Tag: Bharat Biotech

Covaxin booster dose: Bharat Biotech seeks DCGI approval for phase 2/3 trial among two to 18-year-old

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Bharat Biotech has sought permission from India’s drug regulator to conduct a phase 2/3 study of its Covid vaccine Covaxin as a booster dose among those aged two to 18 years, sources told PTI.

Presently, precaution dose of Covaxin and Covishield is administered to all those aged above 18 who have completed nine months after the second dose.

“The Hyderabad-based firm had on April 29 submitted an application to DCGI seeking permission to conduct phase 2/3 trial to evaluate the safety, reactogenicity and immunogenicity of Covaxin as a booster dose in healthy volunteers aged 2 to 18 years,” a source in the know of the developments told PTI. The study is likely to be conducted at six sites, including AIIMS Delhi and Patna.

Also Read: Serum COVID vaccine Covovax now available for 12-17 age group at private centres

India began administering precaution doses of vaccines to the healthcare and frontline workers and those aged 60 and above with comorbidities on January 10 this year.

The comorbidity clause was removed in March making all people aged above 60 eligible for the precaution dose of Covid vaccine. India expanded the ambit of the precaution doses of COVID-19 vaccines and on April 10 began administering the jabs to all aged above 18 years at private vaccination centres.

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Bharat Biotech must address WHO’s Covaxin supply suspension to avoid EUL cancellation, says MEA

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Weeks after the WHO suspended the supply of Covaxin through UN procurement agencies, the MEA suggested that vaccine-maker Bharat Biotech addresses the issue immediately to avoid cancellation of the world health body’s emergency use approval for the jab.

In a communication to Dr V K Paul, the convenor of a key empowered group on COVID vaccination, on Tuesday the Ministry of External Affairs said many issues about vaccines and international travel by Indians have arisen and these must be addressed immediately.

“The issues pertain to m-RNA based booster dose requirement by countries which, in effect, negates our effort to obtain recognition of Covishield and Covaxin, suspension of supply of Covaxin by WHO, acceptance of Corbevax and Covaxin-based vaccination certificates for children and international travel by Indians vaccinated with Sputnik-V,” Foreign Secretary Harsh Vardhan Shringla said.

Also Read | Gap between 2nd dose of COVID vaccine, precaution dose to be reduced to 6 months soon, says report

In his communication, Shringla said following an inspection of the Bharat Biotech premises on March 14 for Covaxin’s emergency use listing (EUL), WHO has announced the suspension of the vaccine’s supply through UN procurement agencies owing to deficiencies in good manufacturing practices.

Although WHO maintained that the vaccine is effective and there is no safety concern, it has recommended that countries using the vaccine take action as appropriate. “This situation further complicates the acceptance of Covaxin-based Indian vaccination certificates by other countries, especially by European Union member states such as Germany and France,” the communication said.

It stated that a proper response or policy from the government needs to be formulated on the issue and on further pursuance of recognition of Covaxin and Covaxin-based certificates by other countries. “Bharat Biotech must address the matter immediately through DCGI and WHO and avoid any situation that may lead to cancellation of WHO’s EUL for Covaxin in future,” Shringla said, requesting that a meeting of the empowered group-five be convened to address the issues.

Also Read | These 5 states are worst-affected due to COVID-19; Maharashtra not on list

In the communication, he also mentioned some authorities abroad, such as in Hong Kong, have begun demanding vaccination certificates for children and only accept m-RNA based jabs for them.

It is necessary to quickly initiate the process of recognition of the Corbevax vaccine and its certificate by other countries while Biological E continues to pursue WHO’s EUL for it, Shringla said. As for Sputnik V, the foreign secretary pointed out that those who have taken the vaccine are unable to international travel abroad as most countries do not accept Sputnik V which does not have WHO’s emergency use listing.

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

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COVID-19: Covaxin, Corbevax, ZyCoV-D get emergency use nod by drug regulator

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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The Drugs Controller General of India (DCGI) recommended emergency use authorisation (EUA) for Bharat Biotech’s Covaxin for children between 6 and 12 years. The DCGI has also recommended EUA for Biological E’s Corbevax for children in the age group of 5 to 12 years and Zydus Cadila’s ZyCoV-D for those above 12 years.

