India’s dangerous medicine industry

A tragedy is unfolding in Bilaspur, India where 14 women have died as a result of complications from sterilization procedures. The use of substandard drugs is one of the reasons for the deaths.

Reacting to the public outcry, Indian officials arrested CEO of Mahawar Pharma Pvt Ltd whose products were dispensed to those that died. According to local media reports, police entered the Mahawar factory last Wednesday but left the plant open. They returned the next day to shut the factory, but not before witnesses reported seeing two men lighting a predawn fire out back.

{mosads}Reuters reported that the cinders contained medicine packets, including for Mahawar Pharma’s Ciprocin 500-milligram pills. Chattisgarh’s state government banned a batch of this product following the deaths, but rural areas appear to still have a supply.

Yet even though products were destroyed without being tested, it appears that officials have already concluded that this was a one-off incident, and prosecuting the principals in these two firms closes this chapter.

It is an abdication of regulators’ responsibility to simply ignore evidence of poor quality. Assurance of taking punitive actions against wrong-doers is not the same thing as proactively protecting public health. Our research of thousands of samples of ciprofloxacin over the past few years in 22 cities of emerging markets has found numerous falsified and substandard products, many made in India. The Indian government is aware of this research: it threatened to sue us over it. We said at the time it was shooting the messenger.

It is often difficult to prove a “causal relationship” which would stand up in court between adulterated and sub-standard drugs and immediate health outcomes, not least in India, which doesn’t really have a functional surveillance system. Effects of adulteration often don’t manifest immediately, and confounding factors make it difficult to attribute blame correctly. This case provides a concrete example of the consequences of poor quality drugs in an acute care setting: it needs to be studied, not swept under the carpet.

In February 2013, the Ghana Food and Drug Authority published a report on the quality of uterotonics (Oxytocin and Ergometrine), used to control post-partum bleeding. The results shocked us, and we’re used to such horror stories: tests on Ergometrine showed that of 99 injection samples, 73 percent failed for active ingredient and 95 percent failed sterility testing; of the 11 tablets tested, 100 percent failed; 90 percent of Ergometrine samples were made in India. This case is hard for the Indian pharmaceutical lobby to dismiss, as the testing was impeccable and crucially, the study was undertaken by the regulator of the country of the victims of shoddy Indian drugs.

The Indian pharmaceutical industry wields enormous power, and policy makers often subscribe to its point-of-view without fully appreciating the damage it is causing to the industry’s – and the country’s – reputation. Since the Ranbaxy scandal, 15 Indian companies, all household names for drugs that Indians buy at the local pharmacist, have been cited by the US FDA for poor “data integrity”, i.e., they faked the testing data to secure US FDA approval to sell their product in the US market. All this while, the Indian regulator, CDSCO continues with business as usual. It is hardly a surprise therefore, that small-time manufacturers whose drugs are suspected in this tragedy get away with murder most of the time when the large and seemingly reputable Indian manufacturers indulge in such data falsification.

India’s drug regulation is weak and outdated; it is based on a law from 1940. It treats its pharmaceutical industry as if it were a cottage industry, where employee lunch is stored in the same refrigerator as clinical samples. While “homespun” goods are culturally virtuous in India, and played an important role in the struggle for independence, medicines are highly technical products and require greater skill and control to manufacture them safely. Adherence to established processes and diligently recording and testing manufacturing steps provides an assurance of quality; brushing it aside as “documentation issues” provides a cover to unscrupulous actors who take advantage of an already fractured regulatory system.

The regulatory mechanism in India that governs drugs needs immediate attention: Responsibilities for manufacture and distribution are fragmented between national and state regulators; there are no consistent standards; the CDSCO needs a leader with unimpeachable integrity, and international experience, will preferably be a medical doctor who brings fresh thinking to regulatory oversight and puts patients first, not a politically-appointed bureaucrat. This position needs to be free of industry influence and roles, responsibility and accountability need to be clearly defined. Without these changes, we cannot be sure drugs made in India are safe.

India is aggressively courting international partners to invest in India through its newly launched “Make in India” campaign. Yet it refuses to acknowledge that its lax quality standards are partly the reason why many of its indigenous pharmaceutical manufacturing facilities thrive. The prevalence of two sets of standards, one for facilities manufacturing medicines to be exported to regulated markets like the United States and a different one with lower thresholds for sale locally in India and export to third world countries is a direct consequence of the policies implemented over the last two decades. Unless it accepts international standards and enforces compliance with them consistently, global pharmaceutical companies will find it difficult to justify making investments in India when they will be at the mercy of a corrupt and incompetent national drug regulator as the Indian Parliament has called CDSCO in the past. 
 
Thakur is the executive chairman of Medassure Global Compliance Corporation. Bate is the author of Phake: The Deadly World of Falsified and Substandard Medicine. Attaran is a professor in the Faculties of Law and Medicine at the University of Ottawa.