In a significant development and in a bid to have enough and improved vaccines to counter the Wuhan virus, the Drug Controller General of India (DCGI) has approved the study on mixing of two Covid-19 vaccines – Serum Institute of India’s Covishield and Bharat Biotech’s Covaxin as recommended by the Subject Expert Committee (SEC) of the DCGI on 29 July granting approval to the study.

The expert committee is granting permission to CMC, Vellore in Tamil Nadu for conducting the Phase-4 clinical trial on 300 healthy volunteers for mixing of Covid-19 vaccines Covaxin and Covishield, reports India Today.

The study will determine if a person can be given two different vaccine shots to complete the vaccination course.

Also, the SEC had in July gave its approval to Bharat Biotech to conduct a trial that will involve combining the doses of Covaxin and Hyderabad-based firm’s other nasal COVID-19 vaccine.

Bharat Biotech is presently conducting trials of its intranasal COVID-19 vaccine in the country and the SEC has given its approval to conduct the phase 2 and 3 clinical trials, administering a dose each of Covaxin and the adenoviral intranasal vaccine with an interval between the two jabs.

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In positive news for India, Bharat Biotech the maker of the indigenous Covid-19 vaccine Covaxin has announced on Thursday (August 5) that it has received a certificate of Good Manufacturing Practice (GMP) compliance from the Hungarian authorities.

The approval was given by the National Institute of Pharmacy and Nutrition, Hungary, certifying the GMP for the manufacture of Covaxin.

Bharat Biotech has said that its certificate of GMP is now listed on the EudraGMDP database, which is the main database of the European Community of manufacturing authorizations and certificates of good manufacturing practice, and has plans to submit documentation for Emergency Use Authorization (EUA) in several additional countries worldwide.

This approval is a major achievement for Bharat Biotech in innovating, manufacturing, and supplying vaccines at global quality standards and has the potential to be a leading pharmaceutical company in the ongoing fight against the Covid-19 pandemic.

In a statement released by the company, it states that This recognition complements its commitment of driving world-class innovation and being a frontrunner in the research and development of vaccines.

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As per a report led by Mathukumalli Vidyasagar and Manindra Agrawal at the Indian Institute of Technology (IIT) in Hyderabad and Kanpur, India may see another rise in Covid-19 cases as soon as August.

The study has stated that the third wave peaking with less than 100,000 infections a day in the best-case scenario or nearly 150,000 in the worst scenario and the third wave of the coronavirus pandemic, may peak in October, reports Hindustan Times.

However, The third wave of Covid-19 is unlikely to be as severe as the second wave when India reported 400,000-plus daily cases, and researchers forecast that this time the surge in Covid-19 cases will be less is based on a mathematical model.

In May, Vidyasagar, a professor at IIT Hyderabad said told Bloomberg, “Our predictions are that the peak will come within a few days. As per current projections, we should hit 20,000 cases per day by the end of June. We will revise this as needed,”. 

However, his prediction that the wave would peak by the middle of last month was incorrect but it turns out his prediction was wrong because of incorrect parameters as “the pandemic was changing rapidly, even wildly, until about a week ago.”

India on Sunday (August 1) reported 41,831 Covid-19 cases and 541 deaths as the Centre cautioned 10 states, including Kerala, Maharashtra, and northeastern regions, as there is a rise in infections and asked them to take necessary steps to stop the spread of the coronavirus.

Experts have also warned that the Delta variant of the coronavirus can easily spread as chickenpox and what is even more threatening is that it can be passed on by vaccinated people leading to a surge in infections. 

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There is good news in the fight against the Wuhan virus as a new study has claimed that the Defence Research and Development Organisation (DRDO) developed the 2-DG drug is effective against all variants of Covid-19 and even reduces the multiplicity of the SARS-CoV-2 virus, reports The Hindustan Times.

The preliminary study also showed that DRDO’s anti-Covid drug alleviates cells from infection-induced cytopathic effect (CPE) and cell death, according to its abstract reviewed by news agency ANI.

DRDO’s Covid-19 drug, 2-deoxy-D-glucose (2-DG), was released at a crucial time by Union ministers Rajnath Singh and Dr Harsh Vardhan on May 17, wherein the central government claimed that the drug has the potential to reduce a patient’s average recovery time by two and a half days and oxygen demand by up to 40%.

