CSIRs anti diabetic drug: Did it deserve Modi's praise?

Bengaluru : Lauding the achievements of the Council of Scientific and Industrial Research (CSIR) on its platinum jubilee earlier this week, Prime Minister Narendra Modi had made a special mention of the "BGR-34" ayurvedic anti-diabetic drug that it had launched with much fanfare in June.

However, going by the negative reactions of several eminent scientists and a stinging editorial in a professional journal on ayurveda, Modi appears to have chosen a wrong example to highlight CSIR's successes.

They are questioning the scientific validity of the drug, launched in press conferences across the country and promoted through commercial advertisements, without any published scientific evidence or clinical trials to support the claims made. They note this raises doubts about the CSIR's "moral, ethical and public health responsibility".

Jointly developed at CSIR's two institutes in Lucknow the National Botanical Research Institute (NBRI) and the Central Institute for Medicinal and Aromatic Plants (CIMAP) BGR-34 is sold online by a private company in New Delhi in an attractive package with the CSIR logo to generate confidence in the public.

The drug is said to contain extracts from four plants mentioned in ayurveda and so, according to NBRI principal scientist A.K.S. Rawat, has no side-effects.

Calling drugs "traditional" simply because they consist of medicinal plants mentioned in ayurvedic texts, is not correct, says Sankaran Valiathan, Chairman of the Task Force on Ayurvedic Biology of the Department of Science and Technology and an Honorary Advisor to Manipal University.

"They are, in fact, new drugs and should undergo the full range of efficacy and safety tests for approval. It is even worse that CSIR is making unsubstantiated claims on ayurvedic drugs," Valiathan, a recipient of the Padma Vibhushan, India's second-highest civilian honour, told this correspondent.

Nitya Anand, a legendary figure on the Indian drug research scene and former director Lucknow's Central Drug Research Institute, concurred. "The Drug Controller General of India now has a special category of drugs for herbal medicines (phyto-pharmaceuticals) that require to be properly standardized, tested and registered with it" before marketing, on similar lines to synthetic drugs, he said over phone.

It is a "very serious matter" if this procedure has not been followed in the case of BGR-34, he added.

"Such populistic and market-driven propaganda actually tarnishes the credibility of CSIR, India's largest scientific network," Mohan Nair, a veteran pharmaceutical scientist and adviser to National Task Force on Phyto-pharmaceuticals, told IANS.

"I feel very concerned about the lack of transparency in the approval and marketing of BGR-34, exposing our population to a drug not fully validated by any standards," he added.

In a harsh editorial, the Journal of Ayurveda and Integrative Medicine, a peer-reviewed publication of Elsevier (which opened its doors 130 years ago), said there is no information about this product on the CSIR, NBRI or CIMAP websites; no research publication; and no record of clinical trials.

Creating headlines in popular print and electronic media instead of publishing in scientific journals "is certainly worrying and calls for serious introspection", the journal said and cautioned that "in the interest of public health, it is crucial to critically look at the validity of scientific evidence in support of various claims".

Neither CSIR Director General Girish Sahni nor the NBRI's Rawat replied to this correspondent's request for comments on the questions raised by the journal, which also warned that "the absence of contra-indications for administration of the BGR-34 is a serious omission and has implications for patient safety".

The editorial also refers to concerns of some experts in the field of ayurveda. It quotes Y.K. Gupta, a pharmacologist at New Delhi's All India Institute of Medical Sciences (AIIMS), as saying that in the case of BGR-34, "marketing strategy has taken predominance over hardcore science".

Shailaja Chandra, a former Secretary to the Ayush Ministry, which deals with ayurveda, has also warned that advocacy through commercial publicity can lead to self-treatment "which is fraught with needless risks and brings the entire science of ayurveda into disrepute".

"The traditional knowledge from ayurveda is certainly valuable for discovering new drugs for diabetes," Bhushan Patwardhan, professor of health sciences at Pune University said, adding: "But it should be based on scientific evidence for safety, quality and efficacy", which is absent in the case of BGR-34.

In contrast, he said, discovery of artemisinin from traditional Chinese medicine which has become a drug of choice for treatment of malaria and got its inventor a Nobel Prize required over three decades of rigorous scientific work.

"India needs to follow the robust path of discoveries like reserpine (derived from the sarpagandha Indian snakeroot), used to treat high blood pressure and not succumb to cheap publicity or short-term economic gains that will eventually erode the credibility of India's traditional knowledge heritage," Patwardhan said.

"At the same time, government regulations, oversight and surveillance is required to ensure that gullible patients are not exploited by misleading commercial advertisements promoting various products by making unrealistic claims," he added.

According to Patwardhan, BGR-34 is not the first ayurvedic diabetic drug to be commercialised without scientific validation. He says no published scientific papers are available regarding Ayush-82 another anti-diabetic drug developed by the Central Council for Research in Ayurvedic Sciences under the Ayush Ministry and commercialised recently.