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Why are re-purposed medicines expensive?

The Hindu July 21, 2020 Why are re-purposed medicines expensive? The burden of a pandemic will have to be borne by governments and pharmaceutical companies alike. The quest for developing a vaccine and finding a definitive treatment for COVID-19 treatment is reportedly making good progress. However, with the number of infections around the globe having crossed 14.7 million, there is no easy containment of this pandemic. Clinical trials with re-purposed antivirals and biologicals have been approved in different geographical settings. These medicines are believed to have some potential in shortening the recovery time in COVID-19 patients. Recently, the Drugs Controller General of India (DCGI) issued approval to Glenmark Pharma to manufacture and market Favipiravir tablets for ‘restricted emergency use’. It also issued approvals to Hetero and Cipla to manufacture and market injectable formulations of Remdesivir, and to Biocon Limited to market injectable formulations of...

Explained: How immunity is developed

Written by Kaunain Sheriff M | New Delhi | Updated: July 15, 2020 A new antibody study suggests immunity to Covid-19 may be lost in months, yet notes antibodies are not the only way the body develops immunity. What is the other way, and does it put a limitation on the study? A longitudinal study by the researchers from King’s College London — first reported by The Guardian on Sunday — has suggested that immunity to Covid-19 might be lost in months. The suggestion is based on a steep drop in patients’ antibody levels three months after the infection. A look at the findings, implications and limitations of the new study, and the broader question of how the body develops immunity against an infection: What are the findings of the study? The researchers analysed the immune response of 90 recovered Covid-19 patients and healthcare workers. In their study, which is not yet peer-reviewed, they found that antibodies that specifically help in neutralising the coronavirus SARS-...

Serum Institute tells Modi govt how pandemic is affecting clinical trials of non-Covid drugs

HIMANI CHANDNA 14 July, 2020 New Delhi: The Pune-based Serum Institute of India (SII) — one of the world’s largest manufacturers of vaccines — has reached out to the Drug Controller General of India (DCGI), highlighting the difficulties it is facing in continuing clinical trials of non-Covid-19 vaccines, ThePrint has learnt. The company, which produces 1.5 billion doses of vaccines annually, has highlighted difficulties in continuing clinical trials for at least three of its non-Covid vaccines due to the pandemic. The company has told the DCGI, the apex body that approves vaccines and their clinical trials in India, about difficulties in conducting trials on Tdap (Tetanus, Diphtheria and Pertussis) vaccine, Hexavalent vaccine and Quadrivalent Human Papillomavirus Vaccine (HPV). Hexavalent vaccine, as the name suggests, gives immunity against six diseases, whereas HPV protects against various cancers, including cervical cancer.  “The firm presented the difficulties...

WHO restarts HCQ trial after Lancet concern over paper that trashed it

The Indian Express June 4, 2020 Abantika Ghosh, Anuradha Mascarenh THE WORLD Health Organisation (WHO) has decided to resume the  hydroxychloroquine (HCQ)  part of its Solidarity Trial, a global effort to find a treatment for  Covid-19 , after The Lancet issued an “expression of concern” over a study it had published that had questioned the effectiveness of HCQ. The  WHO had suspended the HCQ  segment of its trial based on this study published on May 22. This study, ostensibly, used data from hospitals obtained by Chicago-based company Surgisphere founded by Dr Sapan Desai who is one of the co-authors. The study said it had failed to find any benefit of HCQ or CQ (chloroquine, which too is anti-malarial) in Covid treatment. And that these were associated with “decreased in-hospital survival and an increased frequency of ventricular arrhythmias” when used for Covid treatment. After The Lancet red-flagged that study, on Wednesday, WHO quoted its d...

80% dip in infection risk for health staff on HCQ: Study

Hindustan Times June 1, 2020 Rhythma Kaul As many as 80% of the health care workers (HCWs) on six or more prophylactic doses of the anti-malarial drug hydroxychloroquine (HCQ) were not infected by Sars-CoV-2, the virus that causes the coronavirus disease (Covid-19), according to a new pre-print study by the Indian Council of Medical Research (ICMR) -- a finding that could establishing the prophylactic properties of the drug against Covid-19, even as several international studies have dismissed its utility as a therapeutic. The study results were one of the driving factors behind India last week expanding the use of HCQ as a prophylactic drug beyond health care workers in Covid-19 hospitals and close contacts of infected people to frontline workers such as surveillance staff deployed in containment zones, and paramilitary or police personnel involved in Covid-19 related activities. The results are based on a case control study for which participants were randomly drawn from ...

