For over two and half years now, I have tried very hard to convince the Indian government to do something about the widespread prevalence of substandard drugs in the country. A recent report puts the number of substandard drugs as 1 in 7; an audit of the Armed Forces Medical Stores Depot by the Comptroller & Auditor General (CAG) shows that 1 in 4 locally procured drugs are substandard. This means that our Armed Forces personnel and their families are being prescribed significant high percentage of sub-standard drugs.

In September 2014, with great difficulty, I secured an appointment with the then Minister of Health, Dr Harsh Vardhan. A few months earlier, he had criticised the Central Drug Standards Control Organisation (CDSCO) as a “snake pit of vested interests” and had also accepted that the corrupt practices had been exposed by several authorities in the past. Dr. Harsh Vardhan went on to say “I have inherited a poisoned chalice. But a revolution is coming.” Given his public statements, I was very hopeful that he would lend me an ear; an opportunity to explain what I foresaw. Unfortunately, in the few minutes he gave me, he was more concerned with his the logistics of his upcoming trip with his assistant while I tried to hold a conversation with him. I was asked to send my thoughts “in writing” to him which I did, but I never heard back from him. Perhaps his subsequent appointment to the Ministry of Science & Technology meant I was no longer his problem. Disappointed, I tried to reach out to the Quality Council of India (QCI), which is a body setup by the Government in 1996 with the objective of creating an ‘ecosystem for quality’ in the country. The new prime minister had made a high profile appointment to head this organization; I was hopeful that if anyone understood the consequence of what the Indian pharmaceutical industry was engaged in, I thought it would be them. After a few phone calls which initially sounded encouraging, the communication ended abruptly. I never heard back from the head of the QCI for reasons better known to them. As a last resort, I even reached out to the CEO of a very large member of the pharma industry after I read of his commitment to “put things right” that appeared in the media. I offered my help in addressing the problems that his company was facing; sadly, other than a response to agree to meet, nothing ever came of it. Clearly no one seemed to be interested in addressing this public health epidemic in India.

My predictions, to both the Minister of Health and the Head of QCI have now come true. The growth of the Indian Pharma industry is slowing. This growth oriented industry which once provided job opportunities to thousands of young men and women is on the decline. The culprit for this is not just the industry, it is also the regulatory framework that provides oversight to this industry which is riddled with incompetence, corruption and collusion. The combination of an errant industry culture with a dysfunctional regulator has charted a path toward oblivion for this once thriving industry.

No industry in a free market system refrains from pushing the envelope; we see this time and time again. Regulators are often two steps behind the industry. However, when the cost of non-compliance is several multiples of the cost of doing business, it becomes a significant deterrent to companies crossing the line. On the other hand, when it is cheaper to buy your way out, and the criminal justice system is weak, companies take liberties with how far they can push. Especially in India, where we are used to find creative ways to get around what we see as roadblocks, often by taking shortcuts and using jugaad, the temptation to flout rules is very high. The fact that shoddy implementation of the regulatory framework has led to the destruction of thousands of jobs in this industry is not it biggest failure; rather its most consequential and spectacular failure is that it has never protected public health in India. Don’t take my word for it, read the 59^th report & 66^th report of the Parliamentary Standing Committee on Health & Family Welfare.

Soon after Ranbaxy agreed to pay $500 in penalties and fines to the US Government for selling adulterated drugs which I was responsible for reporting, I was called names, referred to as an agent of “western Pharma industry”, asked to go away to some tropical island and enjoy my retirement; and those are just what I can say publicly. Clearly, the Indian pharma industry sees me as an opponent, someone who is out to make them “look bad”. Nothing could be further from the truth. For the record, I have never taken a penny from the Pharma industry in the US and Europe in order to mount a campaign against the Indian Pharma industry. Unfortunately, for those who indulge in propaganda on behalf of the Indian industry, facts don’t seem to matter much.

My interest in this issue is twofold.

First and foremost, no one speaks for public health in India when it comes to substandard and adulterated medicine. Between those who care for access to medicine and those who worry about price of drugs, quality of medicine is an unfortunate orphan. Unlike a car or consumer electronics which are obvious when they don’t function as intended, a lay person doesn’t have the ability to say when a substandard drug doesn’t work (lack of effect) or worse (cause adverse events). We often rely on the word of the chemist or a prescribing physician that the medicine given will help. Bureaucrats appointed to committees with a mandate to protect public health often relinquish their duties by becoming de-facto spokespersons for the industry as was seen with the Drugs Consultative Committee (DCC) when it came to taking policy decisions on safety issues which would affect the profitability of the industry.  Our regulators have sold their soul to the industry and its financial goals. The 59^th report of the Parliamentary Standing Committee on Health had famously said, “The Committee is of the firm opinion that most of the ills besetting the system of drugs regulation in India are mainly due to the skewed priorities and perceptions of CDSCO. For decades together it has been according primacy to the propagation and facilitation of the drugs industry, due to which, unfortunately, the interest of the biggest stakeholder i.e. the consumer has never been ensured.” 

