BE's Corbevax is the first such vaccine in India to be approved as a heterologous COVID-19 booster in the country.
The show-cause notice was issued following reports that human trials of the most promising COVID-19 vaccine candidate, being developed by the University of Oxford, have been put on hold after a United Kingdom participant had an adverse reaction to it.
"We have started the phase-III trials of the vaccine (candidate Covishield). We will administer dose to 150 to 200 volunteers," said Dr Muralidhar Tambe, Dean, Sassoon General Hospital.
'I do not want every Tom, Dick and Harry to collect money. Is there any state control over this collection of funds via crowdfunding?'
There has been an "exponential" rise in the seizure of drugs in India in the last five years with the darknet and the maritime route emerging as the most preferred modes of trafficking, NCB director general S N Pradhan said on Tuesday.
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In a letter to health minister Harsh Vardhan, the Indian Pharmaceutical Alliance, an industry body representing leading pharma companies, including Sun Pharma, Lupin, Dr Reddy's Labs, Cadila Health and Glenmark, stressed the need for an out-of-court settlement with health activists fighting for the rights of clinical trial participants.
In a series of tweets after the Drugs Controller General of India (DCGI) approved Oxford's vaccine Covishield and Bharat Biotech's Covaxin for restricted emergency use, Modi said it will make every Indian proud that both the vaccines are made in India.
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 Pune-based firm had submitted interim safety and immunogenicity data of phase 2/3 bridging clinical trial conducted in the country as well as interim clinical trial data of safety and efficacy from phase3 clinical trials conducted in the UK and the US along with its application.
An expert panel of India's central drug authority on Wednesday recommended granting regular market approval to COVID vaccines Covishield and Covaxin for use in adult population subject to certain conditions, official sources said.
The Subject Expert Committee on COVID-19 examined the data and deliberated on the EUA application on Monday.
India's apex drug regulator has granted permission for conducting the phase II/III clinical trial of Bharat Biotech's Covaxin COVID-19 vaccine in the age group of 2 to 18 years, the Union Health Ministry said on Thursday.
Whistle-blower Dinesh Thakur will speak on Made-in-India drugs at an event in Washington.
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.
Pharmaceutical companies that have failed to meet the deadline -- which expired on July 1 -- to comply with Schedule M of the Drugs & Cosmetics Act will find the going tough in the days ahead.
Codeine-based formulations are under the scanner for misuse as a narcotic product.
Venus Remedies has obtained permission from the Drug Controller General of India for conducting Phase III clinical trials of the new formulation developed by its research and development wing.
The vaccine maker Bharat Biotech said in a statement that preliminary reviews indicated that the death was unrelated to Covaxin.
The Drug Controller General of India (DCGI) has sought clarification from pharma majors Dr Reddy's Laboratories and Mumbai-based Piramal Healthcare, for allegedly sponsoring doctors for conferences.
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.
Roche said the Indian regulatory authorities had approved Biocon and Mylan's products as Trastuzumab, but it was unclear if these met the criteria for biosimilar products.
Ramdev's herbal medicine company Patanjali Ayurved has launched 'Coronil tablet and Swasari vati' medicines claiming they can cure the highly contagious disease within seven days.
The Hyderabad-based firm completed clinical trials of the nasal vaccine with about 4,000 volunteers and there is no side effect or adverse reaction reported so far, company sources had 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.
'We need to prove to the world that quality vaccines and R&D are possible in India.'
Once the UK drug regulator gives its approval to the Oxford vaccine, the expert committee on COVID-19 at the Central Drugs Standard Control Organisation (CDSCO) will hold its meeting and thoroughly review the safety and immunogenicity data from the clinical evaluations conducted abroad and in India before granting any emergency authorisation for the vaccine here, official sources said.
In an exclusive interview with PTI video, the minister also said an extensive risk-based analysis is done continuously to ensure the production of quality medicines in the country, and the government and regulators are always alert to ensure that no one dies due to spurious medicines.
The Serum Institute of India (SII) had put in an application to the Drugs Controller General of India (DCGI) in October for grant of market authorisation of Covovax for restricted use in emergency situations.
PharmEasy, 1mg and Netmeds believe that their disruptive capabilities will power their brands despite the recent court ruling. The Drug Controller General of India recently directed all state FDAs to stop the online sale of medicines as per a Delhi high court order of last year.
Sale of antibiotics is under the scanner. Government to go tough on misuse of these drugs.
The Drugs Controller General of India (DCGI) has granted permission to the Serum Institute of India (SII) to manufacture the Sputnik COVID-19 vaccine in India for examination, test and analysis with certain conditions, official sources said.
'Pfizer India has submitted an application on December 4 to the DCGI seeking emergency use authorization for its COVID-19 vaccine in India'
The central drug regulator has issued show cause notices to these two importers and asked to stop the import of rapid test kits based on the observation by the apex health research body Indian Council of Medical Research (ICMR).
India's first indigenously developed quadrivalent Human Papilloma Virus (HPV) vaccine for the prevention of cervical cancer will be launched in a few months and made available to the people in an affordable price range of Rs 200-400, Serum Institute of India CEO Adar Poonawalla said on Thursday.
Dabur Pharma launched its new nano technology-based chemotherapy agent Nanoxel in the country on Thursday.
A statement issued by the WHO on Saturday said the suspension is in response to the outcomes of its post EUL (emergency use authorisation) inspection held between March 14-22, 2022 and the need to conduct process and facility upgrade to address recently identified GMP (good manufacturing practice) deficiencies.
FDA had also issued warning letters to Ranbaxy's Paonta Sahib and Dewas facilities as it found extensive problems and deviations from manufacturing norms.
Raising hopes for multinational pharmaceutical research companies, India has begun a consultation on steps to ease the existing clinical trial norms to allow Indian volunteers to be subjected to first-in-human phase I studies of potential medicines developed abroad.
In a video, Ramdev was allegedly heard saying, "Allopathy is a stupid science and medicines such as Remdesivir, Fabiflu, and other drugs approved by the Drugs Controller General of India have failed to treat COVID-19 patients." His remarks caused massive outrage and the IMA sent over a legal notice to him.
