Big claims, little evidence

Scant data exists to back government claims of the efficacy of some Ayurvedic drugs

Soon after 49-year-old Niranjan Sakhare, a Mumbai resident, was diagnosed with diabetes two years ago, he saw television advertisements for an Ayurvedic diabetes pill called IME-9, or Insulin Management Expert. A combination of five plant extracts, the drug was developed by the Central Council for Research in Ayurvedic Sciences (CCRAS) — an autonomous body of the Ministry of AYUSH — and based on a formulation called Ayush-82. It was licensed to the Delhi-based Kudos Laboratories for marketing and had the government’s stamp of approval.

Mr. Sakhare began taking it alongside Gluconorm-G, a powerful combination of the anti-diabetic agents glimepiride and metformin, prescribed by his doctor.

Some days later, he began feeling anxious and jittery — symptoms of low blood sugar. He visited his doctor, who admonished him and asked him to stop IME-9 immediately. Mr. Sakhare has been careful ever since.

Like Mr. Sakhare, thousands of Indians have bought into the aggressive advertising for Ayurvedic medicines endorsed by the Indian government. IME-9, easily available online, claims on its website that the drug has “no side-effects” but recommends that it be taken under medical supervision. Mr. Sakhare didn’t consult an Ayurveda doctor before taking the medication.

Using RTI

These advertisements, by the private companies marketing these drugs, claim to have undergone the full battery of efficacy and safety tests. But information elicited under the Right-to-Information (RTI) Act from the CCRAS, the Council of Scientific and Industrial Research (CSIR) and the other government agencies that developed these drugs undermine these claims. When Dinesh Thakur, a health activist, T. Prashant Reddy, Assistant Professor, NALSAR University, Hyderabad and Balaji Subramanian, a student at NALSAR, asked CSIR and other agencies for clinical data, the agencies either said they didn’t have it or pointed to small studies published in low-quality journals.

The Hindu has reviewed the RTI responses.

Apart from IME-9, other drugs from the CSIR and CCRAS stables are BGR-34 (Blood Glucose Metaboliser) for diabetes, Dalzbone for healing fractures, Ayush-64 for malaria and V-1 for arthritis.

The only clinical trial for BGR-34, launched with much fanfare by the CSIR and the Delhi-based Aimil Pharmaceuticals in 2016, is a small study on 56 patients, published in the European Journal of Pharmaceutical and Medical Research . This journal appears in a list of publications flagged by Jeffrey Beall, an authority on spotting fake scientific journals, as ‘possibly predatory’ and therefore with suspect scientific credibility. To be sure, clinical trials are not required for marketing proprietary Ayurvedic drugs such as BGR-34, if they are based on ancient Ayurvedic texts.

Similar problems plague IME-9. The CCRAS did not share data on Ayush-82 or IME-9 in response to RTI queries. A search on Google Scholar, a database for academic journals, reveals that a unit of CCRAS published only one retrospective study of 25 patients on IME-9, in the Journal of Traditional Medicine and Clinical Naturopathy, whose publisher, OMICS International, appears on the Beall list of ‘potential predatory’ publishers.

‘Too small a trial’

In Dalzbone’s case too, RTI queries reveal, the only published trial of 16 patients conducted by the Gujarat-based Pharmanza Herbal Pvt. Ltd., appeared in the Journal of Complementary Medicine and Alternative Healthcare , published by Juniper Publishers, which also appears on the Beall-list. Pankaj Prabhakar Dixit, an Ayurvedic physician and the principal investigator on the Dalzbone trial, told The Hindu that while Dalzbone did show promise, “our trial was definitely too small to prove the drug’s efficacy.” Dr. Girish Sahni, the director of CSIR, whose labs NBRI and the Central Drug Research Institute developed the drugs, said that ideally, such trials would be done, but that it couldn’t happen overnight.

He added that it was the Drugs Controller General of India’s responsibility to bring about regulation requiring clinical trials.

Ayush-64 was patented by the CCRAS in 1980 but only recently commercialised. The CCRAS’s website claims that the drug successfully treated malaria during epidemics in Rajasthan and Assam. In 2000, researchers led by Neena Valecha, a pharmacologist at Delhi’s National Institute of Malaria Research, tested around 100 patients to compare Ayush-64 with chloroquine, the standard treatment for malaria. In their findings published in the peer-reviewed Current Science , they reported chloroquine as being more effective than Ayush-64, which did “not appear promising” as a primary treatment for malaria. Despite this, in February 2016, the CCRAS licensed the drug to Dabur India Ltd., to be launched within six months. Ms. Valecha said an ineffective drug can lead to continued transmission of malaria.

Yet many continue to take these drugs, taken in by the advertisements, until they suffer ill-effects, like Mr. Sakhare did.

priyanka.pulla@thehindu.co.in