He had taken charge as the 25th director general of the Indian Coast Guard on July 19 last year.
The DCGI also directed Serum Institute of India to increase the safety monitoring of the subjects already vaccinated as part of the trial, and submit the plan and report.
Regulator mentions Wockhardt as manufacturer but firm says it only markets drug.
BE's Corbevax is the first such vaccine in India to be approved as a heterologous COVID-19 booster in the country.
India's drug regulator has given permission to Bharat Biotech to conduct phase-3 clinical trial for its intranasal Covid vaccine as booster dose on participants who have been previously inoculated with SARS-CoV 2 vaccines.
The phase 3 clinical trial will cover around 28,500 subjects, aged 18 years and above, and it will be conducted in 21 sites across ten states, including Delhi, Mumbai, Patna and Lucknow.
Dominic Xavier offers his take on the COVID-19 vaccine which experts feel should be expected in mid-2021 only. Till then we have to get used to live with the virus.
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.
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.
Besides opposing the suspension of three medicines, the sector has also questioned the process adopted by the government.
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.
Codeine-based formulations are under the scanner for misuse as a narcotic product.
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.
Covaxin is being indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
SII is the first indigenous company that has sought emergency approval for the vaccine developed along with global pharma giant AstraZeneca and Oxford University.
Roadblocks ahead as these medicines could face new clinical tests, more scrutiny
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 Drugs Controller General of India, the apex drug regulator, has included a new clause in the trial approval letters, making these firms also accountable for any possible adverse event.
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.
'I do not want every Tom, Dick and Harry to collect money. Is there any state control over this collection of funds via crowdfunding?'
The Subject Expert Committee on COVID-19 examined the data and deliberated on the EUA application on Monday.
The remarks of the top court came on a bail plea of an accused who was arrested after opium was found in his fields and has served more than five years in jail.
"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.
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.
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.
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.
Swine flu claimed 38 more lives in the country taking the death toll beyond 800 even as the total number of people affected by the disease on Sunday breached the 13,000 mark.
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.
Pharma industry lauds idea, but suggests looser rules on ground
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.
'We seem to be in a situation where we can do little, and nothing needs to be done anyway.'
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.
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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.
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.
The vaccine maker Bharat Biotech said in a statement that preliminary reviews indicated that the death was unrelated to Covaxin.
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.
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.
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