‘The Role Of The Regulator Is To Protect The Public, Not Pharma Companies’

19 Oct 2022 19 min read  Share

India’s apex drug regulatory body has threatened authors and public health activists Dinesh Thakur and Prashant Reddy with legal action for their comments about whether the agency shares culpability for the deaths of more than 66 children in The Gambia from renal failure linked to four substandard cough syrups manufactured in Haryana. As the World Health Organization advised that the four products be pulled from shelves, Thakur and Reddy told us in an interview why they stand by their opinion.

Authors of the book 'The Truth Pill' - Dinesh Thakur and T Prashant Reddy

Mumbai: As news emerged in September that “dozens” of acute kidney injuries and deaths among children below the age of five years in The Gambia, in West Africa, were linked to four cough syrups manufactured by an Indian company, the World Health Organization (WHO) issued a ‘medical product alert’ for the four “substandard products” manufactured in a facility in the northern state of Haryana. 

A laboratory analysis of the samples of the four products, the WHO said, found “unacceptable amounts” of diethylene glycol (DEG) and ethylene glycol as contaminants, both industrial compounds. By 17 October, the death toll in this latest cough syrup tragedy had risen to 70 children. On 5 October, WHO director-general Tedros Adhanom Ghebreyesus told reporters the United Nations agency was conducting investigations with the company and with Indian regulatory authorities.

On the evening of 15 October, a Saturday, as public health activists and authors Dinesh Thakur and T Prashant Reddy readied for a launch event for their book, The Truth Pill (Simon & Schuster), they received a notice from India’s apex drug regulatory authority, the Central Drugs Standard Control Organisation (CDSCO), which functions under the union ministry of health & family welfare. The notice threatened legal action for comments the duo had made, in the course of a press interview, about the regulator’s role in the tragedy in The Gambia.

Thakur and Reddy said in the interview that the central regulator could not claim it had no role to play, going on to  say there was “plenty of blame to pass along, especially in the higher echelons of the ministry of health”.

The CDSCO notice accused the authors, who filed over 400 Right To Information applications on drug regulation in India in the course of researching and writing The Truth Pill, of trying to “malign the CDSCO and the central government” and “create distrust” in the drug regulatory system.

The book, based on deep research to analyse the functioning of institutions responsible for the safety and efficacy of Indian drug supply, coincidentally opens with a retelling of multiple cough syrup tragedies in India that claimed children’s lives. It contends that there is a serious quality crisis in the  domestic pharmaceutical market that has manifested in the deaths of Indian citizens, and that drug approval processes in India do not follow exacting standards applied in other parts of the world. 

In a strongly worded response to the legal notice, Thakur said the agency, through “a brazen attack on our fundamental right to free speech”, was attempting to muzzle criticism. 

“I am shocked to find that a public functionary of your rank and stature would even contemplate extra-legal measures only to gag us from discussing the Gambian tragedy,” he said. “One would have hoped that the CDSCO would have devoted its resources to investigate the company responsible…”

Speaking to Article 14, Thakur and Reddy said they have in the recent past made substantive recommendations on restructuring the drug regulator to make it more responsive and make processes more transparent. Political will would be needed to overhaul a drug regulatory system that has  

Thakur, a chemical engineer by training, became a whistle-blower against pharmaceutical major Ranbaxy in 2004 after witnessing large-scale data fraud. His efforts led to Ranbaxy pleading guilty to violating American law before an American court in 2013, with the company agreeing to pay a $500 million in penalties. Since then, Thakur has advocated for reform of India’s colonial-era Drugs & Cosmetics Act, 1940. 

Reddy, a lawyer from the National Law School of India University, Bangalore and Stanford Law School, California, has worked in academia and think-tanks before he began to advise Thakur in his advocacy campaign.

Excerpts from an interview with the authors.

India’s drug regulator wants to stop both of you from making comments about the tragedy in Gambia where 70 children died after consuming an India-manufactured cough syrup. Would you tell us why they're unhappy with you and are you withdrawing your statements regarding fixing responsibility for the tragedy?  

Prashant Reddy: It appears that even the government doesn't know how some of these systems run, because they’ve clearly made some inaccurate statements in the legal notice sent to us. But I guess it's a part of a larger strategy just to intimidate people into not talking about it. I think what really upset them were our statements that the ministry of health & family welfare, and especially the leadership in the ministry of health, cannot evade responsibility for what's taken place in Gambia. I mean, they may not be 100% culpable, but as the ministry responsible for drug regulation in India, they do have some responsibility for that particular incident. It is a case of the government trying to muzzle voices.

