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 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.
"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.
The Union health ministry on Thursday termed as 'misleading' and 'fallacious' media reports which claimed that regulatory approval for COVID-19 vaccine Covaxin was rushed due to political pressure.
The respondents were from over 22 states with 85 percent of them being under 35 years while 61 percent were interns or postgraduate trainees.
Indian drug firms like Marksans Pharma, Aurobindo Pharma, Zydus and Jubilant are recalling products in the US market, as per the latest enforcement report by the US Food and Drug Administration (USFDA). While Marksans Pharma is recalling diabetes drug, Zydus Pharmaceuticals (USA) is recalling drug which is used to reduce stomach acid. Similarly, Aurobindo Pharma (USA) is recalling pain relieving drug, while Jubilant Cadista is recalling a medication used to treat schizophrenia.
Move follows a spate of international regulatory enforcements on Indian drug firms.
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.
USFDA issues Form 483 with as many as 14 observations that could impact ongoing operations at Aurobindo's Pashamailaram facility in Hyderabad.
The announcement comes a day after the Subject Expert Committee (SEC) on COVID-19 of the CDSCO recommended granting emergency use authorisation (EUA) to the COVID-19 vaccines Covovax and Corbevax with certain conditions.
Traction for its specialty portfolio, a strong showing in the domestic market, and better regulatory compliance are positives for the country's largest pharmaceutical (pharma) company, Sun Pharmaceutical Industries. Given the triggers, some brokerages have increased their earnings per share estimates and target price for 2024-25 (FY25). This should sustain the momentum for the stock, which has been one of the major pharma gainers in 2023-24 (FY24), rising 57 per cent. It is currently trading at Rs 1,547 per share.
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.
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.
FDA had also issued warning letters to Ranbaxy's Paonta Sahib and Dewas facilities as it found extensive problems and deviations from manufacturing norms.
The Aam Aadmi Party on Sunday said Tihar authorities were 'lying' about specialist doctors examining Delhi Chief Minister Arvind Kejriwal, while his wife Sunita Kejriwal alleged that he was being denied insulin for diabetes as 'they want to kill' him.
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.
China has formally apologised to Nigeria for alleged export of fake drugs including some labelled as 'Made in India' by some Chinese firms to the country and assured to take punitive action against those involved in the scandal.
In his second term in office, UP Chief Minister Yogi Adityanath has retained 34 portfolios.
The US health regulator has pulled up drug major Sun Pharma for manufacturing lapses, including failure to follow appropriate written procedures designed to prevent microbiological contamination of drug products, at its Gujarat-based plant. In a warning letter, the US Food and Drug Administration (USFDA) pointed out various lapses at the Halol plant which produces finished pharmaceutical products. "This warning letter summarises significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals... Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated," the USFDA stated.
Pharmaceutical and biotechnology major, Wockhardt has received final approval from the United States Food & Drug Administration for marketing the cardiac drug.
DCGI, health ministry initiate dialogues with foreign regulators, try to understand global best practices
Paul noted that "three to four months from now, there will be other vaccines and the stockpile will be even bigger. "And more acceleration can be brought about in the vaccination programme," Paul added.
To be called Central Drug Administration or National Drug Authority, it will have 10 sub-authorities to deal with areas like cosmetics, blood safety, medical equipment, etc.
The Directorate General of Civil Aviation (DGCA) has released a draft procedure that calls for testing pilots, other aviation personnel and crew members for psychoactive substances before they take to the skies. The Indian civil aviation regulator has sought comments from stakeholders over the next 30 days before issuing a regulation to this effect. Asking airlines and airports to do random checks on crew and air traffic controllers, DGCA proposed that violators be suspended for a minimum of three years or their licence be permanently cancelled as maximum punishment.
These drugs will be entering in their global Phase -3 clinical trials early next year.
Acting swiftly on the controversy regarding illegal drug-coated stents, the Maharashtra Food and Drug Administration has asked all stent manufacturers and importers to get valid licenses within the next two months from the Drugs Controller General of
The US Food and Drug Administration had in February approved Johnson & Johnson's COVID-19 vaccine that works with just one dose for emergency use.
Indian drug maker Alembic Ltd plans to expand its bulk drugs business in the United States by joining hands with US formulations makers, the Bombay Stock Exchange said on Thursday.
As the COVID-19 vaccination of children falling into the age bracket of 15 to 18 years is scheduled to begin from January 3, the Kerala health department has prepared an action plan for inoculation of all eligible beneficiaries.
To keep price control to a minimum, the government can act in two areas where it has not done so far.
The United States Food and Drug Administration on Tuesday banned the import of more than 30 generic drugs manufactured by Ranbaxy Laboratories Limited alleging that poor quality control at the firm's factories could be harmful to users of these medications used to treat everything from high cholesterol to Type 2 diabetes to everyday allergies.
Normalcy returned to the city, recently renamed as 'Chhatrapati Sambhajinagar', even as the government deployed five companies of the State Reserve Police Force as a precaution.
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 company is set to deliver the first set of 20,000 vials in two equal lots of 10,000 each, one of which will be immediately supplied to Hyderabad, Delhi, Gujarat, Tamil Nadu, Mumbai and other parts of Maharashtra, Hetero Healthcare said in a statement.
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.
Whistle-blower Dinesh Thakur will speak on Made-in-India drugs at an event in Washington.
He said law enforcement agencies are cracking down on those involved in recruitment for terrorist groups as well as narcotic dealers and smugglers.
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.
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