"It has been decided that for approval of COVID-19 vaccines in India for restricted use in emergency situation which are already approved for restricted use by US Food Drug Administration, European Medicines Agency, UK Medicines and Healthcare products Regulatory Agency, Pharmaceuticals and Medical Devices Agency Japan or which are listed in WHO Emergency Use Listing and which are well established vaccines from the stand point that millions of individuals have already been vaccinated with the said vaccines, the requirement of conducting post approval bridging clinical trials and of testing every batch of vaccine by CDL, Kasauli can be exempted, if the vaccine batch/lot has been certified and released by National Control Laboratory of country of origin," it said.
India's drug regulator has initiated a probe and sought further details from the WHO after the global health body issued an alert that cough syrups manufactured by an Indian firm could potentially be linked to the death of children in Gambia.
Maharashtra Chief Minister Uddhav Thackeray has handed over portfolios of nine rebel ministers, who are currently camping in Guwahati, to other ministers.
In bodycam footage released by the Seattle Police Department, Officer Daniel Auderer laughed about the deadly crash and dismissed any implication Dave might be at fault or that a criminal investigation was necessary.
During a review, the EC found that the performance of some officers was "unsatisfactory" and they were found "complacent, if not complicit" in various matters, including the illegal supply of liquor as a possible poll inducement, sources said.
FDA had also issued warning letters to Ranbaxy's Paonta Sahib and Dewas facilities as it found extensive problems and deviations from manufacturing norms.
In a major escalation of the tussle with Punjab Chief Minister Bhagwant Mann, Governor Banwarilal Purohit on Friday warned that he could recommend President's rule in the state and also initiate criminal proceedings if his letters are not answered.
Indian drug firms continue to work closely with the FDA, and most have also appointed consultants to help them grasp the regulatory minutiae in the US.
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 company did not comply to the 'good manufacturing practice' norms.
India on Monday raised serious concerns over the USFDA's audit inspections of Indian pharma companies and 'disproportionate penalties' in some instances and said it would submit a discussion document on the issues to the US.
The Bihar Police's Economic Offences Unit, which is probing the alleged National Eligibility-cum-Entrance Test (Undergraduate) (NEET-UG) paper leak case, on Saturday claimed to have obtained reference question papers of the test conducted by National Testing Agency (NTA) and planned to compare these with documents recovered from a flat in Patna during a search operation last month.
The company said the drug will be made available across India through the group's strong distribution chain reaching out to government and private hospitals treating COVID-19 patients.
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.
Currency played an important role in Q2, with US dollar, Japanese yen and euro appreciating vis-a-vis the Indian rupee, while the Brazilian real, South African rand and Russian ruble depreciating against rupee.
The new regime aims to bring in ease of doing business, as the NITI Aayog has proposed to do away with the need to have manufacturing licences to register medical devices or to get a certificate of compliance.
According to a gazette notification of the draft rules published on June 5, a hospital or medical institution may import new drug for 'compassionate use for treatment of patients suffering from life threatening disease or disease causing serious permanent disability or disease requiring therapy for unmet medical need', which has not been permitted in the country, but under Phase-III clinical trial (human trial) in the country or abroad, by making an application to the Central Drug Regulator.
Quoting officials, The Washington Post said, the foiled assassination was part of an escalating campaign of aggression by RAW against the Indian diaspora in Asia, Europe and North America.
Children who previously had COVID-19 or the inflammatory condition MIS-C are not protected against the Omicron variant of coronavirus, according to a study which found vaccination, however, does afford protection.
Even smaller companies like Torrent Pharma and Alembic file five to 10 ANDAs every year.
Australian health regulator Therapeutic Goods Administration is investigating Indian pharma major Ranbaxy, following US allegations of the company falsifying data and test results of new drug applications, a media report says.
Sameer Kamath, a US citizen, was found dead in the woods on February 5 at approximately 5pm in NICHES Land Trust - Crow's Grove in Williamsport, Indiana.
Super Tuesday is an important phase of presidential primaries when the early contests are over, and voters from multiple states cast ballots in primaries timed to occur on the same date. Almost all the results were one-sided in favour of Trump except for Vermont, where the winning difference was about one per cent.
The police officials said all the five accused will have to undergo the polygraph test, while Sagar and Manoranjan will have to undergo additional naro-analysis and brain mapping tests.
Baltimore-based Lupin Pharmaceuticals Inc is recalling 5,60,922 pouches of Mibelas 24 Fe (norethindrone acetate and Ethinyl estradiol tablets and ferrous fumarate tablets) in the US, as per the latest enforcement report by the USFDA.
DCGI, health ministry initiate dialogues with foreign regulators, try to understand global best practices
The Drugs Controller General of India has approved the manufacture of this Sars-CoV-2 spike protein recombinant nano-particle vaccine for 'examination, test, and analysis', reports Sohini Das.
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 Pfizer vaccine has already been approved for the public in the United Kingdom and, Canada.
Vaccine major Serum Institute of India on Tuesday said the approval for the COVID-19 vaccine 'Covovax' would strengthen immunization initiatives across India and various lower and middle income countries across the world.
As marketing rights for off-patent drugs in the US become less exclusive, companies are scrambling for fresh strategies to make up for the revenue loss.
'Sharapova has been a US resident since early in her career, which does bring in a question of how or why she is using a drug that is not licensed there'
Annamalai has faced criticism for the breakup between the AIADMK and the BJP, but BJP leaders say 'he attracts youth, who needs change'.
Large pharmaceutical firms feel that if the quality parameters and assurance levels are brought up to the level of branded generics, then Jan Aushadhi medicines would find it difficult to retain their affordability.
The company had posted a consolidated net profit of Rs 323.31 crore (Rs 3.23 billion) in the same period last fiscal, Wockhardt Ltd said in a filing to the Bombay Stock Exchange.
A study conducted by the Indian Council of Medical Research (ICMR) has observed that COVID-19 vaccination did not increase the risk of unexplained sudden death among young adults in India, the government informed Parliament on Friday.
An advocate on Wednesday approached the Supreme Court with a PIL seeking cancellation of the license granted to Ranbaxy Laboratories and for initiating probe against the pharma major for allegedly manufacturing and selling adulterated drugs.
GSK is continuing with investigations into the potential source of the NDMA, which is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.
Ranbaxy was scheduled to launch its drug on September 21, the day Diovan's patent expired.
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