Published9 hours agoSharecloseShare pageCopy linkAbout sharingImage source, WHOBy Shruti MenonBBC Reality CheckThe deaths of nearly 70 children in The Gambia, linked to cough syrups made in India, are being investigated amid concerns about effective regulation of the manufacture and trade in medicines. What went wrong in The Gambia? Last week, the World Heath Organization (WHO) issued a global alert over four brands of cough syrups, saying they could be linked to acute kidney damage, following reports from The Gambia of children diagnosed with serious kidney problems.Laboratory analysis of the syrups “confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants”, according to the WHO. The Indian authorities and the cough syrup manufacturer, Maiden Pharmaceuticals, say these syrups have been exported to The Gambia only.Image source, Getty ImagesWhat is known about the manufacturer?Maiden Pharmaceuticals says it adheres to internationally recognised quality-control standards.But some of its products have failed to meet national or state-level quality-control standards in India. Official records there show the company: was blacklisted by Bihar state, in 2011, for selling a syrup failing to meet local standardswas subject to legal proceedings by India’s drug regulator, in 2018, for quality-control violationsfailed a quality-control test in Jammu and Kashmir state, in 2020has failed quality-control tests in Kerala state four times in 2022It is also among nearly 40 Indian pharmaceutical companies blacklisted by Vietnam for exporting sub-standard products.The company, based in Haryana state, has said it is “shocked” by the deaths in The Gambia and had “been diligently following the protocols of the health authorities, including [the] drugs controller general [of India] and the state drugs controllers, Haryana”.We’re not selling anything in domestic market. We’ve been obtaining raw materials from certified & reputed companies. CDSCO officials have taken samples & we are awaiting the results: Maiden Pharmaceuticals Ltd on deaths of 66 children in Gambia allegedly due to their cough syrup pic.twitter.com/HFEJbx1POx— ANI (@ANI) October 8, 2022
The BBC is not responsible for the content of external sites.View original tweet on TwitterIt would not comment further while drugs regulators were still testing, it added.Haryana Health Minister Anil Vij told BBC News samples had been sent for testing and if something wrong was detected, action would be taken.How effective is India’s quality control?India produces a third of the world’s medicines, mostly in the form of generic drugs. It is a major supplier to countries in Africa, Latin America and other parts of Asia. Image source, Getty ImagesIts manufacturing plants are required to adhere to stringent quality-control standards and production practices. But Indian companies have faced criticism and even bans by overseas regulators such as the US Food and Drug Administration (FDA) for quality-control problems at some plants.One analysis of India’s pharmaceutical industry points to underfunding of oversight bodies and a lax interpretation of regulations as key issues, with a lack of interest in ensuring purity standards are adhered to.Public-health activist Dinesh Thakur also highlights the relatively light punishment in India for flouting quality standards – a fine of $242 (£220) and a possible prison sentence of up to two years.”Unless one can causally establish a direct link between a sub-standard drug and a fatality, this is the norm of punishment meted out,” he says. Also, India is not included in the WHO standards for national bodies that regulate medicines, although it is for vaccines.”This may result in inconsistent regulatory control over pharmaceutical manufacturing activities,” Leena Menghaney, head of Médecins Sans Frontières (MSF) Access Campaign South Asia, says.Should The Gambia have tested?The Health Ministry in Delhi has launched an investigation but says it is “usual practice that the importing country tests these imported products… and satisfies itself as to the quality”.But The Gambia’s Medicine Control Agency executive director Markieu Janneh Kaira says it prioritises checks on anti-malarial drugs, antibiotics and painkillers, rather than cough syrup.BBC News contacted the agency for clarification but had no response.The Gambia’s President, Adama Barrow, has said he “would get to the bottom” of the causes of the tragedy and announced the creation of “a quality-control national laboratory for drugs and food safety”.The Gambia would “establish safeguards to eliminate the importation of sub-standard drugs”, he added.MSF wants countries with sufficient testing capacity to help low-income countries such as The Gambia. “This is not about the importing countries responsibility only,” Ms Menghaney says.In Nigeria, the National Agency for Food and Drug Administration and Control is now asking for all imported shipments of pharmaceuticals to be cleared by approved agents prior to leaving India. Read more from Reality CheckSend us your questions

SharecloseShare pageCopy linkAbout sharingimage copyrightGetty ImagesIndian Prime Minister Narendra Modi has said that all adults in India will now get free vaccines. “It has been decided that from 21 June, all adults over the age of 18 will be vaccinated [for] free,” Mr Modi said. “Whether it is the poor, the lower middle class, the middle class, or the upper middle class, under the central government programme, everyone will get free vaccines,” Mr Modi said.But what does this mean for vaccination strategy in India, which has struggled with a severe second wave of coronavirus?How has the policy changed?Prime Minister Modi’s announcement came in a national address on TV, in which he talked about the history and logistics of vaccine programmes in India.Responsibility for vaccinations in India has historically been shared between the federal government in Delhi and state governments.image copyrightReutersUnder the earlier Covid vaccine policy, half of all vaccines produced in India went to the federal government, and the rest went to state administrations and private hospitals.But now the federal government will buy 