 1.4 per cent of the entire batches of the drugs are being tested in the drugs testing laboratory (DTL) at Thiruvananthapuram annually. Government has been very seriously ruminating over the setting up of four more DTLs (one each at Ernakulum, Pathanamthitta, Thrissur & Kozhikode) to touch the testing facility to 10 per cent, for many years, but it will require a long period to complete all the process. So, the best and easiest way to solve the crisis is to set up PPP model PDTLs,” the officer said.
The roadmap suggests that Peripheral Drug Testing Laboratories can be set up in five districts of the state in the first phase, as a PPP initiative between drugs control department and the pharmacy colleges which offer B. Pharm course. The colleges which have already set up basic analytical laboratories as part of the curriculum have to provide the building and manpower to run the PDTL.
The plan suggests that one government analyst from the DTL at Thiruvananthapuram can be deputed to supervise the testing at each PDTL and he should be the custodian of equipments, glass-ware and chemicals provided by the drugs control department. The colleges should provide their manpower and infrastructural facilities except the equipments and chemicals. This will provide for excellent opportunities for exposure of the students in the area of quality control.
Regarding advantages of the PDTL, the officer pointed out that the state could set up five such peripheral drugs testing labs at a cost of Rs.3 crore within a span of six months instead of spending Rs.10 crore on the proposed DTL at Thrissur. On completion of the first phase of the project, the state will have five PDTLs, and in the second phase, all the districts will get one lab each. This will help the government to drop full-fledged DTLs requiring huge sum of money and time.
Another advantage is that the sampling capacity can be tripled to 18000 per annum from the present 3500 and the sample testing time can be drastically reduced to four weeks from the existing 24 weeks.
According to him, Kerala has more than 30 pharmacy colleges spread over the whole of the state, and their managements and staff will be interested in such a partnership benefiting their students, the officer said.