Almost a decade after Ranbaxy’s guilty plea before a federal court in the United States to seven counts of criminal felony, the Indian pharmaceutical industry continues to be dogged by quality issues in its export markets. Unlike the Ranbaxy case, which the Government of India tried to explain away as both a documentation issue and a conspiracy by Big Pharma to defame the Indian pharmaceutical industry, the deaths of 66 children in the Gambia due to adulterated ‘Made in India’ cough syrup cannot be brushed under the carpet.
Separate and apart from high-profile cases like the Ranbaxy plea, the suspension of market authorisation for over 300 drugs in Europe whose approval was based on suspect clinical data from an Indian CRO, or the deaths in Gambia, there has been a steady stream of complaints over the years from countries such as Vietnam, Sri Lanka, Ghana, Mozambique, and Nigeria over the quality of drugs being exported by the Indian pharmaceutical industry to these countries.
Coincidentally, we discovered the name of Maiden Pharmaceuticals, the company that allegedly manufactured the cough syrups behind the tragedy in the Gambia, as one of the 39 pharmaceutical companies blacklisted by the Vietnamese government in 2014. The government is aware of these complaints, as evident from the minutes of meetings of the Drugs Consultative Committee (DCC), and replies by the Ministry of Health to requests for information under the Right to Information Act, 2005. The problem, however, is that the government is never transparent about what remedial measures it has taken to address these complaints.
Instead, it often obfuscates, deflects or threatens academics who speak about the issue. For example, in 2014, a group of American and Canadian academics published a study claiming that the Indian pharmaceutical industry was more likely to sell sub-standard drugs in the poorly regulated markets of Africa than in the slightly better regulated markets of middle-income and emerging economies. The study was based on samples drawn from these markets and tested in laboratories on various quality parameters. Instead of engaging with the authors, the Indian Brand Equity Foundation (IBEF), which is run by the Ministry of Commerce, threatened to sue the academics for defaming the Indian pharmaceutical industry.
An example of deflection is the response of the government to complaints from Nigeria about substandard medicine. In a RTI response to us in 2015, the government simply deflected these concerns by claiming that the drugs were counterfeit and not manufactured in India — a common excuse trotted out by the Indian industry whenever their products fail testing on quality parameters. The RTI response was silent on details of the investigation that led to this conclusion.
Similarly, when it came to the response to the issues raised by Vietnam, the government in its RTI response in 2015 claimed that a high-level delegation of the government was sent to Vietnam, and that the delegation proposed to the Vietnamese authorities that they put in place a pre-inspection agency for all export consignments before they leave India for Vietnam. By any measure, this was an absurd suggestion since it never addressed the root cause of the issue highlighted by Hanoi of poor-quality manufacturing in Indian pharmaceutical companies.
The official response to the deaths of 66 children in the Gambia isn’t any better. The ministry has put out vague if not misleading statements. For example, it has confidently claimed that the company was licensed only for export, and not domestic manufacture. This is simply not true. After all, we have concrete proof that the company was selling its products in India, because it was found to be failing quality tests by various state drug regulators.
The government has also claimed that the cough syrups responsible for the tragedy in Gambia are not sold in India. What this statement hides is whether the company used the same batch of contaminated excipients to manufacture different brands that are sold in India? This is precisely what happened with the 2020 DEG poisoning event in Jammu. The company which made the original cough syrup that caused the deaths in Jammu was also accused of making a different brand which was the cause of the death of a child from Baddi, some eight months later. The government cannot be handing out clean chits without making the investigation reports public.
All the above responses are reflective of a ‘babudom’ that is reluctant to conduct transparent investigations, or tighten the regulatory screws, lest it slows down the growth of the pharmaceutical industry in a political climate that demands greater ‘ease of doing business’. It is unlikely that our trading partners in Africa or Asia will ever forgive us for the deaths of these 66 innocent children. At the very least, we owe those bereaved parents honest answers on why the Indian system failed to prevent the export of these adulterated drugs.
Dinesh S Thakur and Prashant Reddy T are co-authors of ‘The Truth Pill: The Myth of Drug Regulation in India’. Twitter: @d_s_thakur, and @Preddy85. Views are personal, and do not represent the stand of this publication.