Mumbai: Police in The Gambia are investigating the deaths of 66 children, which have been linked to their consumption of four brands of imported Indian cough syrup: Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup. These cough syrups were manufactured in India by an Indian company, Maiden Pharmaceuticals Limited, which apparently failed to provide guarantees about the safety of these products to the World Health Organization (WHO), the international health body said. The Government of India has also begun an investigation.

Maiden Pharmaceuticals has reportedly said that it was shocked and saddened over the incident, that it had followed Indian health protocols and was cooperating with the investigation. While the investigation will take time to provide a clear understanding of what happened in this case, let's try to get an understanding of the larger context of spurious drugs in India.

India's Central Drugs Standard Control Organisation (CDSCO) in a 2009 study tested 24,780 drug samples from 40,000 pharmacies and found that 644 drug samples were 'sound-alike' and 'look-alike' drugs, meaning their names or packaging could sound or look similar to branded drugs, though these were not the same drugs. The drugs themselves, however, were not spurious. Only 11 of the remaining 24,136 drugs (0.046%) were not accepted by manufacturers as genuine. The quantum of spurious drugs thus appeared small, per this sample set collected a while ago.

India, however, is the largest manufacturer of generic drugs, and therefore, it is perhaps logical that counterfeit or spurious drugs are also manufactured here, and potentially exported as well. Let's try to understand the Indian context from two points of view. First, how bad is the problem today, in 2022? And second, are doctors seeing the impact of spurious drugs at the clinical side, as patients consume these?

To find out, we spoke with Rajeev Jayadevan, former president of the Kochi chapter of the Indian Medical Association, and Nakul Pasricha, president and CEO of Pharma Secure, which works with leading pharmaceutical makers to track and verify their supply chains and ensure the authenticity of their drugs. Pasricha is also president of the Authentication Solution Providers' Association (ASPA), a non-profit based in Delhi that works against counterfeiting in India, by building authentication eco-systems.

Edited excerpts:

Mr Pasricha, when we talk about spurious drugs in India, what are we talking about?

NP: That CDSCO study you quoted was the first such comprehensive study that was done in India to measure the extent of spurious and substandard drugs. That study was conducted again, as an update, in 2015. The outcome was similar, where they found about 0.3% of drug samples to be spurious and about 3% to be substandard. However, other studies have been done, including a comprehensive study around the world by the WHO in 2018, which found one out of every 10 drugs sampled [in low- and middle-income countries] to be spurious (which they call falsified), or substandard. So, it is a tremendous problem. Other estimates are as high as 20%, or 30%. ASPA conducted our own meta study, where we just looked at reports of incidents of spurious or substandard drugs in India, and at the number of such reports across the country. That number jumped by 47% from 2020 to 2021, which is the last year for which we have data with us. So, this problem has been brewing. And it is a problem that I believe has been, at least domestically, not given the importance and the attention that it needs in order to save patients' lives.

What does that translate into, let's say in terms of the number of samples in any study?

NP: We didn't do our own sampling. We just looked at the media reports of such incidents that were coming out independently, where it had been discovered, catalogued and reported that spurious or substandard drugs were being sold in the market. Just by that number, you can see that the percentage is increasing. To get an accurate number across the length and breadth of India is, of course, a big challenge, which is why the CDSCO study stands there. There have been other researchers that have come to India and conducted studies and found up to 10% of the samples that they checked were substandard. But it's been over a decade since such a study was done.

When you say 'spurious' and 'substandard', do these terms go together? Or is there a distinction between the two?

NP: That's right. This problem is very important. It used to be that you would just call [spurious drugs] counterfeit. But counterfeit as a term can also be mixed up with the intellectual property rights issue, which is well documented. So, 'spurious' really means a drug that is falsely labelled, to position it or represent it as being made by a genuine manufacturer. It will often not have any active pharmaceutical ingredient in it, it will not be effective, and it will be something that is intended to deceive the buyer or the patient. 'Substandard' is something that typically will be from the manufacturer that it claims to be from, but may not have the right quality of or enough ingredients, so its efficacy is under question.

Dr Jayadevan, what do you think about the issue of spurious or substandard drugs in India today?

