The Central Drugs Standard Control Organisation (CDSCO) is soon likely to adopt a mechanism that will ensure speedy approval of genuine and authentic innovative projects that are focused on research activities related to the field of immunological disorders and other emerging diseases segment. Through this initiative, the central regulatory body hopes to encourage research and development activities (R&D) in this segment within the colleges, research institutes and phrama companies to address the needs of the indigenous patient population.

Under the proposed plan, the regulatory body has decided to give special consideration to innovative research based ideas that will focus on developing strong base in the emerging area of stem cell therapy, gene therapy, transplantation etc. It is understood that in the coming years, one of the main agenda of the CDSCO will be to focus on developing and strengthening the preventive mechanism of health care system in the country along with cementing its hold in the curative techniques.

According to Dr G N Singh, Drug Controller General of India (DCGI), “We have to acknowledge that there is a lacuna in this area that needs to be addressed, so that the Indian patients can also get access to highest quality medicines that are safe and efficacious at an affordable price rather than depend upon other contemporary drugs that are already available in the market at exorbitant price. It is high time for the Indian drug makers and the scientist communities to come together and develop a symbiotic relation in this emerging field to develop drugs that will help addressing the needs of the Indian population.”

Dr Singh stressed that to make this into a reality there needs to be more pro active efforts that are targeted to explore collaborative efforts between the industry-academia and scientific community.

He further pointed out that at present there is a dearth of qualitative research initiatives in the area of developing medicines to address disease relating to immunological disorders. He said that there is a need to identify these grey areas so as to develop a foolproof mechanism aimed at addressing these issues at the latest and expressed his full cooperation in all the regulatory matters whereever possible.