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NPPA steps in to cap price of Liquid Medical Oxygen and Medical Oxygen cylinders

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New delhi: The National Pharmaceutical Pricing Authority of India is now capping price of Liquid Medical Oxygen and Medical Oxygen cylinders.

  1. The present situation of COVID-19 has resulted in increased demand of Medical Oxygen (MO) in the country and hence its availability is of utmost importance. Many of the States/UTs are dependent on the medical oxygen supply from other States/UTs.
  2. The demand of Medical Oxygen has gone up almost four times, from 750MT/day to 2800 MT/day. This has caused strain at all levels in the value chain of production and supply. The manufacturers of Medical Oxygen and Fillers have given representation to the Government for up to three fold price increase in the Ceiling Price of gaseous Medical Oxygen.
  3. The government is committed to uninterrupted supply of Medical Oxygen especially in the times of pandemic. Oxygen Inhalation (Medicinal Gas) is a scheduled formulation, covered under the National List of Essential Medicines (NLEM). Its existing Ceiling Price fixed by NPPA is Rs. 17.49/CUM. However, due to absence of price cap on liquid medical oxygen, manufacturers have hiked prices to fillers. During COVID, supply of medical oxygen through cylinders has increased from 10% to around 50% of total consumption. Price regulation at this end is imperative for continued availability of medical oxygen across the country.
  4. The issue related to availability, including pricing of oxygen has been under the continued consideration of Empowered Group 2, GOI. The Empowered Group 2 has recommended NPPA to consider capping the ex-factory price of liquid oxygen in order to ensure its supply to fillers at reasonable prices. It has also requested NPPA to consider a cap for ex-factory price of oxygen in cylinders in order to ensure supply of oxygen cylinders from filler at reasonable prices.
  5. To deal effectively with the situation, Ministry of Health & Family Welfare (MOH&FW), GOI has vide its letter dated 23.09.2020 conferred the delegation of powers under Section 10(2) (l) of Disaster Management Act, 2005 to NPPA to take all necessary steps to immediately regulate the availability and pricing of LMO and Medical Oxygen in cylinder.
  6. The Authority deliberated upon the matter in its extra ordinary meeting held on 25.09.2020. It has been decided to invoke extra-ordinary powers in public interest, under Para 19 of DPCO, 13 and under Section 10(20) (l) of Disaster Management Act, 2005 to deal with the emergent situation arising due to the pandemic. Accordingly it has been decided:

To cap the ex- factory price of Liquid Medical Oxygen (LMO) at manufacturers end at Rs. 15.22/CUM exclusive of GST; and

To further cap the ex-factory cost of Medical Oxygen Cylinder at filler end at Rs. 25.71/CUM exclusive of GST in suppression of the existing Ceiling Price of Rs. 17.49/CUM, subject to transportation cost fixation at state level, for six months.

  1. The existing rate contracts of state governments for oxygen purchase, as applicable, shall continue, in consumer interest.

The ex-factory price cap of LMO and oxygen gas cylinders will be applicable to domestic production.

The above measures will ensure availability of medical oxygen at consumer end at reasonable price both at hospital level and through oxygen cylinders, especially to distant and interior districts.

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Sanofi, GSK to supply COVAX with 200 mn doses of COVID-19 vaccine

Translate Bio has established mRNA manufacturing capacity and Sanofi expects to be able to supply annual capacity of 90 to 360 million doses.

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New Delhi, Oct 29 : Sanofi and GSK have signed a Statement of Intent with Gavi, the legal administrator of the COVAX Facility, a global risk-sharing mechanism for pooled procurement and equitable distribution of eventual COVID-19 vaccines.

Sanofi and GSK intend to make available 200 million doses of their adjuvanted recombinant protein-based COVID-19 vaccine, if approved by regulatory authorities and subject to contract, to the COVAX Facility.

Both Companies intend to contribute to COVAX’s ambition to ensure successful COVID-19 vaccines reach those in need, whoever they are and wherever they live, once they obtain appropriate approvals.

“To address a global health crisis of this magnitude, it takes unique partnerships. The commitment we are announcing today for the COVAX Facility can help us together stand a better chance of bringing the pandemic under control,” said Thomas Triomphe, Executive Vice President and Global Head of Sanofi Pasteur.

