Page 2 - Cdsco

SEC recommendation in accordance with guidelines: Biocon Biologics

The company said its product approvals are backed by science and clinical data

Virtual audits will not replace physical inspection, says USFDA

Surprise audits of manufacturing sites too are on the cards

Wockhardt gets CDSCO approval to export Russian Covid vaccine Sputnik

The approval is for the export of up to 8 crore doses of Sputnik Light and up to 2 crore doses of Sputnik V Component I vaccines, Wockhardt Ltd said in a regulatory filing

Centre forms 8-member panel for new Drugs, Cosmetics, Medical Devices Act

Committee will frame draft Bill and submit it by November 30

Cipla launches Roche's Covid antibody cocktail in India for Rs 60k per dose

The antibody cocktail (Casirivimab and Imdevimab) is to be administered for the treatment of mild to moderate Covid-19 in adults and pediatric patients

Natco gets approval for emergency use of Baricitinib for Covid-19 treatment

Natco Pharma has received emergency use approval for Baricitinib tablets, for the treatment of Covid-19 positive patients, from the Central Drugs Standard Control Organization (CDSCO) in India

Expert panel clears Bharat Biotech's vaccine for restricted emergency use

This comes a day after giving similar direction for the Oxford Covid-19 vaccine

License required to import, manufacture medical devices: CDSCO

Importers and manufacturers require to take licence for the import and manufacture of nebulizers, BP monitoring devices, digital thermometers, and glucometer

Coronavirus LIVE: Delhi's Covid-19 caseload crosses 600,000-mark

Coronavirus live updates: At 1,868,172, Maharashtra has the highest number of coronavirus cases, followed by Karnataka 896,563, Andhra Pradesh 873,000, Tamil Nadu 794,020, and Kerala 649,000

Russia asked to apply for Sputnik V vaccine trials in India via local rep

Can't let the guard down for next 2-3 months against Covid, says V K Paul of NITI Aayog; ICMR chief sas 50% vaccine efficacy acceptable in case of respiratory viruses

Covid-19: Gilead's remdesivir gets India nod for restricted emergency use

The approval process for remdesivir was accelerated in view of the emergency situation

Coronavirus Update: Major world developments and some good news for India

A lab experiment suggests cats can spread the new coronavirus to other cats without any of them ever having symptoms

NITI Aayog hasn't rejected offer to bring medical devices under CDSCO: Govt

It also proposes a penalty of up to Rs 1 crore on the manufacturers or importers for faulty medical devices having adverse impacts on patients.

Drug regulator making list of dual-use APIs imported from unregistered cos

The CDSCO is strictly monitoring the import of such dual-use APIs for the last few months so as to get an idea on what kind of action should be taken

CDSCO to get a new name; govt invites suggestions from stakeholders

The government has requested all stakeholders to send in their suggestions and comments on the new name and design of the new logo

Domestic drug regulator plans to inspect firms abroad, like USFDA

New Delhi, 14 AprilCentral Drugs Standard Control Organisation (CDSCO) is chalking out an international roadmap while wanting to follow the footstep of its American counterpart. The goal of CDSCO is to inspect pharma companies and their manufacturing units in other countries, especially the US, across Europe, Japan and China. ''The national drug regulator would conduct risk-based assessments of companies which supply to India,'' an official at the CDSCO told Business Standard. So far, the Indian drug controller has only conducted risk-based assessment of manufacturing units in India. Once it starts inspecting manufacturing units overseas, the Indian regulator's role would be similar to that of the United States Food & Drug Administration (USFDA). The American regulator routinely inspects pharma companies, across the world including in India, which export to the US. In fact, last year nine warning letters were issued to Indian pharma companies exporting to the US. Several plants ..

Government to consider extending shelf life of medical device after interim assessment of performance

The government has suggested a five year blanket on shelf life of all medical devices in the draft released on 19th Oct