The Central Drugs Standard Control Organisation (CDSCO) has initiated a nationwide campaign to test, inspect, and audit cough syrup manufacturers following concerns about contaminated products and child deaths. The initiative aims to ensure adherence to safety standards and regulatory compliance.
The DCGI's approval came following recommendation by the Subject Expert Committee of the Central Drugs Standard Control Organisation.
There were no safety concerns arising from the study data and Covovax is safe and immunogenic in the adult population, Prakash Kumar Singh, Director, Government and Regulatory Affairs at the Serum Institute of India (SII), is learnt to have said in the application sent to the DCGI.
Confirming the Drugs Controller General Of India (DCGI) approval, Serum Institute of India CEO Adar Poonawalla on Tuesday tweeted: '@SerumInstIndia's brand Covovax has completed bridging studies in India and has been granted Emergency Use Authorisation by DCGI for adults and for children above the age of 12. Younger age groups will follow shortly.'
The DCGI's nod came after the subject expert committee on COVID-19 of the CSDCO last week recommended granting emergency use authorisation to Covovax for the age group of 7 to 11 years.
The Serum Institute of India, Bharat Biotech and Pfizer have applied to the DCGI seeking emergency use authorisation for their COVID-19 vaccine candidates and are awaiting approval.
Most of the pharma units are failing in documentation, and validation processes, and many don't have full-fledged quality control laboratories.
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.
Under the conditions, the firms shall submit data of ongoing clinical trials and the vaccines to be supplied for programmatic setting.Adverse event following immunisation will continue to be monitored.
If the DCGI grants regular marketing authorisation, Covishied will be the second vaccine in the world to receive such approval.
Covovax is likely to be available on the portal in a few days at a price of Rs 225 per dose plus applicable GST.
It has been approved by the European Medicines Agency for conditional marketing authorisation.
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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.
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.
The approval by the Drugs Controller General of India (DCGI) was given on the basis of recommendations submitted by a COVID-19 subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).
If I follow US standards, I will have to shut almost all drug facilities: G N Singh
Legal experts and official sources said the alleged submission of fake documents can also lead to criminal charges against Novartis.
If things go according to plan, the vaccine would be available in the market by the end of this year.
According to officials, an additional dose of vaccine is different from a booster dose.
According to the purchase order placed on Monday, each dose of the vaccine has been priced at Rs 200 and with GST of Rs 10, it would cost Rs 210.
The Indian Medical Association on Monday expressed shock over the 'blatant lie of World Health Organisation certification' for Patanjali's Coronil tablet, which the company claims is an evidence-based medicine to fight COVID-19, and demanded an explanation from Union Health Minister Harsh Vardhan in whose presence the medicine was launched.
On production capacity of Covishield, the vaccine being manufactured and supplied by Serum in India under a licensing agreement with Oxford and AstraZeneca, he said the present capacity is 130 million doses per month and always try to increase it further.
Last month, the US Food and Drugs Administration had placed Wockhardt's facilities in Waluj near Aurangabad on import alert, barring supply of various products from these facilities to the US.
Dispatch of the vaccine is likely to start by early Tuesday morning, sources said. According to the order placed, each dose of the vaccine has been priced at Rs 200 and with GST of Rs 10, it would cost Rs 210.
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.
As for Bharat Biotech, the Subject Expert Committee (SEC) on COVID-19 of the CDSCO asked the firm to expedite volunteer recruitment for the ongoing clinical trial and said it may conduct interim efficacy analysis for further consideration of restricted emergency use approval for its vaccine Covaxin, they stated.
The CoWIN portal will be made available in Hindi and 14 regional languages by next week, while 17 more laboratories will be added to the INSACOG network to monitor the variants of COVID-19, the health ministry said on Monday.
The move comes in the wake of many facilities of Ranbaxy in India being barred by the US Food and Drugs Administration for supplying medicines to the US.
This is the fifth consecutive day that COVID-19 cases have increased by more than 50,000 in the country.
'Don't panic. Believe in yourself.' 'This is a preventable illness. Only you can prevent it.'
Even as the Supreme Court had recently dismissed the industry's plea against prices fixed by the regulator and its timely implementation, the National Pharmaceutical Pricing Authority has asked companies to pay the overcharged dues with 15 per cent interest.
Move follows a spate of international regulatory enforcements on Indian drug firms.
Roche said the Indian regulatory authorities had approved Biocon and Mylan's products as Trastuzumab, but it was unclear if these met the criteria for biosimilar products.
As the death toll in the country from coronavirus jumped by a record 445 to 13,699, the Centre maintained that the number of infections per lakh population was among the lowest in the world. The new cases surged by over 10,000 for the 11th day in a row and rose by 14,821 to take the total to 4,25,282, according to health ministry data.
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A day after getting a show-cause notice from the Indian regulator, senior executives from Ranbaxy Laboratories approached the drug controller's office on Tuesday afternoon, it was learnt.
Margaret A Hamburg, the first commissioner of the US Food and Drug Administration (US FDA) to visit India officially, will meet heads of major domestic pharma companies such as Ranbaxy, Wockhardt, Cadila Healthcare and Lupin in New Delhi.
Inspections only in domestic authorities' presence, visiting US drug regulator told
Whistle-blower Dinesh Thakur will speak on Made-in-India drugs at an event in Washington.
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