Clinical research in India may soon get a much-needed boost. The Indian Council of Medical Research (ICMR) and drug maker Sun Pharma are in talks to create a structure to fund clinical programmes focused on diseases prevalent here. A joint working group under the existing ICMR-Sun Pharma partnership met on Thursday to discuss avenues to improve innovation in the country through “well-characterised” sites to conduct disease burden studies and clinical trials.
Well-characterised sites have a high burden of the disease as well as healthcare facilities and experts who could diagnose, treat and monitor patients over time, according to Sun Pharma senior advisor for global health Altaf Lal. He is also a chair of this joint working group. The group is considering a hub-and-spoke model of clinical trial and research sites as well as specialised laboratories, said Lal. A central unit linked to ICMR will manage these sites, distributed across the country based on the burden of the disease being studied, he said.
While details of the structure are yet to be chalked out, the group has so far considered prioritising infectious diseases like dengue and TB, Lal said. The sites could require anywhere between Rs 6 crore and Rs 40 crore in funding, according to him. At the same time, the actual funding requirement may vary as the process is still in a nascent stage, he added.
ICMR and Sun Pharma’s joint working group is expected to put together a policy paper by the time it meets again in March 2017 and will seek inputs on it from academicians and the industry, Lal said. The group intends to reach out to other pharmaceutical companies involved in innovation in India, he added. India currently lacks adequate well-characterised sites, which are vital to understand the nature of the pathogen and ailment as well as the clinical manifestation of the illness, according to Lal. It provides a baseline for trials of new drugs and vaccines targeting these ailments, he added.
“We don’t have enough data in India so it becomes difficult to design programs where data (is lacking),” Lal told ET. For instance, out of 26 new drugs approved in India in 2015, over half had no information related to women because the data was lacking, he said. According to ICMR director general Soumya Swaminathan, India needs more information and data on the burden of various prominent diseases, emerging infections and micronutrient deficiency. It also needs long term studies that follow up on patients to understand the risk factor of the disease.
Content Credit: EconomicTimes.Indiatimes.com
Original Article: Click Here
