'Almost 70 per cent production time of a vaccine is dedicated to quality control, which is done through several hundred tests.'
The government is hopeful of a speedy launch of single-dose COVID-19 vaccine Sputnik Light in India and all stakeholders, including the Russian manufacturer and its Indian partners, have been directed to fast-track the application and regulatory approval procedures for the jab to boost the country's vaccination drive, sources said.
'Safety is my first priority.' 'I need to ensure that any drug or vaccine that our citizens get is first safe.'
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.
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 ICMR has approved over 200 labs (both public and private) for COVID-19 testing through-PCR machines.
MicroPort entered the market on Feb 15 and its stent was used in a Mumbai hospital.
The Drug Controller General of India has sent a letter to the Glenmark seeking clarifications on pricing as well as claims of therapeutic efficacy. While Glenmark has claimed this drug is effective in comorbid conditions like diabetes, hypertension, according to protocol summary (of clinical trials) the trial was not designed to access the Fabiflu in comorbid conditions.
Vaccine development is a long process to ensure safety and efficacy through different stages and involves regulatory supervision every step of the way. Ruchika Chitravanshi takes you through this carefully drawn journey of vaccine development.
The government plans to immunise 30 million people in the first phase, starting February, and by July, the target is to vaccinate 250 million people, reports Sohini Das.
An International Policy Network report in 2010 found that seven per cent of drugs bought from wholesale traders were substandard, and 3.6 per cent of the drugs from traders contained no active ingredient whatsoever.
India lost its competitive advantage as China gave fiscal benefits to its local manufacturers. Besides, recent policy flip-flops have, however, dented India's image as the 'pharmacy of the world'.
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.
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.
Senior Congress leader Anand Sharma on Sunday raised concerns over India's drugs regulator granting permission for restricted use of Bharat Biotech's COVID-19 vaccine and asked the government to explain why mandatory protocols and verification of data has been dispensed with.
The approval by the Drugs Controller General of India (DCGI) was given on the basis of recommendations submitted by a COVID-19 subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).
The expert committee sought more information from Serum Institute regarding the Oxford-AstraZeneca vaccine.
Responding to another question, Choubey said that the phase-I of clinical trials have revealed excellent safety of the two candidate vaccines indigenously developed by Bharat Biotech in collaboration with Indian Council of Medical Research and Cadila Healthcare Ltd, and now their immunogenicity testing is in progress. Their phase II clinical trials are ongoing.
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.
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.
The Supreme Court on Monday posed some tough questions to a lawyer, asking him to substantiate his "unfounded allegations" in a PIL that Indian pharma major Ranbaxy Laboratories Ltd was allegedly manufacturing and selling adulterated medicines.
Vardhan stated the government is taking full precautions in human trials of vaccines and the National Expert Group on Vaccine Administration for COVID-19 under the chairmanship of Dr V K Paul, member-health, NITI Aayog, is drawing up a detailed strategy on how to immunize the majority of the population.
The antiviral drug may cost around Rs 55,000 for an 11-dose course, or Rs 5,000 per injection -- much less than the price of imports from Bangladesh, reports Sohini Das.
This is the fifth consecutive day that COVID-19 cases have increased by more than 50,000 in the country.
Alkem Labs was issued drug alerts twice last year -- in June and July -- for its drug Glimekem.
The dry-run was being conducted in state capitals in at least three session sites. Some states also included districts that are situated in difficult terrain or have poor logistical support, according to officials.
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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 vaccine candidate, ZyCoV-D, showed a "strong immune response" in animal studies, and the antibodies produced were able to completely neutralise the wild type virus, Zydus said. The 12 institutes have been asked by the ICMR to fast track clinical trials of the vaccine as it is being considered as one of the top priority projects which are being monitored at the topmost level of the government.
Urjit Patel as the new RBI governor whose focus is on taming inflation has lowered the probability of interest rate cut soon
The big companies too are responsible for the sub-standard drugs in the market.
Gains were led by index heavyweights with Reliance Industries contributing the most.
'This novel format of diplomacy -- the informal summit -- will not only facilitate bilateral communication and reduce miscalculations at the very top level of the two governments, but possibly open the space for China and India to speak in one voice on various issues of mutual concern,' note Feng Renjie and Ding Kun Lei
There are just 1,500 drug inspectors responsible for more than 10,000 factories in India
More lucrative routinely prescribed drugs are at higher risk of failing quality standards
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