Katherine Eban’s book Bottle of Lies focuses on major issues in generic drug manufacturing, using the Ranbaxy scandal as an example of unethical practices in the field. The book is written as a journal of Ranbaxy’s malpractices based on whistleblower testimony and subsequent US- Food and Drug Administration (FDA) investigation, with an occasional mention of other fraudulent companies.
The book makes three things apparent – first, while a drug is expected to work similarly worldwide, the regulatory standards for approving the drug vary. The book tells of manufacturers acknowledging that the best quality drugs are sent to the US, where the FDA is a relatively strict regulator. Countries in Africa on the other hand, do not have a competent regulatory authority, and hence, manufacturers find it easier to pass off poor quality drugs. Second, and more concerning for Indians is that while a foreign regulatory authority caught the scam at Ranbaxy, India’s own regulatory authority, the Central Drugs Standard Control Organisation (CDSCO) failed to do so. Additionally, the whistleblower who took a significant risk and undeterred efforts to bring the Ranbaxy malpractices to light felt confident in divulging details to the FDA, but not to the CDSCO. The book often references his fear in communicating with the CDSCO – fear for his own life and for his family. Consequently, distrust in the regulator prevents individuals from reporting malpractices. These three principal problems – manufacturer malpractice, incompetent regulator, and system mistrust – feed into poor-quality drugs that undermine the health of Indian citizens.
Yet these problems do not plague all Indian companies and they are also not limited to Indian companies. In few fleeting moments, the book speaks of the excellent operations at Cipla and rarely mentions the variety of scandals that haunt brand pharmaceuticals. As a case-study of the wrongdoings of Ranbaxy, the book is a must-read. But it is not an account that anyone should blindly apply to all generics or drugs made in India. A number of scandals – Avandia, 2007; Baxter Heparin, 2008; GlaxoSmithKline, 2010 – have rocked American and European pharmaceuticals. These pharma industries are also not above impunity that may be inferred from Eban’s book. But malpractices of foreign companies do not absolve Indian companies who have been accused of shoddy work ethic. So what do we actually learn from this account that can help us analyse the problem and find possible solutions from an Indian perspective?
The story brings into light three important players;
- The unethical drug manufacturer: A drug manufacturer is running a business and therefore is driven by creating a sustainable, profitable business. Unethical (not all) drug manufacturers subvert regulations to cut corners and save money, compromising on drug quality. Brand pharmaceutical companies can charge heavily for their patented drugs. Generic drugs on the other hand are relatively cheaper and the market is more competitive. In the race to deliver lower prices while maintaining the business top line, an unscrupulous manufacturer can fabricate data, use incorrect protocols and tamper with samples. The low price of the drug created with the flawed process could then drive competitors to also take shortcuts to reduce their costs.
- An inadequate regulator: May it be the FDA or our own CDSCO, there is not enough capacity to check every equipment in every manufacturing unit of every drug manufacturer. As is evidenced in the book, on multiple occasions, manufacturers were able to deceive inspectors by creating hidden rooms or fabricating safety data.
- The invisible victim: Engineering flaws that lead to car breakdowns or flight crashes are apparent and the ensuing damage is tangible However, the invisible victims of substandard medications continue to suffer without the basic cognisance of what is ailing them. They do not understand if the medication is not working because it is incorrect for their condition or if it is of poor quality.
The interplay between these players and systems creates a unique problem. The drug manufacturer has to follow good manufacturing practices (GMP). A stringent GMP requires trained staff, well-equipped facilities, and an efficient product supply chain – all of these drive up costs. In the absence of a monitoring mechanism, the manufacturer has no fiscal incentive to follow GMP. On the other hand, if caught the manufacturer risks losing their manufacturing licence for the facility. Hence, the incentive encourages the manufacturer to fabricate data to pass safety tests. Monitoring drug plants all over the country to capture fraudulent practices at all times might be a near-impossible task. Further, the absence of a redressal mechanism for consumers leads to various poor-quality drugs escaping inspection. But the current system of carrot and sticks is inefficiently laid out – creating too much work for the regulator, not incentivising the adoption of good manufacturing practices, and punishing both manufacturer and consumer when standards are not met.
Does this problem exist across the board of pharmaceutical manufacturers? Indeed, it does. But for brand pharmaceuticals, there is less incentive to do malpractice because they can make a profit by pricing their drugs at a higher price. What stops generic pharmaceuticals from charging higher prices? This is the most important point that Eban’s book does not account for. Most people worldwide are not able to access high-cost pharmaceuticals because of their price. Generic medications are required because they are low priced – Cipla’s intervention brought down drug cost for HIV retroviral cocktail from $12,000 per patient to $300, starting a health revolution in Africa. The world requires generics and by the blanket downplaying of their role in ensuring human health, Eban’s book does a big disservice to the health economy. The answer to issues in drug manufacturing is not to shut down generic manufacturers but to find a way for them to be better monitored. However, the book offers no solution or direction to achieve this.
One thing appears clear – over-regulation is not going to help. Bringing in more regulation might just push more manufacturers into malpractice. In India, we have an additional confounding factor – the government also caps essential drug prices further dis-incentivising quality drug production. Perhaps introducing a little more price flexibility to those companies that have well-established GMP processes would help. An independent entity that randomly tests drugs for quality may be more effective than having inspections performed at all manufacturing facilities. Having a well-established redressal mechanism for collating patient concerns and adverse reactions would help quickly establish a directory of suspect drugs that need to be inspected.
The nexus of healthcare stakeholders runs deep and reminds me of a discussion that a Takshashila batchmate and I had. In olden times, a doctor would barter his services with the farmer for food, with a tailor for clothes, etc. The incentive was for the doctor to keep his patients healthy – so that the farmer could grow his food and a tailor would make his clothes. The wellness of the society meant the barter system could work and keep everyone happy. In the current society, doctors make money from consumers and pharmaceutical companies who give them a cut of the prescription (along with other perks – check out the opioid crisis in America for how pharma keeps doctors happy). The current system incentivises patients to be kept ill so that they take more medicines.
Eban’s book provides excellent evidence for brand pharmaceuticals to be used against generics. But that does not take away from the fact that generics are required for ensuring global health. Regulation of generic drug manufacturing does need to be revamped to ensure bad players are caught and penalised. The release of this book and the recent allegations against Aurobindo Pharma and Lupin provide an excellent opportunity to understand the flaws in the system and improve processes. Finally, access to health is a constitutional right of Indians, and thus, providing access to quality low-cost medicines is a duty of the Indian government.