How reliable is the ‘pharmacy of the world’? Not for the first time, the safety of the Indian pharmaceutical industry is under discussion. The World Health Organization (WHO) warned earlier this month about four cough syrups produced in India. The manufacturer, Maiden Pharmaceuticals, claims that these drugs are only made for export and sold them to The Gambia – where they have now been linked to the deaths of 70 children. On Thursday, Indonesia decided to ban cough medicines from India. The cause is the death of 99 children, who are said to have died after drinking a syrup from the country – in this case not Maiden Pharmaceuticals. Both the children in The Gambia and Indonesia died of acute kidney damage, possibly caused by toxic amounts of diethylene glycol and ethylene glycol in the cough syrups. Indian authorities have forced Maiden Pharmaceuticals to cease production. “That does not mean that the problem has been solved,” sighs lawyer Prashant Reddy T., who has just joined a coffee shop in New Delhi. “It is not clear whether Maiden has only stopped production of the four drugs found in The Gambia. Other brands may still be manufactured for sale in India. Perhaps the bad cough syrups are still available in other pharmacies. The product has not been recalled, so similar cases may still arise.” Reddy T. calls such a lack of clarity typical of the Indian pharmaceutical industry. He co-authored a book on the sector’s lack of oversight with chemical engineer Dinesh S. Thakur, an advocate for better public health in India. The Truth Pill: The Myth of Drug Regulation in India came out this month . “An awfully coincidental timing,” Thakur agrees, given the fatal incidents in The Gambia. “It is illustrative of what we are describing: enforcement and supervision are flawed.” Exporter of medicines India is the world’s largest supplier of generic, cheaper, pharmaceuticals . In terms of volume, India accounts for 20 percent of the global supply of generic drugs. The export of medicines was worth more than 24 billion dollars in 2020, the Indian central bank has calculated . The country has about three thousand pharmaceutical companies , which operate more than ten thousand factories . The pharmaceutical industry accounts for about 2 percent of GDP . The chemical industry, which also includes the pharmaceutical industry, is expected to be worth $304 billion in 2024-25. Poor supervision In their book, the two cite similar events. In the urban district of Gurgaon, close to New Delhi, 33 children died in 1998 from contaminated cough syrup, and in 2020 the same happened to 11 children in northern Jammu. Technically, cough syrup is a tricky product, explains expert Thakur. To make syrup from the active ingredient, a chemical solvent is needed. This entails the risk of contamination or use of the wrong, dangerous substance or the wrong dose. The fact that the drug is intended for children, a vulnerable target group, makes it even more risky. “All things that a manufacturer must take into account. Because an error can always creep into the production process, the producer must – also according to Indian law – build in a method to discover those errors.” But that doesn’t happen, say the authors. On paper, the Indian pharmaceutical industry and regulatory bodies follow the processes recommended by the WHO. Anyone wishing to market a medicine must have a good quality assurance system in place. A specific certificate is then required for export. Thakur and Reddy T. know that regulation is not a sexy subject. But it is necessary to understand the paper reality. Thakur: “Anyone can submit a form. But how do you verify that a company really does what it is supposed to do, and that the form is correct?” The chemist explains that the control of the production of medicines and the issuance of the export license in India is done by different authorities. The national government issues the export certificate that the WHO recommends for the sake of clarity. But actual oversight of the factories in federal India rests with 36 regional authorities. As a result, at least two bodies are involved in the supervision of the same manufacturer. Reddy: “In practice we see that there is too little communication within the Indian government. There is no coordination between the different authorities, even if they have the same task.” No exchange Inspectors in the different federal states do not exchange information either. There are countless, ‘separate’ databases with reports of audit visits to the three thousand companies that together operate ten thousand pharmaceutical factories. Even if such a check is negative, it is not shared at the federal level. Maiden Pharmaceuticals has also received negative reviews from an inspector before, Indian media reported in recent weeks. State authorities have already decided not to buy any more products from this company. But there was no national decision, a formal punishment or fine. The WHO export form is intended as a ‘proof of guarantee’ for countries that purchase medicines elsewhere. That is useful for poor countries; The Gambia, for example, does not have its own facilities to test imported medicines. Samples of the Indian cough syrups had to be tested in foreign labs. The WHO asked Maiden Pharmaceuticals for guarantees for quality and safety of the offending cough syrups, but has not received them. For example, it remains unclear whether the company had the required export licenses. Control in India The authors of The Truth Pill are also critical of the way pharmaceuticals are controlled in India. That control focuses on products rather than the production process. Officials of the federal authorities buy medicines and test them – more or less randomly. Thakur: “You can only guarantee consistent quality by consistently checking the process itself. If you only look at what comes out, on the basis of a pack of medicines you have bought yourself, then you do not have that guarantee. In the system I miss the realization that this method puts patients at risk. The regulator should not look at whether companies ‘pass’ the test, but whether users are safe.” Criticism of India’s flawed regulation is dismissed as conspiracy thinking to play into the hands of big pharma and the West It is not only unwillingness, incompetence and lacunae that characterize control and supervision in India. The problems in Gambia have certainly also involved negligence, according to lawyer Reddy T., both at the state and the central government. He and Thakur believe that their country has a “moral obligation” to African countries. After all, they often rely on Indian suppliers for generic, cheaper medicines. “I haven’t seen a single apology yet,” Thakur said. “That won’t come either,” Reddy T responds. Attack In fact, criticism of India’s drug production often leads to a fierce response from the government, which sees it as an attack on the nation. Under Prime Minister Narendra Modi, the industry grew explosively. The vast majority of drug manufacturers produce for foreign countries, and India presents itself as a cost-effective purchasing alternative for third world countries. Criticism of the inadequate regulation is dismissed as conspiracy thinking to play into the hands of big pharma and the West. While researching their book, the authors found that MPs lobbied against enforcing strict quality standards, because that would penalize small and medium-sized pharmaceutical companies. Reddy T. points out a reluctance to improve the system: “Nobody from the government, not an official from the authorities involved, has commented on the Gambian case. Prime Minister Modi, who usually has something to say about everything, has not tweeted yet.” The national license provider, the Central Drugs Standard Control Organization, also kept quiet. There was no response to questions from NRC . Two days after the conversation with Reddy T. and Thakur – and shortly before the publication of their book – the authors did receive an admonishing letter from this agency. If they were to repeat their criticism, legal action was imminent. “The fact that the focus is so much on image damage for companies and not on public health shows what is wrong in the system,” says Thakur. “Now that the problems are occurring outside India, there is attention. But if the government had taken action after the previous cases, there would have been fewer deaths.” A version of this article also appeared in the newspaper of October 22, 2022