Dr Reddy’s told to resubmit application

Our Bureau New Delhi | Updated on October 06, 2020

Dr Reddy’s Labs has tied up with the Russian Direct Investment Fund for 100 million doses of Sputnik V vaccine following successful conduct of clinical trials in India   -

Expert panel said to have asked company to conduct combined phase 2 and 3 trials

Dr Reddy’s Laboratories, which has tied up with the developers of Russian Covid-19 vaccine Sputnik V, has been asked by the Drugs Controller General of India (DCGI) to resubmit its application for carrying out vaccine trials in the country.

“The said commercial entity has approached the Indian regulator for clinical trials,” Health Secretary Rajesh Bhushan said on Tuesday. “The regulatory authority, after examining the proposal, has made specific suggestions which need to be incorporated by the entity into its clinical trial protocol. The documents submitted by the company need to be submitted again and when that happens the regulator will take a decision in accordance with the Drugs and Cosmetics Act.”

It is said that the Hyderabad-based firm wanted to go for phase-3 clinical trials directly whereas a subject expert committee at the Central Drugs Standard Control Organisation (CDSCO) asked it to conduct combined phase-2 and phase -3 trials of the Russian vaccine in the country.

The Russian Direct Investment Fund is to provide 100 million doses of Sputnik V vaccine to Reddy’s for distribution if the latter successfully conducts clinical trials in India.

Implementation mode

Bhushan, who was briefing the media, also said if everything goes well the country is expected to get vaccine doses by the first quarter of next year. He said a sub-group is looking to develop training modules for vaccinators as well as for those who would report adverse effects post-vaccination, if any. Similarly, another group is looking at syringes and other equipment required for carrying out a massive vaccination drive.

Answering another query, the Health Secretary said insurance cover of ₹50 lakh marked for Covid warriors has already been given to families of 95 Covid workers who lost their lives; another 176 claims are under processing. Besides, another 79 claims are yet to be received from the States, he added.

Equine sera

Indian Council of Medical Research (ICMR) Director General Balram Bhargava said that research has shown that antibodies against the novel coronavirus can be developed in horse sera and limited animal trials have established it is effective for plasm therapy. An application is being submitted for carrying out clinical trials using equine sera, he added.

Meanwhile, there has been a significant reduction in the number of people who tested positive for Covid in the last 24 hours. Just a little over 61,000 have tested positive in 24 hours, while over 75,000 people recovered from the infection during the same period. India currently has 9.19 lakh active Covid cases.

Published on October 06, 2020

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