The apex committee on clinical trials, constituted by the Union health ministry on the directive of the Supreme Court to monitor the clinical trial sector in the country, has cleared only 9 new clinical trial proposals, 5 proposals of global clinical trials (GCTs) and 4 in other areas. These trials were earlier approved by new drug advisory committees (NDACs) and thereafter the technical committee, another high-level panel formed by the ministry on this purpose.
Senior officials in the health ministry said that the apex committee, in its 16th meeting held on August 8 under the chairmanship of health secretary Lov Verma, deliberated in detail on the new proposals and ratified the recommendations made by the technical committee. Earlier, the technical committee in its meeting had evaluated and recommended for 9 proposals of various categories of clinical trials. Out of the total 9 cases, 5 cases were GCTs and the rest 4 cases were related to clinical trials for approval of new drugs including fixed dose combinations, subsequent new drugs and biologicals.
As per the direction of the Supreme Court made in its order April 21, 2014, the proposals of global clinical trials/clinical trials of NCEs are required to be evaluated with regard to three parameters like the assessment of risk versus benefit to the patients; innovation vis-à-vis existing therapeutic option; and unmet medical need in the country.
According to officials, the technical committee had deliberated upon a total of 23 proposals relating to clinical trials which had already been recommended by the NDACs. Out of those 23 cases, 13 cases related to global clinical trials/clinical trials of NCEs and remaining 10 cases related to clinical trials for approval of the new drugs including fixed dose combination, subsequent new drugs and biologicals.
The technical committee had noted that there were several clinical trial proposals concerning the field of oncology. Since Dr. Raju Titus Chacko who is an oncologist, and some other members were absent due to unavoidable circumstances, the committee deferred 12 proposals (7 from GCTs and 5 from others) to next technical committee meeting.
The technical committee had evaluated the remaining cases one by one and made recommendations. It evaluated 6 out of the13 cases of GCTs, considering all aspects of safety and efficacy especially in terms of the three parameters viz. risk versus benefit to the patients, innovation vis-a-vis existing therapeutic option and unmet medical needs in the country. After detailed deliberations, out of 6 cases, the committee recommended 5 cases for approval. In the remaining one case, it sought certain additional data/ information.
The committee also evaluated the 5 out of 10 cases of other than GCTs. After detailed deliberations, out of these 5 cases, it recommended approval of 4 cases as per the recommendation of the NDAC. In the remaining one case, the committee sought certain additional data/information.
CMC Vellore (Coagulation Factor VIII Concentrate), Eli Lilly (LY2605541-Insulin Basal Analog), Novo Nordisk (Semaglutide), MSD (MK-3102), and Max Neeman Medical International Limited (Octafibrin) are the companies who applied for global clinical trials and got the final approval from the apex committee.
Source:Pharmabiz
Senior officials in the health ministry said that the apex committee, in its 16th meeting held on August 8 under the chairmanship of health secretary Lov Verma, deliberated in detail on the new proposals and ratified the recommendations made by the technical committee. Earlier, the technical committee in its meeting had evaluated and recommended for 9 proposals of various categories of clinical trials. Out of the total 9 cases, 5 cases were GCTs and the rest 4 cases were related to clinical trials for approval of new drugs including fixed dose combinations, subsequent new drugs and biologicals.
As per the direction of the Supreme Court made in its order April 21, 2014, the proposals of global clinical trials/clinical trials of NCEs are required to be evaluated with regard to three parameters like the assessment of risk versus benefit to the patients; innovation vis-à-vis existing therapeutic option; and unmet medical need in the country.
According to officials, the technical committee had deliberated upon a total of 23 proposals relating to clinical trials which had already been recommended by the NDACs. Out of those 23 cases, 13 cases related to global clinical trials/clinical trials of NCEs and remaining 10 cases related to clinical trials for approval of the new drugs including fixed dose combination, subsequent new drugs and biologicals.
The technical committee had noted that there were several clinical trial proposals concerning the field of oncology. Since Dr. Raju Titus Chacko who is an oncologist, and some other members were absent due to unavoidable circumstances, the committee deferred 12 proposals (7 from GCTs and 5 from others) to next technical committee meeting.
The technical committee had evaluated the remaining cases one by one and made recommendations. It evaluated 6 out of the13 cases of GCTs, considering all aspects of safety and efficacy especially in terms of the three parameters viz. risk versus benefit to the patients, innovation vis-a-vis existing therapeutic option and unmet medical needs in the country. After detailed deliberations, out of 6 cases, the committee recommended 5 cases for approval. In the remaining one case, it sought certain additional data/ information.
The committee also evaluated the 5 out of 10 cases of other than GCTs. After detailed deliberations, out of these 5 cases, it recommended approval of 4 cases as per the recommendation of the NDAC. In the remaining one case, the committee sought certain additional data/information.
CMC Vellore (Coagulation Factor VIII Concentrate), Eli Lilly (LY2605541-Insulin Basal Analog), Novo Nordisk (Semaglutide), MSD (MK-3102), and Max Neeman Medical International Limited (Octafibrin) are the companies who applied for global clinical trials and got the final approval from the apex committee.
Source:Pharmabiz
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