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Hyderabad, Jun 30: Hyderabad-based Bharat Biotech announced that it has successfully developed Covaxin, India's first vaccine candidate for Covid-19, in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV).

The Drug Controller General of India - CDSCO, Ministry of Health & Family Welfare granted permission to initiate Phase I & II Human clinical trials after the company submitted results generated from preclinical studies, demonstrating safety and immune response. Human clinical trials are scheduled to start across India in July 2020.

The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech.

The indigenous, inactivated vaccine developed and manufactured in the company's Bio-Safety Level 3 (BSL-3) High Containment facility located in Genome Valley, Hyderabad.

Announcing the vaccine development milestone, Dr Krishna Ella, Chairman and Managing Director said: "We are proud to announce COVAXIN, India's first indigenous vaccine against COVID-19. The collaboration with ICMR and NIV was instrumental in the development of this vaccine."

Dr Ella added, "The proactive support and guidance from CDSCO has enabled approvals to this project. Our R&D and Manufacturing teams worked tirelessly to deploy our proprietary technologies towards this platform."
Expedited through national regulatory protocols, the company accelerated its objective in completing the comprehensive pre-clinical studies. Results from these studies have been promising and show extensive safety and effective immune responses.

Speaking about Bharat Biotech's prowess, Suchitra Ella, Joint Managing Director said, "Our ongoing research and expertise in forecasting epidemics has enabled us to successfully manufacture a vaccine for the H1N1 pandemic."
"Continuing our focus on creating the only BSL-3 containment facilities for manufacturing and testing in India, Bharat Biotech is committed to advancing vaccine development as a matter of national importance to demonstrate India's strength in handling future pandemics," she added.

Bharat Biotech's track record in developing vero cell culture platform technologies has been proven in several vaccines for Polio, Rabies, Rotavirus, Japanese Encephalitis, Chikungunya and Zika.

Thiruvananthapuram, Apr 2: With the coronavirus lockdown in place, liquor would be delivered home by state-run retail outlets in Kerala after the left government has decided to issue special passes to tipplers, who exhibit withdrawal symptoms and have doctors prescription.

Protesting the government decision, the Kerala Government Medical Officers Association (KGMOA) wore black badges on Wednesday, but attended duty and seeking immediate withdrawal of the order, saying it was "anti-people".

As per guidelines issued by the Kerala State Beverages Corporation managing director G Sparjan Kumar, for the supply of liquor, a service charge of Rs 100 would be collected from each pass holder for meeting the delivery expenses.

Each person would be entitled to 3 litres of Indian Made Foreign Liquor (IMFL) and sale of wine and beer was not envisaged, the order stated.

Those not willing to undertake the home delivery, the name and details of the employee should be reported to the Head office for submission to the government, it said.

A civil police officer will have to accompany the distribution vehicle.

The sale of liquor should be only to the pass holders, limiting it to the quantity mentioned in the pass.

Any excess sale to pass holders or sales to non-pass holders is strictly prohibited, the order said.

In the order issued on Monday, the government said, following the lockdown and the closure of liquor outlets in the state, there were many instances of social issues, including suicidal tendencies shown by those who consumed liquor regularly and the state government has decided to initiate steps to resolve the matter.

Speaking to reporters, chief minister Pinarayi Vijayan said his government has not forced anyone to prescribe liquor to addicts.

He was responding to a query on the indifference of doctors towards the matter of prescribing liquor to addicts.

"If the doctors are not ready to prescribe liquor, it's fine. We are not forcing anyone to do so. We were just following the protocol which are prevalent at many places. It's been over a week. The family and friends of the addicts can gently persuade them to approach the de-addiction centres," he said.

Sparjan Kumar said the order on home delivery was just a modality, as part of the earlier order issued by the government to provide liquor under prescription.

"We have worked out a modality. We have a meeting tomorrow. Some new order has been issued by the Centre today. The meeting will discuss the implementation of the orders," Kumar told.

A person showing withdrawal symptoms has to get a doctor's prescription on his condition so that he could be provided liquor in a "controlled manner", the order added.

The Indian Medical Association (IMA) has also come out against the government's move.

Meanwhile, Vimukthi, an anti-narcotics campaign launched by the state government, has till now admitted 64 patients since March 24.

"Since March 24, the day lockdown started, we have 64 patients admitted due to withdrawal symptoms. We have also registered at least 200 out patients at various de-addiction centres across Kerala," K Mohammed Resheed, Joint Excise Commissioner in charge of awareness told.