With the maximum dose gap of four months for Covishield, a large part of the population would not even be eligible for the second dose by the end of this year, report Ruchika Chitravanshi and Ishaan Gera.
The Food and Drug Administration said its decision is based on new information, including clinical trial data results, that have led it to conclude that the drugs may not be effective to treat COVID-19 and that its potential benefits for such use do not outweigh its known and potential risks.
'We are in close touch with Indian officials at all levels. We are also closely coordinating with our allies, friends, and Quad partners about how we can collectively support India in its hour of need,' a senior Biden administration official told reporters
'Pfizer India has submitted an application on December 4 to the DCGI seeking emergency use authorization for its COVID-19 vaccine in India'
There are just 1,500 drug inspectors responsible for more than 10,000 factories in India
The central government is importing COVID-19 vaccines and is in talks with COVID-19 vaccine manufacturers Pfizer and Johnson & Johnson, Union Minister of State for Home Affairs G Kishan Reddy said.
Adar Poonawalla said he was hopeful that Covovax, the Novavax vaccine made by SII, will be launched around October this year for adults and for children by the first quarter of next year, depending on DCGI approvals.
If the actress fails to respond to the notice within the stipulated time frame, a case could be registered against her, Food Security Officer Mahimanand Joshi said.
India's drug regulator Drugs Controller General of India has granted permission to Mumbai-based pharmaceutical company Cipla to import Moderna's COVID-19 vaccine for restricted emergency use in the country, official sources said on Tuesday.
In contrast with their strong performance in 2020 and 2021, pharmaceutical and healthcare funds experienced a decline in 2022, with returns plummeting by an average 9.8 per cent. This trend has continued in the current year, with year-to-date return remaining in the negative (-4.9 per cent). In the past three months, pharma funds have been hit hard, experiencing a 7.9 per cent decline.
The US Food and Drug Administration (FDA) says it does not follow an India agenda.
The US will lift all restrictions for fully vaccinated international travellers, including from India, from November 8 but they will have to show proof of a negative coronavirus test before boarding a flight to the country, the White House has announced.
Vice President Mike Pence said Trump had authorised a ban on entry of foreign nationals who travelled to Iran in the last 14 days. The United States also advised its citizens not to travel to parts of South Korea and Italy, from where reports of coronavirus have appeared.
The USFDA has accused Ranbaxy of falsifying data and test results of medicines. A Daiichi Sankyo statement said it takes the issue very seriously. 'Both Daiichi and Ranbaxy have formed a team to solve the issue. Ranbaxy will be responding to the FDA and will continue to cooperate with the agency.' Ranbaxy shares fell more than 18 per cent to Rs 169.85 today on the Bombay Stock Exchange, while Daiichi stock dropped about 10 per cent to yen 1,680 on the Tokyo Stock Exchange.
Once tipped to emerge as the biggest exporter, the pharmaceutical industry is yet to acquire the scale of those in software services, says Krishna Kant.
Many countries found Maggi noodles to be safe for consumption.
Low growth visibility and trouble with regulators have resulted in lack of interest from investors
There are also lingering concerns over the culture of misuse of pharmaceutical products in India, which has, in the past, led to other drugs becoming increasingly ineffective.
An end to Sun Pharma founder Dilip Shanghvi's woes are not in sight.
The move comes in the wake of many facilities of Ranbaxy in India being barred by the US Food and Drugs Administration for supplying medicines to the US.
India consistently ranked among the top three countries whose products were rejected for import by the regulator.
Rosier year-end seen for Indian pharma thanks to faster US approvals.
Suit alleges fraud by hiding significant deficiencies in CGMP regulations enforced by US health regulator.
Some Indian generic drugmakers are, however, uncertain about the pace of approvals in the near future.
Ranbaxy Laboratories and the US health regulator are reportedly negotiating a settlement.
Food and Drug Authority Ghana said in a statement that officials of Bliss GVS Pharma of India and Ghanaian drug maker Tobinco Pharmaceuticals have apologised to it for importing 'fake malaria medicine' to Ghana to treat malaria in children.
The country's drug companies have attracted the highest number of enforcements from the American drug regulator in 2013, a year that has seen the US Food and Drug Administration turning stricter to ensure compliance levels and quality of medicines.
The FDA had imposed a ban on the company's Waluj plant in May.
Ranbaxy's US factory, Ohm Laboratories, is learnt to have got a clean chit from the American regulator. This US facility was under surveillance of the Food and Drug Administration (FDA) since the end of 2012.
India is engaged with American entities for procurement of COVID-19 vaccines from the United States and their possible manufacturing in the country subsequently, the Ministry of External Affairs said on Thursday.
Ranbaxy, which is 63.5 per cent-owned by Japan's Daiichi Sankyo Co and gets more than 40 per cent of its sales from the United States, did not immediately respond to a request on Wednesday for comment on the FDA observations.
Fast Moving Consumer Goods major Nestle may face more action by the Uttar Pradesh Food Safety and Drug Administration, which is testing more batches of Maggi after ordering recall of a batch of about 2 lakh packs of the instant noodles due to higher than permitted levels of lead and a food additive.
The recall is the latest in a series of problems to hit Ranbaxy, which has had all its India factories stopped from sending drugs and ingredients to the United States.
The US Congressional committee, which is inquiring into the country's Food and Drug Administration's handling of drug-marketing approvals of India's leading drug-maker Ranbaxy, has extended its probe into similar permissions given to Iceland's Actavis.
If the DCGI grants regular marketing authorisation, Covishied will be the second vaccine in the world to receive such approval.
All of Ranbaxy's India-based factories are currently banned by the FDA from exporting medicines to the United States, the company's largest market, after the regulator's inspection found violation of its so-called good manufacturing practices.
The US president said the drug has gotten a bad reputation only because 'he was promoting it'.
Global generic drugs producer Sandoz has opened its third plant in India at Navi Mumbai with annual production capacity of one billion tablets and capsules.
Of the 23 Indian billionaires mentioned in the Bloomberg Billionaires Index, only one saw a reduction in net worth, with the companies owned by most of them outperforming the Nifty 50 index by a big margin.
Nestl India is preparing a blueprint for a possible relaunch.
