Apex committee on clinical trials gives approval to 33 proposals of clinical trials

Ramesh Shankar, Mumbai Wednesday, November 12, 2014, 08:00 Hrs  [IST]

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 a total of 33 proposals, 18 proposals of global clinical trials (GCTs) and 15 in other areas, after these were approved by Subject Expert Committees (SECs) and thereafter the Technical Committee, another high-level committee constituted by the ministry on this purpose on the directive of the Supreme Court.

According to senior officials in the ministry, the Apex Committee in its 17th meeting held on October 15 deliberated in detail on the new proposals and ratified the recommendations made by the Technical Committee.  The Technical Committee had deliberated on 35 cases related to approval of clinical trials and protocol amendments.

As per the direction of the Supreme Court made in its order April 21, 2014, the proposals of global clinical trials (GCTs)/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.

Out of these 35 cases, 19 cases were related to GCTs, remaining 16 cases were related to clinical trials for approval of new drugs including fixed dose combination, subsequent new drugs and biologicals. Out of 19 GCT cases, 11 were for approval of clinical trials and remaining 8 cases were for approval of protocol amendments.

After detailed deliberation, the Technical Committee recommended approval for 10 out of 11 cases of global clinical trials and all 8 cases of protocol amendments as per recommendations of the SECs. In one case of global clinical trial of anti-TB drugs (rifapentine, isoniazid), the Committee recommended that the applicant should be asked to make a presentation before the Committee in presence of HIV and TB experts.

PPD (biosimilar rituximab and trastuzumab biosimilar), Wyeth  (bosutinib),  Novartis (glycopyrronium bromide/NVA237, and LDK378 -NCE), MSD (sitagliptin and metformin HCl extended release, FDC tablet), INC Research (hercules-trastuzumab), BMS (dasatinib), Boehringer (BIBW2992-afatinib), Roche (trastuzumab emtansine), Pfizer (axitinib), Klinera (tenofovir disaproxil fumarate), Asiatic (ART-123-thrombomodulin alfa), Amgen Technology (AMG 145), Siro Clinpharm (GZGD03109), Eli Lilly (LY2963016) and Manipal (QPI-1007) are some of the companies which applied for global clinical trials and got the approval.