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India gives restricted emergency use approval for two Covid-19 vaccines pharmaceutical-business-review
January 06, 2021
India's Central Drugs Standard Control Organisation (CDSCO) has given the restricted emergency use approval for Covid-19 vaccines of Serum Institute of India and Bharat Biotech.
CDSCO to identify and set up two additional facilities for testing COVID-19 vaccines expresspharma
December 14, 2020
The CDSCO has identified the challenges associated with COVID-19 vaccines are taking steps to mitigate them, informs Dr Eswara Reddy.
Experts seek data on remdesivir and COVID-19 treatment-related products expresspharma
November 04, 2020
Recently, Dr Reddy’s Laboratories’ plea to change the regulatory approval status of remdesivir injection, COVID-19 treatment drug, from restricted emergency use to full marketing authorisation was rejected by COVID-19 subject expert committee (SEC) of ...
Industry positive about CDSCO’s move to digitalise regulatory approvals expresspharma
October 22, 2020
Central Drugs Standard Control Organisation (CDSCO) plans to adopt a paperless office culture and is in the process of going completely digital for regulatory approvals. Recently, Dr S Eswara Reddy, Joint Drugs Controller, CDSCO had informed that ...
SEC asks CDSCO to submit adverse event report of death during Umifenovir trial expresspharma
October 16, 2020
The Subject Expert Committee (SEC) has asked CDSCO to submit data of the reported serious adverse event (SAE), a single death, from the clinical trials of the drug combination of Favipiravir + Umifenovir by Glenmark Pharmaceuticals.
GoI publishes research procedure for COVID-19 vaccine candidates expresspharma
September 21, 2020
Over 30 vaccine candidates are in different stages of development in the country.
CDSCO asks Karnataka Drug Controller to grant Jan Aushadhi licenses to registered pharmacists only expresspharma
September 18, 2020
In response to a letter sent by the Karnataka State Registered Pharmacists Organisation (KSRPO) to Prime Minister Narendra Modi informing about the sale of medicines at the Jan Aushadhi stores without a registered pharmacist ...
Daewoong Pharma gets CDSCO nod to test anti-parasite drug for COVID-19 expresspharma
August 12, 2020
The South Korean drugmaker is testing the drug in partnership with Mankind Pharma which will continue the second and third phases of trials in India on mild and severe coronavirus patients.
VAV Lipids gets written confirmation from CDSCO for Ratnagiri facility expresspharma
August 11, 2020
This confirmation is a requisite to import active substances into the EU for medicinal products of human use.
CDSCO extends consent to import drugs with less than 60 per cent residual shelf life by three months expresspharma
July 14, 2020
The DCGI has taken this decision after considering the current situation in the country and the need for uninterrupted supply of medicines.

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