75% of all vaccines manufactured.The state governments will receive their vaccines doses for free from the federal government, instead of negotiating directly with manufacturers.However, it’s worth noting that the remaining 25% of vaccines are still set aside for procurement by private hospitals as before.These vaccinations are not free – people have to pay at private hospitals.The federal government has fixed prices for the three approved vaccines at 780 rupees ($10.7; £7.5) for Covishield, 1,145 rupees ($15.7; £11) for Sputnik V, and 1,410 rupees ($19.3; £13.6) for Covaxin. What does it mean in practice?It means that state governments will now receive their allocated vaccine doses from the federal government based on the population of those states, the level of disease, vaccination progress and vaccine wastage. That relieves the state authorities of having to purchase doses from the manufacturer at higher prices than were offered to the federal government.How India’s vaccine drive went horribly wrongimage copyrightGetty ImagesIt also hands more control over the vaccine rollout to Delhi.The announcement also comes just days after the previous policy attracted criticism from India’s top court, which called it “arbitrary” and “irrational”. It questioned the rationale behind making states pay more for vaccines than the federal government had to. States had to procure them on the open market, and so the financial burden on some of the poorest states such as Bihar, Jharkhand and Uttar Pradesh significantly increased.”This is a step in the right direction and will streamline some procurement-related challenges,” says public policy and systems expert Dr Chandrakant Lahariya. What does it mean for ordinary people?The new policy is in fact similar to what India did when it began its vaccine rollout in January this year.This was even acknowledged by Mr Modi himself, who said “the old system, in place before 1 May, will be implemented again.””This announcement doesn’t change much for citizens,” says Dr Lahariya. The original policy was changed in April, when India was hit by a dramatic surge in case numbers and India’s vaccine drive was faltering. States were then allowed to bid for vaccines directly from manufacturers, which it was hoped would encourage other vaccine makers to enter the Indian market and boost supply. Can India get all adults vaccinated this year?But it didn’t work out like that, and shortages of vaccines began to emerge in a number of places as supply couldn’t keep up with demand.We’ve looked in other pieces at the challenges that face Indian vaccine manufacturers in trying to ramp up production.How is the vaccination drive going?India has administered a total of nearly 235 million vaccine doses since January. The vaccine drive picked up pace in early April, with 3.66 million doses administered on 10 April, the highest so far. But that figure then fell by nearly half in mid-May and several states suspended vaccinations for the 18-44 age group due to shortages.India’s adult population is estimated as being over 900 million.The Indian government has pledged to vaccinate all adults by the end of the year, a target many experts say would be difficult to meet at the current pace. Read more from Reality CheckSend us your questions

SharecloseShare pageCopy linkAbout sharingimage copyrightGetty ImagesAbout 12,000 cases of a condition known as “black fungus” have been reported in India, mostly in patients recovering from Covid-19.This severe infection is normally very rare and has a mortality rate of about 50%.Some medical experts have suggested India has seen cases growing because of the high prevalence of diabetes.But are other factors at work and what is happening in other countries?Which countries have got black fungus?Prior to the Covid pandemic, at least 38 countries around the world had reported cases of mucormycosis, more commonly known as black fungus.India and Pakistan had the highest rates with around 140 cases per million annually, according to Leading International Fungal Education.image copyrightGetty ImagesDr David Denning at the University of Manchester, an expert on fungal infections, says reported cases of black fungus in India were “masses more than any other part of the world” well before the pandemic.”Mucormycosis is strongly linked with poorly controlled diabetes and there’s a lot of it [diabetes] in India.”What is diabetes and how can you reduce risks?Deadly ‘black fungus’ cases alarm IndiaIn patients recovering from Covid-19, according to a recent research paper looking at cases globally, 94% of those who had the fungal infection also suffered from diabetes. And the majority (71%) of the reported cases of black fungus were from India.Is a link to diabetes seen in other countries?Of the top countries with a high per-capita prevalence of diabetes, others (apart from India) have reported cases of mucormycosis. India’s neighbours, Pakistan and Bangladesh, both have a high prevalence of diabetes in their populations, and have had mucormycosis cases – but not in especially large numbers. In Bangladesh, doctors have been treating one confirmed case of mucormycosis and are awaiting test results for another suspected case.Doctors told the BBC that both patients also had diabetes. Pakistan has also reported five cases of mucormycosis in recent weeks and four had died as of 12 May, according to media reports. Brazil has reported 29 cases so far, but it’s not yet clear how many of these had Covid and/or were diabetic.Russia has also reported “isolated” cases of mucormycosis in Covid patients recently – but it is unclear how many have been detected so far.The US has a very high prevalence of diabetes – 9.3% of the population is estimated to have the condition.It also has the highest number of Covid cases globally. But mucormycosis is very rare – diabetes cases there are largely managed with only 3% going undiagnosed, according to the US Centers for Disease Control. Why might diabetes be a risk factor?Experts say it’s not so much recorded cases of diabetes as the levels of undiagnosed diabetes that are the issue.The IDF estimates that about 57% of those with diabetes in India, Nepal, Bangladesh, Sri