SRM Centre for Clinical Trials and Research (SRM – CCTR) has been approved by the Indian Council for Medical Research (ICMR) to carry out Phase 1 drug trials.
“It is a matter of pride and a recognition to our commitment to quality, pursuit of excellence in research”: Dr. P. Sathyanarayanan SRM Centre for Clinical Trials and Research gets ICMR nod for Phase 1 trial Kattankulathur SRM Centre for Clinical Trials and Research (SRM – CCTR) has been approved by the Indian Council for Medical Research
(ICMR) to carry out Phase 1 drug trials.
SRM Medical College Hospital and Research Centre received a circular to this effect from ICMR recently.
A great recognition for SRM:
“It is matter of great pride and recognition to our commitment to quality and pursuit of excellence which has yielded such results,” said Dr. P.Sathyanarayanan, Pro-Chancellor
(Academics), while reacting to the development. “It is even more special as more than 30 prestigious and premier institutions took part in the process, and we are the only private medical college and healthcare institution to be selected to conduct Phase 1 clinical trials,” Dr. Sathyanarayanan added.
The work began in June 2022 with ICMR initiating the process for selecting institutions with the requisite infrastructure, capabilities, experience, manpower and other resources to set
up Phase 1 clinical trial infrastructure as part of its endeavour to promote and support drug discovery and development.
Phase 1 trials most crucial:
Dr. Satyajit Mohapatra, Director CCTR, (Centre for Clinical Trials and Research), explained that after late phase trial (phases 2 and 3) network had already been established in the country and now their latest initiative will help in establishing Phase 1 clinical trial network. Phase 1 is important as it is the stage where drugs are tested for their safety and a safe dose is selected for the next phase of development.
He said that since their institution was shortlisted, they had been working tirelessly. The process included presentations about their infrastructure and experience, site visits and
inspection by the ICMR team and a technical review committee.
Dr. Mohapatra said that ICMR had rolled out its plan to establish Phase 1 centres as part of its CARE (Centre for Advanced Research) scheme to encourage in-depth research. “These CARE facilities will be national assets that will immensely help Indian researchers working in drug discovery and development in therapeutic areas of priority to the nation,”
Further, the facilities will function as stand-alone facilities capable of effectively carrying out Phase 1 clinical trials of the highest quality.
The clinical trial centre was established more than a decade ago and carrying out late-phase trials and in 2020, they conducted trials on COVAXIN. They were also part of the Mission COVID Suraksha Project of the Department of Biotechnology, Government of India. They received assistance from BIRAC (Biotechnology Industry Research Assistance Council) that strengthens, empowers the emerging Biotech enterprise to undertake strategic research and innovation, addressing nationally relevant product development needs. The SRM CCTR, Dr. Mohapatra said, was a Centre of Excellence with state-of-the-art facilities with dedicated consent, data storage, blood collection and separate rooms, a pharmacy and
all other facilities meeting laid-down norms of clinical trials. In addition to their existing floor space of about 5,000 square, feet they would be adding another 8,000 square feet to meet the demands to carry out Phase 1 trials.
Dr. Mohapatra said their experience – especially in COVAXIN clinical trials, infrastructure, location within a hospital and being close to an Intensive Care unit (within SRM Hospital)
were some of the strengths.
Recognition for research:
“This is a great and important development, and recognition for the stringent quality and commitment to research at SRM Medical College Hospital and Research Centre. I would like to congratulate Dr. Mohapatra and his team of highly skilled and dedicated staff for this achievement,” Dr. Sathyanarayanan added.
Dr. Lt. Col. A. Ravikumar, Pro Vice Chancellor (Medical), lauded the team, stating that this brought to an end, more than 1 yea of rigorous work. The entire team had worked very hard to ensure that every single norm of ICMR was met with due diligence.