About 3% of drugs routinely taken by Indians for ailments such as hypertension, bacterial infections and allergies are “substandard”, according to a study of samples taken from factories by government inspectors.
Officials have been carrying out random checks on factories after a scandal over Indian-made cough syrups linked to the deaths of children, mostly in countries in Africa.
The “substandard” rating does not mean the drugs are intrinsically harmful, but by being ineffective and failing to treat or control ailments, they can greatly worsen them, help them spread, or make them drug-resistant.
In the latest inspection, covering March, 1,497 samples were taken from plants across the country. Forty-eight, approximately 3%, were found to be “not of standard quality”.
The findings are an improvement on January and February, when 5% of the samples were found to be sub-standard.
One sample that returned a substandard reading was for the hypertension drug Telmisartan.
Nitin Gupta, a retired physiotherapist in Delhi, said his suspicions about the quality of drugs in India had been made worse by the recent government studies.
“I’ve always made a point of getting the branded Telmisartan for my high blood pressure because I don’t trust the generic version but now, with this report, it seems even that isn’t a safe bet,” he said.
Telmisartan’s manufacturer Glenmark said the sample was counterfeit and not manufactured by Glenmark.
Ever since last year’s scare over exports of children’s cough syrup, the Ministry of Health and Family Welfare has sent teams of inspectors across the country to try to root out poor manufacturing practices.
The government cancelled the licences of 18 drug companies on Tuesday as part of its crackdown.
Last year the World Health Organization flagged cases in Uzbekistan and countries in Africa of children’s deaths being linked to their consumption of Indian-made cough syrups.
In the US a deadly outbreak of a drug-resistant bacteria has been linked to Indian-made eye drops. As of March, the US Centers for Disease Control and Prevention had identified 68 patients with a rare strain of an infection. Three people have died, eight have suffered vision loss and four have had their eyes surgically removed.
The US Food and Drug Administration said in a report published earlier this month that the Indian manufacturer, Global Pharma, had violated several safety regulations at its factory in Chennai, after an inspection carried out in late February and early March.
The Indian government takes great pride in calling India the “pharmacy” of the world, thanks to its manufacture of generic medicines. On Wednesday the prime minister, Narendra Modi, told a healthcare conference in Delhi: “India’s goal is to make healthcare accessible and affordable, not only for our citizens but for the whole world.”
The previous day, the WHO issued a medical alert – the third since last autumn – for a contaminated cough syrup made by a company in Punjab. It was found to have traces of diethylene glycol and ethylene glycol, which can be toxic for humans.
Experts say that India’s old, flawed and inadequate regulatory system is to blame for substandard or fake drugs.
T Sundararaman, global coordinator of People’s Movement for Health, said the system needs a “total overhaul”.
He said that for public companies some of the regulatory environment is working, but that the huge private sector needs stricter and more frequent regulation. “The whole system is grossly understaffed and underfunctional,” he said.
One key flaw, he added, was that the responsibility for drug quality is fragmented. The federal government is responsible for some aspects, the state governments for others.
“This fragmentation and division is responsible for companies and safety standards falling between the cracks. The whole regulatory apparatus needs to be massively strengthened. Only then will there be trust in India’s medicines,” Sundararaman said.
• This article was amended on 27 April 2023. An earlier version was wrong to say that Abbott India’s hypothyroidism drug Thyronorm appeared on the March list, and that it had recalled an affected batch. Abbott India is not on the list; a spokesperson said the company had made one voluntary recall of Thyronorm, due to a labelling error on the dose strength.