Lanka are undiagnosed cases – and nearly all of these are found in India.Pakistan is also estimated to have a high proportion of undiagnosed diabetes.”There’s a lot of uncontrolled diabetes in India because people don’t do regular health check-ups,” says Dr Hariprasath Prakash at the International School of Medicine in Kyrgyzstan.He says a large majority of diabetes cases are “discovered through other health complications” and remain untreated. Poorly controlled diabetes puts you at higher risk of certain infections, including some fungal ones. The Africa region also has a high proportion of undiagnosed diabetes at nearly 60%, but estimates show the incidence of mucormycosis there is low – only 3%. Dr Denning points out that “it could be because [mucormycosis] cases might be going undiagnosed… it is not the easiest thing to diagnose.” Studies have suggested that cases of black fungus go undiagnosed because of the difficulty in tissue sample collection and the lack of sensitivity of the diagnostic tests. What else might cause black fungus?Experts also suggest that the indiscriminate use of steroids for some Covid treatments could be linked to mucormycosis or other fungal infections. Two widely prescribed steroids – dexamethasone and methylprednisolone – are used for Covid patients in India to reduce the inflammation caused by the body’s immune response.image copyrightGetty ImagesHowever, with hospitals and doctors overwhelmed by a growing numbers of cases, there’s evidence that these steroids are being taken without medical supervision. The Indian authorities have recently warned against such self-medication, which can have seriously harmful consequences including, says Dr Denning, such as an increased the risk of developing mucormycosis.A UK-based trial conducted on around 2,000 Covid patients showed that dexamethasone helped reduce mortality in those with a moderate or severe infection, but could potentially be harmful for those with a mild infection. That study showed the efficacy of steroids when used in a hospital setting. However, some states in India are reported to have distributed dexamethasone to the public along with home isolation kits. “It is very clear (through studies) that more steroids is not better,” said Dr Denning. Read more from Reality CheckSend us your questions

SharecloseShare pageCopy linkAbout sharingimage copyrightGetty ImagesIndia has been hit by a huge second coronavirus wave, but its government has said the pandemic is showing signs of slowing down in some regions. What’s happening to infection rates? India’s surge in infections began around mid-March and increased rapidly, reaching a peak of more than 400,000 recorded daily cases on Friday, 30 April. Over subsequent days the numbers fell, with just under 360,000 on Monday, 3 May – leading to speculation that a peak had been reached.But in the past few days, they have started to rise again, in line with a weekly pattern of fluctuations that shows the numbers usually dipping on a Monday. And on Thursday, 6 May, the number of new recorded daily infections reached a new high of more than 414,000. The seven-day moving average (smoothing out daily fluctuations) is also still trending upwards.Are testing levels being maintained?Accurate assessments of the extent of the virus are only possible with widespread testing.India has been conducting nearly two million tests a day. This dipped at the start of this month to 1.5 million.But by Wednesday, 5 May, daily testing was back at almost two million again.This temporary fall in testing may go some way to explaining the extent of the dip in recorded daily infections in the first few days of May.Testing has also been highly variable across the country, with some regions showing significant declines.”This happened during the previous peak, in September, too,” World Health Organization (WHO) consultant and economist Dr Rijo John says.”When India was about to touch 100,000 cases per day, the testing rates fell.” When the authorities say case levels have fallen in some states – Maharashtra, Gujarat, and Telangana and the capital, Delhi – these same states have also seen a fall in testing. In mid-April, when Delhi was conducting nearly 100,000 tests a day, recorded daily case numbers were around 16,000. But by the end of April, when the case numbers had risen by more than 55%, testing had fallen by 20%, suggesting a much higher underlying level of infections.Similar trends were observed in Gujarat and Telangana.image copyrightGetty ImagesTesting capacity is clearly under great strain, with people unable to access tests because facilities are overburdened, Dr John says.And across the country, the rate of testing, about 1.3 per 1,000 people, compares with three in the US and 15 in the UK.What proportion of tests are positive?A high percentage of positive tests suggests the likelihood of many more people in the community with undetected coronavirus, according to Johns Hopkins University.And last year, the WHO recommended countries waited until their positive test rate was below 5% for at least two weeks before considering easing restrictions. Gautam Menon, a mathematical modeller and professor of physics and biology, at Ashoka University, near Delhi, says: “Test positivity rates are still quite high, over 20% countrywide. “So I would certainly think there is no reason yet to believe that India is past its second wave.”What kind of tests are being used?India mainly uses two types.Polymerase chain reaction (PCR) tests are considered the gold standard, although there have been reports of new variants going undetected even in symptomatic patients. But some state health authorities have been moving over to rapid antigen tests, which are quicker and easier to administer but less reliable.image copyrightGetty ImagesIn Delhi, nearly 35% of tests in April were rapid antigen. The Indian Council for Medical Research (ICMR) has now recommended that rapid antigen tests be used more widely to deal given the current surge in cases.It has also relaxed rules regarding getting mandatory PCR tests for travellers to “reduce the burden on laboratories”. Read more from Reality CheckSend us your questions