The Union health ministry will soon constitute an expert committee comprising of experts from various therapeutic areas to re-examine the issue as to whether clinical trials can be allowed to be conducted in hospitals having less than 50 beds with or without emergency facilities.
A recommendation to this effect was given by the apex committee on clinical trials which was constituted by the Union health ministry in April this year on the directive of the Supreme Court to monitor the clinical trial sector in the country.
“An expert committee comprising of experts from various therapeutic areas viz. two experts each from medicine, pharmacology, oncology, cardiology, nephrology and one expert each from ophthalmology, dermatology and endocrinology needs to be constituted to re-examine the issue as to whether, depending on nature of clinical trial in a particular therapeutic area, clinical trial can be allowed to be conducted in hospitals/institutes having less than 50 beds with/without emergency facilities”, the apex committee in its 16th meeting held on August 8 under the chairmanship of health secretary Lov Verma recommended, ratifying the recommendations of the technical committee, another high-level panel formed by the ministry on this purpose.
The committee also opined that the proposed expert committee may co-opt suitable expert(s) from other discipline as per requirement.
The issue came up for discussion in the apex committee meeting on August 8 as Dr. Sunil M. Jain, managing director of TOTALL diabetes Hormone Institute, Indore, Madhya Pradesh had once again requested to revise the essential need of 50 bedded hospitals to conduct a clinical trial and to grant permission for the conduct of clinical trials at their 20 bedded facilities.
The applications for inclusion of TOTALL was submitted by Novo Nordisk India Ltd (the sponsor) to CDSCO for two global clinical trials in subjects with type II diabetes i.e. CT/76/13: a trial comparing cardiovascular safety of insulin degludec versus insulin glargagine in subjects with type 2 diabetes at high risk of cardiovascular events; and CT/69/13: efficacy and safety of Semaglutide once weekly versus Sitagliptin once daily as add on to Metformin and/or TZD in subjects with type 2 diabetes.
Early last year, Dr Sunil Jain had approached the CDSCO for the same. The technical committee and apex committee in its meetings dated 23.08.2013 and 30.08.2013 had recommended that for all clinical trials the sites should be multi specialty hospitals with emergency services and having institutional ethics committees.
In view of the representations made by Dr. Sunil Jain, the matter was again put forth to the technical committee experts in the 14th meeting dated 28.04.2014. The committee after due deliberation did not recommend for the addition of this site under the said studies as the site is having only 20 beds. The committee further recommended that the clinical trial sites should have minimum 50 number of beds in the institute/hospital with emergency medical care facility.
But, Dr Jain once again requested to reconsider the proposal. The apex committee in its latest meeting on August 8 recommended that under the present circumstances, the status quo shall be maintained with respect to the requirement of 50 bedded hospital with emergency medical care facilities for conducting clinical trial.
However, the committee recommended that an expert committee comprising of experts from various therapeutic areas needs to be constituted to re-examine the issue.