In December 2022, the World Health Organization linked Indian-made cough syrups to the acute kidney failure and deaths of 66 children in the West African country, The Gambia. WHO’s laboratory analysis said the cough syrups contained “unacceptable amounts of diethylene glycol and ethylene glycol,” chemicals often meant for industrial use.” WHO called for manufacturers to check the quality of medical products to prevent this from happening. Shortly afterward, Indian authorities shut down Maiden Pharmaceuticals in the Northern Indian state of Haryana, near Delhi, where the medicines were manufactured. At the time, NPR spoke about the issue with Dinesh S Thakur, a public health activist, and lawyer Prashant Reddy T, authors of The Truth Pill: The Myth of Drug Regulation in India. In this follow-up interview, we examine official responses to this and other cases and check back with the authors for their perspective. Here are five takeaways.
Indian pharma is still a huge force.
In spite of the Gambia controversy and other cases of allegedly toxic or ineffective medication, the industry is thriving. India’s drug manufacturers account for 20% of the global demand for drugs and 60% of vaccines used worldwide. Its biggest success story has been in the export of generics. A generic drug has the same chemical components as well-known branded medicines but can be sold at a much cheaper rate after the patent for the higher-priced branded drug expires. Sales of these generics currently account for 70% of India’s export revenue that it earns from pharma.
“Year on year, the Indian pharma industry has grown and there are no signs of slowing down,” says Prashant Reddy.
Over the past year, additional made-in-India drugs have come under fire.
Since October 2022, the World Health Organization has issued 6 medical alerts for contaminated syrups and estimates that 15 Indian companies are involved in their distribution. Investigations with India’s Central Drugs Standard Control Organisation are ongoing.
In December 2022, Nepal blacklisted 16 Indian pharmaceutical companies because authorities claimed that they failed to comply with the WHO quality manufacturing standards. Local agents were asked to immediately recall the medication. The Nepalese authorities said that this move came after they’d sent a team of drug inspectors to India to the manufacturing facilities of the pharmaceutical companies that had applied to export their products to Nepal; these 16 companies failed to make the cut. The companies that were blacklisted have not responded to these claims.
On August 11, in Uzbekistan, an Indian national representing the pharma company Marion Biotech, based in Noida, near Delhi, was put on trial. The Uzbekistan government accused the company of distributing contaminated cough syrup that killed 65 children in December 2022 and paying local officials a bribe of $33,000 to skip the country’s mandatory quality testing. In March, Indian authorities suspended Marion Biotech’s license after a probe revealed that 22 of the company’s products were “not of standard quality” and that the cough syrups they’d exported were contaminated. The company has denied the charges.
Such adulteration to cut costs is fairly common, the authors of The Truth Pill point out. Indian pharma manufacturers don’t test batches as vigilantly as they should, the authors say.
Propylene glycol, which is an essential chemical ingredient in cough syrups, is often contaminated with the cheaper ethylene glycol and diethylene glycol used in industries as solvents for paints, plastics and antifreeze fluid for brakes. And this can be toxic.
Then there was the issue of price-fixing.
In the US, the Indian pharma giant Glenmark admitted guilt and agreed to pay a penalty of $30 million to the U.S. Department of Justice. Glenmark was charged with conspiring with Israeli drug maker Teva to fix the price of pravastatin, a generic drug for high cholesterol. Price fixing is illegal globally because it raises prices of drugs.
But in India itself, prosecution of pharmaceutical companies is challenging.
Legal loopholes exist in India for these companies to escape prosecution.
“The Indian parliament passed a bill in the recent monsoon session [on July 27, 2023] that decriminalized two provisions of India’s Drugs & Cosmetics Act. The revised law says that those who manufacture drugs “that are not of standard quality” could escape jail time by choosing to pay fines —a paltry $200,” says Thakur.
“Reports of contaminated drugs can affect sales, so governments have a financial incentive to step in and protect the companies,” says Reddy.
Even the case of the deaths in Gambia has not brought a response from India’s government. “Gambian officials had done an investigation linking the deaths of the children to the cough medicine manufactured in India. The United States Center for Disease Control’s investigation established a strong link as well,” says Dinesh Thakur.
However, India’s Health Minister, Mansukh Mandaviya, categorically denied that the cough syrups were contaminated and that this was the cause of death. Speaking with the news agency the ANI, he said that the cause of the death was probably that the children in the Gambia were given cough syrup when they’d already been suffering from diarrhea.
The Gambia experienced severest flooding in July, and this was linked to a diarrheal outbreak. However, a WHO laboratory analysis of the cough syrups confirmed that they contained “unacceptable amounts of diethylene glycol and ethylene glycol as contaminants,” which when consumed, can prove fatal.
A new requirement to use QR codes on medication boxes to prevent distribution of fake drugs has been introduced since August 1. Critics don’t think it will help.
In March, the Indian Health Ministry asked India’s Department of Pharmaceuticals to devise a list of 300 widely used drug brands, so that they could put QR codes (a machine-readable barcode) on the boxes. The QR code would assure both pharmacists and customers that the medication was authentic and that it could be traced back to the company that produced it in case of any complaints.
“QR codes on boxes can help identify a drug and prevent counterfeiting,” says Thakur. “But the government’s own data shows that counterfeit (fake) drugs aren’t the problem in India. The bigger problem is the drugs that are not of standard quality.”
In 2016, India’s Central Drugs Standard Control Organization analysed a total of 47,012 samples of medication available in the open market. Eight samples were found to be fake — lacking any of the active chemical ingredients mentioned in the labelled drug. However, 1,011 samples were deemed “not of standard quality,” which means that they had all the active ingredients but just not in the right amounts.
The World Health Organisation isn’t likely to step in.
Asked if they would play a bigger role in monitoring the quality of drugs from India, the World Health Organisation gave this response to NPR from Rutendo Kuwana, team lead, Incidents and Substandard/Falsified Medical Products: “WHO is not an agency that prosecutes but we may liaise with law enforcement agencies if it is in the interest of protecting public health. Also, we do support countries to maintain their own high standards. We facilitate collaboration through something called the member state mechanism. This will address the issue of tackling substandard and falsified medical products in a transparent, inclusive way. We also run regional workshops/meetings to train and discuss this work. Our alerts are one way to bring awareness, support action and protect people plus our guidelines provide a framework for countries to build their own systems of cooperation.”
A lack of a global regulatory framework for pharmaceutical quality is sorely felt, the authors say, because these companies cannot be held to account for the harm they cause, either by their own governments or by a global body such as the WHO.
“The WHO says it’s voluntary compliance — up to the buyer and the seller. There are no consequences if something goes wrong,” says Thakur. “And that is a problem.”