Move follows a spate of international regulatory enforcements on Indian drug firms.
Dr Reddy's Laboratories on Friday soft-launched imported COVID-19 vaccine Sputnik V, with Deepak Sapra, a senior executive of the drug-maker, taking the first shot in Hyderabad.
'We seem to be in a situation where we can do little, and nothing needs to be done anyway.'
The remarks of the top court came on a bail plea of an accused who was arrested after opium was found in his fields and has served more than five years in jail.
"The guidelines would cover all ethical issues."
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.
The other measures which have been or will be undertaken include mandatory registration of clinical trial proposals and forming guidelines for ethics committees.
Earlier this week, AstraZeneca said it had paused the trials because of 'an unexplained illness' in a participant in the study.
"The phase-III trial of 'Covishield' vaccine will begin at Sassoon hospital from next week. It is likely to start on Monday. Some volunteers have already come forward for the trial. "Around 150 to 200 volunteers will be administered the vaccine candidate dose," Dean of the state-run Sassoon General Hospital Dr Muralidhar Tambe 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.
Indian pharmaceutical companies are stepping up their efforts to combat the problem of counterfeit drugs, employing a variety of strategies, from packaging innovations to engaging private investigation agencies. The stakes are high, as counterfeit medicines not only harm consumers but also tarnish the reputation of leading brands.
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 company has developed detailed logistical plans and tools to support effective vaccine transport, storage, and temperature monitoring. Sohini Das and Ruchika Chitravanshi report.
'Once DCGI will give us the permission to restart the trials in India, we will resume the trials,' Serum Institute of India (SII) said in a statement.
The approval by the Drugs Controller General of India comes following recommendations by the Subject Expert Committee on COVID-19 of the Central Drugs Standard Control Organisation.
The current total installed capacity of the seven manufacturers of remdesivir is 38.80 lakh vials per month, the Ministry of Chemicals and Fertilizers said in a statement.
Covaxin is being developed by Bharat Biotech, in collaboration with the Indian Council of Medical Research - National Institute of Virology.
The DCGI's nod came after the subject expert committee on COVID-19 of the CSDCO last week recommended granting emergency use authorisation to Covovax for the age group of 7 to 11 years.
The vaccine option for this age group would only be Covaxin, according to guidelines issued by the Union Health Ministry on December 27.
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
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.
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.
Adar Poonawalla said he was hopeful that Covovax, the Novavax vaccine made by SII, will be launched around October this year for adults and for children by the first quarter of next year, depending on DCGI approvals.
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 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 move comes even as India's drug regulator has extended Covishield's shelf life from six to nine months from its manufacturing date.
Confirming the Drugs Controller General Of India (DCGI) approval, Serum Institute of India CEO Adar Poonawalla on Tuesday tweeted: '@SerumInstIndia's brand Covovax has completed bridging studies in India and has been granted Emergency Use Authorisation by DCGI for adults and for children above the age of 12. Younger age groups will follow shortly.'
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.
DCGI, health ministry initiate dialogues with foreign regulators, try to understand global best practices
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.
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 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.
Commercial launch and supply to major government and private hospitals is expected in mid-June.
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.
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.
"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.
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.
