Health ministry issues draft notification on NDCT Rules to substitute word “CLA” with “DRA” towards regulation

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The NDCT Rules are today applicable to all new drugs, investigational new drugs for human use, clinical trial, BE study and Ethics Committee. The Union health ministry has issued draft notification on New Drugs and Clinical Trials (NDCT) Amendment Rules, 2021 for inclusion of  word Designated RegistrationAuthority (DRA)” in place of “Central Licensing Authority (CLA)” … Read more

DCGI nod to Phase-1 human trials of ‘antisera’ with potential to treat COVID-19

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The Drugs Controller General of India has given permission for conducting Phase-1 human clinical trial for an “antisera” that was developed by injecting inactivated SARS-CoV-2 in horses and can be a potential treatment for COVID-19, ICMR officials said on Tuesday. The ‘antisera’ has been developed by the Indian Council of Medical Research (ICMR) in collaboration … Read more

Centre estimates to utilise 40-50 cr COVID-19 vaccine doses on 20-25 cr people by July 2021: Vardhan

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The Centre estimates to receive and utilise 40-50 crore doses of COVID-19 vaccine covering 20-25 crore people by July next year and it is preparing a format for the states to submit by October-end their list of priority population group to receive the vaccine, Union Health Minister Harsh Vardhan said on Sunday. He said priority … Read more

Is Key Safety Data at Risk in Race for COVID Vaccine?

Grace Lee, MD, professor of pediatric infectious diseases, Lucile Salter Packard Children’s Hospital, Stanford University, Stanford, CA. William Schaffner, MD, professor, preventive medicine, health policy, infectious diseases, Vanderbilt University Medical Center, Nashville. Tom Frieden, MD, president and CEO, Resolve to Save Lives, New York City. Hearing, U.S. Senate Committee on Health, Education, Labor and Pensions: … Read more

Phase-III trial of Oxford vaccine to begin in Pune next week

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PUNE: The phase-III human clinical trial of the COVID-19 vaccine developed by Oxford University and being manufactured by the Serum Institute of India (SII) will begin at the Sassoon General Hospital in Pune next week. Dean of the state-run Sassoon General Hospital Dr Muralidhar Tambe told this to PTI on Saturday. “The phase-III trial of … Read more

Govt talking to Russia for possible advancement of its COVID vaccine here: Health Ministry

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NEW DELHI: The Centre is in consultations with the Russian government for exploring the possibility of cooperation between the two countries for advancing the COVID-19 vaccine in India, Parliament was told on Friday. The Central Drugs Standard Control Organisation (CDSCO) has informed that it has received information about one COVID-19 vaccine developed and approved in … Read more

View: How the development of the Covid vaccine could influence the US polls outcome

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While Trump continues to be heavily criticised for his handling of the Covid-19 situation in the US, would the announcement of a vaccine just before the election enhance the chance in his re-election bid? Synopsis The November 3 election certainly is an important factor to the ‘race for a Covid vaccine’. By Atanu BiswasDuring the … Read more

Trial Tests MMR Vaccine to Help Prevent COVID-19

FRIDAY, Sept. 4, 2020 (HealthDay News) — A new clinical trial will try to determine whether the measles, mumps and rubella (MMR) vaccine can protect health care workers from being infected with COVID-19. Hundreds of millions of people have received the MMR vaccine since it was developed nearly 50 years ago. It’s usually given … Read more