That is why authorisation was given for emergency use by the Drugs Controller General of India (DCGI) on June 1 as an adjunct therapy for moderate to severe coronavirus patients.

The new study assessing the viability of DRDO’s anti-Covid drug was conducted by Abhishek Kumar, Dhiviya Vedagiri, Annat Narayan Bhatt, Yogesh Rai, and others. It has not been peer-reviewed yet, ANI noted.

DRDO’s anti-Covid drug according to the government will be priced at ₹900 per sachet in the market, and this drug is manufactured by the Hyderabad-based Dr Reddy’s Laboratories (DRL).

However, the central government has said that it will also provide the drug at discounted prices to the central and state governments.

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As per a report in Deccan Herald, in February 2020, a group of researchers from Kusuma School of Biological Sciences, Indian Institute of Technology Delhi, published a paper titled “Uncanny similarity of unique inserts in the 2019-nCoV spike protein to HIV-1 gp120 and Gag”, which they later were forced to withdraw.

As a growing number of scientists across the world are now calling for investigation for the lab-leak theory of the Covid-19 virus/Wuhan Virus, this particular paper has come into the limelight, being the first scientific research in light of lab-made virus theory.

One of the excerpts from the withdrawn paper reads, “We are currently witnessing a major epidemic caused by the 2019 novel coronavirus (2019- nCoV). The evolution of 2019-nCoV remains elusive. We found 4 insertions in the spike glycoprotein (S) which are unique to the 2019-nCoV and are not present in other coronaviruses.”

“The finding of 4 unique inserts in the 2019-nCoV, all of which have identity /similarity to amino acid residues in key structural proteins of HIV-1 is unlikely to be fortuitous [accidental] in nature. This work provides yet unknown insights on 2019-nCoV and sheds light on the evolution and pathogenicity of this virus with important implications for diagnosis of this virus. ” it further adds.

The withdrawal note on biorxiv.org states that [researchers] “intend to revise it in response to comments received from the research community on their technical approach and their interpretation of the results.”

A researcher associated with the paper, PhD scholar at IIT Delhi, Ashutosh Kumar Pandey, tweeted, “If published this will be tight slap on the cartel of Virologists who are hell bent to make this virus natural. SARS-CoV-2 is not natural. We said this in Jan 2020, we are saying it again.” mentioning a study by British Professor Angus Dalgleish and Norwegian scientist Dr Birger Sørensen.

https://t.co/QxJGnRquuB

If published this will be tight slap on the cartel of Virologists who are hell bent to make this virus natural. SARS-CoV-2 is not natural. We said this in Jan 2020, we are saying it again.

— Ashutosh Kumar Pandey (@asrayagiriraj) May 29, 2021

The United Kingdom(UK) based newspaper Daily Mail recently had obtained  and published a study which claims that Chinese scientists created COVID-19 in a Wuhan lab, and when it leaked they tried to cover their tracks by reverse-engineering versions of the virus to make it look like it evolved naturally from bats.

The authors of the papers were Dr Dalgleish and Sørensen, who had submitted their findings in the Quarterly Review of Biophysics Discovery.

Also, Antony Fauci who is a physician-scientist and immunologist and is the director of the U.S. National Institute of Allergy and Infectious Diseases and the chief medical advisor to the president was aware of the Indian research but chose to ignore the findings. He called the results “outlandish”.

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As India fights back the second wave of the Chinese virus, the first batch of the revolutionary 2-deoxy-D-glucose (2-DG) drug developed by the Defence Research and Development Organisation (DRDO) will be released by Defence Minister Rajnath Singh today (17 May).

The Drugs Controller General of India (DCGI) 8 May had approved the anti-COVID-19 drug for emergency use and hospitals will start receiving the supplies of the drug from Monday (17 May) with the first batch comprising of around 10,000 doses to be supplied to various hospitals in Delhi.

An anti-Covid-19 therapeutic application of the drug 2-deoxy-D-glucose (2-DG) has been developed by the Institute of Nuclear Medicine & Allied Sciences laboratory (INMAS), a lab of the Defence Research and Development Organisation (DRDO), in collaboration with Dr Reddy’s Laboratories (DRL), Hyderabad.

Clinical trial results have been exceptionally good and as per reports this new life-saving drug helps in faster recovery of hospitalised patients and reduces supplemental oxygen dependence.

