19 October 2019
A few decades ago, a poor man in India, suffering from tuberculosis is prescribed a tablet of antibiotic costing about a Dollar, to be taken after his meal. The problem was that the man earned only a Dollar a day, and the dilemma was whether he should have his meal or the medicine. This was perhaps the case with most poor patients not only in India but in most developing nations. Health care was elusive, and if available, prohibitively expensive. Today, most lifesaving prescription drugs that are priced in Dollars in USA cost the same but in Rupees in India. (1 USD = Rs 71 approx. One can imagine the cost differential and affordability of generics developed by Indian pharma companies.) While the argument for protecting Intellectual Property is tenable, the fact that science should serve the overall good of humanity, especially the diseased and downtrodden, was at the core of Gandhiji’s thinking.
The situation was no different in USA, where branded drugs, were prohibitively expensive. The Hatch-Waxman act of 1984 was a landmark legislation that enabled low cost, high quality generic drugs, that brought healthcare closer to humanity. Till this point, I too was a champion of generic drugs, till I read this book.
What if the low-cost generics are also low in quality? What if these drugs lack efficacy and are ineffective in curing the disease? What if the drugs contain impurities that are hazardous? What if these drugs are counterproductive, and result in patient deaths? What if poorer countries that have higher need for life saving drugs are shipped the worst quality of drugs? A nightmare indeed, even if a fraction of this is true.
Now, what if these substandard drugs are manufactured in India, our homeland and exported worldwide. Personally, I felt ashamed and simultaneously angry, after reading page after page of unscrupulous factories of fraud, run by unscrupulous owners and managers, who profiteer at the expense of global health, and national pride. This book not only open our eyes, but gives sleepless nights, with a gripping narrative of what ails the generic pharma industry in India.
This book brings out company wide cultures of cheating, that is mentioned as ‘Indian Culture’ and ‘Jugaad’. Frauds are often cases of individuals gone astray. But here we find entire companies, in collusion with the regulators and bureaucracy. It appears to be a disease that has eaten into the entire system. ‘Everyone does it’ is a common excuse that we often hear from those who willfully violate the law. In addition, the culture of meek deference to those in authority, with fear of reprisal, isolation and even threat to personal safety keeps prospective whistle-blowers at bay. Hence, the ‘Chalta hai’ attitude becomes ubiquitous and keeps thriving profitably.
What is also shocking is that the FDA of United States, is not only seemingly understaffed and overloaded to stop this menace through stricter surveillance, but here too, the collusion between capitalists, politicians and bureaucracy renders it a paper tiger in most cases. The agency is under pressure to approve generics to avoid shortages. Evidence suggests that there were more than 100 cases of dilution of inspection reports from a stricter OAI (Official Action Initiated) to VAI (Voluntary Action Initiated) by FDA. So much about concern for patient safety at the agency meant to be the custodian of the law.
When India has embarked on a new phase of economic transformation and growth through ambitious initiatives like Make in India, this book comes as a shocker. Even if the contents of the book are not entirely true, it is safe to assume that the situation needs to be addressed at the highest level in Government with a strong political will to enact appropriate legislations to crack down on malpractices, protect and reward whistle blowers and usher in world class processes. Let us work to make India great again.
What stands out in this book is relentless pursuit of truth, the courage of conviction, flawless character and endurance under severe stress, of whistle blower Dinesh Thakur. At the USFDA, Peter Baker and Debbie Robertson stand tall with thorough professionalism and immaculate standards that uphold the core values of the organization they work for. It is these men and women who make a big difference, even at the cost of great personal sacrifice and challenges. The honest are few and far between. They always stand alone. But when history is written, humanity stands in salute with gratitude for their sacrifices, even if they are unnamed and unsung. Satyameva Jayate. JAI HIND.