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).
Firms, foreign and Indian, reiterate they follow the rules fully. Earlier, SC had rapped govt for gaps in law and enforcement, including on compensation.
The novel mRNA vaccine candidate, HGCO19, is supported with seed grant under the Ind-CEPI mission of the Department of Biotechnology. The mRNA vaccines do not use the conventional model to produce immune response. Instead, they carry molecular instructions to make the protein in the body through a synthetic RNA of the virus.
A senior official at the health ministry told ANI: "For HCQ, we have placed orders for about 11.45 crore tablets to two Indian firms -- IPCA laboratories and Zydus Cadila. So far, we have received 6.64 crore HCQ drugs and remaining will arrive by May 16."
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.
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.
The institute expects to complete both, phase-2 and 3 trials in India by the end of this year.
As for Bharat Biotech, the Subject Expert Committee (SEC) on COVID-19 of the CDSCO asked the firm to expedite volunteer recruitment for the ongoing clinical trial and said it may conduct interim efficacy analysis for further consideration of restricted emergency use approval for its vaccine Covaxin, they stated.
The CoWIN portal will be made available in Hindi and 14 regional languages by next week, while 17 more laboratories will be added to the INSACOG network to monitor the variants of COVID-19, the health ministry said on Monday.
Pharma industry lauds idea, but suggests looser rules on ground
Ind Swift Ltd received DCGI approval for manufacturing anti-infective Clarithomycin Clarie-SR.
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.
'Don't panic. Believe in yourself.' 'This is a preventable illness. Only you can prevent it.'
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.
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.
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.
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.
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.
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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.
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.
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.
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.
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.
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.
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.
This is the fifth consecutive day that COVID-19 cases have increased by more than 50,000 in the country.
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.
India's COVID-19 cases and deaths per million population are amongst the lowest in the world, the govt says.
The vaccine would be first made available to the vulnerable population and eventually, it would be available in the private market for all.
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.
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.
Move follows a spate of international regulatory enforcements on Indian drug firms.
The health ministry said that 86 per cent of the total active cases were recorded in 10 states of the country.
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.
'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'
