Drug Regulation Traditional Knowledge

Innovation and Regulation of Ayurvedic medicine: CSIR’s BGR-34, nimensulide in Ayurvedic medicine and other such stories

A few years ago, Open magazine published an excellent cover story “Ayurveda: Hoax or Science?” by Priyanka Pulla, one of India’s best science journalists. (She’s written for us on a couple of occasions over here and here). That cover story discussed several issues surrounding Ayurvedic drugs and how despite having a Rs. 8,000 crore market in India there is still not enough evidence for modern medicine to prescribe any Ayurvedic medication. In her story Priyanka asks “Why hasn’t the dazzling array of research into Ayurveda resulted in proven drugs? Why are these drugs incomparable to modern medicine? Is it that Ayurveda works on faith alone? If so, what is one to make of the thousands of ‘scientific’ studies arguing for Ayurvedic drugs?” One possible answer to the above questions is the lack of adequate regulation of the Ayurvedic drug industry – India’s regulatory laws do not demand the same level of proof from the Ayurvedic drug industry as they do from the Allopathic drug industry – as a result medical practitioners aren’t quite convinced of the merits of Ayurvedic drugs.

Recently there have been several stories in the media about BGR-34, an Aurvedic drug which has allegedly been “scientifically validated” to meet “allopathic standards” through clinical trials. The drug has been developed by the public funded Council for Scientific & Industrial Research (CSIR) and marketed by AIMIL Pharmaceuticals, a private company. The drug allegedly treats diabetes and has allegedly been “approved” by the Ministry of Ayush.

The regulatory framework for Ayurvedic drugs

Shortly after news of the drug hit the market, The Wire carried a piece by Manasi Gandhi questioning the science, or rather the lack of it, backing the claims of the marketing campaign advertising the drug – in particular she points to the lack of peer-reviewed studies backing the claims being made by CSIR and AIMIL. She also points out how the prescribing information isn’t very clear – a dangerous proposition when these drugs can be bought without prescription. She also writes about how some patients have been complaining about this drug on the internet and that it isn’t working on them.

I followed up on Gandhi’s piece with another one on the Wire explaining the regulatory framework for Ayurvedic drugs. I’m reproducing a short extract as follows:

Currently in India, traditional medicines under the Ayurvedic system and Unani system are not required to submit any proof pertaining to their safety or efficacy. In fact when India’s first drug regulatory law – the Drugs Act – was enacted in 1940, the law completely excluded from its purview, traditional medicine systems like Ayurveda and Unani. It was only the Drugs & Cosmetics (Amendment) Act, 1964 that brought traditional medicine systems like Ayurveda and Unani under the purview of the Drugs Act, 1940.

The focus of these amendments was on ensuring quality of the final product being sold in the market – the manufacturer would therefore be required to ensure that the Ayurvedic drug was manufactured in a factory that complied with certain safety norms and that the product had the ingredients as advertised on the packaging. There is no requirement under the Drugs & Cosmetics Act, 1940 for the Ayurvedic manufacturer to conduct rigorous clinical trials and establish that the drug actually has the effect that it claims to have on the human body.

So when CSIR and AIMIL Pharmaceuticals claim that they have conducted clinical trials on BGR 34 and that the drug has been “approved” by the Ministry of Ayush, it does not really mean much in the eyes of the law because there is no such requirement under the law. It is therefore important for the medical community to ask CSIR and AIMIL Pharmaceuticals, as to what exactly they mean when they claim that their drug was “approved” by the central government. What was the basis of this “approval”? This question is important not only from a legal perspective but also because of the reported design of the clinical trials for BGR-34. As per the brochure of BGR-34 made available on the BGR-34 blog, the clinical trial for BGR-34 at Agarwal Hospital, New Delhi was conducted on just 48 patients – 24 received the drug, while the remaining 24 received the placebo.

A full-fledged clinical trial in modern medicine can involve up to 500-1000 patients – under the Drugs & Cosmetics Act it should involve at least 500 patients during the Phase III trials. So for AIMIL to claim that BGR-34 (tested on 48 patients) is tested up to “Allopathic standards” may not be entirely true. As I explain in the piece on Wire, the government keeps announcing that it will make clinical trials mandatory for the Ayurvedic drug industry – the industry however always fights back, partly because of costs, partly because people may actually discover that a lot of these drugs don’t work as claimed.

Does CSIR need a code of ethics and more transparency?

a_largeAn equally important question to ask at this stage is the manner in which CSIR is allowing its name to be used in the promotion of this drug. The packaging of the drug (picture on left) prominently features CSIR’s name. While AIMIL is a pharmaceutical company looking at profits, CSIR is a community of scientists with ethical duties towards the public – the general public places a lot of faith in CSIR and it does not behove of CSIR to associate itself with a marketing campaign which claims that the drug has been tested up to “Allopathic standards” when the drug has been tested on a mere 48 patients. The Wire piece also asks questions of the manner in which CSIR awarded the deal to AIMIL – I touch on the issue in my piece too. To put it briefly, CSIR’s licensing deals are a complete mystery – I have written about these deals on this blog and even pursued CSIR to provide us with information on revenues etc. – I failed to get any cogent responses.

Allopathic active ingredients found in Ayurvedic drugs

The lack of clinical trials is only one of the issues dogging the several claims made by the Ayurvedic drug industry. An equally troubling aspect is the fact that several Ayurvedic drugs sold in the market actually contain allopathic medicine and the same is never labelled on the containers. During the course of my research last year for Dinesh Thakur, the Ranbaxy whistle-blower, I came across three govt. lab reports (accessible over here 1, 2 & 3).

The first report is regarding an Ayurvedic skin cream which was meant to treat hyper-pigmented skin and scars. The labelling indicated a long list of Ayurvedic ingredients. However when the lab tested the drug, turned out that it had 7.7% hydroquinone – a chemical used to treat skin depigmentation until some jurisdictions like the US banned it because of concerns that it may actually be a carcinogen. The second report is for an Ayurvedic drug that was meant to treat chronic joint pains. As with the previous case the labelling indicated a long list of Ayurvedic ingredients. When the lab tested the sample, it found that the sample contained 62.32 mg nimensulide, a very powerful painkiller which has a controversial history. It’s banned for use on children because of the likelihood of it causing liver damage. Unfortunately we have unscrupulous Ayurvedic companies slipping such painkillers into Ayurvedic drugs without disclosing it on the packaging. What if a parent were to administer such a drug on their child continuously? Who is going to be liable? The third report is about an Ayurvedic syrup which was supposed to provide men “3 times passion for intimate moments”. The label contained a long list of Ayurvedic ingredients and that it was a “government approved formulae” but the lab tests found that the sample in fact contained sildenafil citrate – the active ingredient in Viagra, a drug used to treat erectile dysfunction. This again is a prescription drug.

In all three cases, the govt. lab classified the drugs as spurious or not-of-standard quality. We unfortunately do not have information whether the manufacturers were prosecuted. In any case, this is the state of affairs in the Ayurvedic drug industry, so please, do be careful when you purchase Ayurvedic drugs in the future. I don’t have any policy prescriptions – only tougher enforcement on the grounds will combat this menace.

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Prashant Reddy

Prashant Reddy

T. Prashant Reddy graduated from the National Law School of India University, Bangalore, with a B.A.LLB (Hons.) degree in 2008. He later graduated with a LLM degree (Law, Science & Technology) from the Stanford Law School in 2013. Prashant has worked with law firms in Delhi and in academia in India and Singapore. He is also co-author of the book Create, Copy, Disrupt: India's Intellectual Property Dilemmas (OUP).


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