RJ: For our readers, I think we must break these technical terms down because 'spurious' is not a word that is commonly used in India, outside of technicalities. So, I'll explain this with a simple example. Here's an envelope that says [it contains] Rs 100. Now, suppose this envelope contains only Rs 50 instead of Rs 100, then it becomes a [Category B] 'substandard' product, which means the product promises to deliver Rs 100 but contains only Rs 50. Now, sometimes this envelope may contain nothing at all. Then, that is called Category A 'spurious', which means, the product has Rs 100 written on it, but it contains nothing. And then, the third Category C is when the Rs 100 note itself has some imperfections, it may be torn, and so on. In other words, spurious simply means that the product does not come up to the standard. It can be a completely fake, or nakli product, or it may be something that does not have all that it promises, or it has minor irregularities. CDSCO has classified this into A, B and C – A is absolutely nakli, B is the Rs 50 rupee example and C will be the torn Rs 100 note. That is a gross oversimplification for readers.

Let's consider a medication. Say you go to the doctor, who gives you a prescription. You go to the pharmacy and buy the antibiotic. If the antibiotic doesn't contain the antibiotic, then your treatment fails. Or, the antibiotic dose is 100 milligrams and the tablet you get contains only 10 milligrams, you may partially improve, but it may create other problems. The doctor may then give you another, stronger antibiotic because he believes [there was] treatment failure, and that may induce what is called antibiotic resistance. We often hear about antibiotic resistance, where these bugs don't get killed by routinely used antibiotics. That's a big problem that doctors are trying to counter.

You asked me where this issue of spurious drugs fits with current day practice. Healthcare delivery is a long chain. It's not just a doctor, or medication, that's involved. Healthcare delivery starts with a patient who approaches a healthcare provider, say a doctor or another qualified person, who makes a diagnosis and decides that the patient needs medication. The prescription gets written out, the patient takes it to the pharmacy, it gets dispensed and the patient takes it. That completes a simple circuit. But, a chain can break at many levels. The doctor himself or herself might not be well qualified, or has a fake degree. Fortunately, that doesn't happen very commonly. Second is the institution that the doctor is working at might not be maintaining standards. Third, the medication that is dispensed to the patient might not be of top quality. So these are all areas that are continuously worked upon in terms of quality improvement.

However, as Nakul said, I believe that overall the situation in India is getting better over the years, as more regulations are coming in, transparency increases and more reporting occurs. There is one more point I would like to raise. Just because a problem is being reported more, that does not mean it is becoming more common. In fact, it may be the opposite. If we start hearing about fake drugs, it might be a good thing. It might be a sign that authorities have started checking more and more. I think readers must take this in perspective as well. There is no excuse for a spurious drug at all. It must be zero. We know zero is ideal so we must keep [spurious drugs] as close to zero as possible.

Dr Jayadevan, on the clinical side, what have you seen? An extreme example is this case in Gambia, the most unfortunate part being that the children may not have been able to resist a spurious drug, which an adult may have suffered from but not succumbed to.

RJ: Yes, what happened in Gambia is so tragic. I believe a full investigation report is awaited, but the preliminary information is that [there were] contaminants within these cough syrups along the lines of diethylene glycol, which is a kidney toxic agent. It's like, if I make pickles with poisoned chilli powder and sell them, I might not know that the chilli powder is poisoned until a consumer comes back to me and says, 'I ate your pickle and I got sick'. Then an investigation is launched and I find that one of my ingredients was wrong. What happened over there is something like that. For further details, we have to wait for [the investigation] to happen, but it's clear that kidney failure can be caused by this agent.

Such reports have already occurred in the past, not only in healthcare but also in other industries. Contamination occurs in all sorts of products that humans use, not just medications. You asked if we commonly see it. Fortunately, I'm happy to say that in India, where I practice and where I network with other doctors, complications as a result of [drug] contamination is not something we see every day. I will not say it doesn't exist, but I have not seen it happen. But one way that doctors stay safe is by prescribing products such that their patients will come back and say 'doctor, I took the medicine and everything was fine'. Doctors like me are very cautious because the patient comes to us with absolute trust and it's a doctor's duty to deliver that trust, so I might not [prescribe] something which I'm not familiar with. That's my style of practice. So when I say I have not seen it happen, it might be because my prescribing pattern is a safe one. And I've checked with the organisation. Reports of fatalities from India are there in the media. I believe in 1973 an incident occurred in Egmore [in Chennai], and then later in Jammu and Kashmir, and so on. So there are reports, but in everyday practice, I don't see this.

