Regulator mentions Wockhardt as manufacturer but firm says it only markets drug.
The NTAGI has also stated that those having laboratory test proven SARS-CoV-2 illness should defer COVID-19 vaccination for six months after recovery, the sources said.
According to medical practitioners, the treatment is especially useful in controlling disease among those who have not received the vaccine or got only one shot and also the high-risk contacts of a patient.
Firms, foreign and Indian, reiterate they follow the rules fully. Earlier, SC had rapped govt for gaps in law and enforcement, including on compensation.
Addressing a press briefing, Union Health Secretary Rajesh Bhushan said healthcare workers and frontline workers need not register themselves as their database has been populated on to the Co-WIN vaccine delivery management system in a bulk manner.
Last month, the US Food and Drugs Administration had placed Wockhardt's facilities in Waluj near Aurangabad on import alert, barring supply of various products from these facilities to the US.
'Don't panic. Believe in yourself.' 'This is a preventable illness. Only you can prevent it.'
Over the last four days, the Indian arm of US pharmaceutical giant Pfizer, Pune-based Serum Institute of India and Hyderabad-based pharmaceutical firm Bharat Biotech have applied to the Drugs Controller General of India seeking emergency use authorisation for their COVID-19 vaccines.
As India holds its breath for the Covid vaccination to be begin, Sudhir Bisht provides a quick checklist of what you must know about the vaccines that will be administered to citizens.
FabiFlu is the first oral favipiravir-approved medication in India for the treatment of COVID-19. Favipiravir can be used for coronavirus patients with co-morbid conditions such as diabetes and heart disease with mild to moderate COVID-19 symptoms.
Swiss drug maker Novartis might face tough action from the country's drug regulator for allegedly giving fake documents while seeking renewal of registration for Tiamulin Hydrogen Fumerate (80 per cent granules), sources said.
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 health ministry on Saturday recommended the use of antiviral drug remdesivir in moderate stage of COVID-19 while backtracking from its earlier stance on hydroxychloroquine, saying the anti-malarial drug should be used in the early course of the disease and not on critically ill patients.
Pharma industry lauds idea, but suggests looser rules on ground
Alleging that the candidate vaccine was not safe, he has also sought cancelling approval for its testing, 'manufacture and distribution', failing which legal action would be taken.
Ind Swift Ltd received DCGI approval for manufacturing anti-infective Clarithomycin Clarie-SR.
There were apprehensions in the SII about rival Bharat Biotech's 'indigenous' tag, opening up shortcuts for it. One senior person, who was very familiar with the sector, told me, 'The message has gone out from the very top. Somani (V G Somani -- drug controller general of India) has told me "Bharat ka karna hai".' A fascinating excerpt from Abantika Ghosh's Billions Under Lockdown: The Inside Story Of India's Fight Against COVID-19.
Pune's Serum Institute of India, the world's largest vaccine maker by volume, is placing its bets on the Oxford-AstraZeneca vaccine candidate AZD1222 with CEO Adar Poonawalla stating he would start manufacturing at personal risk.
The online pharmacy market, which was worth about $512 million in 2018, is growing at a CAGR of 63 per cent and is expected to hit overall revenues of over $3.6 billion by 2022.
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.
These brands belong to about 320 drugs of leading Indian pharmaceutical companies. The Drug Controller General of India's (DCGI's) office feels that these have been launched without its approval.
The drug regulatory agencies of India and Canada are planning to collaborate on improving the quality of drugs traded between the two countries, besides helping the industry in both the countries to tap the opportunities in the field of generic medicines and drug development.
This is the fifth consecutive day that COVID-19 cases have increased by more than 50,000 in the country.
The vaccine would be first made available to the vulnerable population and eventually, it would be available in the private market for all.
India's COVID-19 cases and deaths per million population are amongst the lowest in the world, the govt says.
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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.
Biocon Ltd ill seek Drug Controller General of India's approval for its novel monoclonal antibody indicated towards the treatment of head and neck cancer, Biomab EGFR.
Even as the Supreme Court had recently dismissed the industry's plea against prices fixed by the regulator and its timely implementation, the National Pharmaceutical Pricing Authority has asked companies to pay the overcharged dues with 15 per cent interest.
As the Indian Army reported its first case of the infection with a 34-year-old soldier testing positive in Leh, the Army said it has taken a series of precautionary measures to prevent the spread of coronavirus among the forces such as checking flu symptoms among soldiers on their return from leave and cancelling non-essential travel, conferences and recruitment drives.
The health ministry said that 86 per cent of the total active cases were recorded in 10 states of the country.
'We must not compromise with the standard, the quality. We don't need to be the first to launch a drug but what we need is a Made in India vaccine that the entire world can rely on'
As the death toll in the country from coronavirus jumped by a record 445 to 13,699, the Centre maintained that the number of infections per lakh population was among the lowest in the world. The new cases surged by over 10,000 for the 11th day in a row and rose by 14,821 to take the total to 4,25,282, according to health ministry data.
'In our country, there is a lot of checks and balances, the figures cannot go wrong.' 'Because they are being checked by not only the governments, but by doctors themselves.'
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.
Move follows a spate of international regulatory enforcements on Indian drug firms.
The Philippines launches probe after Sanofi reveals WHO-approved dengvaxia - a dengue vaccine - aggravates symptoms in some cases.
The move comes in the wake of many facilities of Ranbaxy in India being barred by the US Food and Drugs Administration for supplying medicines to the US.
Aurobindo Pharma, Cadila Healthcare and Serum Institute are readying their vaccine candidates.
Once the patients are identified, the government will decide on the quantum of compensation in each case and then approach J&J for claim settlement.
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