“This moment also reflects our long-term commitment to global health and ensures our COVID-19 vaccines are affordable and accessible to those most at risk, everywhere in the world.”

Roger Connor, President of GSK Vaccines added, “Since we started working on the development of COVID-19 vaccines, GSK has pledged to make them available to people around the world. We are proud to be working with Sanofi to make this adjuvanted recombinant protein-based vaccine available to the countries signed up to the COVAX Facility as soon as possible – this has the potential to be a significant contribution to the global fight against COVID-19.”

The COVAX Facility is part of COVAX, a global collaboration of governments, global health organisations, businesses and philanthropic organisations working to accelerate development, production, and equitable access to COVID-19 vaccines. COVAX is co-led by Gavi, the Coalition for Epidemic Preparedness Innovations (CEPI) and WHO and forms the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator. More than 180 countries and economies have signed onto the COVAX Facility to get timely and cost-effective access to vaccines to meet the global scale of the COVID-19 pandemic.

Through the COVAX Facility’s efforts, vaccines will be distributed in participating countries through the WHO’s recently published Allocation Framework, and the WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) Values Framework which has begun to frame future guidance on vaccine use. These allocation principles aim to ensure that people in all parts of the world will get access to COVID-19 vaccines once they are available.

Sanofi and GSK initiated a Phase 1/2 study on September 3 with a total of 440 subjects enrolled, and anticipate first results in early December 2020, to support the initiation of a pivotal Phase 3 study before the end of the year. If these data are sufficient for licensure application, it is planned to request regulatory approval from the first half of 2021. In parallel, the Companies are scaling up manufacturing of the antigen and adjuvant respectively.

In addition to the recombinant protein-based vaccine in collaboration with GSK, Sanofi is developing a messenger RNA vaccine in partnership with Translate Bio. With several innovative vaccine platforms currently being investigated across the industry, mRNA is considered among the most promising.

Preclinical data showed that two immunizations of the mRNA vaccine induced high neutralizing antibody levels that are comparable to the upper range of those observed in infected humans. Sanofi expects the Phase 1/2 study to start in the fourth quarter of 2020, with earliest potential approval in the second half of 2021. Translate Bio has established mRNA manufacturing capacity and Sanofi expects to be able to supply annual capacity of 90 to 360 million doses.

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Covid Vaccine: Infections reported among Sputnik V trial volunteers

On August 11, Russia became the first country in the world to register the vaccine against coronavirus which was named Sputnik V.

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Moscow: There have been instances of infection among volunteers of Sputnik V trials, the world’s first registered vaccine against Covid-19 virus, according to a top official of the developer of the Russian vaccine, said a media report.

This is the reason why the developer of the vaccine, the Gamaleya National Research Center for Epidemiology and Microbiology of the Russian Healthcare Ministry, is considering the possibility of disclosing the data on who among the volunteers were administered the vaccine, before summing up the results of the study, Russian news agency TASS reported on Wednesday.

Earlier, Deputy Research Director of the Gamaleya National Research Center, and Associate Member of the Russian Academy of Sciences, Denis Logunov, reported that trial participants will find out whether they received the vaccine or the placebo only after the end of tests.

The center’s director Alexander Gintsburg reported that the last group of volunteers out of the total of 40,000 may be inoculated by the end of January 2021.

“…Apparently, there are (coronavirus) infections (among the post-registration trials participants). At some point in mid-November the provisional results will be summed up, then we will find out the difference between the placebo and the test samples,” Gintsburg was quoted as saying to TASS.

In response to a question on how the results can be obtained before the end of the study if the data can be disclosed only after its completion, the director said that currently the center is thinking of introducing relevant amendments to the legislation.

The center’s director also explained that coronavirus infections among the volunteers may be related to the fact that an individual wasn’t vaccinated, that is, received the placebo.

On August 11, Russia became the first country in the world to register the vaccine against coronavirus which was named Sputnik V.

Russia faced criticism for approving a vaccine before conducting crucial phase-3 trials.

Post-registration trials of the preparation started in Moscow on September 7, with the first volunteers receiving the vaccine on September 9.

In all, 40,000 people participate in the program, 10,000 of whom will receive a placebo instead of the vaccine, TASS reported.