भारत की कोविड से लड़ाई अब और अधिक मज़बूत @CDSCO_INDIA_INF ने

>6 से <12 आयुवर्ग के लिए 'Covaxin'

>5 से <12 आयुवर्ग के लिए 'Corbevax'

12 से ऊपर के आयुवर्ग के लिए 'ZyCoV-D' की 2 डोज को

'Restricted Use in Emergency Situations' की मंज़ूरी दी है।

— Dr Mansukh Mandaviya (@mansukhmandviya) April 26, 2022

Covaxin, one of the main vaccines administered to adults in India, is currently being administered to children in the age group of 15-18 years and all adults. The vaccine is administered in two doses, with a gap of 28 days between the first and second doses.

Corbevax is being used to inoculate children against COVID-19 in the age group of 12 to 14 years. Covaxin has been granted Emergency Use Listing (EUL) by the DCGI for the age group of 12 to 18 years on December 24, 2021.

India began inoculating children aged 12-14 on March 16. The countrywide vaccination drive was rolled out on January 16, 2021, with healthcare workers getting inoculated in the first phase. Vaccination of frontline workers started from February 2, 2021. The next phase of COVID-19 vaccination commenced on March 1, 2021, for people over 60 years of age and those aged 45 and above with specified co-morbid conditions.

India launched vaccination for all people aged more than 45 years from April 1, 2021. The government then decided to expand its vaccination drive by allowing everyone above 18 years of age to be inoculated against the viral disease from May 1, 2021. The next phase of vaccination commenced on January 3 for adolescents in the age group of 15-18 years.

India began administering precaution doses of vaccines to healthcare and frontline workers and those aged 60 and above with comorbidities from January 10. Precaution doses of COVID-19 vaccines to all aged above 18 years were allowed at private vaccination centres from April 10.

With inputs from PTI

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COVID-19 vaccine: Covishield, Covaxin price cut to Rs 225 for private hospitals

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Domestic vaccine makers Serum Institute of India and Bharat Biotech have reduced the price of coronavirus vaccines Covishield and Covaxin to Rs 225 per dose, the companies announced on Saturday.

“Announcing #CovaxinPricing . We welcome the decision to make available precautionary dose for all adults. In consultation with the Central Government, we have decided to revise the price of #COVAXIN from Rs 1200 to Rs 225 per dose, for #privatehospitals,” Bharat Biotech’s Co-Founder Joint Managing Director Suchitra Ella said in a tweet.

Adar Poonawalla, CEO of SII, too took to the microblogging site to say, “We are pleased to announce that after discussion with the Central Government, SII has decided to revise the price of COVISHIELD vaccine for private hospitals from Rs.600 to Rs 225 per dose. We once again commend this decision from the Centre to open precautionary dose to all 18+.”

On Friday, SII said that the precaution dose of its Covishield vaccine will be priced at Rs 600 per shot for eligible individuals.

Also Read | SII to sell Covishield precautionary doses for Rs 600 each to pvt hospitals; free replacement for expired vaccines: CEO Adar Poonawalla

Bharat Biotech and Serum Institute’s announcements come a day after the Union Health Ministry said those above the age of 18 years who have completed nine months after the administration of the second dose will be eligible for the precaution dose.

According to the ministry, so far, about 96 percent of all those above the age of 15 years in India have received at least one vaccine dose, while about 83 percent have received both doses.

More than 2.4 crore precaution doses have also been administered to healthcare workers, frontline workers and those aged above 60 years.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

No impact of WHO action on Covaxin, have not supplied to any UN agency: Bharat Biotech

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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With World Health Organization (WHO) announcing the suspension of Covaxin supply through UN procurement agencies, Bharat Biotech sources said on Monday the pharma company has not supplied the COVID-19 vaccine to any UN agency and no impact of the suspension would be felt.

So far, sources said, the firm has supplied vaccines to the Indian government and nine countries under the Centre’s Vaccine Maitri programme, and has made direct commercial supply under emergency use authorization.

Covaxin has received emergency use approvals from over 25 countries “We have not received any orders from any UN agency so far,” a source said. Gavi Covax, the international vaccine alliance, has also not placed any orders for Covaxin.

