MicroPort entered the market on Feb 15 and its stent was used in a Mumbai hospital.
The Supreme Court on Monday posed some tough questions to a lawyer, asking him to substantiate his "unfounded allegations" in a PIL that Indian pharma major Ranbaxy Laboratories Ltd was allegedly manufacturing and selling adulterated medicines.
The Subject Expert Committee on COVID-19 of the CDSCO on October 12 after deliberating Bharat Biotech's EUA application had recommended granting emergency use approval to Covaxin for use in the 12-18 years age group with certain conditions.
Hyderabad-based vaccine manufacturer Bharat Biotech, which is carrying out its phase 3 trial will publish the data in July following that the company will be applying for the full licensure of Covaxin.
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.
The DCGI arrived at the conclusion on Wednesday based on the recommendations of an independent expert committee which has also opined that compensation should not be paid to the volunteer, they said.
An expert committee of the Central Drugs Standard Control Organisation (CDSCO) on Wednesday sought additional safety and efficacy data for COVID-19 vaccine candidates of Serum Institute and Bharat Biotech, after deliberating upon their applications seeking emergency use authorisation for the shots, official sources said.
The company had in December said that the CDSCO had approved a 12-month shelf life for Covaxin, which was nine months earlier, Sohini Das reports.
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.
The company has developed detailed logistical plans and tools to support effective vaccine transport, storage, and temperature monitoring. Sohini Das and Ruchika Chitravanshi report.
Ramdev's herbal medicine company Patanjali Ayurved has launched 'Coronil tablet and Swasari vati' medicines claiming they can cure the highly contagious disease within seven days.
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.
'Safety is my first priority.' 'I need to ensure that any drug or vaccine that our citizens get is first safe.'
There are just 1,500 drug inspectors responsible for more than 10,000 factories in India
'Almost 70 per cent production time of a vaccine is dedicated to quality control, which is done through several hundred tests.'
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 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.
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.
Currently, phase 2 and 3 clinical trials of the Oxford vaccine candidate is going on in the United Kingdom, phase 3 clinical trial in Brazil and phase 1 and 2 clinical trials in South Africa.
In a tweet, Patanjali Ayurved said, "Moment of pride!! Efforts of scientists at Patanjali to make corona medicine have been successful today. We are pleased to announce the First evidence based medicine for Covid-19 by Patanjali."
As India launches the world's most ambitious and biggest vaccination drive against COVID-19, the country will encounter the formidable challenge of rapidly scaling up distribution of the vaccines to secure immunity for its entire population, two prominent Indian scientists at World Health Organisation have said.
The institute expects to complete both, phase-2 and 3 trials in India by the end of this year.
More lucrative routinely prescribed drugs are at higher risk of failing quality standards
The Central Drugs Standard Control Organisation has granted restricted emergency use authorisation to two new vaccines and a drug for COVID-19, taking the number of preventives and treatments available in India to 12.
If the pandemic persists, at least a portion of the blame should go to greed and nationalism that got in the way of the world acting together, notes Prosenjit Datta.
Paul noted that "three to four months from now, there will be other vaccines and the stockpile will be even bigger. "And more acceleration can be brought about in the vaccination programme," Paul added.
Vaccine development is a long process to ensure safety and efficacy through different stages and involves regulatory supervision every step of the way. Ruchika Chitravanshi takes you through this carefully drawn journey of vaccine development.
The transition of Class A and Class B medical device makers to the licensing regime by October 1 seems to be an uphill task with several small and medium manufacturers saying they are still awaiting the audit from the government authorities. If the licenses don't come through, either due to lack of audits or MSME units not clearing the audits, then a few thousand small-scale medical device units will face the issue of business continuity in three weeks. Class A medical devices are those with low to moderate risk to the patient or user (surgical dressings for example), while Class B medical devices refer to devices with moderate risks that require special controls (catheters for example).
Do we have enough trained oncologists and medical professionals in India to man these over 4,500 beds in the public sector?
The government is hopeful of a speedy launch of single-dose COVID-19 vaccine Sputnik Light in India and all stakeholders, including the Russian manufacturer and its Indian partners, have been directed to fast-track the application and regulatory approval procedures for the jab to boost the country's vaccination drive, sources said.
India lost its competitive advantage as China gave fiscal benefits to its local manufacturers. Besides, recent policy flip-flops have, however, dented India's image as the 'pharmacy of the world'.
The situation is severe in North India as most of the logistics operation was manned by migrant labourers from Uttar Pradesh and Bihar. The problem with manpower is not only in courier and delivery services, but also at a shop level.
The highly transmissible Delta variant of SARS-CoV-2 has mutated further to form the 'Delta plus' or 'AY.1' variant but there is no immediate cause for concern in India as its incidence in the country is still low, scientists in New Delhi said.
The ICMR has approved over 200 labs (both public and private) for COVID-19 testing through-PCR machines.
Vardhan stated the government is taking full precautions in human trials of vaccines and the National Expert Group on Vaccine Administration for COVID-19 under the chairmanship of Dr V K Paul, member-health, NITI Aayog, is drawing up a detailed strategy on how to immunize the majority of the population.
Senior Congress leader Anand Sharma on Sunday raised concerns over India's drugs regulator granting permission for restricted use of Bharat Biotech's COVID-19 vaccine and asked the government to explain why mandatory protocols and verification of data has been dispensed with.
The manufacturing licence of Noida-based pharmaceutical firm Marion Biotech has been cancelled by the Uttar Pradesh authorities, according to officials.
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).
The expert committee sought more information from Serum Institute regarding the Oxford-AstraZeneca vaccine.
According to medical practitioners, the treatment is especially useful in controlling disease among those who have not received the vaccine or got only one shot and also the high-risk contacts of a patient.
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