With India still predominantly being a generic drugs producing country, the focus should be on innovation, research and development especially on diseases of relevance to the Indian context such as tuberculosis, HIV and malaria, S. Eswara Reddy, Drugs Controller General of India, Central Drugs Standard Control Organisation, Union Ministry of Health and Family Welfare said.
Delivering the address at the 29th convocation of Sri Ramachandra Institute of Higher Education and Research (SRIHER) on Monday, he said, “India has been recognised as the world’s pharmacy, the biggest supplier of high quality, low priced generic medicines and vaccines that form the backbone of affordable care throughout the developing world. It has been our endeavour to promote generic drugs so as to make the medicines more affordable.”
One of the prime objectives of the regulator, he said was to ensure safety of medicines marketed in the country. “We have initiated Pharmacovigilance Programme of India. It gathers Adverse Drug Reactions (ADR) reported from across 250 ADR monitoring centres in the country. Majority of these centres are located in various medical colleges,” You have to play an important role in communicating ADRs to concerned authorities,” he said.
Due to the large patient pool, they were able to generate robust and quality data that is further analysed for signals, he said, adding that recently, they have issued directions to manufacturers to revise safety data for various antibiotics based on the signals from the Pharmacovigilance Programme.
Dr. Reddy pointed out that separate rules for regulation of medical devices were put in place. “The New Drugs and Clinical Trial Rules 2019, which was notified recently, will promote academic medical research, ensure time-bound approvals for clinical trials among other features,” he added. They would approve clinical trial protocols within a period of 30 days, he noted.
They were looking to regulate online pharmacies in the future, he added.
P. V. Vijayaraghavan, Vice-Chancellor of SRIHER, said the institute was in the process of establishing the faculty of engineering and technology and faculty of integrated medicine.
Gold medals were awarded to 22 students, while degrees were distributed to 452 graduates including Ph.D, super specialties, postgraduates and MBBS, a press release said. V.R. Venkataachalam, chancellor of the university, was present.
Article source: https://www.thehindu.com/news/cities/chennai/focus-of-research-should-be-on-tb-and-malaria/article26915796.ece