How drug whistle-blowers in India have to fight a long battle
Since 2014, Narayan Konduru Reddy has been relentlessly writing emails to drug regulators from the US to Europe asking them to investigate the malpractices he alleged of his former employer GVK Biosciences, a leading contract research firm based in Hyderabad. According to Reddy, GVK was fudging data to pass the efficacy test of certain medicines. One of his emails landed with the French drug authorities who banned in 2015, 700 drugs — across EU — that GVK tested. This article was originally published in The Economic Times.
Reddy's actions turned him into one of the pharma industry's most prominent whistle-blowers in recent years. Sounds heroic, right? But his expose also put him on a collision course with his superiors in GVK and eventually ended his career. Reddy left the company in 2011; the company later used an alleged extramarital affair to portray him as a disgruntled employee gone rogue. He was eventually arrested under criminal defamation charges once the company found that he was sending incriminating mails to various regulators.
GVK has denied any wrongdoing. A spokeswoman said characterising Reddy as a whistle-blower is wrong. "It is only when the legal proceedings against Reddy got close to implicating him that he has taken an avatar of a whistle-blower."
Reddy is now languishing in his home town in Andhra and devotes a lot of time writing to the US Food and Drug Administration about his expose. He wants to be compensated for his troubles.
To truly appreciate Reddy's expose, one must take a look at the fraudulent and dangerous practices prevalent in India's pharma industry. According to estimates by India's drug controller, 0.4 per cent of drugs produced in India are fake, and substandard drugs account for 8 per cent of drugs consumed in India. India's Rs 85,000 crore pharma industry accounts for about 8 per cent of the global production and 2 per cent of the world pharma market. The industry exports pharma products worth Rs 35,000 crore. A study by World Health Organisation revealed that one in seven drugs produced in India is of substandard quality.
Even big Indian companies have not been able to meet FDA's quality standards. In the last two years, companies like Sun Pharma, Dr Reddy's and Cadila have all faced FDA's heat for not meeting good manufacturing practices.
That means for some time now, India has been grappling with the dreadful image of being a producer of poor quality drugs. The health ministry has announced a reward worth $55000, or around Rs 37 lakh, to those who will come forward and expose counterfeit or substandard drug syndicates, but few are biting.
It is not hard to see why. Prashant Reddy, a lawyer, says the path of Indian whistle-blowers is littered with draconian defamation laws and a regulator with a pathetic track record of holding the pharma industry accountable. "Not only is a whistle-blower liable to get sued under both civil and criminal defamation laws (and perhaps jailed), he is also unlikely to get any reward from the CDSCO because the regulator has a very poor track record of enforcement."
In other words, whistleblowers in pharma — and in other sectors — in India are not only not celebrated, they also have to struggle. Take the case of IFS officer Sanjiv Chaturvedi. As the Chief Vigilance Officer of All India Institute of Medical Sciences (AIIMS), he exposed how private clinics were selling fake medicines in AIIMS thanks to a powerful nexus between the drug industry and hospital administration.
Chaturvedi's efforts were recognised with a Magsaysay Award in 2015, but today he is running from one courthouse to another fighting with the Appointments Committee of Cabinet (ACC) headed by Prime Minister Narendra Modi over a mere No Objection Certificate that would allow him to take up a job with the Delhi state government.
"In our country being honest has become extremely difficult," Chaturvedi told ET in a telephonic conversation from Delhi. "I have been sitting at home without a job. I get my full salary and have an accommodation, but my appraisal reports have been held back," he said.
Chaturvedi has been transferred a dozen times in the last five years by various state governments of all political hues. "I was transferred for doing my job as an honest officer," he said.
Anti-corruption activists and officers like Chaturvedi have long been waiting for the Whistleblowers Protection Amendment Bill to end their agony. The bill allows public interest disclosures against acts of corruption or criminal activity by public servants. But the bill does not cover or protect employers of the private establishments. (But the bill leaves out disclosures that fall under 10 categories that relates to national security, scientific and economic interests of India.)
The bill is stuck in the Rajya Sabha, or the upper house, for approval. But activists and whistle-blowers themselves are not optimistic that the bill will help whistle-blowers though. "The bureaucracy has aimed at making an example out of Chaturvedi and they've likely succeeded in their efforts," said Prashant Reddy. Yet, Chaturvedi is grateful that he holds a government job. "If I was in private sector the minute I raise my voice I will be sacked, so thanks to our constitution as a public servant I can still raise my voice against corruption in the administration," he said.
Another good example of how badly whistle-blowers are treated in India is the turn of events that greeted the expose by Dinesh Thakur. Thakur, the former employee of Ranbaxy labs, now a part of Sun Pharma, caused much grief to his employer by exposing a huge manufacturing fraud in the company. He received $48.6 million, or roughly Rs 244 crore, as a reward from the US Department of Justice for his whistle-blowing efforts.
But in India his efforts have not even been acknowledged, according to him. Thakur has turned his attention to drugs produced and consumed by Indian citizens, but has hardly been able to make a dent.
"I tried to speak to the administration, the companies who continue to engage in this double standard but every time I came back empty. It was like breaking my head against the wall," Thakur wrote in an email to ET. "Not only did the industry lobby try to besmirch my reputation by calling me an agent of western pharma, but even the regulator, who ought to know what his primary responsibility is joined the chorus."
Thakur's motive of reaching out to the Indian administration was triggered by the response of Indian companies to the Ranbaxy incident. "I was witness to how the Indian pharma industry responded to regulatory action from the US and the EU. After initially dismissing the behaviour that Ranbaxy pled guilty to, they finally began to accept that this is a problem and their top and bottom lines were being affected if they continued with business as usual," he explains.
But the vigour with which Indian companies responded to quality Thakur notes was limited to those facilities that export to the US and EU. Nothing changed for the facilities that manufacture product for India, according to him. "Yes, the drug supply for the Americans and the Europeans has gotten better over the last few years, but what about us? Don't we deserve the same quality of medicine as they do? Is a life in India less valuable than one in America?" he asks.
It was this lack of response from the Indian health officials that forced Thakur to reach out to the Supreme Court of India with a public interest litigation (PIL) through which he challenged the working of the entire drug regulatory system in India. But to his shock, the PIL was dismissed without even a hearing. Thakur said his team of lawyers had invested over two years of back-breaking research, legal strategy and what they thought was incontrovertible evidence of how corruption, incompetence and collusion affects people who have no other means in their most vulnerable state.
Thakur might have exhausted his legal options, but he persists with his efforts to highlight how the administration has been working when it comes to giving approvals to drugs and the lack of regulatory oversight at the manufacturing facilities for drugs manufactured in India, among other things. He has taken to Twitter where almost every day he posts links to his blog that documents all the things that needs fixing in the public health system.
Are the authorities listening?
Originally published in The Economic Times