India must save the reputation of its pharma industry

It has now been a year since a ‘Made in India’ cough syrup was linked to the deaths of over 70 children in the West African nation, The Gambia. Since that tragedy, there have been several accusations from across the world, ranging from Uzbekistan to the United States, from Sri Lanka to Cameroon. Each of these countries has accused ‘Made in India’ medicines of causing deaths, blindness and severe injury to their citizens.
 

Separate and apart from these tragedies in foreign jurisdictions is the fact that Indian doctors protested against a new rule introduced by the National Medical Commission (NMC) mandating that all doctors write prescriptions with only the generic names of drugs and not brand names. The reason for the pushback was the apparent lack of faith amongst doctors on the quality of all generics sold in the Indian market.
 

When both our trading partners and our own doctors raise questions about the quality of medicines we make, what is the government doing to assuage these valid concerns? I suspect the government has failed to understand the underlying structural issues plaguing the current Indian approach to drug regulatory reform. Without the correct diagnosis, there cannot be any treatment leading to a cure. 
 

Export only after testing
 

Take, for example, its response to the cases of adulterated cough syrups causing deaths in India’s export markets. The most likely reason for these deaths is that manufacturers of such drugs often lack qualified personnel and equipment to conduct mandatory tests for adulterants such as diethylene glycol.
 

The answer should have been to conduct rigorous inspections of all facilities manufacturing cough syrup in order to examine whether they have the right testing equipment and qualified personnel with appropriate training and rigorous processes to operate the equipment. But this apparently never happened. Instead, the Ministry of Commerce, which has no role to play in drug regulation, announced that it was introducing a new rule under the Foreign Trade Act, 1992 mandating testing of all cough syrups meant for export at government-run laboratories. Not only does this rule not fit within the regulatory logic of the Drugs and Cosmetics Act, 1940, which requires manufacturers to conduct such testing before they ship the product, it also fails to tackle the issue of adulterated cough syrup causing deaths within the country, like the case in 2020 of the 12 children from Jammu who reportedly died after consuming adulterated cough syrup. Mandatory testing for only exports will not rescue future Indian patients from adulterated cough syrups and their lethal consequences.
 

The revolt against the NMC rule
 

Similarly, the pushback by Indian doctors against the new NMC rule on mandatory generics demonstrated the lack of faith amongst doctors in the government’s claim that all generic medicines manufactured and available in India are therapeutically equivalent to each other and hence can be interchangeably prescribed. Apart from the public health implications of generic medicines not performing as well, the lack of faith in the quality of all generic medicine available in the Indian market has direct implications on the price of medicine since the lack of faith likely means that patients in India are not benefitting from competition between different brands of generics.
 

The doctors’ rejection of the NMC rule should have rung alarm bells within the government about the quality of Indian generics. Instead of getting to the bottom of the matter, the government simply put the new rule into cold storage, while a similar mandate issued by the Directorate General of Health Services to government doctors continues to be in effect. Without any attempt at educating the general public on the reasons underlying the opposition by doctors to the new rule, it will be difficult to address the lack of confidence amongst Indian doctors in ‘Made in India’ generic medicine.
 

New legislation falls short
 

The failure to understand underlying issues plagues even a serious policy exercise like the new Drugs, Medical Devices and Cosmetics Bill, 2023, which was first advertised last year in July as a replacement to the colonial-era Drugs and Cosmetics Act, 1940. The draft legislation, too, does not address burning issues raised by the government itself in the past.
 

For example, a core issue dogging the regulation of the pharmaceutical industry in India has been the lack of a centralised regulator. As per current law, domestic manufacturing of most categories of drugs is licensed by state drug regulatory authorities and not a central regulator. As a result, the quality of drug regulation and, therefore, medicine varies widely across states in the Union.
 

The government’s own expert committees, in 1954 and then again in 2003, have recommended the centralisation of the licensing function in order to promote consistency in regulation across the country. Yet the new legislation proposed by the central government does little to address this fundamental issue. Similarly, the new Bill ignores a proposal contained in one of its earlier draft legislations from 2013, which sought to give the national drug regulator an independent corporate character like other regulators such as the securities regulator (Sebi) or the food safety regulatory (FSSAI). Such an administrative setup would go a long way in improving administrative dexterity of the drug regulator by allowing it to hire and retain specialised skills needed.
 

If the aim of the government is to go beyond jugaad or showpiece reform, it needs to have a serious internal reckoning on a host of issues affecting the quality of ‘Made in India’ medicine. While public health concerns are at the front and centre of any policy exercise of quality of medicine, there are also material consequences to reputational damage caused by ineffective regulation. The US, which is the largest market for us, is investing heavily in onshoring pharmaceutical manufacturing in light of decades’ long warning letters to Indian manufacturers highlighting quality lapses. Likewise, the nations in Africa are also considering building capacity to manufacture vaccines and drugs locally and not be dependent on the “pharmacy to the developing world”. India must save the reputation of its pharmaceutical industry before it is too late. 

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The writer is the co-author of  The Truth Pill: The Myth of Drug Regulation in India