Dinesh Thakur: It’s silly. We've responded and have said clearly that the government’s own drug consultative committee meeting minutes and representations made to court counter what the current narrative is. 

But the point is why a government agency is so menacing in its response. If you believe we made a mistake, have a conversation, let them know that their opinion is flawed, or that they’re barking up the wrong tree, and here's what the reality is.  How about that?

We’re just saying this is our opinion based on the information we  have that you cannot absolve yourself of the responsibility. If you disagree with that, it’s fine. But don’t bully those with a different opinion.

PR: They misinterpreted our statements. For example, we have not said that the cough syrup exported had the COPP (certificate of pharmaceutical product). We only said the facility where this cough syrup was manufactured shows up on a list of COPP-certified facilities published by the CDSCO. The Gambian regulatory law, which we have finally seen, clearly states that any imports into the country need to have a certificate of analysis or the COPP. We don’t know what  exactly Maiden Pharmaceuticals sent in this particular case, but that's something for the government to investigate. 

Do you anticipate further pushback?

PR: Yes, definitely. It’s a bit ironic because we end the book with anecdotes of some citizens who are standing up and asking for reform in drug regulatory law and the common pushback each has faced is some kind of threat of defamation action or they’ve actually been sued. In the case of bureaucrats, they've been punished with transfers to  insignificant posts. We are trying to let people know that this is a high risk enterprise. 

The 2012 Parliamentary standing committee report on the CDSCO said the ministry of health & family welfare had stated the agency’s mandate to be “to meet the aspirations… demands and requirements of the pharmaceutical industry”. Do you find that drug regulators across the world actually work on a mandate to primarily protect the patient?

DT: Never have I come across a situation anywhere in the world where the regulator says  our job is to promote the industry. I've never come across it. Only in India. 

The role of the regulator is to protect the public. That's the reason why you exist. That doesn't mean that you don't work with industry, which is an important stakeholder. But there is a fine line to draw between industry and  patients, activists, people like us, all stakeholders in the process. And the guiding principle has to be to protect the people of the country.

There are other arms of government to promote industry, whose role is to go out and bat for the companies.  

PR: There's a different department, the department of pharmaceuticals under the ministry of chemicals & fertilisers, which is entrusted with growing the pharma industry. And  you have the ministry of commerce & industry, then Pharmexcil, the India Brand Equity Foundation formed to brand India abroad, especially Indian pharma. So the drug regulator needs to get its mandate correct, which it just doesn't appear to understand, that patient safety is its priority.

How do we address such a fundamental problem?

PR: This can only be solved by a politician, maybe a health minister who reorients the bureaucracy to a new political goal. This has happened because previous  ministers have  either ignored the problem or sent a signal to the drug controller that they should ensure the industry grows.

If the health minister clearly cracks down and tells the CDSCO that the ministry wants to protect public health, and that industry’s profits are another department's responsibility, that will do it. 

DT: A  lot of what we see is lack of  political will. The proximity of the CDSCO to the minister, that person is four times removed in terms of accountability. How will you get the kind of mentoring and messaging you need in such a scenario?

When the government put out a draft bill (Drugs, Medical Devices and Cosmetics Bill, 2022) for consideration earlier this year, we went through it and made some very substantive recommendations on  how to restructure the drug regulator, raising the level of the DCGI within the hierarchy of the bureaucracy. Hierarchies matter. 

Our suggestions on how to change and restructure the administration included how to make it a lot more responsive. The ministry  should  put out all such comments they get from people like us. They should publish all of this, declare what they’re going to consider and why. That would be giving citizens a voice as well in the law-making process.

Coming back to the Gambian tragedy, your book interestingly begins with one and then more cases of cough syrup-caused fatalities. Why is this a recurring phenomenon in India?

DT: Our small to medium scale units don't have the wherewithal for compliance with what are called Good Manufacturing Practices. The larger units do, because they export to markets like the United States and western Europe. 

Even within those companies, they have dual standards, one factory  catering primarily to the export markets and another factory catering to the  local market where compliance is significantly weaker. But if you look at the kind of issues we saw, like the one in Jammu or the current one in Haryana, these are  small to midsize enterprises, they don't have the same level of compliance requirement because they primarily cater to one, Indian markets, and two, markets where regulators are not that efficient and competent such as in Africa, Southeast Asia and Latin America to largely to government buyers.

I’m saying this based on the CDSCO’s  own numbers. I believe the data is flawed, but nonetheless, the CDSCO commissioned a survey to assess drug quality.

