Drug regulatory structure is not sound: Whistleblower, Dinesh Thakur

Thakur discusses the lacunae in the regulation regime that potentially places our lives at great risk

aasha

Aasha Khosa | May 6, 2016 | New Delhi


#Whistleblower   #Dinesh Thakur   #Drugs   #Health  


Dinesh Thakur, 48, first hit headlines in May 2013, when his campaign against his former employer Ranbaxy’s unsafe practices and lax quality control in its US facilities concluded successfully: the drug-maker was forced to pay $500 million to the authorities. Thakur, as the whistleblower in the case, received $48.6 million. He has since turned his energies to researching and campaigning against substandard and fake drugs. Recently, he went to the supreme court with a public interest litigation, seeking ‘a direction to the drugs and health regulators to enforce safety standards, create a framework for the recall of unsafe drugs and also an expert panel to examine faulty drug approvals’. The apex court, however, rejected his plea in March.

Your PIL was dismissed by the supreme court on the ground that you have no locus standi on the issue.

The case was reported wrongly by the media. Yes, the judge had raised the issue of my locus standi since I am a US citizen. Media reported this. However, it did not report that my counsel had explained my standing to the judge. The judge had however decided not to take up the PIL saying, “Look, this is an academic issue; we don’t have time for this.”

What are you planning next?

It’s [the supreme court decision] still fresh. I am thinking of the next course of action. But look at what was happening in the Delhi high court with the FDC (fixed drug dose) issue. Counsel for pharmaceutical companies whose products are included in the ban on 344 FDC is asking in the court how the government can ban drugs for which the regulator had already given approvals. So, the point is, the regulatory structure in this country is not sound; its implementation is not proper. The manufacturers are asking the government in the court how the central regulatory authority can ban drugs for which they have obtained permission from the state regulators. The government is clearly on the back foot in the court. In fact, the FDC issue is symptomatic of the larger malaise of poor drug regulation in India.

The supreme court raised the issue of your citizenship. There is a perception that some foreign powers are not happy with the growth of a formidable industry of generic drugs in India. Your comments?

As regards my citizenship, yes, I am an American national. But the Indian citizenship law recognises the overseas citizens of India. Besides, I am a dutiful taxpayer of this country and therefore entitled to judicial relief. In fact, I have put in a lot of due diligence in this case. But the judge had made up his mind; otherwise how can an issue that has implication on health of 1.2 billion people be an academic issue? This order has taken me two steps back.

In buying and consuming medicines, what choice a patient has after doctors prescribe these to them?

A lay person does not have knowledge about the drugs prescribed by a doctor in terms of how they work. For example, a patient goes to a doctor; gets the prescribed medicines; pops them. If he does not get well he goes back to the doctor. The doctor prescribes him the same drug from another company and he improves. Ask the doctor the reason for changing the medicine and he will tell you that he has better confidence in the other company. But from a patient’s point of view, he was made to waste money on useless drugs and also his disease got prolonged in the process.

I will give you an example. During rains, we see huge prevalence of dengue in Delhi. The doctors prescribe antiviral drugs to treat this disease. However, there have been cases where because of the substandard drugs the time for recovery has been prolonged. More importantly, we are seeing the development of drug-resistant pathogens which are a direct result of using substandard drugs.

What can be done in such cases?

There should be a system in which a doctor can call a particular telephone number and report about the ineffectiveness of a particular drug. This way, at least, we will be able to collect data. Later, based on this, either pull the drug from the market or ask the pharmaceutical company to conduct a root cause analysis of why this is so. But there is no system to monitor this in India today.

Obviously, this has a huge implication for public health.

The government is putting a lot of effort and attention into the secondary and tertiary healthcare system. What about the basic healthcare? In its absence people from far-off places are forced to go to the big hospitals to get treated. A good basic healthcare system could arrest this trend. There is no accountability, no records, no data. There are no think tanks to study and work on policy-related issues. The ongoing battle on FDCs in the high court has shown us that undoing the existing regulation is very difficult. It is very hard to fix the problem of poor enforcement of the regulation in a piecemeal manner.

So, what is the solution?

I am talking about beginning with a clean slate [on drug regulations]. We have a colonial law which governs our regulatory system. Successive governments have tried to address the gap and loopholes in a patchwork way which is the root cause of the mess we are in. The problem is that there is no proper governance or accountability of people in the system. If one looks at how TRAI (Telecom Regulatory Authority of India) has changed the telecom sector, a lot of nonsense can also be fixed in this [drug] industry. Today in telecom, the consumer is the king.

As against the TRAI, the drug regulator has got no teeth. We all do admit that the situation is grim but we also allow it to continue. Take the case of the Mashelkar committee [Report on drug regulatory issues and problem of spurious drugs by a committee headed by Dr RA Mashelkar]. It had made formidable recommendations on the problem of substandard drugs. Not a single recommendation has been implemented adequately.

Is the existing law not enough to deal with this?

