On October 5, 2022, the World Health Organization issued a global alert on four contaminated medicines after they were linked to the deaths of nearly 70 children in The Gambia. The cough syrups, which had been imported from India, caused fatal acute kidney failure in the affected children in what seems to be one of the biggest death crises due to cough syrups imported from India.
In a similar story that was reported in January 2022, dozens of children, aged between two months and six years, who had received similar cough syrups in India’s Jammu region began to feel sick with vomiting, high fevers, and reduced urination after using the medicines. By the time the mystery was unraveled, no less than 12 of the children had died from severe kidney problems.
According to the WHO’s laboratory analysis, the cough syrups contained “unacceptable amounts of diethylene glycol and ethylene glycol,” substances that are only meant for industrial use in making paints, ink, and brake fluids, and are toxic to the human body. In its initial response to the WHO, India’s federal drug regulator dismissed the WHO’s report, citing that the “clinical features and the treatment received by the children as shared by WHO so far are inadequate to determine the etiology [of the deaths].
The crisis dates back to several years ago when as many as 33 children died after receiving cough medicines found to be contaminated with DEG in Gurgaon, India in 1998. In the book, The Truth Pill: The Myth of Drug Regulation in India, authors, public health activist Dinesh S. Thakur and lawyer Prashant Reddy T, note that since 1972, more than 70 people, mostly children, have died in five separate cases, from poisonings related to drugs manufactured with DEG.
The series of reports have once again exposed India’s $50 billion drug manufacturing industry. Investigations, therefore, reveal that despite reforms and mandatory checks required for both raw materials and formulations, industrial chemicals have found their way into pharmaceutical product manufacturing out of negligence and corruption.
India exports medicines to more than 200 countries and is one of the largest producers of generic drugs for the United States. More than 40 percent of over-the-counter and generic medicines sold across the U.S and about 25 percent of all medicines administered in the UK are produced in India. Further, the country contributes nearly 70 percent of anti-retroviral medicine supplies globally to fight HIV. Outside the U.S., India has the most number of drug-manufacturing plants that comply with U.S. health and safety standards.
So how can a country that has such a significant stake in global drug production be fraught with allegations of quality and lax drug regulations?
Some industry experts have cited poor regulation and quality checks as the main driver of this crisis. In a report published in The Lancet, it was found that an inspection done on Oct 7 2022 in the case of Maiden Pharmaceuticals had 12 violations of Good Manufacturing Practices, which included non-testing of propylene glycol for contamination. While the drug company declined to respond to questions about the deaths linked to its medicines in children in The Gambia, it noted that its raw materials were sourced from “certified and reputed companies,” so had a very low risk of contamination.
Mahesh Zagade, former Head of the Food and Drug Administration in Maharashtra state reported that during his tenure, he found that quality checks and measures were seldom conducted and when conducted were only “casual and perfunctory.” In another statement noted in The Lancet, Sourirajan Srinivasan, Managing Trustee, Low-Cost Standard Therapeutics noted that manufacturers often take production shortcuts in the hopes of avoiding regulatory checks both in India and the importing country, leading to mass production of poor-quality medicines.
Official reports also reveal that India’s drug regulators may be in cahoots with drug firms to thwart the regulatory processes to optimize profits. In June 2022, the Central Bureau of Investigation arrested a joint drug controller of the federal drug control agency, Central Drugs Standard Control Organization (CDSCO), and an official of a Bangalore drug firm over allegations of conspiring to influence the approval process of an insulin medicine that was undergoing evaluation.
In a recent BBC report about the death crises, India’s top drug regulator was quoted to have told a newspaper that “If I follow U.S. standards, I will have to shut almost all drug facilities,” essentially pointing to the lax regulatory framework undergirding one of the world’s largest drug producers.
In 2013, after an investigation that lasted seven years, top Indian drug maker Ranbaxy Laboratories was fined $500million in the U.S., for improper production, storage, and testing of some medicines in what is the biggest fine handed down to a generic drug manufacturing company.
Official government data reveals that between 2007 and 2020, more than 7,500 medicine products sampled in three of India’s 28 states failed quality tests and were declared “sub-standard” or inferior, Thakur noted. The drugs were found to either contain toxic contaminants or lacked essential ingredients needed for their dissolution in patients' blood. These medicines, nonetheless, have found their way into tens of importing countries, potentially affecting millions of people in some way.
A report from the Vidhi Centre for Legal Policy, a think-tank based in New Delhi, India, found that a strong factor driving the weak drug regulation in the country was the fragmentation and discordance between state-level and federal drug regulation agencies, effectively leading to non-uniformity and poor execution of drug regulatory frameworks.
While these reports do not necessarily dismiss international quality reports and assessments of many of India’s drug manufacturing firms, it exposes the dark world of poor regulations and corruption that plague the industry, and which may continue to undermine confidence and trust in India-produced medicines, and also put many patients at risk of serious health complications,
These poor metrics may potentially wear away the gains of India's medical tourism industry. Health payers and consumers may slowly lose trust in the country's medical travel offerings, decreasing inbound travel to India. In the post-pandemic era of medical tourism, trust is a major determinant, and an inability to ensure patient's safety and well-being will lower a destination's attractiveness.
The first step is for India’s government and drug regulatory bodies to identify these problems and take responsibility for addressing them. The regulatory framework for drug manufacturing needs to be overhauled to meet global standards and all drug regulators must work in sync to ensure uniformity in creating legislation and clear policies guiding drug production. In addition, all stakeholders must ensure routine and thorough quality assessments across all stages of the drug manufacturing process with clear penalties for defaults.
To restore standards and trust in its healthcare and medical travel industry, key players in the industry need to also leverage international evaluators, including Global Healthcare Accreditation (GHA), to ensure its operations are in line with global best practices. GHA is focused on rebuilding trust as the medical tourism industry recovers from the ruins of the pandemic by providing destinations and programs with the requisite tools, training, and resources to rebrand and remodel to meet evolving patient needs.
GHA offers a strategic partnership through an accreditation that demonstrates commitment not only to a high quality of care, but also to the well-being and safety of patients. To learn more about GHA, click here.