Indian Council of Medical Research (ICMR) may soon approve formation of a network of representatives from the clinical research fraternity in the country. These could include experts from medical colleges, pharmacy colleges, government medical centres, private hospitals and research centres across the country. This network of professionals could be engaged in providing the required support and assistance for the conduct of drug monitoring  and human studies in country.

The move is expected to bolster efforts to register the disease registries in the country to be able to get a direction on the kind of novel drugs required in the country to tackle some of the infectious diseases.

The Council has assessed the shortfall of experts over the growing number of drugs available for any disease or disorder. Therefore, it is looking to ensure a system in place with the formation of a network of representatives. The working committees and expert groups are already formed to put in place a network of clinical research representatives.

“We have sent in a proposal to our parent body, ICMR, for the creation of a network of representatives from the clinical research space,” said Dr Nilima Kshirsagar, National Chair (Clinical Pharmacology), Indian Council of Medical Research, dean, ESI-PGIMSR MGM Hospital.

Dr Kshirsagar who was in Bengaluru for the IPSCON 2013 stated that the network of clinical research representatives identified by ICMR would look to partner with the Medical Council of India and the Department of Health Research. This would be the first effort to capacity building of human resources in the sector of clinical research and pharmacovigilance.

“India needs policy action and evaluation of the current protocols in the area of clinical research. There is need for studies with old generic drugs, evaluation of risks and cost availability benefits with the existing medicines. The lacunae  is that despite some of the excellent research centres, the country lacks the representative data of drug studies on humans. This has seen the delay in the regulatory approvals. If the necessary drug references are made accessible, it would also be easy for drug regulators to speed up clearances,” she added.

Now the key benefit of the network of representatives is that  it could provide the required efficiency and transparency in having a better understanding of a disease and plan for research. It could help the country to maintain a database of drugs in the market and in the pipeline. The big benefit would be to the regulatory authority in helping take faster decisions on the submitted application for dug clearances by the pharma industry, she noted.