The Serum Institute of India (SII) had put in an application to the Drugs Controller General of India (DCGI) in October for grant of market authorisation of Covovax for restricted use in emergency situations.
Fund managers said investors remained positive on the pharma manufacturing activity in India, which further strengthened during the Covid-19 period, on account of restrictions imposed on pharma imports from China.
The DCGI said it has no objection in respect of 'Extension of Shelf Life of Covishield Vaccine' in multi-dose glass vial (10 dose-5ml) from six months to nine months.
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.
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.
The Central Drugs Standard Control Organisation has granted restricted emergency use authorisation to two new vaccines and a drug for COVID-19, taking the number of preventives and treatments available in India to 12.
Bharat Biotech is targeting to manufacture one billion doses of its intra-nasal vaccine in 2022 which is under clinical trials now.
Centre mulls strategy to ensure powers given to the agencies are not misused.
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.
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.
Security breach came days after the firm got approval to conduct trials for Covid-19 vaccine candidate Sputnik V.
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.
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.
Import alert on Ranbaxy's Mohali unit; Strides' injectible arm gets warning letter
The government on Thursday listed bills on personal data protection, to amend forest conservation laws and on the contentious ordinance on Delhi services for the monsoon session of Parliament beginning next week.
Once available, Sputnik V will be the third vaccine to be used in India against coronavirus.
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.
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.
Animal's violence isn't for the fainted-hearted unless you have an appetite for Korean style mayhem, like Sukanya Verma.
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.
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.
People close to Shanghvi reveal he is known to make surprising moves both inside and outside the pharma industry.
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.
'We would like to develop Andhra Pradesh into a logistics hub not only for India, but also for South Asia.'
These things are cheaper than equivalent branded drugs, to patients, says Modi
The move comes even as India's drug regulator has extended Covishield's shelf life from six to nine months from its manufacturing date.
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.
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?
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.
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.
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.
'We seem to be in a situation where we can do little, and nothing needs to be done anyway.'
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.
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.
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.
'India is a pharma dada. We can manufacture enough for our people and for the world.'
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.
