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.
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.
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.
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’.
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’.
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.
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.
Low-cost hepatitis C drugs sofosbuvir, used in combination with daclatasvir, has shown promise in reducing chance of death among hospitalised Covid patients.
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.
Standing up to America is usually not a personal risk for a leader in India. Any suggestions of foreign pressure unites India behind who they see as leading them in that fight.
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