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.
Baltimore-based Lupin Pharmaceuticals Inc is recalling 5,60,922 pouches of Mibelas 24 Fe (norethindrone acetate and Ethinyl estradiol tablets and ferrous fumarate tablets) in the US, as per the latest enforcement report by the USFDA.
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 Hyderabad-based manufacturer uses a proprietary adjuvant Algel-IMDG, which has now proven to be a safe and effective adjuvant, especially to stimulate memory T cell responses.
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.'
Officers sitting over untapped potential to make COVID-19 vaccines need to be charged with 'manslaughter' as it is leading to so many deaths, the Delhi high court said on Wednesday, observing that a lot of scope and infrastructure is available in India which is not being used.
The Philippines launches probe after Sanofi reveals WHO-approved dengvaxia - a dengue vaccine - aggravates symptoms in some cases.
GSK is continuing with investigations into the potential source of the NDMA, which is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.
Thackeray, whose Maha Vikas Aghadi government fell after a rebellion in June last year by his cabinet colleague Eknath Shinde, who went on to become CM, also warned he would extract revenge for his ouster.
Reinvent and innovate will be the key mantra for the Indian pharma industry in the New Year as the 'pharmacy of the world' looks to move from volume to value leadership, amid emerging challenges of inflation and pricing pressures in the global markets. While R&D investment, market competitiveness, regulatory scrutiny, and domestic price regulations are expected to shape the growth of generics and injectable products, concerns such as price control and customs duties on medical equipment will continue to bother the healthcare industry in 2023. The industry believes that in view of India's G20 Presidency, digital health innovation, achieving universal health coverage, improving healthcare infrastructure and delivery will continue to be the key driving factors in 2023.
India lost its competitive advantage as China gave fiscal benefits to its local manufacturers. Besides, recent policy flip-flops have, however, dented India's image as the 'pharmacy of the world'.
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 papers noted that the 5G network is built on easily accessible and open Internet protocols and it inherits all the vulnerabilities of previous generations which make it vulnerable to cyber-attacks and compromising the security of the entire system.
Kerry is scheduled to head to India later this month for the fourth annual US-India Strategic Dialogue.
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.
'With Trump, the relationship was very transactional, whereas with President Biden it is very structured.'
In September, Bharat Biotech aimed to supply 35 million doses, and take this up to 55 million by October. This is still less than what the Indian government expects from the company.
The bone of contention is product approvals, which pharma and neutraceuticals companies say cannot be re-introduced through the regulation route
In a series of tweets after the Drugs Controller General of India (DCGI) approved Oxford's vaccine Covishield and Bharat Biotech's Covaxin for restricted emergency use, Modi said it will make every Indian proud that both the vaccines are made in India.
Besides Aryan Khan, the arrested accused are identified as Munmun Dhamecha, Arbaaz Merchant, Ismeet Singh, Mohak Jaswal, Gomit Chopra, Nupur Sarika, and Vikrant Chhokar.
Sun Pharmaceutical's acquisition of Ranbaxy has received final approvals.
Hetero has priced the injectable drug at Rs 5,400 per 100 mg vial. With More drugmakers in line to launch the drug soon, the prices may see a further erosion.
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.
'Almost 70 per cent production time of a vaccine is dedicated to quality control, which is done through several hundred tests.'
BE's Corbevax is the first such vaccine in India to be approved as a heterologous COVID-19 booster in the country.
This apart, to further increase capacities, Bharat Biotech has partnered with Indian Immunologicals (IIL) to manufacture the drug substance for Covaxin. The technology transfer process is underway and IIL has the 'capabilities and expertise' to manufacture the inactivated viral vaccines at commercial scale.
The vaccine would not have production scalability issues unlike Covaxin, Bharat Biotech's COVID-19 virus vaccine.
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."
In a setback that could potentially delay the launch of Bharat Biotech's Covid-19 vaccine Covaxin in USA, the Food and Drug Administration there has "recommended" Ocugen Inc, the US partner of the Indian vaccine maker, to go for Biologics Licence Application (BLA) route with additional data, nixing hopes of Emergency Use Authorisation.
Easy access to this kind of test could help people determine what kind of precautions they should take against COVID-19 infection, such as getting an additional booster shot, the researchers said.
Pune-based Serum Institute of India (SII) is sitting on 200 million doses of Covishield that were manufactured in December and are set to expire in September. The company is likely to destroy these vaccines if nothing works out, Sohini Das reports.
The court, in its order, noted that the investigation in the case was of prime importance and considering this aspect, the further presence of the accused before the NCB was necessary.
As cases of 'black fungus' among COVID-19 patients in the country rise to cross 7,000, the Centre on Thursday urged all states and union territories to declare it as a notifiable disease under the Epidemic Diseases Act to ensure mandatory surveillance to tackle the 'new challenge'.
Next week, US Secretary of State John Kerry travels to India for the fourth annual US-India Strategic Dialogue
The first 100 beneficiaries of such foreign vaccines shall be assessed for seven days for safety outcomes before it is rolled out for further immunisation programme within the country, the Union health ministry said.
The company had in December said that the CDSCO had approved a 12-month shelf life for Covaxin, which was nine months earlier, Sohini Das reports.
An expert panel of the country's drugs regulatory authority had recommended against granting such approval to the firm at this stage just two days ago, officials said.
The Goods and Services Tax (GST) Council, chaired by Union Finance Minister Nirmala Sitharaman, will likely consider on Saturday a GST rate cut for Covid-19 relief essentials and drugs for treating the black fungus disease and might leave the vaccines untouched. The meeting is being held following a report submitted by a Group of Ministers (GoM) to the GST Council on Monday. The GoM, set up by the Council on May 28, was mandated to look at tax exemption and concessions on various Covid items including vaccines, drugs, and equipment.
The DCGI arrived at the conclusion on Wednesday based on the recommendations of an independent expert committee which has also opined that compensation should not be paid to the volunteer, they said.
Aryan Khan was arrested on October 3. He is currently in judicial custody and lodged at the Arthur Road prison in Mumbai.