Amongst the cases that you have seen, or have heard of, in the last 10 or 20 years, what was the common thread? Were these suspect manufacturers? Or were the drugs substandard?

RJ: I am quoting media reports here. The adverse outcomes are frequently the result of an ingredient which should not have been there in the product. If a tablet of paracetamol should contain 500 mg and delivers only 100 mg, the patient might not have a complication. The fever might not come down, but the patient is not harmed, in that sense. But if the product contains a dangerous substance, which should not be there, yes, the patient might get harmed. And that's really what happened in Gambia.

The other situation that could happen is, let's say medicines contain preservatives. So when I say an antibiotic tablet is spurious, it might also mean that the ingredients in it are abnormal. The normal, or active ingredient, itself might be of good quality. But the other parts, like the colouring agent, or the preservative, filler, capsule, or the cap of the pill bottle, even these have to be of good quality. Quality is distributed across multiple angles and aspects of a medication. Let's take an injection. The injection is meant to be kept in stable form and if one of the preservatives is spurious, the person who received the injection might have a serious outcome, even death. These are possibilities.

But there are not that many cases of patients falling ill after taking spurious or substandard drugs, that you have encountered, or have heard of from your peers, at least in recent years?

RJ: It is something we are careful against. We monitor through official reporting, like Nakul talked about how surveys and sampling are done. I understand that the sampling process has improved over the years. I know it's nowhere near ideal, but among all the batches that are being manufactured in India, we are in a better position now compared to say 15 years ago, when fewer batches were being tested. That's the information I have.

Mr Pasricha, the CDSCO study had found just 11 samples out of 23,000+ samples to be spurious, and you said the 2015 survey figure is somewhat similar. Is that something to worry about, or is that something to be sanguine about?

NP: Obviously, even one life lost is a tragedy and we must do something, we must be more vigilant in terms of ensuring quality and that we don't have spurious or substandard medicines. As Dr Rajeev said, 'spurious' is a term that is not commonly used outside of the technical context. So I'll just switch to 'counterfeiting' and take you on a journey across other industries in India, as a way of answering your question.

One out of three auto parts sold in the aftermarket are considered to be counterfeit. These are industry figures. In fast-moving consumer goods, studies have found up to 30% [are counterfeit]. In nutraceuticals, an Assocham study reportedly found 60 to 70%. Pesticide, seeds, and fertilisers, again, 60 to 70%. So, to be very honest, if you tell me that in pharmaceuticals across India--and I'm not talking about the reputed practices in urban centres where ethical and careful doctors like Dr Rajeev may be practising, I'm talking about tier 2, tier 3 towns--the rate of spurious drugs is 0.3%, I would be a little bit sceptical of that, given how widespread counterfeits are in other industries and also given the immense profit margins that unethical bad actors stand to make. In fact, statistics I saw from one of the large pharma companies, among their presentations, said that being a drug counterfeiter can actually be more profitable and lucrative than being a heroin distributor. So that's the kind of profit that people stand to make, and that surely may be a lure for many criminals. So I don't think we should let the statistics necessarily make us feel good. I would still continue to be very vigilant.

But there is some good news. I've been in this industry, looking at this issue right from the 2009 CDSCO report. In 2009, actually, there was a very prominent incident of counterfeit, spurious drugs landing up in Nigeria, marked as 'made in India'. The question was raised to the Indian government, on why these fake drugs are coming into our country. An investigation was launched and it was found that these drugs never originated from India, but from another country, from China, and were falsely labelled as 'made in India'. So the government actually took a fantastic initiative to protect our exports of pharmaceuticals, through a technology [Drug Authentication and Verification Application; or DAVA] of serialisation and traceability, which many regulators around the world have also adopted after that. So India, in many ways, was a leader in that. That's something that I've seen being adopted and helping to secure supply chains.

