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Earlier this week, a committee of experts had deferred a decision on the request of SII to start trials and asked the company to amend its protocol for the clinical study. The subject expert committee (SEC) had recommended eight amendments to be made to the firm's proposal to conduct Phase-II and -III trials.
The COVAX Advance Market Commitment (AMC) forms part of the COVAX Facility, a mechanism hosted by Gavi, the Vaccine Alliance, designed to guarantee rapid, fair and equitable access to COVID-19 vaccines for every country in the world.
Israeli Ambassador to India Ron Malka on Friday visited the special testing site created at the Dr Ram Manohar Lohia (RML) Hospital to witness the ongoing trials being conducted since the last three days for rapid COVID-19 testing, the Israeli release on his visit said.
Online applications filed by exporters only from August 5 to 8 will be considered for getting licences or permission by the Directorate General of Foreign Trade (DGFT) for shipments of 2- and 3-ply surgical masks, medical goggles and diagnostic kits, according to trade notices of the DGFT.
While Sikkim is still under lockdown, the state government has allowed pharma units outside containment zones to operate with minimum staff, subject to strict adherence to social distancing norms and regulation of movement of people and goods.
The US private equity fund is understood to have pipped a rival offer from a consortium consisting another PE fund Carlyle Group and former Mylan Labs CEO Hari Babu. Bangalore-based Microlabs controls the entity currently. An official announcement is expected soon.
A major contributor to lead poisoning is a surge in the recycling of lead in automotive batteries to satisfy soaring growth in the numbers of cars and trucks, particularly in the developing world, the study said. While lead recycling for batteries is heavily regulated in the United States, it is often done haphazardly in poor and middle-income countries.
AIIA has also been designated as COVID-19 testing centre (RT-PCR and Rapid antigen testing) by the Government of Delhi. A COVID Call Centre has been established at AIIA for handling public queries related to coronavirus telephonically. The Institute has an important role in preventive and curative health care and research areas under the aegis of Ministry of AYUSH.
Several Mumbai slums have seen steep drops in infections in recent weeks after cases first erupted in April, even as India’s overall cases grow at the fastest pace globally. Credit has largely been given to the intensive containment measures officials implemented in the slums, like door-to-door health screenings and rapidly-erected quarantine facilities.
A bench comprising judicial member Ravish Sood and accountant member G Manjunatha ruled that a Central Board of Direct Taxes circular and the IMC’s regulations could not be relied upon to disallow a drug company’s expenditure claims. The IMC’s code of conduct applies only to medical practitioners and doctors and not to pharmaceutical companies and the healthcare sector, it said.
The NPPA can only control prices of devices and products that are defined as drugs under the Drugs and Cosmetics Act. A product or device that is not notified as a drug goes out of the NPPA's purview.
India's COVID-19 case fatality rate (CFR) is lower than what it is globally. On Wednesday, the CFR stood at 2.23 per cent, the lowest since April 1, the health ministry said in a statement.
This is the second drug developed by Hetero after Covifor, the generic version of Remdesivir injection to be administered intravenously in a hospital for treatment of severe Covid-19, under the license from Gilead Sciences.
Two injections of the vaccine protected against heavy exposure to the virus at two different levels of dosage, Moderna said in findings published Tuesday in the New England Journal of Medicine.
Price sensitivity among formulation companies is declining amid a receding threat of supply chain disruptions from Chinese suppliers, which had also occurred in the past, he said. Considering that India has the highest number of API facilities approved by the US Food and Drug Administration, it will remain a critical part of the global supply channel, Munde noted.
A serological survey conducted by the Brihanmumbai Municipal Corporation, Niti Aayog and Tata Institute of Fundamental Research showed that 16% of the people living in apartment buildings had been infected by the virus that causes Covid-19.
India and the UK will be enhancing their science and research collaboration with five new projects worth 8 million pounds to tackle anti-microbial resistance, which could lead to important advances in the global fight against antibiotic-resistant bacteria and genes.
The BCG vaccine is administered routinely to all newborns as part of the national childhood immunisation programme to prevent tuberculosis (TB), an infection caused by bacteria that mainly affects the lungs. It has beneficial heterologous effects and proven antiviral and immune modulatory properties that protect against infectious diseases through induction of trained innate immunity and heterologous adaptive immunity.
In a statement, the Health Ministry said as many as 13,657 health and wellness centres (HWCs) were operationalised within the period of the coronavirus pandemic itself (between January to July 2020). These centres provide comprehensive and quality primary care close to the community.
The much-awaited trial of BBV152 COVID-19 vaccine or Covaxin commenced at the Institute of Medical Sciences and SUM Hospital, one of the 12 centres selected by Indian Council of Medical Research (ICMR) for conducting phase one and two of the process.
The focused efforts of the Centre, state governments and Union Territory administrations on early detection and isolation through aggressive testing and efficient clinical management of hospitalised cases have shown results with continuously falling case fatality rate and improving recovery rate, the health ministry said.
The Israeli defence ministry research and development team has been working with India's chief scientist K Vijay Raghavan and Defence Research and Development Organisation (DRDO) to develop rapid testing for COVID-19 in less than 30 seconds, the Israeli Embassy had said last week.