The numbers said 3% of private drug supply and 10% of public drugs were substandard. If the CDSCO itself says public procurement in India, where the government engages in buying medicine for public hospitals and public utilities, if 10% of that is substandard, what does it tell you?

PR: Cough syrup manufacturers need to purchase industrial solvents used to dissolve the medicines in syrup form and they need to conduct a simple test to see whether the solvent is contaminated with DEG (diethylene glycol). The test is well known because the problem is well-documented in the industry. They just don't do that one simple test. They are required to do it by law.

So these manufacturers just presume that propylene glycol or whatever solvent they're purchasing from a chemicals trader is of adequate quality but we know from history that there are screw-ups when the trader is supplying the industrial solvent to the pharmaceutical company.  This very simple test is not conducted by companies and hence we keep seeing tragedies like these. 

Your book describes how despite states acknowledging that they have large numbers of drugs found to be NSQ (non-standard quality), the number of units that face prosecution is a very, very small percentage. Where does the buck stop for that?  And is prosecution an adequate solution?

PR: Prosecution is definitely a required solution. Because if any company is making a product that is harming the health or body of a patient, or citizen, they definitely deserve to go to jail just like any of us would be if we caused harm to a fellow citizen. 

Now, when it comes to these  prosecution guidelines, it's really quite astounding how this process has been in place and how it's being followed. With every law, there is some amount of prosecutorial discretion that the government has, but it's usually decided on a case by case basis based on whether the prosecutor or the investigating officer thinks there is enough evidence. 

It's quite spectacular to see guidelines specifically telling the bureaucracy and drug inspectors not to prosecute these types of cases unless it's the last resort, because what they are effectively doing is undermining the Drugs and Cosmetics Act which has been put in place by Parliament. 

This is not a mistake. This happened I think because the  industry demanded it and all these drug controllers got together, the drug consultative committee (DCC) and accepted it. 

I can't think of any other parallel under any other law in India when the bureaucracy has come together like this to undermine Parliament’s intent. Our stand is that this is clearly illegal—those guidelines need to go.

These guidelines were challenged in one of the PILs that Dinesh filed in 2016 but the SC declined to hear it.  

DT: In the book, we document how even after the government has notified its Schedule M (which includes good manufacturing practices, requirements of premises, plant and equipment for pharma products), under pressure from elected representatives in whose constituencies these small and medium units exist, they roll back some of the requirements, they have representations from industry saying some are too hard to comply with. 

This could be, for example, demarcation issues regarding keeping separate areas for manufacture of drugs and other chemicals, or use of steam sterilisers to decontaminate surfaces, those kinds of things. Thus, even after notifying our schedule M, they systematically hollow out the  regulations. This basically speaks to regulatory capture.

On the subject of Indian-manufactured generic drugs’ success in global public health/ welfare programmes, would you agree that our cheaper medicines have had a positive impact? And if regulators across the world tighten the screws, would such a success story fizzle out?

DT: That is a false binary.  To the first question, absolutely yes. 

You must watch Dylan Mohan Gray’s film Fire In The Blood (2013) which is about cartelisation by pharma firms to stop AIDS medicine from getting to Africa in the Seventies and Eighties. Indian drug manufacturers sent life-saving  medicines to Africa. That's an amazing story, an example of how the industry can do good. 

The US healthcare system today cannot run without Indian generic drugs, that’s how big the Indian generic drug industry is. But we have to understand that what we export to the US is of a significantly different standard. We comply with the US standard for medicines sold in the US. We do not comply with those same standards for the local market.  

PR: As Bottle Of Lies showed, a lot of the medicine exported to Africa also was on the basis of fabricated data. Even the medicines that went there, God knows how many of them actually worked, because as Katherine documents in her book, there were several complaints from doctors, including from MSF, that a lot of the medication just didn't work.  

We’ve seen a small flurry of books on the malaise in medicine manufacture –  Katherine Eban’s books, one onf rogue chemists peddling Novel Psychoactive Substances (NPS), others on anti-depressants and more. So if there is worldwide consternation at a culture of fraud, corruption and deception in the pharma  industry, surely some transnational regulatory steps have been taken?

PR: That is one of the problems—we globalised trade without having a globalised system of regulation. The WHO is barely involved in what is happening on the regulatory front unless countries specifically put in requests with the WHO  for assistance in inspecting pharma plants in other countries. 

So there is nothing international. 