How the humble hydroxychloroquine has become India’s unlikely new global strategic asset

The Print Dated April 10, 2020 Himani Chandna When the US drug regulator placed Indian generic pharma firm Ipca Laboratories under an import ban on 15 June 2017 after its facility failed USFDA’s routine inspection, not a lot of questions were raised. The US Food and Drug Administration (USFDA) routinely goes after Indian drugmakers, and Ipca, with an annual income of Rs 3,700 crore, isn’t a big fish. But questions were raised on 20 March, when the USFDA peremptorily and somewhat inexplicably lifted the ban, and Ipca Labs happily notified this to the stock exchanges. What brought about this sudden change of heart in the USFDA? The mystery wasn’t as deep as it appeared. How IPCA gained because of Trump During his 19 March White House coronavirus briefing, US President Donald Trump declared hydroxychloroquine (HCQ), a seven decade-old anti-malarial drug, as a Covid-19  “game-changer”  the world had been waiting for. Indian companies produce approximately 70 per ...

Coronavirus: More ‘striking’ evidence BCG vaccine might protect against Covid-19

The Irish Times Dated : April 06, 2020 By Kevin O Sullivan More “striking” evidence has emerged that the BCG vaccine given to counter TB may provide protection against Covid-19 and significantly reduce death rates in countries with high levels of vaccination. A study of 178 countries by an Irish medical consultant working with epidemiologists at the University of Texas in  Houston  shows countries with vaccination programmes – including  Ireland  – have far fewer coronavirus cases by a factor 10, compared to where BCG programmes are no longer deployed. This translates into a death rate up to 20-times less, according to urologist  Paul Hegarty  of the  Mater Hospital , Dublin. Their “correlation” study, expected to be published shortly by PLOS journal, is largely a statistical one and comes with caveats because of possibility of confounding factors. But it is more comprehensive than an initial one conducted in New York, which prompted a ...

India, China spar over export curbs on medical products

The Indian Express February 27, 2020 India, China spar over export curbs on medical products India and China were locked in a verbal duel on Sunday over export restrictions on medical products in the wake of the coronavirus outbreak. Chinese medical institutions, charity organisations and local authorities have complained that medical products needed in fighting the epidemic in China are prohibited for export by the Indian side. In a statement, Chinese embassy spokesperson Ji Rong said on Sunday that the WHO has repeatedly opposed any travel and trade restrictions on China, which should be followed by all parties. “It is hoped that the Indian side could review the epidemic situation in an objective, rational and calm manner, handle with China’s much-needed items in a cooperative and constructive way, and resume normal personnel exchanges and trade between our two countries as soon as possible,” she said. In response, Ministry of External Affairs spokesperson Rave...

Coronavirus — blame the unhygienic meat industry

PT Jyothi Datta  | Updated on January 28, 2020  Instead of culling animals once there is an outbreak, the more civilised thing to do is to examine the trade It was on an uninvited visit to a slaughterhouse many years ago, that a disturbing truth was revealed. That humans working and living in these areas lived in as despicable a condition as they kept the animals. The unmistakable stale stench that hung oppressively, the wet boggy ground and the lack of medical officers to check if the animals being brought in were sick or diseased. It was a classic recipe for disaster. The message from these squalor-filled human and animal co-habitations was ominous. Ensure hygiene and better farm practices in the meat industry, if you don’t want to have disease-ridden meat coming to your table or viruses jumping species and mutating dangerously to infect and kill humans. This grim truth has reared its head again as the international scientific community now investigates the...

The Observer view on the coronavirus outbreak

Sun 26 Jan 2020 Worldwide health challenges serve as a grave warning to those who would bury their heads in isolationism The world’s most populous country yesterday celebrated the lunar new year, usually a time of family reunion and joyful celebration. For many Chinese people who have moved away from their place of birth, it is the one time of year they get to visit their familiesThis year the coronavirus outbreak has profoundly muted the celebrations in China, with several cities in lockdown, the imposition of quarantine measures unprecedented in their scale, and many citizens anxious about their own health and that of their families. The Chinese have borne the brunt of the outbreak so far: coronavirus is known to have killed more than 40 people, and infected another 1,300. But the first cases have already been recorded in the US, Australia, and – on Friday – in Europe. Like Sars (severe acute respiratory syndrome, also a coronavirus), bird flu and Ebola, this coro...