A dubious diabetes drug, regulatory confusion, and a potential PIL

On September 26, Prime Minister Narendra Modi said, “CSIR has developed the first Ayurvedic medicine of the country for diabetic patients. All of you are aware about the potential of this medicine. Now our goal should be to make people aware of the benefits of this medicine so that they can make best use of the same.” He was speaking at the 75th Foundation Day celebration of CSIR.

Clearly, the Prime Minister trusts CSIR to do scientific work and can’t possibly ask for evidence. But other scientists and doctors are asking questions, and they can’t find any answers. The so-called drug is technically herbal extract and is being marketed as a medicine which is “scientifically validated” and “meets allopathic standards”.

Both these claims are dubious.

First, the definition

Since the drug is available in any chemist shop, marketed sometimes as Ayurvedic medicine and sometimes as a ‘diabetes drug’, it calls for a clarification. Because if it is the former, it needs to offer clinical evidence of safety and efficacy of its drug properties; if it is the latter then it is illegal as advertisement of drugs is a criminal act in India and it ought to have the Drug Controller’s approval.

If an Ayurvedic product falls under the category of “Classical Preparation” in the Ayush system, those documented in the ancient text, it need not seek the Drug Controller’s approval. It’s like Chyavanprash; any number of companies can make it. But the extract that BGR-34 claims to be made of does not fall in the Classical list. Moreover, it’s a composition of extracts from six plants. A non-trivial feat if the mechanism of action, safety, efficacy and evidence of clinical management of diabetes is proven and peer reviewed. Except, it is not.

Several researchers, even among CSIR, and medical doctors have been rummaging the literature but can’t find any documented evidence, not even of the clinical trial which CIMAP claims to have conducted on 56 patients at Agrawal Dharmarth Hospital Society in Shakti Nagar, Delhi.

When asked, CIMAP director Anil Kumar Tripathi said the two institutions have done “pre-clinical studies on small animals to optimize the efficacy of the formulation and its ingredients and evaluated the safety”.

Why isn’t the data public?

Because the researchers have filed for a patent; a “scientific paper disclosing the content of the patent can be published only six months after the filing of the patent”, said Tripathi. He says his team is ready with a manuscript now. To put it in perspective, it may take anywhere from a few months to a year to publish, depending on the quality of the journal.

However, as per the PCT rule, a patent application automatically gets published after 18 months of filing. So was BGR-34 patent, published in December 2015. On the face of it, it is a weak process patent and in the long term may not even be granted, says seasoned pharmaceutical scientist and IPR consultant Mohan D Nair.

But that’s not what makes it complicated.

A drug which is claiming intellectual property and aspires to position itself as a “botanical drug” globally, as the PCT filing implies, does not even follow the botanical drug route in India. Botanical drugs are derived from plant materials and it’s a promising and clearly defined category under the US Food and Drug Administration. In India, it is known as phytopharmaceuticals and has a new approval mechanism under the Drug Controller.

In the case of BGR-34, even before anyone could review the data, the product is being sold.

Why is that a big deal? Consider this study in contrast: A similar work by a group of Indian researchers and industry was published in July in the Journal of Ethnopharmacology. It is also a polyherbal extract but this study shows it is safe to be developed further as a botanical drug.

The claim

There are inconsistencies galore – in the number of patients BGR-34 is tested upon; the duration of the clinical trial; the span of research itself, which ranges from 18 months to five years. A senior scientist who has worked at CIMAP says the lab did not even have an animal facility until 2013. “Between 2013 and October 2015, when the drug was launched, it is hard to believe anyone could have done the quality science required to prove the claims,” says this scientist who doesn’t want to be named as he still works in the CSIR system and could face a backlash.

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