The Pune-based firm had submitted interim safety and immunogenicity data of phase 2/3 bridging clinical trial conducted in the country as well as interim clinical trial data of safety and efficacy from phase3 clinical trials conducted in the UK and the US along with its application.
Wockhardt MD Murtaza Khorakiwala said his firm had responded to the FDA's observations but declined to give details.
The Bharatiya Janata Party in Maharashtra objected to the pharma executive's grilling by Mumbai police, saying the Shiv Sena-led government in the state was playing politics amid the pandemic.
The consignment was imported by a trading company registered in Vijaywada in Andhra Pradesh.
The government on Thursday took a series of measures in view of the rising number of COVID-19 cases in several parts of the world, including China.
'We would like to develop Andhra Pradesh into a logistics hub not only for India, but also for South Asia.'
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.
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.
The Hyderabad-based firm will first make the drug available in high case load areas of Maharashtra and Delhi under the brand Covifor. A single dose vial is likely to cost Rs 5,000-6000.
In his second term in office, UP Chief Minister Yogi Adityanath has retained 34 portfolios.
Nearly 50 million doses of Bharat Biotech's COVID-19 vaccine, Covaxin lying with the firm are set to expire early next year as there are no takers owing to poor demand, company sources said.
We have the workforce, now we need to ensure that we take full advantage of game-changing technologies and geopolitical openings, suggests Jayant Sinha, chairman, Parliament's Standing Committee on Finance.
The National Investigation Agency on Monday detained gangster Chhota Shakeel's aide Salim Qureshi aka Salim Fruit and a trustee of the Haji Ali Dargah in Mumbai after conducting raids at over 20 places in the city and in adjoining Thane district against associates of fugitive underworld don Dawood Ibrahim, an official said.
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.
'There is no shortage of any APIs (active pharmaceutical ingredients) in the country'
Once tipped to emerge as the biggest exporter, the pharmaceutical industry is yet to acquire the scale of those in software services, says Krishna Kant.
'With Trump, the relationship was very transactional, whereas with President Biden it is very structured.'
India's Directorate General of Foreign Trade on March 25 banned the export of Hydroxychloroquine but said that certain shipments on humanitarian grounds may be allowed on a case-by-case basis. With more than three lakh confirmed cases of coronavirus infection and over 8,000 fatalities, the US has emerged as the worst sufferers of the deadly coronavirus diseases to which there has been no cure.
Aryan Khan was arrested on October 3. He is currently in judicial custody and lodged at the Arthur Road prison in Mumbai.
Bharat Biotech has completed the Phase 2/3 trials of COVID-19 vaccine, Covaxin for use in children under 18 years of age and is expected to submit the data by next week to the Drugs Controller General of India (DCGI), Chairman and Managing Director of Bharat Biotech International Ltd, Krishna Ella said
Since 2013, the FDA has banned around 30 Indian drug manufacturing units for various violations
The first consignment of 75,000 vials will reach India on Friday, it added.
A pick of just 10 watchable (a couple of them admittedly in the so-bad-it's-fun category) foreign films starring Bollywood stars in significant roles are available to watch on streaming platforms.
Like pharmaceutical companies globally - which used to enjoy a preferential exchange rate in Venezuela - Indian producers have been left badly stung by the collapse of the bolivar currency
Security breach came days after the firm got approval to conduct trials for Covid-19 vaccine candidate Sputnik V.
The central government has for the first time allowed a private company, Bajaj Healthcare, to process opium to extract alkaloids used to make pain-killers, cough syrups, and even cancer drugs. Two government factories in Ghazipur, Uttar Pradesh, and Neemuch, Madhya Pradesh, do the work yet, processing some 800 tonnes of opium gum annually to extract alkaloids. The government on Tuesday gave Thane-based Bajaj Healthcare an initial contract to process 500 tonnes of opium gum annually and wants production to be at 800 tonnes per annum (tpa) in the next five years, indicating the state's exit from the highly-regulated sector.
'A stable and strong Pakistan with an anti-India mindset and hatred is not good for us.'
Domestic majors, such as Himalaya and Baidyanath, are in a dilemma after the UK Medicines and Healthcare products Regulatory Agency made traditional herbal registration mandatory for herbal medicines.
On Saturday, an online marijuana sale racket was busted by Bhind police in Madhya Pradesh, leading to the arrest of two persons and seizure of 20 kilograms of the contraband, according to an official. The accused were operating the racket through a leading e-commerce firm, which received two-thirds of the profits generated, as per the official.
India's first indigenously developed quadrivalent Human Papilloma Virus (HPV) vaccine for the prevention of cervical cancer will be launched in a few months and made available to the people in an affordable price range of Rs 200-400, Serum Institute of India CEO Adar Poonawalla said on Thursday.
'I want to thank Prime Minister Modi of India for allowing us to have what we requested for the problem arose and he was terrific. We will remember it'
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.
Hydroxychloroquine has been identified by the US Food and Drug Administration as a possible treatment for the COVID-19 and it is being tested on more than 1,500 coronavirus patients in New York.
The Food and Drug Administration said its decision is based on new information, including clinical trial data results, that have led it to conclude that the drugs may not be effective to treat COVID-19 and that its potential benefits for such use do not outweigh its known and potential risks.
'The Centre and state need to take a unified approach and take concerted action before this matter assumes menacing proportions because unemployment, the drug trade and the levels of frustration among the youth make them vulnerable to any maverick who promises something better.'
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."
This import duty exemption would remain in force till October 31 this year.
Import alert on Ranbaxy's Mohali unit; Strides' injectible arm gets warning letter
If not contained quickly, it will have a knock-on effect in the world economy and disrupt global supply chains, Crisil analysts warned.
Once touted as a 'wonder drug', HCQ has been battling global controversies around its safety and efficacy as a prophylactic against the new coronavirus SARS-CoV-2.
