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Thursday, September 25, 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

Theaterisation reform is stuck on ranks and roles — India’s military needs clarity

On paper, the idea of theaterisation is elegant. In practice, it is paralysed by ambiguities of rank and command.

Market regulator SEBI clears Adani Group of impropriety alleged by Hindenburg Research

SEBI probe concluded that purported loans and fund transfers were paid back in full and did not amount to deceptive market practices or unreported related party transactions.

China navy achieves breakthrough with new fighter jet launch system. What are electromagnetic catapults

China’s most advanced aircraft carrier—Fujian—uses electromagnetic catapults, a core component of future aircraft carriers.

India doesn’t give walkovers to Pakistan in war. Here’s why it shouldn’t do it in cricket either

Many really smart people now share the position that playing cricket with Pakistan is politically, strategically and morally wrong. It is just a poor appreciation of competitive sport.