National model for replicating benchmarking of basic research investigations in govt institutes: a case for ministries of science and technology and health and family welfare

ANNALS COMMENTARY " Good Laboratory Practices (GLP) " enshrined under the OECD guidelines provide an excellent framework in raising the bar in research productivity in our country. Ironically, none of the publicaly funded labs in the country have adopted these norms for basic research investigations. If these norms are adopted it may result in enhancing the quality standards, increase credibility, efficiency and transparency of research and diagnostic facilities. This is the first time that the Neuro-science Research Lab at PGI chandigarh was awarded National Award by Quality Council of India for implementing quality principles voluntarily. This innovation has led to a system dependent technical and managerial procedures facilitating research audit and document control, improving purchase and accounting procedures as well as human resources besides delivery of patient care diagnostic services. The conventional system of running research labs in India is based on no established or uniform method of management relying on individual preferences and experiences. Unfortunately, even the individual medical institutes do not define modules of running research facilities unless mandated by GMP requirements defined by regulatory authorities. This happens in the case of clinical trials where patient's safety and care is involved. These trials have been presumably halted due to questionable data and lack of back trace-ability of information. The ability to bring clinical level safety at the pre-clinical (basic research investigation) level makes this innovation unique transparent and credible for effective clinical translation. This can stimulate knowledge economy and attract huge investments from around the globe. The current quality systems in Neuro-science Research Lab encourages goal driven, self proposed monthly master schedule of activities in consultation with the study director, using the combination of Standard Operating Procedures (SOPs), Data Recording Sheets (DRSs) and master schedules. The Quality Assurance (QA) conducts periodical audit of the progress, compliance and reproduc-ibility of experiments giving a new lease to research output. The data generated is filed in a defined format using a mandatory raw book, master code, calibrated instruments (with IQ, OQ, PQ), log sheets with continuously regulated infrastructure and room environment providing back up for each facility (including power outrage). This data and samples (if any) are archived in defined shelves or freezers as the case may be so that research productivity and quality is enhanced. The electronic repository of entire data is maintained in dedicated servers secured by physical installation of firewalls. The entire system in the research facility operates …