The Union health ministry on Thursday termed as 'misleading' and 'fallacious' media reports which claimed that regulatory approval for COVID-19 vaccine Covaxin was rushed due to political pressure.
A three-member team each from the Central Drugs Standard Control Organisation (CDSCO) and the State Drug Controller visited the plant in Tamil Nadu's Kancheepuram, 40 km from Chennai, on Friday after the company recalled the eye drop.
The Drug Controller General of India has sent a letter to the Glenmark seeking clarifications on pricing as well as claims of therapeutic efficacy. While Glenmark has claimed this drug is effective in comorbid conditions like diabetes, hypertension, according to protocol summary (of clinical trials) the trial was not designed to access the Fabiflu in comorbid conditions.
The Pune-based vaccine major has entered into a collaboration with the University of Oxford and AstraZeneca to manufacture the vaccine.
.jpg)
In a letter to health minister Harsh Vardhan, the Indian Pharmaceutical Alliance, an industry body representing leading pharma companies, including Sun Pharma, Lupin, Dr Reddy's Labs, Cadila Health and Glenmark, stressed the need for an out-of-court settlement with health activists fighting for the rights of clinical trial participants.
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.
Covaxin is being developed by Bharat Biotech jointly with the Indian Council of Medical Research (ICMR)- National Institute of Virology (NIV). The Phase III human clinical trials of Covaxin began mid-November, targeted to be done in 26,000 volunteers and it is the country's first and only Phase III efficacy study for a COVID-19 vaccine, a press release from the vaccine maker said on Saturday night.
The panel also recommended giving approval to Bharat Biotech for carrying out a study on interchangeability of its Covaxin and the under-trial adenoviral intranasal vaccine candidate BBV154, but asked the Hyderabad-based firm to remove the word "interchangeability" from the study title and submit a revised protocol for approval.
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
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.
Gennova has also got permission for phase-2 and 3 clinical trials for its lyophilised mRNA vaccine for injection from the subject expert committee advising the Central Drugs Standards Control Organisation, reports Sohini Das.
An expert panel of the country's drugs regulatory authority had recommended against granting such approval to the firm at this stage just two days ago, officials said.
The big companies too are responsible for the sub-standard drugs in the market.
Concerned about the rise of antibiotic resistance and the time it takes for drugs developed abroad to reach Indians, the government is considering holding its own clinical trials. Clinical trials for new drugs have so far primarily been conducted only by private Indian or foreign drug firms. But given the stringent nature of India's regulatory environment for clinical trials, several pharmaceutical companies have moved their trials out of India. As a result, only 1.2 per cent of global clinical trials take place in India.
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.
Bharat Biotech applied to the Drugs Controller General of India (DCGI) seeking permission for conducting phase 1 and phase 2 clinical trials of the intranasal vaccine following which the subject expert committee of the CDSCO on Tuesday deliberated on the application and recommended granting permission for phase 1 trial.
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 vaccine candidate -- 'Covaxin' -- is being indigenously developed by the Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
The approval by the Drugs Controller General of India comes following recommendations by the Subject Expert Committee on COVID-19 of the Central Drugs Standard Control Organisation.
The vaccine would not have production scalability issues unlike Covaxin, Bharat Biotech's COVID-19 virus vaccine.
Bharat Biotech is targeting to manufacture one billion doses of its intra-nasal vaccine in 2022 which is under clinical trials now.
The ICMR-National Institute of Virology has been regularly undertaking studies to understand the protective efficacy of COVID-19 vaccines against emerging variants.
As many as 150 applications are stuck at evaluation stage, says official.
The government has capped the trade margin on oxygen concentrators at 70 per cent in order to keep in check the price of the much in demand critical life saving component amid the second wave of the coronavirus pandemic. The trade margin has been capped at 70 per cent on price to distributor level on oxygen concentrators. In an official release, the chemicals and fertilisers ministry said the decision has been taken in view of the extraordinary circumstances arising due to the pandemic which has resulted in volatility in Maximum Retail Prices (MRP) of oxygen concentrators.
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.
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.
An International Policy Network report in 2010 found that seven per cent of drugs bought from wholesale traders were substandard, and 3.6 per cent of the drugs from traders contained no active ingredient whatsoever.
If things go according to plan, the vaccine would be available in the market by the end of this year.
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.
Zydus plans to initiate the clinical trials of ZyCoV-D in July 2020 across multiple sites in India. In animal studies the vaccine was found to elicit a strong immune response in multiple animal species like mice, rats, guinea pigs and rabbits.
Ahmedabad-based Zydus Cadila, Bharat Biotech's intra-nasal candidate are among the candidates who got approval from the expert panel to conduct clinical trials, Sohini Das reports.
The phase 3 clinical trial will cover around 28,500 subjects, aged 18 years and above, and it will be conducted in 21 sites across ten states, including Delhi, Mumbai, Patna and Lucknow.
Once the UK drug regulator gives its approval to the Oxford vaccine, the expert committee on COVID-19 at the Central Drugs Standard Control Organisation (CDSCO) will hold its meeting and thoroughly review the safety and immunogenicity data from the clinical evaluations conducted abroad and in India before granting any emergency authorisation for the vaccine here, official sources said.
If the DCGI grants regular marketing authorisation, Covishied will be the second vaccine in the world to receive such approval.
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 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.
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 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.
© 2026 Rediff.com - Investor Information - Advertise with us - Disclaimer - Privacy Policy - Sitemap - Feedback - About us - Terms of use - Grievances