"It has been decided that for approval of COVID-19 vaccines in India for restricted use in emergency situation which are already approved for restricted use by US Food Drug Administration, European Medicines Agency, UK Medicines and Healthcare products Regulatory Agency, Pharmaceuticals and Medical Devices Agency Japan or which are listed in WHO Emergency Use Listing and which are well established vaccines from the stand point that millions of individuals have already been vaccinated with the said vaccines, the requirement of conducting post approval bridging clinical trials and of testing every batch of vaccine by CDL, Kasauli can be exempted, if the vaccine batch/lot has been certified and released by National Control Laboratory of country of origin," it said.
Nirma's tryst with the pharmaceutical space started in 2006 when it acquired the ailing Core Healthcare in a deal reported to be worth Rs 300 crore. The Ahmedabad-based manufacturer of intravenous fluids was subsequently renamed Nirlife. Pharma industry insiders say Nirma, which broke open the detergent market in the 1990s with low prices and massive advertising, tried an encore of the low-price strategy in pharma, but with mixed results.
The Supreme Court has directed the Centre to formulate within two weeks a national policy on admissions to hospitals in the wake of the second wave of COVID-19 and said no patient shall be denied hospitalisation or essential drugs in any state for lack of local residential proof.
Nationalist Congress Party leader Ajit Pawar was given the finance and planning portfolio on Friday, nearly two weeks after he broke away from the original party and took oath as Maharashtra's deputy chief minister.
These four patients were given blood for the treatment of Thalassemia, post which they were found infected.
In the 15-page order, the details of which were made available on Saturday, the ACMM said 'this court ceases its jurisdiction to entertain the applications for bail' considering section 36A and the fact that all three were held for one crime under various provisions of the NDPS Act for which the prescribed punishment was more than three years.
The number of COVID-19 cases are rising rapidly with 24,000 fresh cases reported in the last 24 hours, he said in an online media briefing.
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.
Amid a row over Remdesivir supply in Maharashtra, Shiv Sena MLA Sanjay Gaikwad has said he wishes he could "stuff coronavirus in the mouth" of Bharatiya Janata Party leader Devendra Fadnavis, sparking protests by the Opposition.
India expects 2.16 billion doses of Covid-19 vaccines between August and December, including the jabs that are currently in clinical trials, reports Sohini Das
The bench issued notice to the Centre and said it would hear the matter on Friday.
'This government did not have any plan for safety stocks of essential medicines.'
According to sources close to ANI, "Bharat Biotech has informed Union health ministry that it will rectify the issues pointed out by WHO in 15 to 20 days." "World Health Organisation (WHO)'s suspension is not related to safety or efficacy issues but limited only to supply for United Nations agencies."
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Earlier, the district administration had issued an order that hospitals should not be asking patient's relatives to arrange the Remdesivir injection from outside, and instead, they should themselves procure it from chemists based on their requirement and use it for treatment.
Besides Aryan Khan, the arrested accused are identified as Munmun Dhamecha, Arbaaz Merchant, Ismeet Singh, Mohak Jaswal, Gomit Chopra, Nupur Sarika, and Vikrant Chhokar.
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.
BE's Corbevax is the first such vaccine in India to be approved as a heterologous COVID-19 booster in the country.
Joint Secretary in the Ministry of Health Lav Agarwal said that India has a stock of 3.28 crore tablets of hydroxychloroquine, which is three time more than the projected requirement of one crore tablets in the country for the coming week and that tie-ups have been made for additional supply of 2 to 3 crore tablets for the future need.
Artificial shortages and brazen hawking of the drug on the streets at 15 times the normal price rule the day as the official machinery tries desperately to stamp out the parallel market, reports Sohini Das
Cautioning that the country is passing through a phase when there are festivals and potential gatherings, he said this is a critical phase as the virus can spread again.
This will boost availability of these items as well as make them cheaper, it said, adding that Modi also directed the revenue department to ensure seamless and quick custom clearance of such equipment.
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.
Once a difficult market to crack, in recent years, China has relatively opened up its drug market, enacting reforms and speeding up approval time.
It noted that the government could not accurately anticipate the gravity of the possible resurgence of the pandemic and its subsequent waves.
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'.
Seeking to allay concerns over shortage of Remdesivir, the minister said the government held talks with pharma companies and ensured sufficient supply of the medicine for COVID-19 patients.
The minister asserted that India has taken major action against terrorism under the Modi government and referred to the surgical strikes carried out across the Line of Control (LoC) in 2016 and the Balakot air strike in 2019.
'India is a pharma dada. We can manufacture enough for our people and for the world.'
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 NCB spoke about Aryan Khan, Bollywood actor Shah Rukh Khan's son, and others of being accused of a conspiracy, but it never pressed that charge officially following their arrest in a drugs case, their lawyer told the Bombay High Court during bail hearing on Wednesday.
The termination of the MoU came after the deal with the Brazilian government for supply of 20 million doses of the vaccine landed in controversy and attracted investigation by authorities in that country.
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.
Maharashtra Chief Minister Uddhav Thackeray has handed over portfolios of nine rebel ministers, who are currently camping in Guwahati, to other ministers.
If the DCGI grants regular marketing authorisation, Covishied will be the second vaccine in the world to receive such approval.
According to police, Lakhwinder Singh was nabbed from Sarai Kale Khan on September 24, and Gurjeet was apprehended near ISBT Kashmiri Gate on October 13.
As fear grips the world, demand for protective gear used by health care professionals and citizens is on a rise. And, supply disruption from China has opened a window of opportunities for Indian medical device makers.
The child's mom continued to sob and pray. The Vistara staff was valiantly standing by offering as much assistance as they were capable of.
'Almost 70 per cent production time of a vaccine is dedicated to quality control, which is done through several hundred tests.'
"We suspended the deal as a simple preventive measure, since there are complaints that could not be explained well by the complainant, so we opened a preliminary investigation last week," said Rosario, head of the Federal Comptroller General.