Apex panel on clinical trials gives nod to 21 fresh proposals

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The apex committee set up by the Union health ministry to monitor the clinical trials sector and headed by the health secretary has cleared 21 out of the 22 fresh proposals for clinical trials, after they were recommended by new drug advisory committees and thereafter the technical committee, another high-level panel formed by the ministry.

In a recent meeting of the apex committee, 22 applications were taken for ratification after the clearance by the technical panel and the panel evaluated the cases in view of risk versus benefit to the patients, innovation vis-à-vis exiting therapeutic option and unmet medical need in the country. The committee then ratified the recommendations by the technical committee in this regard.

Out of the 22 cases came up before the technical committee, four cases of clinical trials were for new drugs, 11 cases for global clinical trials and the remaining were clinical trial proposals related to fixed dose combinations, biological and institutional trial.

In the case of study on Ifetroban by Max Neeman, the CRO, the technical committee recommended to submit the proposal along with the opinion of the pharmacologist,, though it was cleared by the NDAC. In all other 21 cases, the panel recommended the approval by the authorities.

Siro Clinpharm (N 201), Excel Life Sciences (fluocinolone acetonide intravitreal insert), Novartis (ranibizumab), Aurobindo Pharma (cyclosporine), Bicad (algeron), Maya Clinicals (masitinib mesylate), Parexel (asenapine), PPD (permapanel and E2007-perampanel) and Novartis (biosimilar adlimumab) applied for global clinical trial and got the approval.

Bharat Serums and Vaccines Ltd (recombinant human chorionic gonadotrophin), Dr Reddy’s Laboratories (rituximab), Reliance Life Science (trastuzumab),  Fresenius Kabi (smofkabiven peripheral and smofkabiven), Wockhardt (nadifloxacin), Dr Pratibha D Singhi (tizanidine), Sanofi-Synthelabo India Ltd (plerixafor solution),  Hetero Labs (retigabine), Zuventus Healthcare Ltd (fenspiride hydrochloride) and Glenmark Pharma (crofelemer) also got the clearance by the panels for clinical trials.

The health ministry had formed the two high-level panels to streamline the approvals to the clinical trials in wake of severe criticism by the Supreme Court on the malpractices and lethargy in the sector.

Source: PharmaBiz


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