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subject expert committee

Zydus granted permission for clinical trials of antibody cocktails

by Medically Speaking Team June 4, 2021

New Delhi: The only Indian company Zydus Cadila which claims to have developed neutralising monoclonal antibodies (mAbs)-based cocktail for the treatment of Covid-19 has been given permission to conduct clinical trials by the Subject Expert Committee (SEC) of Central Drugs Standard Control Organisation (CDSCO), according to sources.

“SEC gives a recommendation for the Phase I and II clinical trials of Zydus Cadila’s biological therapy ZRC-3308, a cocktail of two SARS-CoV-2-neutralising monoclonal antibodies (mAbs) that can emerge as one of the main treatments for mild Covid-19,” the sources said.

These antibodies are made by cloning unique white blood cells. Domestic pharmaceutical major Zydus Cadila sought the Drug Controller General of India (DCGI) permission recently to undertake clinical trials.

June 4, 2021 0 comment

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Sputnik V gets no Nod from CDSCO panel

by Medically Speaking Team April 2, 2021

written by Medically Speaking Team

An expert panel of India’s central drug authority has sought additional data and information from Dr Reddy’s Laboratories which has sought emergency use authorization for Russian Covid-19 vaccine Sputnik V, while deferring its decision on it till the next meeting, sources said.

In light of February 24 meeting of the Subject Expert Committee (SEC) on Covid-19 of the Central Drugs Standard Control Organisation (CDSCO), the firm presented the interim safety and immunogenicity data of the Gam-Covid-Vac combined vector vaccine generated in the country, along with interim data from the ongoing Russian study.

“We have had our meeting with the SEC today and will await the feedback from the CDSCO. We will provide an update once we have the feedback,” Dr Reddy’s Laboratories said in a statement.

On February 19, the firm said it had approached drugs regulator DCGI for emergency use authorization (EUA) for Sputnik V.

According to the sources, the SEC, which deliberated on the EUA application on Thursday, recommended that the firm should present data pertaining to all immunogenicity parameters, unblinded data of serious adverse events and RT-PCR positive cases, along with causality analysis reported till date for further examination.

The Drugs Controller General of India (DCGI) has already given the EUA nod to two Covid-19 vaccines – Covaxin of Bharat Biotech and Covishield of Oxford – AstraZeneca, being manufactured by the Serum Institute of India in Pune.

Sputnik V has demonstrated an efficacy rate of 91.6 per cent in the interim analysis of phase 3 clinical trial, which included data on 19,866 volunteers in Russia.

Source: The Print

April 2, 2021 0 comment

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Akums Drugs directed by CDSCO to revise phase 3 protocol for Mifepristone

by Medically Speaking Team March 8, 2021

written by Medically Speaking Team

The Subject Expert Committee under the CDSCO (Central Drug Standard Organization) has directed the Akums Drugs and Pharmaceuticals to revise the phase 3 clinical trial protocol for abortion drug Mifepristone Tablets 10/25mg.

In the 58^th SEC meeting held on 25.02.2021 firm presented Phase 3 Clinical Trial protocol for Mifepristone Tablets 10/25mg.

The drug Mifepristone is a steroidal anti-progestin drug that is used to induce abortion and functions as a competitive progesterone receptor antagonist in the presence of progesterone. It causes the pregnancy to end by blocking the hormone progesterone, which is to keep the pregnancy going.

Moving to the launch of the said drug the clinical trial and the Bioequivalence Study waiver was presented by Akums Drugs and Pharmaceuticals for granting permission to manufacture Mifepristone Tablet 10mg & 25mg at the 50^th Subject Expert Committee meeting held last year. Responding to this the committee recommended that the firm should conduct a clinical trial to examine the efficacy and safety of the drug in the proposed indication and said that the firm submit the clinical trial protocol for further review.

Committee reviewed the clinical trial protocol in its recent meeting and after a detailed deliberation, the committee recommended the firm to revise the clinical trial protocol according to below conditions:

Patients with age group 18 to 40 years are to be included in the study.
Patients with any coagulation in disorder are to be excluded.
Patients using any contraceptive method other than the conventional methods, barrier, male of female sterilization is to be excluded.
Justification for randomisation of patients in treatment groups in ratio 3:1:1 ratio.
Trans-abdominal ultrasound to be carried in addition to transvaginal ultrasound in screening and follow up of patients.
Biopsy test needed to be carried out for patients not having any menstrual disorders. For the patients with menstrual disorder, the biopsy can be carried out during screening and at the end of the study.
Statistical justification for sample size.

The committee added that the firm should submit the revised protocol before the committee for further consideration.

March 8, 2021 0 comment