New Delhi, May 13: India's apex drug regulator has granted permission for conducting the phase II/III clinical trial of Bharat Biotech's Covaxin COVID-19 vaccine in the age group of 2 to 18 years, the Union Health Ministry said on Thursday.
The trial will be conducted on 525 healthy volunteers.
"The National Regulator of the country, the Drugs Controller General of India (DCGI), after careful examination, has accepted the recommendation of Subject Expert Committee (SEC) and accorded permission to conduct the Phase II/III clinical trial of Covaxin (COVID vaccine) in the age group 2 to 18 years, to its manufacturer Bharat Biotech Ltd on May 12," the ministry said.
Hyderabad based Bharat Biotech had proposed to carry out the clinical trial in the age group of 2 to 18 years.
In the trial, the vaccine will be given by intramuscular route in two doses at day 0 and day 28.
As rapid regulatory response, the proposal was deliberated in Subject Expert Committee (SEC) on COVID-19 meeting held on May 11.
The Committee, after detailed deliberation, recommended for grant of permission to conduct proposed phase II/III clinical trial to certain conditions.
Earlier the proposal was deliberated in the SEC meeting on February 24 and the firm was asked to submit a revised clinical trial protocol.
Covaxin, which has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), is being used on adults in India's ongoing COVID-19 vaccination drive.
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Bengaluru, Jun 12: Karnataka police on Saturday said they have busted a Rs 290 crore plus scam that involved duping people through a mobile app after promising attractive interest on investment and two Chinese nationals were among the nine arrested.
The scam, aided by shell companies, is linked to money laundering and the suspected kingpin is a Kerala based business man with proximity to Chinese 'hawala' operators, they said.
Cyber Crime Division of CID said it has arrested accused persons, including two Chinese nationals, two Tibetans and five others acting as directors of the companies involved, and a search is on for the rest.
A complaint from Razor pay Software Private Limited said accused persons availed 'payment solutions' from them, claiming that they are in gaming, social and e-commerce businesses.
They, however, defrauded the company by using computer resources and by deviating from their original, registered line of business, the plaint said.
They started routing their transactions to collect payments from a different business named "Powerbank", an app listed in Google Playstore, cyber police said in a release.
Through customer complaints, the complainant company got to know that public invested money in the "Powerbank" app to earn interest on the invested amount.
The accused persons, after accepting the investments, neither gave the agreed interest nor the principal amount and cheated customers.
A case was registered under the Information Technology Act and 420 IPC (Cheating), the CCD said and added that the investigating team were successful in arresting nine men.
During investigation, it was found that Anas Ahmed, a Kerala based businessman, is the main person involved.
"We have also identified that he has very proximate connections with the Chinese hawala operators, which has come to light during the course of the investigation.
He had opened shell companies in the name of Bull Finch Technologies, H & S ventures and Clifford ventures to route the fraud money. Anas Ahamed is married to Chinese national and incidentally he did his studies in China," police said in the release.
Online applications hosted by him were later camouflaged and converted into different apps including Power Bank application, seeking investment from the public and promising good returns, the CCD said.
An unusual spike was seen in investments on the day Anees Ahmed announced much higher returns.
Subsequently, such apps were removed from Google Playstore and other websites and he absconded with the money.
Investigation showed Rs 290 crore inflow into his bank accounts and the CCD was successful in freezing a significant portion of it. There was a huge spike in opening of shell companies since November 2020.
"We have also observed that the Chinese handlers are in possession of a huge number of shell companies and bank accounts. Lured by the offer of the Chinese nationals, many innocent Indians and Tibetans have fallen in their trap to open shell companies and open bank accounts for them."