#India’s speedy approvals of #COVID19 #vaccines come under fire. “It sets a dangerous precedent which could be very damaging for vaccine confidence and uptake down the road.” #Modi #BJP #pandemic #health https://www.science.org/content/article/india-s-speedy-approvals-co...

A COVID-19 vaccine named Corbevax looked like a triumph for India’s burgeoning drug industry. Because its U.S. developers hadn’t claimed a patent on it, an Indian manufacturer named Biological E was able to sell the two-dose protein-based vaccine to the government at the extraordinarily low price of 145 rupees ($1.90) per dose. In March, the country began to give the shots to 12- to 14-year-olds, a group for which India did not yet have a licensed COVID-19 vaccine.

But the celebration was quickly drowned out by questions over whether India’s drug regulator, the Central Drugs Standard Control Organization (CDSCO), had properly vetted the vaccine.

In February, CDSCO had authorized the use of Corbevax for adolescents ages 12 to 18. But within weeks, the Indian media outlet The Wire Science revealed that the National Technical Advisory Group on Immunisation (NTAGI), an expert group that advises the health ministry on which vaccines to add to the national immunization program, had questioned whether Biological E had shown the vaccine is effective. In adolescents, who are at a lower risk of severe COVID-19, the benefits of a vaccine should be beyond any doubt, NTAGI member Jayaprakash Muliyil tells Science: “Anytime you vaccinate children, you have to be extremely careful.”

Other CDSCO approvals of COVID-19 vaccines have raised questions as well, both from NTAGI and independent experts. The agency has used “suboptimal” standards on several occasions, says Vineeta Bal, an immunologist at India’s National Institute of Immunology. That has led some scientists to ask whether the agency has the capabilities—and is independent enough—to oversee the quality of medicines for India’s 1.4 billion people. The implications go beyond India, because the country is a major global medicine supplier. The World Health Organization has “prequalified” 54 vaccines produced in India for use elsewhere, and WHO relies on CDSCO to oversee the manufacturers.

CDSCO didn’t respond to questions from Science about the criticism. In May 2020, India’s health ministry appointed a committee to advise it on how to restructure India’s drug regulatory system in line with global best practices, but that committee’s recommendations haven’t been published. It’s unclear whether they will address vaccine regulation.

--------

In January 2021, for example, the agency greenlit Covaxin, an inactivated-virus vaccine produced by Bharat Biotech, without data from large-scale efficacy trials—only phase 2 data about the immune response generated by the vaccine. By the time the company published data showing 78% efficacy against symptomatic COVID-19, 6 months later, millions of Indians had already received the shot.

NTAGI also differed with CDSCO’s assessment when the regulator approved a COVID-19 vaccine named ZyCoV-D for use in both adults and adolescents in August 2021. Produced by Zydus Cadila in Gujarat state, ZyCoV-D is the first DNA vaccine approved by any country for use in humans. CDSCO based its decision on results of a trial in about 28,000 participants over 12 years of age, which found the vaccine 67% efficacious at preventing symptomatic COVID-19.

NTAGI, which does not typically make its advice public, opposed the use in adolescents, Muliyil says; it felt a completely new vaccine platform should only be used in adults at first. Moreover, the phase 3 trial had a single efficacy estimate for all ages, says another NTAGI member who asked not to be identified, even though efficacy can differ by age group. (In Western countries, COVID-19 vaccines for adolescents and children were authorized after separate trials in those age groups.)

#India confirms #Asia's first #monkeypox death. The 22-year-old #Indian man died on Saturday in #Kerala. It's only the fourth known fatality in the world from the disease in the current outbreak. #Modi #Disease #BJP #Hindutva #Health https://www.reuters.com/world/india/india-confirms-its-first-monkey...


India confirmed its first monkeypox death on Monday, a young man in the southern state of Kerala, in what is only the fourth known fatality from the disease in the current outbreak.

Last week, Spain reported two monkeypox-related deaths and Brazil its first. The death in India is also the first in Asia. The World Health Organization declared the outbreak a global health emergency on July 23.

The 22-year-old Indian man died on Saturday, Kerala's revenue minister told reporters, adding that the government had isolated 21 people who had come in contact with him.

"The person reached Kerala on July 21 but visited a hospital only on July 26 when he displayed fatigue and fever," Minister K. Rajan said, adding that there was no reason to panic as none of the primary contacts were showing symptoms.

Kerala's health minister, Veena George, told reporters on Sunday that the man's family told authorities the previous day that he had tested positive in the United Arab Emirates before returning to India.

India's federal health ministry had no comment on the death, except for saying that the government had formed a task force of senior officials to monitor monkeypox cases in the country, where local media have reported at least five infections.

The WHO said late last month 78 countries had reported more than 18,000 cases of monkeypox, the majority in Europe.

It says the monkeypox virus causes a disease with less severe symptoms than smallpox and occurs mainly in central and west Africa. The disease is transmitted from animals to humans.

Human-to-human transmission happens through contact with bodily fluids, lesions on the skin or on internal mucosal surfaces, such as in the mouth or throat, respiratory droplets and contaminated objects.

India-made cough syrups may be tied to 66 deaths in Gambia: WHO | Business and Economy News | Al Jazeera


https://www.aljazeera.com/economy/2022/10/5/india-made-cough-syrups...

The WHO also issued a medical product alert asking regulators to remove Maiden Pharma goods from the market.


The deaths of dozens of children in The Gambia from kidney injuries may be linked to contaminated cough and cold syrups made by an Indian drug manufacturer, the World Health Organization said on Wednesday.

WHO Director-General Tedros Adhanom Ghebreyesus told reporters that the UN agency was conducting an investigation along with Indian regulators and the drugmaker, New Delhi-based Maiden Pharmaceuticals Ltd.

Maiden Pharma declined to comment on the alert, while calls and Reuters messages to the Drugs Controller General of India went unanswered. The Gambia and India’s health ministry also did not immediately respond to a request for comment.

The WHO also issued a medical product alert asking regulators to remove Maiden Pharma goods from the market.

The products may have been distributed elsewhere through informal markets, but had so far only been identified in The Gambia, the WHO said in its alert.

The alert covers four products – Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.


Lab analysis confirmed “unacceptable” amounts of diethylene glycol and ethylene glycol, which can be toxic when consumed, the WHO said. The Gambia’s government said last month it has also been investigating the deaths, as a spike in cases of acute kidney injury among children under the age of five was detected in late July.

Medical officers in The Gambia raised the alarm in July, after several children began falling ill with kidney problems three to five days after taking a locally sold paracetamol syrup. By August, 28 had died, but health authorities said the toll would likely rise. Now 66 are dead, WHO said on Wednesday.

The deaths have shaken the tiny West African nation, which is already dealing with multiple health emergencies including measles and malaria.

Maiden Pharmaceuticals manufactures medicines at its facilities in India, which it then sells domestically, as well as exporting it to countries in Asia, Africa and Latin America, according to its website.