In the last six months, there have been four global alerts from the World Health Organization (WHO) for “Made in India” medicine where patients have either died, been blinded or suffered adverse incidents.
Two alerts, one in October and the other in January, were for adulterated cough syrups manufactured by two different Indian companies. These syrups are suspected to have caused the deaths of up to 71 children in the Gambia and 18 children in Uzbekistan. A third alert, in December, involved a cancer drug sold in Yemen and Lebanon which was found to be contaminated with dangerous bacteria. The fourth alert, in February, was for eyedrops sold in 55 countries that the WHO recommend be removed from circulation due to quality issues.
In addition, in February, the United States Food and Drug Administration (USFDA) sounded an alert over “Made in India” eyedrops found to be contaminated with drug-resistant bacteria suspected to have caused the death of one patient and adverse events, including blindness, in a total of 55 patients in 12 states.
The response from India’s government, which generally boasts of the country being the “pharmacy to the world”, has oscillated between blaming the affected countries, conspiracy theories and typical non-action. For example, the immediate response to the WHO alert in the Gambia was to blame that country for not testing the medicine before dispensing it to patients. The health minister then claimed there was an attempt to sully India’s international reputation as a manufacturer of quality medicine.
The more grating response was a coarsely worded letter sent by the Drug Controller General of India to the WHO in December, accusing it of maligning the character of the Indian pharmaceutical industry without adequate evidence that the “Made in India” cough syrups could have been linked to the deaths of the 71 Gambian children. This was despite the fact that the WHO tests found toxic amounts of diethylene glycol and ethylene glycol in the syrups collected from the Gambia.
More recently, Gambian doctors and the American government’s Centers for Disease Control and Prevention published a study that “strongly suggests” that the Indian cough syrups caused the deaths in the Gambia.
The Indian response to the tragedy in Uzbekistan was slightly better, since the state drug regulator admitted that testing revealed the syrups were contaminated, and the manufacturers were arrested. But for a truly responsible public health-oriented response, India should have also warned other countries to whom the same cough syrup was exported to remove it from circulation. State-level Indian drug inspectors involved in the investigation, who confirmed that the company was exporting to multiple countries, have publicly expressed their concerns on the urgency of informing other countries in order to prevent further casualties.
These tragedies and the response of the Indian government raise two important issues from a global health perspective.
First, the efficacy of existing international mechanisms to guarantee quality in cross-border commerce of medicine. Created in 1969 by a resolution of the World Health Assembly, the current framework to regulate the quality of medicine is a self-certification mechanism that depends entirely on national regulatory authorities of exporting countries to issue a “certificate of pharmaceutical product” (COPP) along with each export consignment. This certificate guarantees to the importing countries that the medicine has been manufactured in a facility that complies with “good manufacturing practices” as recommended by the WHO; that all product information including labelling is authorised by the certifying country; and that the product is authorised to be placed on the market of the certifying country.
Under this mechanism, the WHO has no real authority to conduct inspections. Trading partners of countries like India are essentially at the mercy of Indian regulators to be competent at their jobs.
This is precisely why developed countries like the US and much of Europe send their own drug inspectors to India to check manufacturing facilities. Over the past decade, these inspectors have uncovered a plethora of scandals in manufacturing facilities and clinical research organisations which generate regulatory data for pharmaceutical companies.
India’s national drug regulator has mostly turned a Nelson’s eye toward all these scandals. We cannot find a single instance of prosecution by Indian authorities, despite evidence of brazen data fraud.
The knowledge of efficient foreign inspections among the Indian pharmaceutical industry has given rise to dual-track manufacturing in India. Facilities monitored by American and European inspectors produce better-quality medicine than those that cater to developing countries in Africa, Latin America and Asia who cannot afford to send their regulators to India to inspect manufacturing facilities.
It is this precise problem that needs to be solved through an international treaty if we are to avoid future tragedies.
The second issue, particularly relevant after these multiple cross-border deaths, is the urgent need for an international legal framework to allow swift cross-border investigations, mandatory sharing of information after a tragedy and a compensation mechanism for victims.
These investigations are also necessary to enable emergency public health measures such as a swift recall of contaminated medicine from the global market before more patients come to harm. There is currently no international legal framework to govern such investigations or to ensure that compensation is payable to cross-border victims.
Over the years, the pharmaceutical industry has managed to protect its interests through international treaties like the Trips agreement on trade-related intellectual property rights, which forced every country to protect patent rights of the industry. Why then has the global health community failed to use international law to hold the pharmaceutical industry liable for its misdeeds?
The writers are co-authors of The Truth Pill: The Myth of Drug Regulation in India published by Simon & Schuster