Citing good manufacturing practices (GMP) deficiencies, the World Health Organization (WHO) on April 2 confirmed the suspension of supply of Covaxin through UN procurement agencies and recommended countries that received the vaccine to take actions as appropriate. In a statement, WHO had said this suspension is in response to the outcome of WHO post Emergency Use Listing (EUL) inspection and the need to conduct process and facility upgrade to address recently identified GMP deficiencies.

Also Read: Temporarily slowing down production of Covaxin: Bharat Biotech

On facility upgrade, company sources said on Monday that none of the facilities where Covaxin is being made were designed specifically for manufacturing Covaxin. These are repurposed facilities, which were already existing for manufacturing other vaccines.

“We will be upgrading the existing facilities and make them 100 percent specific for Covaxin,” the source said. Our vaccine certificates remain valid and there will be no interruption in supplies in India, the source said.

WHO officials conducted an inspection of the BB facility during March 14-22. It was not a surprise visit, the sources said, adding there was no inspection before the EUL was granted and the WHO audit was only for Covaxin.

The source said once all facility upgrades are done “we will apply to WHO for full licensure for Covaxin” in due course of time. In response to a question on the nasal vaccine, the company source said the phase-3 trial is going on and in four months it will have the data as this is a very complex trial.

“After analyzing the data we will decide if we should go for additional trials or apply for licensure,” the source said.

Also Read: ICMR study has shown rise in antibodies post Covaxin booster dose: MoS Health tells Rajya Sabha

The WHO had said that Bharat Biotech has committed to comply by addressing the GMP deficiencies and is developing a corrective and preventive action plan, for submission to the Drugs Controller General of India DCGI and WHO.

In the interim and as a precautionary measure, Bharat Biotech has indicated its commitment to suspend its production of Covaxin for export, the WHO had said. The WHO said risk assessment to date does not indicate change in the risk-benefit ratio. The data, available to WHO, indicates the vaccine is effective and no safety concern exists.

Bharat Biotech also said the WHO announcement will not impact the Ocugen trials. Ocugen had entered into a deal with Bharat Biotech to develop, supply, and commercialize Covaxin for the US market.

The FDA has cleared application for Phase 2-3 adult clinical trials of Covaxin. Bharat Biotech last month touched its annualized maximum capacity of 1 billion for Covaxin.

Also Read: Sweden to give 4th COVID-19 shot to people over 65

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Temporarily slowing down production of Covaxin: Bharat Biotech

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Bharat Biotech on Friday said it is temporarily slowing down production of its COVID-19 vaccine Covaxin across its manufacturing units for facility optimisation as it has already completed its supply obligations to procurement agencies and foresees decrease in demand. The company further said after the recent WHO post Emergency Use Listing (EUL) inspection, it is working on further improvements and upgrades to ensure that the production of Covaxin continues to meet ever increasing global regulatory requirements.

“For the coming period, the company will focus on pending facility maintenance, process, and facility optimisation activities,” Bharat Biotech said in a statement As all the existing facilities were repurposed for the manufacture of Covaxin, with continuous production during the past year to meet the public health emergency of COVID-19, these upgrades were due, the company added. “Certain highly sophisticated equipment which were required to enhance the process stringency were unavailable during the COVID-19 pandemic. It has to be stressed that the quality of Covaxin was never compromised at any point in time,” it said.

#COVAXIN #bharatbiotech pic.twitter.com/EsmQOnsfX4

— BharatBiotech (@BharatBiotech) April 1, 2022

Bharat Biotech further said during the recent WHO post Emergency Use Listing inspection, it agreed with the World Health Organization (WHO) team on the scope of the planned improvement activities and indicated that they will be executed as soon as practical. “The company was also pleased to learn from the WHO, that the necessary optimisation work ‘does not indicate a change in the risk-benefit ratio (for Covaxin) and the data, available to WHO, indicates the vaccine is effective and no safety concern exists’,” it added.

The WHO has further stated the vaccine is currently under its Emergency Use Listing (EUL), it added. This risk assessment by the WHO is based on the supply of hundreds of millions of doses of Covaxin globally, during which the product has demonstrated an excellent safety and efficacy profile in detailed and thorough post marketing surveillance activities, the company asserted.

