Of the 289 faulty hip implant victims identified, 93 patients had undergone revision surgeries. The company, however, said it could reach only 67 patients and would pay Rs 25 lakh each to the other 26 as well after verifying their claims and if those patients approached J&J.
If the DCGI grants regular marketing authorisation, Covishied will be the second vaccine in the world to receive such approval.
'Safety is my first priority.' 'I need to ensure that any drug or vaccine that our citizens get is first safe.'
Serum Institute has the capacity to make 250 million doses of Covishield monthly.
The PM directed officials to evaluate various technology tools to ensure efficient and timely vaccination in due course of time. He also emphasised that detailed planning for such large scale vaccination should be undertaken immediately.
If things go according to plan, the vaccine would be available in the market by the end of this year.
Hyderabad-based vaccine manufacturer Bharat Biotech, which is carrying out its phase 3 trial will publish the data in July following that the company will be applying for the full licensure of Covaxin.
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.
A joint venture of Synbiotics, a wholly owned subsidiary of Ambalal Sarabhai Enterprises (ASE), and CoDiagnostics, CoSara Diagnostics is the first and only Indian company so far to receive a licence from the Central Drugs Standard Control Organisation (CDSCO) to manufacture coronavirus diagnostic test kits.
The Central Drugs Standard Control Organisation (CDSCO), the apex drug regulator, may soon ban the production and sale of three medicines in the country. The drugs - cisapride, phenylpropanolamine (PPA) and human placenta extracts - have been controversial medicines for their alleged adverse reactions for several years now.
Covaxin is being developed by Bharat Biotech jointly with the Indian Council of Medical Research (ICMR)- National Institute of Virology (NIV). The Phase III human clinical trials of Covaxin began mid-November, targeted to be done in 26,000 volunteers and it is the country's first and only Phase III efficacy study for a COVID-19 vaccine, a press release from the vaccine maker said on Saturday night.
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 government has capped the trade margin on oxygen concentrators at 70 per cent in order to keep in check the price of the much in demand critical life saving component amid the second wave of the coronavirus pandemic. The trade margin has been capped at 70 per cent on price to distributor level on oxygen concentrators. In an official release, the chemicals and fertilisers ministry said the decision has been taken in view of the extraordinary circumstances arising due to the pandemic which has resulted in volatility in Maximum Retail Prices (MRP) of oxygen concentrators.
The vaccine candidate -- 'Covaxin' -- is being indigenously developed by the Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
An expert panel of India's Central Drug Authority on Tuesday recommended granting permission to Serum Institute of India (SII) for conducting phase 2/3 trials of Covid vaccine Covovax on children aged 2 to 17 years with certain conditions, official sources said.
According to sources, around 10 crore doses of the Sputnik V vaccine is likely to be imported for emergency use in the country in the next six to seven months.
Gennova has also got permission for phase-2 and 3 clinical trials for its lyophilised mRNA vaccine for injection from the subject expert committee advising the Central Drugs Standards Control Organisation, reports Sohini Das.
Zydus plans to initiate the clinical trials of ZyCoV-D in July 2020 across multiple sites in India. In animal studies the vaccine was found to elicit a strong immune response in multiple animal species like mice, rats, guinea pigs and rabbits.
This is apart from the requirement to stock hydroxychloroquine (200 mg) and Azithromycin (500 mg) tablets for patients requiring ICU management, asymptomatic healthcare workers and asymptomatic household contacts of positive cases.
It said clinical trials of the drug 2-deoxy-D-glucose (2-DG) showed that it helps in faster recovery of hospitalised patients and reduces supplemental oxygen dependence.
As India launches the world's most ambitious and biggest vaccination drive against COVID-19, the country will encounter the formidable challenge of rapidly scaling up distribution of the vaccines to secure immunity for its entire population, two prominent Indian scientists at World Health Organisation have said.
'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.
Of the 137,000 drug government tested 345 turned out to be fake.
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 institute expects to complete both, phase-2 and 3 trials in India by the end of this year.
The Central Drugs Standard Control Organisation said while the rights, safety, and well-being of trial subjects were of paramount importance, protocol amendment, deviation or modification might be necessary in some cases owing to unavoidable circumstances.
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.
More lucrative routinely prescribed drugs are at higher risk of failing quality standards
Alkem Labs was issued drug alerts twice last year -- in June and July -- for its drug Glimekem.
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.
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.
In a video issued by the Health Ministry, Dr Randeep Guleria, Director of the All India Institute of Medical Sciences (AIIMS) answered commonly asked questions regarding the dosage of the vaccine saying that two doses of the vaccine will have to be taken 28 days apart and protective levels of antibodies generally would develop two weeks after the second dose.
The expert committee sought more information from Serum Institute regarding the Oxford-AstraZeneca vaccine.
The ICMR has approved over 200 labs (both public and private) for COVID-19 testing through-PCR machines.
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.
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.
This is the fifth consecutive day that COVID-19 cases have increased by more than 50,000 in the country.
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.
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