We are all well aware that the regulatory aspect of pharmaceuticals is different for exports and for the domestic market. Unfortunately, what [the government] didn't do was put regulation in place domestically. There were steps, research, delays, draft notifications, what have you. But finally, there has been something published in the gazette reportedly saying that the top 300 drugs in India will have QR codes which consumers can scan using their smartphones to get information about the product, and be able to assess for themselves, at least based on that information whether the drug is genuine. We would hope that this won't be just for the top 300 brands but will expand across the industry. Such measures are needed to empower consumers and I'm glad to see that the regulation is finally coming. I think we will have some way of checking other than just a visual inspection of the package.

Where does the onus really lie? Let's take, for example, a drug like Combiflam manufactured by Sanofi, which I'm only quoting because we had covered this in the context of misinformation around that particular drug. Assuming there is some degree of counterfeit or spurious manufacturing happening for that brand, and under this manufacturer's label, whose responsibility is it primarily to investigate this?

NP: That's an interesting question. When I speak to drug regulators or see their presentations at conferences, there's one common theme, which is that they are under-resourced. It is virtually impossible for any kind of drug controller, either at the national or state level, to really say, 'Look, I'm going to go and take the responsibility to examine every drug that's out there and ensure that it's safe and efficacious'. But obviously, there is a responsibility, and I think we need to strengthen that arm of our system so that we're able to deploy more resources in the market and be able to fish out these drugs.

Second, in my view, it is the manufacturer's responsibility. There is a long supply chain and, as in this [Gambia] case, it could have been at fault. The investigation may find that something up the supply chain caused this issue. But at the end of the day, what's the last line of defence before a drug goes out and into the hands of a patient? So I do think that certain measures need to be taken [by manufacturers]. For example, Dr Rajeev will be well aware that in Kerala, Maiden Pharmaceutical's drugs have been found to be substandard five times. So, what is the point at which we say, 'this company needs to take some measures in order to make the drug safer'. But given all of that, given that it is a complex issue, my view is that, although consumers don't have the ability to get into lab testing, at the very least they should be able to get information about the product, like an e-leaflet which they can scan and check for themselves.

Mr Pasricha, as you look ahead, what are the two or three areas that you feel India should be focusing on extensively, either from a regulatory standpoint or from a manufacturing standpoint?

NP: India is really the pharmacy to the world. Our pharma industry is fantastic. It has been growing steadily. It is one of our star industries. Because I have the opportunity and the privilege to interact with people from around the world, I feel that such incidents, no matter what the cause, should make us sit up, should make us accept that we have a tremendous responsibility. From a regulatory standpoint, a responsibility to our industry. There is a business and economic responsibility, but also a moral responsibility [for regulators] to do more. I think we have been taking certain steps and we need to continue to focus on that from a regulatory perspective. We need to take all different concerns into consideration, but in the end, we have to be moving forward and getting better.

From a manufacturer's perspective, I would say there's an economic angle to it, obviously. If our exports are under any kind of shadow because of such high profile incidents, it is clearly not good for business. Manufacturers need to just make sure that they get the best kind of quality checks and solutions in place to ensure that spurious and also substandard medicines are not leaving their doors.

Dr Jayadevan, what kinds of regulatory tightening would you like to see? Also, how would you advise patients to check prescriptions at the doctors' clinic or at the point of pharmacy purchase, to ensure that they are buying the right drugs?

RJ: The ideal thing to happen would be for all medical products, regardless of genre, to have a universal seal of quality that is endorsed by the Government of India. That is utopian, ideal. We might not reach that, but second best will be a suitably high percentage of batches of medications receiving an external and neutral inspection, preferably from the government or a neutral body outside of the manufacturer.

From a personal perspective, from my practice and from working in multiple nations, the best form of monitoring is self-monitoring. I believe that. In my practice, we audit everything. We audit patient feedback, medication given to patients, results, biopsies, everything, and we sit together and look for imperfections and we find them. That is how we run a practice. That is one way. But when you have a large number of manufacturers doing the same, in the same business, it is impossible to expect each one of these manufacturers to engage in diligent self-monitoring, for various reasons. Thus, a company doing internal monitoring must be given credit points. I would rate that company very highly. That is where the role of an external agency comes in. Hence, what is ideal is to promote self-monitoring and transparency, and also a greater percentage of products being officially verified by the government of India through its agencies.

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