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.
Healthcare and frontline workers and citizens above 60 years of age with comorbidities would be administered the third dose of the same vaccine they had been given before.
In a report submitted Monday to Rajya Sabha chairman and Vice President M Venkaiah Naidu, the Parliamentary Standing Committee on Home Affairs also said there was a need for a comprehensive public health law to keep a tab on private hospitals and check black-marketing of medicines.
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.
If the DCGI grants regular marketing authorisation, Covishied will be the second vaccine in the world to receive such approval.
If things go according to plan, the vaccine would be available in the market by the end of this year.
The DMK also warned of legal action against those who attempt to link Sadiq with either the party or its leaders.
Biological E Limited plans to complete production at a rate of 75 million doses of its COVID-19 vaccine Corbevax per month, anticipating over 100 million doses per month from February 2022 which will enable the Hyderabad-based company to deliver 300 Million doses as promised to the Centre, BE said on Tuesday.
However, he also said traditional ayurveda, yoga and naturopathy have also controlled and provided permanent solution to several complex diseases like blood pressure, thyroid, sugar, arthritis, hepatitis and asthma.
More lucrative routinely prescribed drugs are at higher risk of failing quality standards
As per RDIF, Sputnik V has a number of key advantages, including that there are no strong allergies caused by Sputnik V.
The seizure, as per officials, is estimated to be worth over Rs 10 crore in the international market (about Rs 5K-7K per blot) and all the six who have been taken into custody, beginning late last month, are students and youngsters who wanted to make 'easy money' by remaining anonymous within the deep layers of secret internet-based apps and messenger service like WICKR.
In a recent letter to Union Home Minister Amit Shah, SII said its employees have been working round the clock in spite of various challenges because of the pandemic.
Biological E has received approval for conducting phase II/III human clinical trial of COVID-19 vaccine candidate Corbevax on children above five years and adolescents, the Department of Biotechnology (DBT) said on Friday.
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.
There were apprehensions in the SII about rival Bharat Biotech's 'indigenous' tag, opening up shortcuts for it. One senior person, who was very familiar with the sector, told me, 'The message has gone out from the very top. Somani (V G Somani -- drug controller general of India) has told me "Bharat ka karna hai".' A fascinating excerpt from Abantika Ghosh's Billions Under Lockdown: The Inside Story Of India's Fight Against COVID-19.
Taking people for ransom and winning business by defaming scientific medicine are unpardonable offenses, the IMA said.
Senior counsel Amit Desai, appearing for Aryan Khan, termed the NCB's contention as 'inherently absurd' and argued that when there was no recovery of drugs from him, then he should not be penalised at the stage of granting bail.
The global trials were halted after a study participant suffered a 'potentially unexplained illness, reports Sohini Das.
The next hearing on Pfizer's plea is slated for March 21
The Philippines launches probe after Sanofi reveals WHO-approved dengvaxia - a dengue vaccine - aggravates symptoms in some cases.
The trial is being conducted in three phases by segregating children into categories according to their age. The first trial was started in the age group of 12 to 18 years followed by the age group of 6 to 12. Trials for children between the ages of and 2-6 years are currently undergoing trials.
In the trial, the vaccine will be given by the intramuscular route in two doses on day 0 and day 28.
'We are also seeing the birth of new evil, the new face of drug distribution where human interface has reduced; consumers are using the Dark Web to source supplies and using cryptocurrencies as payment mode.'
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.
In phase I, the vaccine would be tested on 375 volunteers and the maximum of 100 of them would be from AIIMS.
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.
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.
Since India is one of the largest vaccine producers in the world, it is the country's 'moral responsibility' to fast-track vaccine development process to break the chain of coronavirus transmission, ICMR Director General Dr Balram Bhargava said referring to the two vaccine candidates developed indigenously.
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.
The new regime aims to bring in ease of doing business, as the NITI Aayog has proposed to do away with the need to have manufacturing licences to register medical devices or to get a certificate of compliance.
The phase-three human clinical trial of indigenously developed anti-coronavirus vaccine candidate Covaxin began at the AIIMS in New Delhi on Thursday, with Dr M V Padma Srivastava, the chief of Neurosciences Centre at the premier institute, and three other volunteers receiving the first dose.
Pune-based Serum Institute of India (SII) is sitting on 200 million doses of Covishield that were manufactured in December and are set to expire in September. The company is likely to destroy these vaccines if nothing works out, Sohini Das reports.
A senior official at the health ministry told ANI: "For HCQ, we have placed orders for about 11.45 crore tablets to two Indian firms -- IPCA laboratories and Zydus Cadila. So far, we have received 6.64 crore HCQ drugs and remaining will arrive by May 16."
Thanking all, including doctors, nurses, healthcare staff, security personnel and journalists, who have been at the frontline in the fight against the pandemic, the minister said they ensured India reaches the stage when vaccine gets delivered to the people.
As part of the charm offensive, New Delhi has invited global regulators -- including the FDA -- to visit Indian production units to get first-hand evidence of measures taken to ensure the quality of locally manufactured generics.
National security advisor Ajit Doval on Friday suggested that various central armed police forces of the country should have "jointness" and interoperability among themselves like the ongoing plan for the defence forces.
Drug firm Zydus Cadila on Thursday said it has applied for emergency use authorisation (EUA) with the Indian drug regulator for its three-dose COVID-19 vaccine ZyCoV-D, and plans to manufacture 10-12 crore doses annually.
This could also be India's first vaccine for children aged 12 years and above as the company has conducted trials on the age group. The decision, however, lies with the regulator, reports Sohini Das
Choubey said till February 4 total 81 AEFIs, which is 0.096 per cent of the total beneficiaries who have been administered Covaxin, have been reported.
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