DCGI directs bulk drugs manufacturers to submit applications online of already issued valid WCCs

DCGI directs bulk drugs manufacturers to submit applications online of already issued valid WCCs

Centre for Development of Advanced Computing (CDAC) in collaboration with Central Drugs Standard Control Organisation (CDSCO) has developed a module for online processing of applications for issuance of WCC as per the requirement of the European Union (EU). The Drugs Controller General of India (DCGI) has directed bulk drugs manufacturers to submit applications online of … Read more

Covid-19: Zydus Cadila’s ZyCov-D vaccine gets nod for emergency use in India — here’s everything you must know about country’s sixth vaccine

Covid-19: Zydus Cadila’s ZyCov-D vaccine gets nod for emergency use in India — here’s everything you must know about country’s sixth vaccine

CDSCO on Friday approved Zydus Cadila’s three-dose COVID-19 DNA vaccine for emergency use authorisation in adults and children aged 12 years and above India’s drug regulator, Central Drugs Standard Control Organisation (CDSCO), on Friday approved Zydus Cadila’s three-dose COVID-19 DNA vaccine for emergency use authorisation in adults and children aged 12 years and above. This … Read more

CDSCO classifies 80 IVD medical devices under new medical device rules for their effective regulation

CDSCO classifies 80 IVD medical devices under new medical device rules for their effective regulation

These 80 classified devices are covered under categories of clinical chemistry, hematology category, immunology and microbiology among others for effective regulation and patient safety. The Central Drugs Standard Control Organisation (CDSCO) has classified around 80 in-vitro diagnostic (IVD) medical devices under Medical Device Rules (MDR) -2017 based on risk based classification for their effective regulation. … Read more

COVID-19 treatment: Roche’s antibody cocktail explained; why it is approved in India

COVID-19 treatment: Roche’s antibody cocktail explained; why it is approved in India

The antibody cocktail is expected to be administered among patients who are at a high risk of developing a severe form of COVID-19 infection. Last week, drug firm Roche India received approvals for the Emergency Use Authorisation (EUA) from the Central Drugs Standards Control Organisation (CDSCO) for the antibody cocktail to be used in treatment … Read more

Covid-19: After Oxford vaccine, expert panel recommends conditional nod to Bharat Biotech’s Covaxin

Covid-19: After Oxford vaccine, expert panel recommends conditional nod to Bharat Biotech’s Covaxin

Coronavirus vaccine update: After giving its approval to Oxford-AstraZeneca Covid-19 vaccine, the subject expert committee of the Central Drugs Standard Control Organisation(CDSCO) on Saturday gave its nod for Covaxin for the emergence use. According to sources, the panel recommends granting approval for restricted emergency use of Bharat Biotech’s indigenous COVID vaccine Covaxin in India, news … Read more

Covid Vaccine in India: After UK nod, India to decide on emergency use approval of AstraZeneca vaccine

Covid Vaccine in India: After UK nod, India to decide on emergency use approval of AstraZeneca vaccine

The subject expert committee (SEC) on COVID-19 at the Central Drugs Standard Control Organisation (CDSCO) will meet soon to consider Serum Institute of India’s application for emergency use approval of its COVID19 vaccine, which is being developed in collaboration with Oxford University and pharmaceutical company Astra Zeneca. This is a developing story, more details awaited. … Read more

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

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

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

Coronavirus vaccine: These seven companies have licence to manufacture Covid-19 vaccine in India; check list

Coronavirus vaccine: These seven companies have licence to manufacture Covid-19 vaccine in India; check list

The CDSCO also said that the approval procedure and guidelines for clinical trials of the vaccine candidates and their marketing have been enumerated under the New Drugs & Clinical Trials Rules, 2019. Even as the Coronavirus spike continues in India, the Central Drugs Standard Control Organisation (CDSCO) has provided its approval to as many as … Read more

We are going to do phase-4 trial of psoriasis drug on Covid patients: Kiran Mazumdar Shaw – The Economic Times

We are going to do phase-4 trial of psoriasis drug on Covid patients:  Kiran Mazumdar Shaw – The Economic Times

Our US partners are also very keen to start a trial of the psoriasis drug on severe Covid-19 patients in the US, says Chairperson & MD, Biocon. Last weekend you had a news flow which you shared with your shareholders and more importantly with all the consumers that there is a drug which was used … Read more