The Centre has allowed companies to begin lab testing immediately after filing applications instead of waiting for detailed scrutiny, in a move to expedite approvals for manufacture, or import of new drugs.
A government hospital in Gwalior, Madhya Pradesh, is investigating a complaint about worms allegedly found in a bottle of Azithromycin antibiotic medicine given to a child. The entire stock has been sealed and sent for testing following the complaint.
Samples of the powder for babies did not conform to standard pH value during a laboratory test, the regulator said.
A vacation bench of Justices NJ Jamadar and Sharmila Deshmukh passed the decision on Wednesday while hearing a petition filed by the company challenging two orders of the state government.
A joint team of the state and the Centre inspected the unit and found 12 violations or deficiencies.
The Bombay high court on Wednesday ordered for fresh testing of Johnson & Johnson baby powder samples and permitted the company to manufacture the product but to not sell it, as per the Maharashtra government order. The company had filed a petition challenging two orders of the state government- one dated September 15 cancelling the license and the second dated September 20 ordering to immediately stop manufacturing and sale of the company's baby powder product. The orders were passed by the joint commissioner and licensing authority of the state Food and Drug Administration (FDA).
The outcome reaffirms the company's own testing and the long-standing assurance it gave that its baby shampoo does not contain formaldehyde or any formaldehyde-releasing ingredients, J&J said.
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.
Dr Reddy's, which has tied up with Russian Direct Investment Fund for Sputnik V in India, soft launched the vaccine in India in May 2021, after receiving Emergency Use Authorisation in April 2021.
More than 90 lakh Covid-19 vaccine doses are still available with states and Union territories which will receive over 7 lakh additional doses in the next three days, the Union health ministry said on Tuesday.
"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.
More than 1.82 crore COVID-19 vaccine doses are available with states and union territories, and over 4 lakh will be received by them within the next three days, the Union health ministry said.
India's drug regulator has initiated a probe and sought further details from the WHO after the global health body issued an alert that cough syrups manufactured by an Indian firm could potentially be linked to the death of children in Gambia.
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.
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.
'Promises of free vaccination, it appears, are good only for winning elections, and dumping the people thereafter'
The move comes even as India's drug regulator has extended Covishield's shelf life from six to nine months from its manufacturing date.
The central government is importing COVID-19 vaccines and is in talks with COVID-19 vaccine manufacturers Pfizer and Johnson & Johnson, Union Minister of State for Home Affairs G Kishan Reddy said.
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.
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.
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 measles vaccine administered to children in Tamil Nadu has been given a clean chit by the Central Drugs Laboratory at Kasauli in Himachal Pradesh. Human error at the local level could have caused the deaths of four infants last month.
India's drug regulator Drugs Controller General of India has granted permission to Mumbai-based pharmaceutical company Cipla to import Moderna's COVID-19 vaccine for restricted emergency use in the country, official sources said on Tuesday.
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.
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.
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.
'Almost 70 per cent production time of a vaccine is dedicated to quality control, which is done through several hundred tests.'
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.
With West Bengal Chief Minister Mamata Banerjee seeking a uniform vaccination policy for the country, Union Health Minister Harsh Vardhan on Friday assured her that the Modi government was firm in its resolve to help the state fight the COVID-19 pandemic, but also flagged more than 40 per cent positivity rate in some districts of the state.
A rise in the number of daily COVID-19 cases and mortality has been observed in Assam, West Bengal, Odisha, Bihar and Jharkhand, indicating the pandemic is moving eastwards, the Union health ministry said.
Based on this price, state governments, private hospitals, industrial establishments, etc would be able to procure vaccine doses from the manufacturers.
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.
More lucrative routinely prescribed drugs are at higher risk of failing quality standards
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