Bharat Biotech is targeting to manufacture one billion doses of its intra-nasal vaccine in 2022 which is under clinical trials now.
The Drugs Controller General of India will take a final call on the recommendation. If approved, it will be the third COVID-19 vaccine to be available in India.
Animal's violence isn't for the fainted-hearted unless you have an appetite for Korean style mayhem, like Sukanya Verma.
Once the UK drug regulator gives its approval to the Oxford vaccine, the expert committee on COVID-19 at the Central Drugs Standard Control Organisation (CDSCO) will hold its meeting and thoroughly review the safety and immunogenicity data from the clinical evaluations conducted abroad and in India before granting any emergency authorisation for the vaccine here, official sources said.
The stock of Divis Laboratories is up 10 per cent over the last couple of trading sessions on expectations that the worst is behind and the company could see a sequential growth in the March quarter of the 2022-23 financial year (Q4FY23). The stock witnessed the highest downgrades among Nifty50 index stocks with earnings cuts over a third after the Q3FY23 results. The company had posted a 32 per cent drop in revenues over the year ago quarter in Q3FY23 and 8 per cent sequentially, which was sharply lower than Street expectations.
Drug major Ranbaxy Laboratories on Thursday said it plans to launch more generic products in the US market with possible marketing exclusivity, while keeping options open for overseas acquisitions to grow its business in various global markets.
Remdesivir is considered a key anti-viral drug in the fight against Covid-19. In addition, the government has taken three steps to ensure easy access of hospitals and patients to Remdesivir.
Security breach came days after the firm got approval to conduct trials for Covid-19 vaccine candidate Sputnik V.
With the government asking the companies to operate with only 50 per cent staff strength, and exports dipping to almost zero, the truck and bus drivers idling at the petrol pump say they hardly have any work now. At a petrol pump on the deserted Bavla-Changodar highway near Ahmedabad in Gujarat, several trucks and buses are neatly parked in a row.
A longer shelf life is critical, given many makers have started manufacturing vaccines and stockpiling them, so as to make them available in the market immediately after approval, reports Sohini Das.
Once available, Sputnik V will be the third vaccine to be used in India against coronavirus.
A statement issued by the WHO on Saturday said the suspension is in response to the outcomes of its post EUL (emergency use authorisation) inspection held between March 14-22, 2022 and the need to conduct process and facility upgrade to address recently identified GMP (good manufacturing practice) deficiencies.
'We would like to develop Andhra Pradesh into a logistics hub not only for India, but also for South Asia.'
Import alert on Ranbaxy's Mohali unit; Strides' injectible arm gets warning letter
The Indian vaccine industry largely feels there are two ways in which vaccine innovation can be spurred - one, get a high price for the product and two, have the government buy a few hundred million doses of the product at a certain price.
The government on Wednesday approved a production-linked incentive (PLI) scheme for the pharmaceutical sector, entailing an outlay of Rs 15,000 crore. The Union Cabinet, chaired by Prime Minister Narendra Modi, approved the scheme which will benefit domestic manufacturers, help create employment and is expected to contribute to the availability of a wider range of affordable medicines for consumers. The duration of the scheme would be from 2020-21 to 2028-29 and is expected to promote the production of high value products in the country and increase the value addition in exports, an official release said.
There's an entire gurdwara dedicated to immigration. People present tiny airliner models here in the hope that Waheguru will soon give them a ticket, passport and visa to leave, reveals Shekhar Gupta.
While Lupin is working on a Remdesivir powder for inhalation, Glenmark has tied up with a Canadian Biotech firm for nitric oxide nasal spray that reduces Sars-CoV-2 viral load and thus transmission.
Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research.
An expert panel of India's central drug authority on Wednesday recommended granting regular market approval to COVID vaccines Covishield and Covaxin for use in adult population subject to certain conditions, official 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.
People close to Shanghvi reveal he is known to make surprising moves both inside and outside the pharma industry.
DGCA's move seeks to ban perfumes for pilots as they have alcohol and can affect the results of breathanalyser tests. But the FAA and EASA have different standards, says senior journalist Shobha John.
These things are cheaper than equivalent branded drugs, to patients, says Modi
Laws governing compensation in case of adverse side effects for Covaxin and Covishield may differ in accordance with the kind of approvals given, say legal experts.
Dominic Xavier ponders the Vaccine Dilemma: Should he take the shot or not?
'We seem to be in a situation where we can do little, and nothing needs to be done anyway.'
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.
Stressing that while framing any policy, there is a need to look at it from India's strategic point of view, Modi said there were instances when notes from the national security council were not given due importance.
This will be Modi's first interaction with chief ministers following the recent approval of two coronavirus vaccines for restricted emergency use by India's drug regulator.
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.
Drug firm Zydus Cadila on Thursday said it has applied for emergency use authorisation (EUA) with the Indian drug regulator for its three-dose COVID-19 vaccine ZyCoV-D, and plans to manufacture 10-12 crore doses annually.
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.
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.
'India is a pharma dada. We can manufacture enough for our people and for the world.'
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.
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.
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.