The only thing the WHO has is, which is what the CDSCO is fighting with us over, is  a legal framework through which countries can certify their exports through Certificate of Pharmaceutical Products (COPP). But the WHO doesn’t play any role in ensuring that all the players are sticking to the rules. It’s left to  each country to self regulate, that’s how this operates. That is the problem with globalisation, you’ve opened up your borders, trade is flowing, but you've not created a system of regulation, a binding set of rules that regulate how safety standards are implemented across the world,

In India we rarely know much about the manufacturer or quality of a drug. With low levels of education people may not even be aware of expired products. What is your advice for citizens and patients?

PR: There is unfortunately not much that citizens and patients can do individually to cure the situation. Our simplest suggestion so far has been to increase transparency in the system. For example, like a simple database, where you can check the track record of a company by looking at its past inspection reports, the number of times its products have failed quality testing. That would be one way to empower citizens. 

In the comments we gave on the new draft bill too, we asked the government to ensure that information is available to citizens, and that legal pathways are available for citizens to challenge regulatory decisions without having to go to court. We have a right to participate in some of these decisions, just like, for example, the public hearings in an environmental impact assessment.

We need to democratise drug regulation. We just can't hand it over to a bunch of bureaucrats and expect them to do the job. Until we have more transparency, there's really nothing that individual citizens or patients can do to try and rectify the situation.

DT: Even during Covid, if you look at all the drugs that were approved, there was very little by way of transparency. A lot of decisions were made behind the scenes. Even when asked to disclose the basis on which some approvals were granted, they  kind of dilly-dallied and obfuscated until somebody asked a question in Parliament. Even so, what they put out is so little, how can anybody, even well meaning people, engage with them if they don't tell us how they’re working?

Transparency is really, really important. If nothing else, the first step is to enable people to ask questions. As Prashant said, we must democratise this process because at the end of the day it affects all of us. Why is drug regulation a state secret? If they’re approving medicines based on an established process of established medical arguments, then it cannot be a state secret. 

Other countries  do it—the United States publishes an assessment of all applications received. 

How do you inspire confidence among people that the regulator is doing right by you? The way to do that is by making these things transparent, telling citizens these are the processes, these are the people who are evaluating, these are the potential conflicts of interest. There are experts who have served on these committees who have a conflict of interest that was not disclosed, how is that okay?

About your role as a whistleblower, not just with the Ranbaxy story, but also now with this book, tell us why democracies need whistleblowers. What would be an ideal scheme for protection or incentivising whistleblowers?

DT: It’s not just about pharma. We live in a representative democracy in which we tell elected representatives this is the governance we want, we make laws, we want to participate in the lawmaking process. People who essentially ask questions and  demand accountability, it is very important for them to be present in the process to make the system of governance run.  

India doesn’t have a strong law for whistleblower protection. That was a big difference between the United States and India. The US actually has a very, very strong whistleblower protection law that protects people like me who try to do the right thing. In India we've seen people attacked for doing the right thing. Officials may get a ‘punishment posting’, or they take away all your powers. 

The whistleblower law  Whistleblowers Protection Act, 2014) in the books is limited to government and government entities.  

PR:  I don’t see whistleblower schemes ever working in India because trust in the Indian state is just so low.  Even if there was a whistleblower scheme, I wouldn't trust it, given how the bureaucracy works. 

Look at the notice we have received just now—we are facing an open threat from the government for an interview we have given. Why would you trust the government for anything? For whistleblower protection to work, you need to have immense faith in the state, to maintain confidentiality of information and to protect. I'm not even sure that confidentiality will be maintained in India, nine out of 10 times. 

In the Ranbaxy case in the US, Dinesh invoked the US’s False Claims Act, which basically provides financial incentives to whistleblowers and protection, to expose any kinds of fraud in public procurement of goods or services by the federal and state governments.

This is important if people are risking their lives. For example, after what Dinesh did at Ranbaxy, chances are he wouldn’t have found another job in the pharma industry, because that's how vindictive these companies can be. That’s why whistleblower schemes have financial incentives, to let people know they will be taken care of.

It’s not even a question of trust in any state agency, but just trust in the state as a whole. I don't think people who have the conscience in India to blow the whistle will ever have that trust in the state.

DT: I agree 100%. It's a sad reflection of that fact that we don’t have systems and processes in place to protect people who are trying to do the right thing.

Look at the heavy hand of the state in civil liberties with regard to the sedition law and UAPA. Whistleblowing is  a far cry from just basic human rights and liberties, and if we cannot trust the state on that, we can hardly expect to see trust in the state for whistleblowing.