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.
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.
If the DCGI grants regular marketing authorisation, Covishied will be the second vaccine in the world to receive such approval.
The United States has so far allocated only 7.5 million doses of Covid vaccines to India, which is not enough, a top Indian-American Congressman said while urging the Biden Administration to do more.
Indian drugmaker Ranbaxy Laboratories Ltd has received approval from the US Food and Drug Administration to market an oral suspension form of Warner Chilcott's Duricef antibiotic, the Bombay Stock Exchange
Drugmaker Dr Reddy's Laboratories has filed an application with the US Food and Drug Administration to market a generic form of Eli Lilly's schizophrenia drug Olanzapine in the US
JB Chemicals & Pharmaceuticals Ltd on Thursday announced the filing of its first Abbreviated New Drug Application with the United States Food and Drug Administration.
The Indian Council of Medical Research will start national-level sero surveys to assess the spread of Covid-19 and all states/Union territories should also be encouraged to conduct them so that information from all geographies can be collected, the Union health ministry said on Friday.
Various domestic companies such as Ranbaxy, Wockhardt and Agila Specialities recently came under the US FDA scanner for lapse in manufacturing practices.
The US Food and Drug Administration has tightened rules for selling dietary supplements in the US market, making compliance with current good manufacturing practices mandatory for manufacturers.
Post Ranbaxy episode, domestic pharma companies may face frequent inspections and deeper scrutiny.
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 US Food and Drug Administration (USFDA) has issued a warning letter to RPG Life Sciences for violation of current good manufacturing practice (CGMP) norms at its two plants at Ankleshwar and Mumbai.
Wockhardt Ltd said on Tuesday it has got US Food and Drug Administration's approval to market painkiller tablets containing a combination of Dextropropoxyphene napsylate and Acetaminophen in the US market.
As part of the charm offensive, New Delhi has invited global regulators -- including the FDA -- to visit Indian production units to get first-hand evidence of measures taken to ensure the quality of locally manufactured generics.
The recent recalls come amid increased FDA scrutiny of medicines produced in India.
The company has been held responsible for the violation of the Drugs and Cosmetic Act, 1940 and the rules framed in 1945.
The US drug regulator raised the issue of significant deviations from the current good manufacturing practice (cGMP) in three of DRRD's plants in a letter issued in November 2015
'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
Trump has been aggressively promoting the use of hydroxychloroquine in the treatment of COVID-19 patients.
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.
The weakness in the stock was because of inspections by the American drug regulator at its Halol plant in Gujarat which resulted in eight observations, as well as a downward revision of speciality drug payoffs.
Whistle-blower Dinesh Thakur will speak on Made-in-India drugs at an event in Washington.
Margaret A Hamburg, the first commissioner of the US Food and Drug Administration (US FDA) to visit India officially, will meet heads of major domestic pharma companies such as Ranbaxy, Wockhardt, Cadila Healthcare and Lupin in New Delhi.
The Food and Drug Administration says all those areas are currently in compliance with blood screening, but that expanded testing is now needed.
Nestl India is preparing a blueprint for a possible relaunch.
With the US education system operating independently from the government, universities are adopting varying strategies when it comes to Covid vaccination.
'WHO issued an emergency use listing for Covovax, expanding the basket of WHO-validated vaccines against COVID-19. The vaccine is produced by the Serum Institute of India under licence from Novavax,' the world health body said in a tweet on Friday.
Both the units were under the scanner of FDA since 2011.
Researchers at McGill University in Canada carried out a survey of 28 experts working in vaccinology in late June 2020. The majority of those surveyed were mostly Canadian or American academics with an average of 25 years of experience working in the field.
The recalled drugs were manufactured and distributed in the US by Ohm Laboratories.
A common antibacterial substance found in toothpaste may combat life-threatening diseases such as cystic fibrosis, or CF, when combined with an already FDA-approved drug.
Company is among the few companies in the sector getting pulled up by FDA for violations at its factories in India.
Slapped with Rs 242-crore fine by US authorities for rule violations at Toansa unit, say sources; 2nd such hefty rap in the recent past from US regulators for bending rules.
Gland Pharma, promoted by China's Fosun, has extended its gains, is up 40 per cent since its listing.
Indian drugmaker Dr Reddy's Laboratories said on Thursday it had filed an application with the US Food and Drug Administration to market a generic form of GlaxoSmithKline's anti-nausea drug Zofran.\n\n
The US laws authorise the drug and health watchdog to assess and collect user fees for certain applications and supplements for human generic drug products