In such a situation, the least we can do is to have a dialogue about who is the guardian of public health when it comes to someone who earns 300 Rupees a day and is made to spend half of that to buy medicine in her most vulnerable state (when sick) which doesn’t work? Who speaks for the elderly who rely on good quality medicine to help them through their golden years. Who speaks for the children of this country who are routinely given adulterated, substandard medicines when they catch an infection while playing out in the evening? Sadly, despite trying to talk with the Ministry, the bureaucracy and the industry itself, I came back empty handed.

Second, many poor countries in Africa, SE Asia and Latin America rely heavily on medicines made in India for their people. And since the US FDA confirmed my allegations on how Ranbaxy functioned, they have unfortunately seen the similar behavior in the largest members of the Indian industry. I am very familiar with the arguments that are made to justify this behavior; that quality standards in India are different from what the US expects and what the European Medicines Agency did with clinical studies in India is merely a documentation problem. Unfortunately, no one yet has been able to point out where in Indian law does it say that it is ok to cheat, to destroy results from tests that fail, repeat tests until you get the result that you want, release substandard product knowingly to the market, redirect product that failed testing from the US market to India. We continue to learn of this behaviour among the biggest of our industry, just read the warning letter issued to Dr Reddys Labs last November, to Cadilla in December and to IPCA Labs last month. If the largest and most respected members of the Indian pharma industry function in this manner, what confidence do you have in the ability of the small and medium size companies to do things right? Is anyone bothered about this?

The sad part of this story is that the Indian industry has begun to correct itself, but only for manufacturing “export quality” product. Under immense pressure from the US FDA, the MHRA and EMA, they have now begun to acknowledge that they need to change. It only took them three years, but public comments from the industry lobby and the CEOs of the industry’s largest are beginning to speak consistently about making fundamental changes to their “culture of quality”. Unfortunately, if you play close attention, this change is limited to those facilities which manufacture product that is “exported” to the US and Western Europe. Clearly, regulators in those countries are doing all they can to protect their patients. What about the rest of us?

Yes, there are are two quality standards in the Indian industry, one for export-oriented “regulated” markets and a different (read “lower”) standard for domestic “less regulated” markets. And no, this is not about documentation as the industry spun its problems; it is about a culture of cutting corners. No one seems to care that the industry continues with its business as usual modus-operandi when it comes to medicine that it sells in India, or ships to poor third-world countries. We often tout ourselves as the pharmacy to the world; but that moniker is becoming ill suited fast. Not only do the US and EU don’t want our product (look at the list of import alerts for Indian pharma), we have similar complaints from Vietnam, Sri Lanka, Ghana etc. to name a few.

The last option I had at my disposal was to knock on the doors of the legal justice system. For the last year and half, my team of researchers, attorneys and RTI activists have filed over 125 RTI applications with the central and state health authorities. We were given the usual run around; our applications were transferred from one jurisdiction to another, were cited obsolete laws to justify inaction and even provided responses which while syntactically and grammatically correct didn’t answer the question we asked; they would have made Sir Humphrey Appleby proud. We received responses in local languages which had to be translated; but we persevered.  This experience gave us first hand feel for how a common man gets the run-around despite strict RTI laws in the country. Finally, after over a year, we were finally able to analyze the collective responses we received and a partial picture of a systematic well designed dysfunction emerged. The arguments that we made in both PILs are a direct result of what we learned from the RTI process coupled with our own research of how drug regulation is implemented in the country.

Today, the Supreme Court of India heard the two Public Interest Litigations that I filed back in January this year for admission. Unfortunately, the Supreme Court declined to admit either of the petitions but has given us liberty to approach any other appropriate forum for remedy. While I am disappointed that the court decision, I will continue to fight for the quality and safety of medicines for patients worldwide.

Making changes to the current regulatory system is very hard; the previous government tried twice, once in 2007 and a second time in 2013. While the amendments in 2007 tried to create a Central Drugs Authority, the amendments in 2013 sought to give the central government the sole power to regulate exports and called for centralised licensing for certain classes of drugs. Making substantive changes to the law governing this industry is next to impossible; the Indian pharma lobby exercises undue influence over policy making; it has scuttled the process both times. These PILs were the best chance to wipe the slate clean and start afresh. As we argued in the second PIL, the band-aid approach that we have taken for the last sixty odd years will only exacerbate the situation. We need to rip the current system up from its roots and start with a clean slate. I still believe this is the right approach. Doing so will bring the regulatory framework on par with internationally accepted standards and hold the regulator truly accountable for public health to the people of India. This will also help the industry in India grow again, provide good paying jobs to our young women and men.

Both Writ Petitions and their Annexures are available in the Legal section of my blog site.