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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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Male sex hormones may help treat breast cancer: Study

While endocrine therapy is standard-of-care for estrogen receptor positive breast cancer, resistance to these drugs is the major cause of breast cancer mortality.

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Sydney : Researchers have found new evidence about the positive role of androgens, commonly thought of as male sex hormones but also found at lower levels in women, in breast cancer treatment.

In normal breast development, estrogen stimulates and androgen inhibits growth at puberty and throughout adult life.

Abnormal estrogen activity is responsible for the majority of breast cancers, but the role of androgen activity in this disease has been controversial.

The new research published in the journal Nature Medicine showed that androgens have potential for treatment of estrogen receptor positive breast cancer.

A cancer is called estrogen receptor positive if it has receptors for estrogen, according to Breastcancer.org.

Using cell-line and patient-derived models, the global team, including researchers at the University of Adelaide and the Garvan Institute of Medical Research in Australia, demonstrated that androgen receptor activation by natural androgen or a new androgenic drug had potent anti-tumour activity in all estrogen receptor positive breast cancers, even those resistant to current standard-of-care treatments.

In contrast, androgen receptor inhibitors had no effect.

“This work has immediate implications for women with metastatic estrogen receptor positive breast cancer, including those resistant to current forms of endocrine therapy,” said lead researcher Theresa Hickey, Associate Professor at the University of Adelaide.

“We provide compelling new experimental evidence that androgen receptor stimulating drugs can be more effective than existing (e.g. Tamoxifen) or new (e.g. Palbociclib) standard-of-care treatments and, in the case of the latter, can be combined to enhance growth inhibition,” said Wayne Tilley, Director of the Dame Roma Mitchell Cancer Research Laboratories, Adelaide Medical School, University of Adelaide.

Androgens were historically used to treat breast cancer, but knowledge of hormone receptors in breast tissue was rudimentary at the time and the treatment’s efficacy misunderstood.

Androgen therapy was discontinued due to virilising side effects and the advent of anti-estrogenic endocrine therapies.

While endocrine therapy is standard-of-care for estrogen receptor positive breast cancer, resistance to these drugs is the major cause of breast cancer mortality.

“The new insights from this study should clarify the widespread confusion over the role of the androgen receptor in estrogen receptor driven breast cancer,” said Elgene Lim, a breast oncologist and Head of the Connie Johnson Breast Cancer Research Lab at the Garvan Institute.

“Given the efficacy of this treatment strategy at multiple stages of disease in our study, we hope to translate these findings into clinical trials as a new class of endocrine therapy for breast cancer.”

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Expert panel recommends Phase 1 trial of nasal Covid-19 vaccine

According to the firm, an intranasal vaccine stimulates a broad immune response at the site of infection, in the nasal mucosa, which is essential for blocking both infection and transmission of Covid-19.

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New Delhi, Jan 20: The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) on Tuesday recommended Bharat Biotech’s intranasal vaccine for coronavirus for phase 1 clinical trials. The final call will now be taken by the Drugs Controller General of India.

Days after getting the Drugs Controller General of India’s nod for restricted emergency use of India’s first indigenously-made coronavirus vaccine, Bharat Biotech had applied to the drug regulator for permission to start the clinical trials of their nasal coronavirus vaccine.

The nasal vaccine is different from the intramuscular vaccine which recently got approval, as it is non-invasive, needle-free, doesn’t require trained healthcare workers, eliminates needle-associated risks, suits children and adults and has scalable manufacturing.

Earlier on Tuesday, Dr VK Paul, Member, NITI (National Institution for Transforming India) Aayog had said, “A nasal vaccine candidate has been identified. It has come for consideration for phase 1 and phase 2 trials. If it works then it could be a game-changer.”

“Phase 1 has been recommended,” top government sources told IANS. Clinical trials of Bharat Biotech’s ‘BBV154’ — a novel adenovirus vectored, and intranasal vaccine for coronavirus — will be conducted at various locations. The vaccine will be single-dosed.

According to the firm, an intranasal vaccine stimulates a broad immune response at the site of infection, in the nasal mucosa, which is essential for blocking both infection and transmission of Covid-19.

The vaccine has demonstrated protective efficacy in mice and hamsters. Mice and hamsters immunized with its single-dose conferred superior protection against the SARS-CoV-2 challenge, “more so than one or two intramuscular immunizations of the same vaccine and dose.”

“Thus, intranasal immunization of ChAd-SARS-CoV-2-S can create an immune response in the nose, which is the point of entry for the virus, thereby protecting against disease, infection and transmission,” Bharat Biotech said in a statement.

On January 3, two intramuscular vaccines – Bharat Biotech’s Covaxin and Oxford-AstraZeneca’s Covishield manufactured by the Serum Institute of India were approved for restricted emergency use and have been administered to over four lakh people till now. Both are two-dose vaccines.

While the full efficacy of Covaxin is yet to be determined, it was given the go-ahead by the DCGI citing ‘public interest’. Covaxin is an indigenously developed vaccine by Bharat Biotech, in collaboration with the Indian Council of Medical Research (ICMR).

Public health experts believe that intranasal vaccines for coronavirus, administered through the nose rather than muscles, can be a potential game-changer in India’s fight against the coronavirus pandemic.

Last month, Pune-based Serum Institute of India and Codagenix Inc had announced that they have received regulatory approval in the United Kingdom to begin an early-stage trial of their single-dose, intranasal coronavirus vaccine.

(Aakanksha Khajuria can be contacted at [email protected])

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Covid-19 vax: WHO warns of ‘catastrophic moral failure’

He said over 39 million vaccine doses had been given in 49 richer states – but one poor nation had only 25 doses.

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Geneva, Jan 19 : The world faces a “catastrophic moral failure” because of unequal Covid-19 vaccine policies, the head of the World Health Organization (WHO) has warned.

WHO chief Tedros Adhanom Ghebreyesus said it was not fair for younger, healthy people in richer nations to get injections before vulnerable people in poorer states, the BBC reported.

He said over 39 million vaccine doses had been given in 49 richer states – but one poor nation had only 25 doses.

Meanwhile, both the WHO and China were criticised for their Covid response.

An independent panel commissioned by the WHO said the UN public health body should have declared an international emergency earlier, and also rapped China for not taking public health measures sooner.

So far, China, India, Russia, the UK and the US have all developed Covid vaccines, with others being made by multinational teams – like the American-German Pfizer vaccine.

Almost all of these nations have prioritised distribution to their own populations.

Speaking at a WHO executive board session on Monday, Tedros said: “I need to be blunt: the world is on the brink of a catastrophic moral failure – and the price of this failure will be paid with lives and livelihoods in the world’s poorest countries.”

Tedros said a “me-first” approach would be self-defeating because it would push up prices and encourage hoarding.

“Ultimately, these actions will only prolong the pandemic, the restrictions needed to contain it, and human and economic suffering,” he added.

The WHO head called for a full commitment to the global vaccine-sharing scheme Covax, which is due to start rolling out next month.

“My challenge to all member states is to ensure that by the time World Health Day arrives on April 7, Covid-19 vaccines are being administered in every country, as a symbol of hope for overcoming both the pandemic and the inequalities that lie at the root of so many global health challenges,” Tedros said.

So far, more than 180 countries have signed up to the Covax initiative, which is supported by the WHO and a group of international vaccine advocacy groups. Its aim is to unite countries into one bloc so they have more power to negotiate with drug companies.

Ninety-two countries – all of them low or middle-income – will have their vaccines paid for by a fund sponsored by donors.

“We have secured two billion doses from five producers, with options of more than one billion more doses, and we aim to start deliveries in February,” Tedros said.

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