However, what makes the drug unique is that it prevents virus growth by stopping viral synthesis and energy production as it accumulates in the virus-infected cells and the selective accumulation in virally infected cells makes this drug unique.

A higher proportion of patients treated with 2-DG showed RT-PCR negative conversion in Covid patients and the best news is since it is a generic molecule and analogue of glucose, it can be easily produced and made available in plenty in the country.

This is the most non-evasive Covid-19 drug as it comes in powder form in a sachet, which is taken orally by dissolving it in water.

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The central government has taken a cautious stand on utilising the statutory provisions available to it under domestic law and TRIPS (Trade-Related Aspects of Intellectual Property Rights) flexibilities that permit it to seek patent waivers during national health emergencies citing adverse consequences.

The centre has said that exercise of the statutory powers would be “counter-productive” at this stage, and is actively engaging with global organisations at a diplomatic level to find out a solution in India’s best possible interest.

“Any exercise of statutory powers either under the Patents Act 1970 read with TRIPS Agreement 65 and Doha Declaration or in any other way can only prove to be counter-productive at this stage, ” the Centre said in an affidavit filed before the Supreme Court that is hearing the matter related to suo moto writ petition on the government’s response to the COVID-19 pandemic.

“It is earnestly urged that any discussion or a mention of exercise of statutory powers either for essential drugs or vaccines having patent issues would have serious, severe and unintended adverse consequences in the country’s efforts being made on global platform using all its resources, good-will and good-offices through diplomatic and other channels,” the affidavit added.

The Supreme Court in its order dated April 30 observed that the central government can consider using its powers under Sections 92, 100 or 102 of the Patents Act to increase production of essential drugs to ensure that the supply of those drugs is proportional to the demand.

Section 92 permits the government to issue a compulsory licence on a drug even if patents are in force during a national emergency or in circumstances of extreme urgency. Section 100 allows the central government and any individual to use the invention for the purposes of the government, even if the invention is protected by patents.

Furthermore, the government in its affadavit added that the main constraint is in the availability of raw materials and essential inputs.

“Therefore, any additional permissions and licences may not result in increased production immediately,” it said.

The government said that it was presumptuous to assume that the patent holder will not agree to more voluntary licences for such manufacturers who have a new drug manufacturing permission from the DCGI.

“However, if such a manufacturer applies for a compulsory licence under Section 92, the same may be suitably considered by the DoC,” the government said.

Mixed reactions to Centre’s stance

The position has surprised activists who are striving for access to drugs, but got support from pharmaceutical industry lobby groups such as Indian Pharmaceutical Alliance (IPA).

IPA represents large domestic pharmaceutical companies.

“The position the government has taken (on patent waivers) is the right one,” said Sudarshan Jain, Secretary-General, IPA.

“What is the point of patent waiver, when we don’t have technology transfer and raw materials; so working with global companies through voluntary licensing is a better route,” Jain said.

He added that there are many cases where the global companies have entered into voluntary licensing with Indian companies during the COVID-19 pandemic to expand the access of the drugs.

But others weren’t excited at a time when India along with South Africa is insisting on patent waivers at WTO.

“It is beyond comprehension – they don’t want to use existing legal provisions under domestic law and under TRIPs law for current problems but are asking for IP waiver at global level,” said Sandeep K Rathod, General Counsel and Vice President (Legal), ‎JB Chemicals & Pharmaceuticals.

“Ultimately, other countries can simply ask us — when you don’t want to use current IP flexibility or put your tech on access, why should you demand the same from us? The access movement has got a massive step back,” Rathod added.

Diplomatic option bogged with challenges

Legal experts say that India is still a long way from a TRIPS waiver which would require unanimity at the World Trade Organisation (WTO) and that negotiations are time consuming. Even if the TRIPS waiver is agreed to at the WTO and by patent holders, technology transfers and scale-up will take months.

“Presently, the government appears to be favouring a diplomatic approach instead. However, this decision needs to be made on the basis of the advice and inputs from scientific experts considering the criticality of the present situation in India and subsisting supply chain of essential drugs and vaccines,” said Anupam Shukla, Counsel at Pioneer Legal.