More than 1 million doses of Covaxin were introduced under clinical trial mode, where safety of subjects was actively documented. Finally, Covaxin was extensively evaluated in around 30,000 subjects in more than 10 controlled clinical trials, resulting in more than 15 publications. “Based on this wide body of data as well as a wealth of empirical evidence from India and globally, this is a strong justification for the WHO conclusions on Covaxin safety and efficacy,” it added.

Also read: ICMR study has shown rise in antibodies post Covaxin booster dose: MoS Health tells Rajya Sabha

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

COVID-19 vaccines: SC reserves judgment on PIL seeking clinical trial data; Centre, Bharat Biotech, SII allege propaganda, mischief

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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The Supreme Court has reserved orders on a public interest litigation (PIL) that is praying for entire clinical trial data and post vaccination data to be made public. This plea saw stiff opposition from not just the Central Govt but also the two leading vaccine manufacturers, Serum Institute of India (SII) and Bharat Biotech.

While the PIL cited public health in seeking access to data, the Centre warned that such “misconceived fears” and “motivated propaganda” could lead to vaccine hesitancy. Meanwhile, SII and Bharat Biotech claimed that the PIL was looking to cause “mischief”.

The PIL has been moved in the SC by Jacob Puliyel. He is a former member of the National Technical Advisory Group on Immunization (NTAGI). The PIL has also sought for quashing of the order of various State Governments that have allegedly sought to made essential services subject to a vaccine certificate.

At the very outset, the petitioner clarified that he was not against the Government’s vaccination drive. The petitioner argued that he understood the need for a grant of Emergency Use Authorisation (EUA) to vaccines. He, however, also submitted that while the EUAs were needed, there was no logical case for NOT disclosing clinical trial data. He submitted that in the interest of public health, it was imperative to subject clinical data to public scrutiny.

He argued that clinical data is not available publicly, and not even under the RTI Act. The petitioner further pointed out that in a departure from healthy medical practices, adverse events have not been adequately reported and shared in the public domain.

PIL argues that the government must publish Covid-19 vaccine clinical trial data, post-vaccination data as per international medical norms. Further, the PIL seeks for DCGI to disclose reasoned order for granting EUA for Covid Vaccines. PIL also argues that post-vaccination data such as infections, hospitalisations, and deaths should be placed in the public domain.

Govt meanwhile cited national interest and argued that such “misconceived doubts and motivated propaganda” against vaccines may result in vaccine hesitancy.

The Govt assured that a statutory regime was in place for trial and approval of vaccines and that the regime has been complied with.

The Govt further submitted that vaccination trial data is in the public domain and that the plea has raised a false alarm and needs to be dismissed.

Meanwhile, echoing the government’s arguments the vaccine manufacturers— SII and Bharat Biotech—batted against sharing entire clinical trial data. Instead, they argued that peer-reviewed publication in Lancet has already carried the vaccine trial data. They submitted that the petitioner has no locus to ask for such data and that the relevant information, as required under law, has already been shared with the regulator.

The manufacturers further claimed confidentiality over the data sought and claimed that their proprietary rights over the data cannot be diminished. They also argued that with crores of people having been vaccinated worldwide, the newer variants of Covid-19 were growing weaker and had diminished ill effects.

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

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DCGI gives permission to Bharat Biotech for intranasal COVID booster dose trial

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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The Drugs Controller General of India (DCGI) on Friday gave permission to Bharat Biotech for intranasal COVID booster dose trials. The trials will be done at nine different sites.

Bharat Biotech had in December said that it has submitted an application to the DGCI to in this regard. “We have submitted phase 3 clinical trial application to DCGI,” a Bharat Biotech spokesperson said in a statement, adding that an intranasal vaccine as a booster dose will be easier to administer in mass vaccination campaigns.

India is yet to approve the use of Bharat Biotech’s intranasal vaccine, BBV154. In August, BBV154 had received regulatory approval for mid- to late-stage trials. There were reports that the mid-stage trial has been completed.