Earlier, the Janssen-Cilag company, the pharmaceutical division of US multinational Johnson & Johnson, temporarily suspended clinical trials in Brazil of a vaccine against Covid-19.

Before that, the Oxford Covid-19 vaccine trial was temporarily paused as one of the participants reported a suspected severe adverse reaction. The trial resumed after a safety review.

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Long-Term Exposure To Air Pollution Can Contribute To Mortality In Covid Cases: Top Medical Body ICMR

Every winter, the air quality in north India, including in Delhi, dips to a dangerous low. Experts have warned that high levels of air pollution can aggravate the COVID-19 pandemic.

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New Delhi: Studies in Europe and the US have established that long-term exposure to air pollution can contribute to mortality in COVID-19 cases, ICMR Director General Balram Bhargava said on Tuesday.

He stressed that studies have found “virus particles remain suspended with PM 2.5 particulate matter, but they are not active viruses”.

“There have been studies in Europe and the US, where they have looked at polluted areas and compared mortality during lockdown and correlation with pollution… they found that pollution is clearly contributing to mortality in COVID-19 and that’s well established by these studies,” Mr Bhargava said at a press conference.

Every winter, the air quality in north India, including in Delhi, dips to a dangerous low. Experts have warned that high levels of air pollution can aggravate the COVID-19 pandemic.

It is well-proven that pollution is related to mortality, Mr Bhargava said and asserted that the most inexpensive prevention for COVID-19 and pollution is rapid and widespread adoption of wearing masks.

He said in some cities with high pollution levels, people wear masks even when there is no pandemic.

“Following COVID-appropriate behaviour, be it wearing masks, maintaining social distancing, respiratory etiquette and hand hygiene, do not cost us anything. Wearing a mask has a double advantage as it can protect one from COVID-19 as well as from pollution,” the ICMR chief said.

About the spread of coronavirus infection among children in India, he said the country’s overall figure show that of the total COVID-19 positive cases, only eight per cent are below the age of 17.

“For those below five years, the figure would be probably less than one per cent,” Mr Bhargava said, adding there is some evidence that children “can be spreaders, rather super-spreaders”.

Long-Term Exposure To Air Pollution Can Contribute To Mortality In Covid Cases: Top Medical Body ICMR
Every winter, the air quality in north India, including in Delhi, dips to a dangerous low. (File)

New Delhi: Studies in Europe and the US have established that long-term exposure to air pollution can contribute to mortality in COVID-19 cases, ICMR Director General Balram Bhargava said on Tuesday.
He stressed that studies have found “virus particles remain suspended with PM 2.5 particulate matter, but they are not active viruses”.

“There have been studies in Europe and the US, where they have looked at polluted areas and compared mortality during lockdown and correlation with pollution… they found that pollution is clearly contributing to mortality in COVID-19 and that’s well established by these studies,” Mr Bhargava said at a press conference.

Every winter, the air quality in north India, including in Delhi, dips to a dangerous low. Experts have warned that high levels of air pollution can aggravate the COVID-19 pandemic.

It is well-proven that pollution is related to mortality, Mr Bhargava said and asserted that the most inexpensive prevention for COVID-19 and pollution is rapid and widespread adoption of wearing masks.

He said in some cities with high pollution levels, people wear masks even when there is no pandemic.

“Following COVID-appropriate behaviour, be it wearing masks, maintaining social distancing, respiratory etiquette and hand hygiene, do not cost us anything. Wearing a mask has a double advantage as it can protect one from COVID-19 as well as from pollution,” the ICMR chief said.

About the spread of coronavirus infection among children in India, he said the country’s overall figure show that of the total COVID-19 positive cases, only eight per cent are below the age of 17.

“For those below five years, the figure would be probably less than one per cent,” Mr Bhargava said, adding there is some evidence that children “can be spreaders, rather super-spreaders”.

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In response to a question, Mr Bhargava said that India, so far, has not reported any cases of Kawasaki disease among COVID-19 patients.
Kawasaki is an auto-immune disease that affects children who are less than five years and presents with fever, thrombocytosis and a condition in which the arteries of the heart become dilated.

“It is less common in India. This has been described with COVID-19 in different parts of the world. I don’t think we have had any experience of Kawasaki with COVID-19 in India so far. It is a very rare condition,” Mr Bhargava said.

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