Three employees of a Noida-based pharmaceutical firm, whose cough syrup is alleged to have led to the death of 18 children in Uzbekistan last year, were arrested on charges of manufacturing and sale of adulterated drugs, officials said.
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 move comes even as India's drug regulator has extended Covishield's shelf life from six to nine months from its manufacturing date.
Maya Chemtech India Pvt Ltd supplied propylene glycol used in Marion Biotech's cough syrups that were found to be "not of standard quality", according to the regulator.
'Promises of free vaccination, it appears, are good only for winning elections, and dumping the people thereafter'
The drug controlling authority in Chhattisgarh on Thursday raided and sealed a unit of an antibiotic manufacturing company, whose product was used in sterilisation camps in Bilaspur district where 13 women died and several others fell ill.
More than 1.84 crore COVID-19 vaccine doses are still available with states and UTs, while nearly 51 lakh doses are in the pipeline and will be received by them within the next three days, the Union Health Ministry said.
According to a gazette notification of the draft rules published on June 5, a hospital or medical institution may import new drug for 'compassionate use for treatment of patients suffering from life threatening disease or disease causing serious permanent disability or disease requiring therapy for unmet medical need', which has not been permitted in the country, but under Phase-III clinical trial (human trial) in the country or abroad, by making an application to the Central Drug Regulator.
More lucrative routinely prescribed drugs are at higher risk of failing quality standards
Dinesh Thakur is famous for exposing Ranbaxy safety problems
The move has come days after the state government announced to form a special investigation team to probe into the death of Disha Salian, the former manager of late actor Sushant Singh Rajput.
The announcement comes a day after the Subject Expert Committee (SEC) on COVID-19 of the CDSCO recommended granting emergency use authorisation (EUA) to the COVID-19 vaccines Covovax and Corbevax with certain conditions.
The firm presented that Sputnik Light vaccine is approved in 29 countries, including Russia and Argentina.
The manufacturing licence of Noida-based pharmaceutical firm Marion Biotech has been cancelled by the Uttar Pradesh authorities, according to officials.
Samples of the cough syrup have been taken from the manufacturing premises in Noida and sent to the Regional Drugs Testing Laboratory (RDTL) in Chandigarh for testing, Mandaviya said.
The Bombay high court on Wednesday permitted Johnson & Johnson to manufacture, sell and distribute its baby powder and quashed three orders of the Maharashtra government revoking the company's license and asking it to stop the product manufacture and sale, terming them as "stringent, unreasonable and unfair". A division bench of Justices Gautam Patel and S G Dige also came down heavily on the state Food and Drug Administration (FDA) for its delay in carrying out tests on a sample of the company's baby powder seized in December 2018. The bench noted that while maintaining standards of quality and safety are of utmost importance for cosmetic products, at the same time it does not seem reasonable to shut down the whole manufacturing process when there is a slight deviation in one of the products.
The ICMR-National Institute of Virology has been regularly undertaking studies to understand the protective efficacy of COVID-19 vaccines against emerging variants.
'Almost 70 per cent production time of a vaccine is dedicated to quality control, which is done through several hundred tests.'
A Central team on Friday said there were no cases of total drug-resistant tuberculosis reported in the country and the cases made out by a Mumbai hospital fall in the category of extensively drug-resistant TB.
With just two days to go before the COVID-19 vaccination opens for the people above 18 years and only two days after Maharashtra administered the highest number of 5 lakh doese in a day, reports of the shortage of the vaccines poured in from various parts of the state on Wednesday including Mumbai, officials said.
The Delhi High Court on Friday stayed the ban on some fixed dose combination (FDC) drugs of Glaxo SmithKline, Wockhardt and Laboratories Griffon but said action against their sale could be taken in the absence of valid sale and marketing licence.
The emergency use of the drug will be for adult COVID-19 patients with SpO2 93 percent and who have a high risk of progression of the disease including hospitalisation or death subject to certain conditions
According to the advance visibility provided by the Centre to states and Union territories, a total of 5.86 crore Covid vaccine doses will be provided free of cost to them from May 1 to June 15, the Union health ministry said on Wednesday.
NPIL had announced that it would team up with the French company to develop a drug for the epidemic about six months ago, following the spread of the disease, mainly in southern India and Maharashtra in the last two years. Currently, drugs are not available to effectively treat the disease and doctors in the country administer viral disease drugs such as paracetamol and other anti-biotics to check the infection.
The hounding of Rhea Chakraborty in the Sushant Singh Rajput case is a drug that is being carefully pumped into India's veins to make it comfortably numb as it is wracked by economic ruin and disease, notes Sumit Bhattacharya.
There are just 1,500 drug inspectors responsible for more than 10,000 factories in India
The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation has recommended the conduct of Phase III clinical trials of Russia's single dose COVID-19 vaccine Sputnik Light.
The central government had announced that the vaccination for those above 18 years will begin across the country from May 1 as part of the third phase of the inoculation drive.
The Delhi High Court has quashed a demand of approximately Rs 5 crore (Rs 50 million) raised by the central government against Ranbaxy Laboratories.
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.
According to the recommendations of the Subject Expert Committee (SEC) meeting held on July 30, which have been approved by the Drugs Controller General of India (DCGI), Sputnik-Light is the same as the component-1 of Sputnik V and as its safety and immunogenicity data in the Indian population has already been generated in a trial here, there seems to be inadequate data and justification for conducting a separate, similar trial.
According to the sources, there are limited prospects of J&J exporting its vaccine from the US to other countries in the near future and the "entire production" at the BE facilities in India, beginning July/August, will be handed over to the pharma giant under a contract between the companies.
'My father is a postman. My mother is a homemaker. No one in my family had studied medicine.' 'I wanted to be the first doctor in my family so I could listen to people like me and help them feel better about themselves,' says Archana Vijayan, an MBBS student with a disability, who was initially denied admission into medical school, even after passing the NEET twice.
Which entrepreneur would willingly part with her or his hard-earned money for grasping, self-serving politicians? asks Debashis Basu.
'The vast majority of people are going to get better.' 'And the small fraction, who are not going to get better, unfortunately, there's no drug that we have that can that can alter the trajectory.'
In the letter, Somani said the samples of four made-in-India cough syrups linked to the deaths of 66 children in Gambia which were tested in government laboratory here were found to be complying with specifications and not to have been contaminated with DEG or EG according to the test reports.
Several companies, including Indian units of Abbott Laboratories and Pfizer Inc, and domestic firms like Cipla Ltd and Macleods Pharmaceuticals, went to the Delhi High Court to try to get the ban lifted.
Currently, the country is using two 'made-in India' jabs -- Covishield and Covaxin -- to inoculate its billion-plus population and has administered 20 crore doses since launching the world's largest vaccination drive in mid-January. A third vaccine, Russian-made Sputnik V, has been approved by the government and is being used on a smaller scale at present.
The Hyderabad-based Bharat Biotech has fixed the price of its COVID-19 vaccine, Covaxin, at Rs 600 per dose for state governments and at Rs 1,200 per dose for private hospitals. The Pune-based Serum Institute of India, the world's largest vaccine maker in terms of volume, has announced a price of Rs 400 per dose for its COVID-19 vaccine, 'Covishield', for state governments and Rs 600 per dose for private hospitals.
Indian Council of Medical Research Director General Balram Bhargava said the purpose of the COVID vaccine drive would be to break the chain of viral transmission.
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