There were no safety concerns arising from the study data and Covovax is safe and immunogenic in the adult population, Prakash Kumar Singh, Director, Government and Regulatory Affairs at the Serum Institute of India (SII), is learnt to have said in the application sent to the DCGI.
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 other measures which have been or will be undertaken include mandatory registration of clinical trial proposals and forming guidelines for ethics committees.
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 Delhi High Court on Friday stayed the ban on some fixed dose combination (FDC) drugs of Glaxo SmithKline, Wockhardt and Laboratories Griffon but said action against their sale could be taken in the absence of valid sale and marketing licence.
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.
The NCB has widened its probe into a recent seizure of about 50 kg of heroin from a house in south Delhi's Shaheen Bagh area with the arrest of three more people on Friday, officials said.
The move comes even as India's drug regulator has extended Covishield's shelf life from six to nine months from its manufacturing date.
Prime Minister Narendra Modi, in his address at the 76th session of the United Nations General Assembly on Saturday, invited the global manufacturers of vaccines to come and make vaccines in India, stressing that the country's "faith is to serve people".
The DMK also warned of legal action against those who attempt to link Sadiq with either the party or its leaders.
A senior health official said the probe will find out how the teenager was given the shot even though the government is yet to roll out any anti-COVID 19 vaccination programme for minors.
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.
Union Health Minister Mansukh Mandaviya on Tuesday told Bharatiya Janata Party MPs that Covid vaccination for children is likely to start soon, sources said.
As the COVID-19 vaccination of children falling into the age bracket of 15 to 18 years is scheduled to begin from January 3, the Kerala health department has prepared an action plan for inoculation of all eligible beneficiaries.
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.
The parties intend to start the production of Sputnik V in the beginning of 2021, it added. Currently, Phase III clinical trials are approved and are ongoing in Belarus, the United Arab Emirates, Venezuela and other countries, as well as Phase II-III in India, RDIF said.
Cadila Healthcare on Friday said it had received permission to conduct clinical trials on its new molecular entity - ZYH1 - a formula to check cholesterol in blood. The drug controller general of India gave its approval to conduct phase I clinical tr
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.
"India expands its vaccine basket! Johnson and Johnson's single-dose COVID-19 vaccine is given approval for Emergency Use in India. Now India has 5 EUA vaccines. This will further boost our nation's collective fight against COVID-19," tweeted the minister.
The Narcotics Control Bureau has seized about 50 kg of 'high-quality' heroin and arrested a man after it conducted raids in the Shaheen Bagh area of Delhi's Jamia Nagar, the federal anti-narcotics agency said on Thursday, claiming to have busted an Indo-Afghan drug-smuggling racket.
'Even if you are not in possession (of drugs) but you are part of the conspiracy, you are punishable under the same section of the law. Aryan Khan was aware that Arbaaz was in possession. Charas was for smoking and it was for the consumption of both, though it was with Arbaaz physically,' ASG Anil Singh told the HC.
The Union home ministry said several steps have been taken to augment the production and supply of Remdesivir injections from 38.80 lakh units per month to 74 lakh units per month by early next month, and asked the states to ensure its seamless supply and transport.
India achieved this coverage in 130 days as against the USA's feat in 124 days.
Speaking at a virtual conference organised by the Confederation of Indian Industry, Suchitra Ella, joint Managing Director of the city-based vaccine maker, said the company's facilities in four cities -- Hyderabad, Bengaluru, Pune and Ankaleshwar -- are currently producing Covaxin.
Poonawalla wished the country and Prime Minister Narendra Modi success for the vaccination programme.
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.
Healthcare and frontline workers and citizens above 60 years of age with comorbidities would be administered the third dose of the same vaccine they had been given before.
The vaccine candidate -- 'Covaxin' -- is being indigenously developed by the Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
The Serum Institute of India, Bharat Biotech and Pfizer have applied to the DCGI seeking emergency use authorisation for their COVID-19 vaccine candidates and are awaiting approval.
According to the recommendations of the Subject Expert Committee (SEC) meeting held on July 30, which have been approved by the Drugs Controller General of India (DCGI), Sputnik-Light is the same as the component-1 of Sputnik V and as its safety and immunogenicity data in the Indian population has already been generated in a trial here, there seems to be inadequate data and justification for conducting a separate, similar trial.
The seizure, as per officials, is estimated to be worth over Rs 10 crore in the international market (about Rs 5K-7K per blot) and all the six who have been taken into custody, beginning late last month, are students and youngsters who wanted to make 'easy money' by remaining anonymous within the deep layers of secret internet-based apps and messenger service like WICKR.
If the DCGI grants regular marketing authorisation, Covishied will be the second vaccine in the world to receive such approval.
In a report submitted Monday to Rajya Sabha chairman and Vice President M Venkaiah Naidu, the Parliamentary Standing Committee on Home Affairs also said there was a need for a comprehensive public health law to keep a tab on private hospitals and check black-marketing of medicines.
If things go according to plan, the vaccine would be available in the market by the end of this year.
Currently, phase 2 and 3 clinical trials of the Oxford vaccine candidate is going on in the United Kingdom, phase 3 clinical trial in Brazil and phase 1 and 2 clinical trials in South Africa.
National security advisor Ajit Doval on Friday suggested that various central armed police forces of the country should have "jointness" and interoperability among themselves like the ongoing plan for the defence forces.
Biological E Limited plans to complete production at a rate of 75 million doses of its COVID-19 vaccine Corbevax per month, anticipating over 100 million doses per month from February 2022 which will enable the Hyderabad-based company to deliver 300 Million doses as promised to the Centre, BE said on Tuesday.
However, he also said traditional ayurveda, yoga and naturopathy have also controlled and provided permanent solution to several complex diseases like blood pressure, thyroid, sugar, arthritis, hepatitis and asthma.
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