“After all, negotiating voluntary IP licences and temporary patent waivers with pharma giants and first-world nations may prove to be a fairly time-consuming process. If the central government’s political efforts do not bear fruit soon enough, then it may have to consider using the powers available to it under Sections 92 and 100 of the Patents Act now and deal with the diplomatic fallout later,” Shukla added.

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 As the nation is reeling under the second wave of the Wuhan virus, the Defence Ministry on Sunday (9 May) issued an order to the Armed Forces Medical Services (AFMS) to recruit 400 retired medical officers of the Army Medical Corps (AMC), reports Time of India.

These doctors will be recruited into the AFMS under the Short Service Commission (SSC) for a maximum of 11 months contract.

Indian hospitals in several states are running short of health workers, vaccines, oxygen, drugs and beds.

The Defence Ministry’s statement noted: “Under the ‘Tour of Duty’ scheme, 400 ex-AMC/SSC medical officers, released between 2017 and 2021, are expected to be recruited on contract basis for a maximum period of 11 months.”
These medical officers will be paid a fixed monthly lump sum amount, which will be calculated by deducting the basic pension from the salary drawn at the time of retirement, it said.

The Defence Ministry further added, “The amount would remain unchanged for the term of the contract and no other allowances would be paid. The medical officers to be recruited are required to be medically fit as per civilian standards,”.

The AFMS has already been at the forefront and has deployed additional doctors, including specialists, super specialists and paramedics, at various hospitals as the government has granted them an extension till December 31, to augment the strength by 238 more doctors.

India recorded 4,03,738 fresh Covid-19 cases in a day, which pushed the tally to 2,22,96,414, according to the Union health ministry data updated on Sunday.

The death toll from the pandemic climbed to 2,42,362 with 4,092 new fatalities, the data updated at 8 am showed.

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India’s drug regulator DCGI has given the green signal for a glucose analogue called ‘2-DG’ for COVID treatment on an emergency basis. This is to be used as an adjunct treatment mechanism to supplement the primary treatment that is given to the patients.

“The Drugs Controller General of India (DCGI) has given permission for the emergency use of drug 2-deoxy-D-glucose (2-DG) as an adjunct therapy in moderate to severe Covid-19 cases,” said Defence Research and Development Organisation on Saturday.

“Being a generic molecule and analogue of glucose, it can be easily produced and made available in plenty. It has been developed by the DRDO lab-Institute of Nuclear Medicine and Allied Sciences-in collaboration with Dr Reddy’s Laboratories. Clinical trials have shown that this molecule helps in the faster recovery of hospitalized patients and reduces supplemental oxygen dependence,” the release added.

In 2020, Patanjali had published a research paper about using this drug for COVID treatment. “The 2-DG can dock efficiently with viral main protease 3CLpro as well as NSP15 endoribonuclease, thus efficiently inactivating these viral receptors leading to incapacitation of the SARS-CoV-2 virus. Such incapacitation was possible by means of the formation of a hydrogen bond between 2-DG and proline residues of viral protease. The 2-DG derivative formed a hydrogen bond with the glutamine amino acid residues of the viral spike glycoprotein,” their paper said. Following this, DRDO had collaborated with Dr Reddy’s Laboratories to develop the analogue ‘2-DG’. After clinical trials were successful, it was submitted for approval to the DCGI and has now been approved for usage.

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The farmer’s protest took a turn for the worst when Momita Basu (25), daughter of communist leader Utsav Basu from West Bengal, died of Covid-19 on Friday (30 April).

Basu had reached the protest site at the Tikri border on 12 April as the second wave hit India and fell ill on 26 April as per a report published in The Times of India.

She had an infection in her lungs apart from testing positive for Covid-19. It must be noted that so-called farmer leader Rajesh Tikait has vowed not to end his demand risking the lives of many people.

Punjab Kisan Union leader Jasbir Kaur Natt told the reporters: “She was in my direct contact. She was an active girl and was participating in various programmes at the farmer protest. When she felt uneasy on 26 April, my daughter Navkiran Kaur Natt took her to a private hospital at Bahadurgarh. She had to put in a lot of effort to get her admitted to the hospital. In the Covid test, she turned positive and passed away on Friday evening. Her mortal remains were consigned to flames at Bahadurgarh.”

Delhi reported 18,043 new Covid-19 cases, 20,293 discharges and 448 deaths in the last 24 hours (3 May), taking the active cases tally to 89,592.

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