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Thursday, December 4, 2025
TopicDrug Controller General of India

Topic: Drug Controller General of India

Modi govt likely to bring in stricter pan-Indian system to recall substandard drugs from market

Provision included in draft bill to be approved by Union cabinet. Existing drugs law mentions product recall, but doesn't specify timelines or system for auditing and accountability.

Serum Institute seeks DCGI permission to manufacture Sputnik V vaccine

The SII has already told the government that it will be able to manufacture and supply 10 crore Covishield doses in June and is also manufacturing the Novavax vaccine.

Pfizer says couldn’t attend Modi govt meetings on its vaccine due to ‘extremely’ short notices

The US pharma firm is in the process of compiling responses to queries raised by Drugs Controller General of India on its vaccine data, says a Pfizer spokesperson.

Respect govt decision to bar Covishield export, expect nod in March-April, says Serum CEO

Adar Poonawalla, CEO of Serum Institute of India, says the govt restrictions ‘will be eased out very soon once the most vulnerable population starts getting vaccinated’.

No pressure on drug regulator to approve Covid vaccines, says NITI Aayog member VK Paul

Speaking at a FICCI event, Paul says the govt will wait till all parameters are met. Bharat Biotech MD Krishna Ella slams the media for covering the vaccine issue like a ‘Bollywood movie’.

Govt begins internal review of Pfizer and Serum Covid vaccines, focus on safety & quality

The recommendations on granting of authorisation will be made on three parameters — safety, quality and efficacy. The Drug Controller General of India will take the final decision.

Cardiac, prostate drugs found to have new side-effects, govt panel wants them listed on packs

The decision is based on recommendations of Signal Review Panel-Pharmacovigilance Programme of India, which is responsible for detection, assessment & prevention of adverse effects from drugs.

Modi govt panel rejects proposal to make chewable Favipiravir tablets for Covid patients

Committee didn’t find MacLeods Pharma’s proposal adequate, but is considering US firm Mylan’s proposal to test Favipiravir with three other drugs.

Pharma giant Mylan wants hepatitis C drug’s clinical trial for Covid waived, regulator says no

Low-cost hepatitis C drugs sofosbuvir, used in combination with daclatasvir, has shown promise in reducing chance of death among hospitalised Covid patients.

After complaint, Modi govt asks states to keep vigil to stop ‘black-marketing’ of remdesivir

The order comes after the govt received a complaint from LocalCircles, saying the drug, whose MRP is Rs 5,400, is being sold at a price of between Rs 15,000 and Rs 60,000. 

On Camera

Why Bihar migrates has a 500-year old answer — from Mughal taxpayers to peasant warriors

Migration in North India isn’t just due to lack of development today. It was shaped by the evolution of labour markets under Sher Shah, Mughals, and the East India Company.

India’s Russian oil imports are showing up in cryptic new places. The crude map stands redrawn

December oil imports from Russia may drop nearly 50%, but Indian buyers already shifting to non-designated Russian entities and opaque trading channels to keep Russian oil flowing.

From nuclear cooperation to defence, trade to oil, what is expected from Putin’s two-day India visit

New Delhi is interested in firming up bilateral agreements for increased trade, mobility, upgrade of Su-30 MKI fighters and the increased range of BrahMos supersonic missiles.

Gaali cricket: Bavuma stands tall, India’s Test ego cut to size

The India-South Africa series-defining fact is the catastrophic decline of Indian red ball cricket where a visiting team can mock us with the 'grovel' word.