INTERVIEW : Nakul Pasricha

Nakul Pasricha

President and CEO of Pharma Secure

The CDSCO’s 2009 study was the first such comprehensive study that was done in India to measure the extent of spurious and substandard drugs. It 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.

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.

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.

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.

'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 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 from 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.

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 the Gambia case, it could have been at fault. 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]. What is the point at which we say, 'this company needs to take some measures in order to make the drug safer'.

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.