Let’s look at the basis of this law that governs drug regulation in India. It’s a pre-independence law [The Drugs and Cosmetic Act of 1940]. The law was meant to deal with the prevalence of infectious diseases that time. The situation has changed now. Today non-communicable diseases like hypertension, diabetes and cancer are on the rise. Therefore, the law has to be updated and changed to meet the new requirements.

India is the largest producer of generic drugs. What is the impact of the lopsided policy on quality control on this?

Indian quality control may be lax but the world is doing its own quality check on the Indian generic drugs. As a result of this scrutiny, 44 manufacturing plants in India are not allowed to ship their drugs to the USA. After Ranbaxy was found guilty of selling substandard drugs in the USA, the US FDA (Food and Drug Administration) has clearly told these 44 plants that unless they produce quality medicines, they will not be able to sell their product in the US market. Many African countries are getting to the point where the governments are keen to protect the health of its citizens against fake or substandard Indian drugs. Countries like Ghana, South Africa and Nigeria are taking precautions while the conflict-ridden states like Congo and Sudan are not able to do so right now. The Indian ambassador to Vietnam had written to the ministry of health that there was a problem with the quality of drugs coming from India and whether something could be done about it.

What should be done?

I would like to see the government fix the law on drug regulation. I would like to see the government have a dedicated [telephone] number on which a doctor can report a suspected drug that is not working. We want a national system of drug recalls where we know that bad drugs are systematically removed from the market. We want the criminal justice system to hold the wrongdoers accountable. We also want the law to mandate that marketing authorisation to drug companies be given only after they are able to prove therapeutic benefits from their product to patients. If we want this situation to change each one has to do our bit.

How harmful are substandard drugs? Can you give an example?

Just take the example of a patient who is suffering from acid reflux or burning sensation because of eating spicy food. A doctor will generally prescribe a ranitidine hydrochloride drug to be taken half an hour before he takes food. Imagine if the concoction is substandard and it is showing only half the impact. If you continue this medicine for several months, it will leave you with a stomach ulcer. The amount of human suffering and cost to healthcare is huge. We don’t have people who can explain everything about the medicine that a doctor prescribes. Medicine, being the first line of defence against ailments in our primary health system, has to be the best.

Why are companies making substandard drugs knowing fully well the implication on humans?

The trouble is not with companies. There is something called the concept of ‘jugaad’ in India that we have grown up with. This makes us believe that if we can’t get a thing right 100 percent, we can try jugaad. The situation gets exacerbated when you do such things concerning people’s health. Ultimately, somebody in the system should think that drug manufacturing is not akin to making a bicycle. Look, what happened in Bilaspur last year when 14 women died of medicines that had traces of rat poison after tubectomy? Can medicines be kept in the same place where rat poison has been kept? Where is the accountability?

To change such a horrifying situation we all have to push our boundaries to set things right. The legal justice system has to do it; the criminal justice system has to respond to it as well. As such the legal system is so pathetic that it takes years for cases to settle. In our findings on cases of spurious drugs in the states, we have found that in six cases, punishment to the convicts was jail till the rising of court. Is this accountability for playing with human lives? We need to ask ourselves these questions.

How do you see your role in India after your role as a whistleblower in exposing Ranbaxy in the US?

I tried in the court but did not succeed. Now I am engaged in creating awareness about it and I am getting a lot of response, especially from youngsters on the social media. However, the message has to be reinforced because people’s attention span is very short.

How is the system of drug regulation in the US?

The system in the US is very strict and transparent. The justice department has sent CEOs of pharma companies like Perdue Pharma to jail for wrongdoing. In the US, the companies have a civil liability on drug quality but the individual CEOs face criminal charges for the same. Pfizer was fined $7 billion; Johnson and Johnson was fined a similar amount. Mind you, this is not for counterfeit drugs but for exaggerating the value and qualities of the same.

How effective is their whistleblower law?

I had filed a complaint as a whistleblower against Ranbaxy with the US FDA in 2007 and the case was finalised in 2013. All these years my name was not made public, like it was done in the case of Manjunath here. I was awarded a part of the fine that Ranbaxy had to pay. Despite a weak whistleblower law, I don’t see systems working so perfectly here unless we the people who care for country think beyond my party and me. We have wonderful people like Vinod Rai [the former CAG] and Justice [RM] Lodha; people look up to them.

A lot of religious and spiritual leaders have comes into healthcare product manufacturing.

It does not matter who comes into manufacturing drugs. What is important is that we have systems in place to check their products for quality. At present, we have to have systems in place; [there is] no accountability of individuals.

Have you ever felt threatened by the industry against which you have been raising your voice?

I wasn’t employed in India after Ranbaxy – one reason they could not approach me. In fact even if they wish to, they can’t harm me since I don’t live here. I can always leave (for the US) since I enjoy the luxury (of being a US citizen) that people like N Manjunath and Ashok Khemka did not or do not have. But I sincerely feel that human lives should be given importance. I recently felt shocked to see on TV the fall of the bridge in Kolkata and then people in position of accountability saying that it was an act of god. Where on earth such things can happen?

aasha@governancenow.com

(The interview appears in the May 1-15, 2016 issue)

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