Bharat Biotech applied to the Drugs Controller General of India (DCGI) seeking permission for conducting phase 1 and phase 2 clinical trials of the intranasal vaccine following which the subject expert committee of the CDSCO on Tuesday deliberated on the application and recommended granting permission for phase 1 trial.
According to the purchase order placed on Monday, each dose of the vaccine has been priced at Rs 200 and with GST of Rs 10, it would cost Rs 210.
The Indian Medical Association on Monday expressed shock over the 'blatant lie of World Health Organisation certification' for Patanjali's Coronil tablet, which the company claims is an evidence-based medicine to fight COVID-19, and demanded an explanation from Union Health Minister Harsh Vardhan in whose presence the medicine was launched.
India is not keen to 'bow down' to demands related to indemnity against legal liabilities in case any vaccine recipient develops severe adverse reactions post inoculation.
Favipiravir is the only oral anti-viral treatment approved in India for potential treatment of patients with mild to moderate Covid-19 disease.
In a joint statement posted on their respective twitter accounts, the companies said Serum Institute Chief Executive Officer Adar Poonawalla and Bharat Biotech Chairman Krishna Ella communicated their combined intent to develop, manufacture and supply the COVID-19 vaccines.
The Drug Controller General of India (DCGI) has sought clarification from pharma majors Dr Reddy's Laboratories and Mumbai-based Piramal Healthcare, for allegedly sponsoring doctors for conferences.
Zydus Cadila COVID-19 vaccine for children above 12 years is expected to be available by August as its trials are likely to be completed by July-end, said Dr N K Arora, Chairman, National Technical Advisory Group on Immunisation (NTAGI).
'SII has started stockpiling the vaccine and now has roughly 40 million doses ready. It is using some of the capacities it had for under development products for the COVID-19 vaccine and by January we will have a capacity to make 100 million doses per month and a stockpile of 200 million doses.'
Legal experts and official sources said the alleged submission of fake documents can also lead to criminal charges against Novartis.
On production capacity of Covishield, the vaccine being manufactured and supplied by Serum in India under a licensing agreement with Oxford and AstraZeneca, he said the present capacity is 130 million doses per month and always try to increase it further.
The phase-three human clinical trial of indigenously developed anti-coronavirus vaccine candidate Covaxin began at the AIIMS in New Delhi on Thursday, with Dr M V Padma Srivastava, the chief of Neurosciences Centre at the premier institute, and three other volunteers receiving the first dose.
Indian Council of Medical Research Director General Balram Bhargava said the purpose of the COVID vaccine drive would be to break the chain of viral transmission.
Over 20 drug companies marketing anti-obesity drug sibutramine under a variety of brand names are likely to soon face a ban on selling the medicine.
The senior officials of the health ministry apprised the minister on various improvements that have been made to make the pan India dry run glitch free, such as number of telephone operators has been increased to answer every possible query from the teams on the ground conducting the dry run.
To address the shortage of COVID-19 jabs in the country, the government is exploring the possibility of boosting production of vaccines, including identifying manufacturing sites for indigenously developed Covaxin outside India, sources said.
The medical devices, which have been in high demand during the Covid-19 pandemic, will now see a drop in prices, as the earlier margins were up to 709 per cent for some of these products.
The announcement comes a day after the Subject Expert Committee (SEC) on COVID-19 of the CDSCO recommended granting emergency use authorisation (EUA) to the COVID-19 vaccines Covovax and Corbevax with certain conditions.
DCGI, health ministry initiate dialogues with foreign regulators, try to understand global best practices
The company is set to deliver the first set of 20,000 vials in two equal lots of 10,000 each, one of which will be immediately supplied to Hyderabad, Delhi, Gujarat, Tamil Nadu, Mumbai and other parts of Maharashtra, Hetero Healthcare said in a statement.
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.
Dispatch of the vaccine is likely to start by early Tuesday morning, sources said. According to the order placed, each dose of the vaccine has been priced at Rs 200 and with GST of Rs 10, it would cost Rs 210.
'Forcing the development of an indigenous vaccine as a cure for COVID-19, bypassing all health & safety norms, to be announced by PM Modi on Independence Day is fraught with horrendous human costs'
Drug majors Pfizer and Abbott stopped sale of their popular cough syrups Corex and Phensedyl respectively.
The company has developed detailed logistical plans and tools to support effective vaccine transport, storage, and temperature monitoring. Sohini Das and Ruchika Chitravanshi report.
A Chennai-based man has demanded a compensation of Rs 5 crore from the SII after his health worsened allegedly after volunteering for the clinical trials for a COVID-19 vaccine.
The company has received approval from the Drugs Controller General of India (DCGI) to market Itolizumab injection 25mg/5mL solution for emergency use in India for the treatment of cytokine release syndrome in moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19.
Wockhardt said, the drug regulator suspended the manufacture, sale or distribution of fixed dose combination of Dicyclomine Hydrochloride IP 10mg
Poonawalla, during an interaction with Odisha Chief Minister Naveen Patnaik through a video conference, expressed optimism that the COVID-19 vaccine could be ready by October-November this year and the next phase of the trial can start in mid-August in India. According to a press note released by the CMO, Poonawalla has informed that the Oxford University vaccine has shown promising results in the first phase trial.
The Corosure Kit has received ICMR approval with the highest score and DCGI approved with a very high sensitivity and specificity.
AIIMS-Delhi is among the 12 sites selected by the Indian Council for Medical Research (ICMR) for conducting Phase I and II randomised, double-blind and placebo-controlled clinical trials of Covaxin.
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.
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).
Industry is gathering scientific data to approach the regulator, DCGI, for a review of the suspension order.
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."
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.
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.
Firms could lose licence if products not launched within 6 months of approval.
The institute expects to complete both, phase-2 and 3 trials in India by the end of this year.
In what could be the beginning of fresh troubles for Ranbaxy Laboratories, which has just managed to settle long-pending issues with the US Department of Justice after agreeing to pay a penalty of $500 million, the health ministry in India, too, has decided to initiate a probe.
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