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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.

New Delhi, Jul 24: The Delhi High Court on Friday asked the ICMR to come out with a clarification that mobile number, government-issued identity card, photographs or even a residential proof ought not to be insisted upon for Covid-19 test of mentally ill homeless persons.

According to an Indian Council of Medical Research (ICMR) advisory of June 19, every person who was to be tested for Covid-19 has to provide a government-issued identity proof and should have a valid phone number for tracing and tracking the individual and his/her contacts.

A bench of Chief Justice D N Patel and Justice Prateek Jalan said that ICMR should issue a clarification by way of a circular or an official order that the identity proof, address proof and mobile number are not required for testing mentally ill homeless persons.

The high court said a camp can be organised for testing such persons as is being done across Delhi for others.

"Guidelines have to be given by you (ICMR). You put it in black and white for the states'' benefit. You only need to clarify in two-three lines that mobile number, address proof and identity cards are not required for testing mentally ill homeless persons," it said.

"Use your powers for the public at large. Once you do so (issue the clarification), all states will comply," the bench added.

Additional Solicitor General Chetan Sharma, appearing for ICMR, sought time to take instructions from the government regarding the observations made by the bench.

The high court, thereafter, listed the matter for further hearing on August 7.

The bench was hearing a PIL moved by advocate Gaurav Kumar Bansal seeking directions to ICMR and Delhi government to issue guidelines for Covid-19 testing of mentally ill homeless persons in the national capital.

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The high court on July 9 had asked the ICMR to consider the plight of the mentally ill homeless persons and see whether they can be tested without insisting upon a mobile number, government issue identity card and residential address proof.

The bench had said to ICMR that many homeless mentally ill persons are institutionalised or in shelter homes and therefore, traceable, so there was no need for their identity proof or phone numbers to test them for Covid-19.

In response to the court''s query, ICMR has filed an affidavit stating that the purpose behind the submission of government identity card and telephone number was to ensure proper tracking and treatment of positive cases and their contacts as ''Test/Track/Treat'' is the best strategy for control of Covid-19 pandemic. 

It further said that since health was a state subject, the concerned state health authority may consider adopting a suitable protocol to ensure that the strategy of ''Test/Track/Treat'' is followed and the grievance raised in the PIL is also addressed.

ICMR, in its affidavit, has said that it has only advised facilitating contact tracing as well as tracking of the Covid-19 infected patients.

"The modalities regarding the contact tracing as well as tracking of the Covid-19 infected patients completely falls under the domain of IDSP. NCDC and state health authorities. 

"ICMR is a research organization and the contact tracing, as well as tracking of the Covid-19 infected patients, is not under the domain of ICMR," it has said in its affidavit.

Bansal has claimed in his petition that the Delhi government has not taken seriously the lack of guidelines with respect to Covid-19 testing of mentally ill homeless persons.

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He has said the high court had on June 9 directed it to address the grievances raised by him in another PIL with regard to mentally ill homeless persons in accordance with law, rules, regulations and government policy.

He said that on June 13 he also sent a representation to the Chief Secretary of Delhi government for providing treatment to mentally ill homeless persons in the national capital who have no residence proof. 

However, nothing was done by the Delhi government, he had told the court.