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Tuesday, July 22, 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

Bihar mimics 19th-century American South. Citizenship is now weaponised to exclude voters

Disenfranchisement by institutional fiat is profoundly undemocratic. The effect of the ECI's new documentary process in Bihar will tilt the scales in favour of the BJP.

India-US set to ink mini trade deal soon, reach understanding on agricultural & dairy products

Mini deal will likely see no cut in 10% baseline tariff on Indian exports announced by Trump on 2 April, it is learnt, but additional 26% tariffs are set to be reduced.

Not just AK-203, India & Russia to jointly manufacture AK-19 and PPK-20 for domestic use and export 

India-Russia JV is also racing to deliver 7,000 more AK-203 assault rifles by 15 Aug. These are currently being made with 50% indigenisation and this will surge to 100% by 31 December.

Strategic partner one day, tactical nightmare the next: India’s learning Trumplomacy the hard way

Public, loud, upfront, filled with impropriety and high praise sometimes laced with insults. This is what we call Trumplomacy. But the larger objective is the same: American supremacy.