"The objective is to make India self-reliant in production of 53 critical (active pharmaceutical ingredients) APIs or Key Starting Materials (KSMs), and in production of medical devices, for which India is crucially dependent upon imports," Sadananda Gowda, the federal minister for chemicals and fertilisers, tweeted on Monday.
Dr Reddy's Laboratories said it is working to commercialise this product through partners. In a regulatory filing, Dr Reddy's Laboratories announced it has received "approval of Xeglyze (abametapir) lotion... by the US Food and Drug Administration (USFDA)".
The IPA wants the government to accord infrastructure status to the Active Pharmaceutical Ingredients (API) industry, and provide a boost to innovation through tax incentives on patent income, streamlined pathways for testing and approval of experimental therapies, its president, Satish Reddy told ET.
The experts feel that the rapid antigen test has changed the script for the national capital due to its affordability, quicker result and its ability to serve as a fast diagnostic tool. The rapid antigen tests started in Delhi from June 18. The total number of tests conducted in the national capital stands at 9,46,777 till date, which means 49,830 tests per million.
The permission to market the drug was granted for the treatment of cytokine release syndrome in 'moderate' to 'severe' Acute Respiratory Distress Syndrome patients due to COVID-19.
As per the latest Enforcement Report of the US Food and Drug Administration (USFDA), Lupin is recalling 4,92,858 bottles of Metformin Hydrochloride extended-release tablets in 500 mg and 1,000 strengths.
The virtual launch event will be attended by Union Health Minister Harsh Vardhan and the chief ministers of Maharashtra, West Bengal and Uttar Pradesh -- Uddhav Thackeray, Mamata Banerjee and Yogi Adityanath respectively.
From Italy to New Zealand, irrespective of how well the virus was contained, governments acknowledge that fresh waves of the deadly coronavirus are likely and that the policy tools to mitigate the damage are limited.
Already stretched thin by the pandemic, freight companies face problems ranging from shrinking capacity on container ships and cargo aircraft to a lack of visibility on when a vaccine will arrive.
The institute has to harness 100 volunteers for the trial. Sources said that nearly 3,500 people have registered to participate in the trial, a little over 50% of them from other states.
Both BB and Zydus were granted permission for Phase I and II clinical trials and administered the first doses of their vaccine candidates to volunteers on July 15. A third vaccine candidate, developed by Oxford University, is soon to be tested in India. Serum Institute, which is in a manufacturing partnership with the UK’s Astra Zeneca, has said it will begin human trials as soon as it receives regulatory approval.
According to data updated at 8 am, the total recoveries have climbed to 8,17,208, while there are 4,40,135 active cases of coronavirus in the country at present, the ministry said as the COVID-19 tally surged to 12.87 lakh.
Already, over 3,500 volunteers have registered themselves for the trial at AIIMS since last Saturday, of whom the screening of at least 22 people is underway, said Dr Sanjay Rai, Professor at the Centre for Community Medicine at AIIMS and the principal investigator of the study.
"With COVID-19 Ag Respi-Strip, we are bringing CE certified and ICMR approved kits at affordable prices, which is also our company's driving force for all other product lines," Vishat Diagnostics MD Pratik Chaitala said. At a time when India is touching its peak in daily numbers of cases, it becomes critical to rapidly increase testing, he added.
Under a deferred prosecution agreement reached with the DOJ, it said, adding that the dept will file an information for conduct that took place between 2013 and 2015. Taro Pharmaceutical said, if the company adheres to the terms of the agreement, including the payment of USD 205.7 million, the DOJ will dismiss the information at the end of a 3-year period.
Worldwide shortages of protective equipment have led the U.S. Centers for Disease Control and Prevention and other health authorities to recommend homemade cloth face coverings as an alternative to surgical face masks.
"Waste masks and gloves in general households should be kept in paper bag for a minimum of 72 hours prior to disposal of the same as dry general solid waste after cutting the same to prevent reuse," the CPCB said. This is the fourth time the CPCB has issued guidelines on management of bio-medical waste generated from coronavirus.
"We are extremely privileged to announce that Dr. Dangs Lab, New Delhi has been provided the opportunity to serve the nation by being selected as the central lab for the Human Clinical trials of Covaxin; India's indigenous COVID-19 vaccine being developed and manufactured by Bharat Biotech in collaboration with the ICMR - NIV," it said in a statement.
The administration maintains that the health infrastructure in Valley is equipped enough to deal with the crisis, however, the scenes at the hospitals and complaints of patients belie the official claims.
Many recent accounts tap into people’s anxieties that they are destined to succumb to Covid over and over, feeling progressively sicker, and will never emerge from this nightmare. These stories fuel fears that we won’t be able to reach herd immunity — the ultimate destination where the virus can no longer find enough victims to pose a deadly threat.
While little is definitively known about the coronavirus just seven months into the pandemic, the new virus is behaving like most others, they said, lending credence to the belief that herd immunity can be achieved with a vaccine.
Results from the Phase 3 trial showed numerical improvements for the primary efficacy endpoint with 28.6 per cent faster viral clearance in the overall population in the Favipiravir plus standard supportive care compared to those in the standard supportive care alone (control arm) , Glenmark said in a statement.