Krishna Ella, the chairman of Bharat Biotech, had earlier said the company is focusing on the intranasal vaccine as existing vaccines require two-dose intramuscular injections and a country like India needs 2.6 billion syringes and needles which may add to pollution. An intranasal vaccine will not only be simple to administer but reduce the use of medical consumables such as needles, syringes, etc significantly impacting the overall cost of a vaccination drive, he had said.

Covaxin, the company’s COVID-19 vaccine was approved for emergency-use approval in the county, is administered through an injection.

With inputs from agencies

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

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Covishield, Covaxin receive regular market approval for use in adult population

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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India’s drug regulator on Thursday granted regular market approval for COVID-19 vaccines Covishield and Covaxin for use in the adult population subject to certain conditions, official sources said. The approval was granted under the New Drugs and Clinical Trials Rules, 2019. Under the conditions, the firms shall submit data of ongoing clinical trials and the vaccines to be supplied for programmatic setting besides recording all vaccinations done within the country on the CoWIN platform, the sources said.

Adverse event following immunisation will continue to be monitored as part of the conditions. The Drugs Controller General of India’s (DCGI) approval came after the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) on January 19 recommended granting regular market approval to the Serum Institute of India’s (SII’s) Covishield and Bharat Biotech’s Covaxin for use in adult population subject to certain conditions.

Prakash Kumar Singh, Director, Government and Regulatory Affairs at SII, had submitted an application to the DCGI on October 25 seeking regular market authorisation for Covishield. The DCGI had sought more data and documents from the Pune-based company following which Singh recently had submitted a response along with more data and information.

Also Read | Each dose of Covishield, Covaxin likely to be capped at Rs 275 after getting regular market approval

“Such a large-scale vaccination with Covishield and containment of COVID-19 infection is in itself a testimony of the safety and efficacy of the vaccine,” he had said. In an application sent to the DCGI, V Krishna Mohan, whole-time director at the Hyderabad-based Bharat Biotech, submitted complete information regarding chemistry, manufacturing and controls, along with the pre-clinical and clinical data while seeking regular market authorisation for Covaxin.

Bharat Biotech International Limited (BBIL) took up the challenge to develop, produce and clinically evaluate a vaccine (Covaxin), from the SARS-CoV-2 strains isolated from COVID-19 patients in India, Mohan had said in the application. Covaxin and Covishield were granted Emergency Use Authorisation (EUA) on January 3.

Also, catch all the live updates on COVID-19 situation with CNBC-TV18.com’s blog

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

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Each dose of Covishield, Covaxin likely to be capped at Rs 275 after getting regular market approval

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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The price of Covishield and Covaxin, the COVID vaccines which are expected to soon get regular market approval from India’s drug regulator, is likely to be capped at Rs 275 per dose plus an additional service charge of Rs 150, official sources said. According to them, the National Pharmaceutical Pricing Authority (NPPA) has been directed to start working towards capping the price to make the vaccines affordable.

As of now, Covaxin is priced at Rs 1,200 per dose while Covishield costs Rs 780 in private facilities. The prices include Rs 150 service charge. Both the vaccines are only authorised for emergency use in the country. A Subject Expert Committee on COVID-19 of the Central Drugs Standard Control Organisation on January 19 recommended granting regular market approval to COVID vaccines Covishield and Covaxin for use in the adult population subject to certain conditions.

Also Read | Sputnik V Covid vaccine shows higher Omicron-specific antibodies than Pfizer: Study

“The NPPA has been asked to work towards capping the price of the vaccines. The price is likely to be capped at Rs 275 per dose along with an additional service charge of Rs 150,” an official source said. Prakash Kumar Singh, the director (government and regulatory affairs) at Serum Institute of India, had submitted an application to the Drugs Controller General of India on October 25 seeking regular market approval for its Covishield vaccine.

A couple of weeks ago, V Krishna Mohan, the whole-time director at Bharat Biotech, submitted complete information on the chemistry, manufacturing and controls, along with the pre-clinical and clinical data while seeking regular market authorisation for Covaxin. Covaxin and Covishield were granted Emergency Use Authorisation (EUA) on January 3 last year.

Also, catch all the live updates on COVID-19 situation with CNBC-TV18.com’s blog

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow