In recent times a large number of drugs are being promoted and marketed as ‘Ayush’ drugs without supporting clinical and safety data. The presumption is that since the plants in these drugs used are mentioned in classical texts and have a long record of use, further validation of their safety and efficacy are not needed before they are administered to humans.
While there have been many proposals to curb these practices through appropriate new legislations, nothing tangible has emerged so far. No system can claim superiority over others; however for the proper integration of the various systems of medicine to develop a holistic model of medicine incorporating the good parts of all systems, it is essential to ensure that minimum standards of utility and safety are prescribed and practised regardless of what system of medicine they originate from.
In many ways the systems and practices followed for an equitable delivery of an effective healthcare system is going through the cross roads for different reasons. Availability of suitable drugs for most non communicable diseases, their affordability for patients who need them the most, unacceptable adverse reactions to drugs, neglect of efforts to develop drugs for poor man’s diseases are some of the major issues. For this predicament, several factors including the callous attitude of all the stakeholders are responsible. That includes the medical professionals, administrators of healthcare delivery systems, public and private funding agencies, hospitals, the pharmaceutical industry and even the patients.
One such example, notably in India is the promotion of traditional medicines based drugs in the public media and direct sales to the consumers (patients) of these drugs. In recent times more and more such drugs developed under the Ayush label are being promoted in the public media (both print and visual) and marketed through direct marketing, retail outlets and even on line as OTC drugs. These drugs are neither approved for marketing by the stipulated authority namely the Drugs controller General of India (DCGI); nor were they subjected to scientific validation of their safety and efficacy.
The primary objective of the companies which market such products through this route is to ensure maximum market reach regardless of erosion of standards of morality.
The rationale is that the system of administration in India (Ministry Of Health) permits such an approach if the components of the drug promoted are mentioned in classical texts of traditional medicines (e.g. Ayurveda) as useful for same indication. In the US and some other markets, such products are allowed to be marketed under the Dietary Supplements and Educational Bill (DSHEA 1994) with no specific therapeutic claims being allowed. Since most of them (mainly medicinal plants) are in the GRAS list or Pharmacopoeia, their safety is deemed to be assured. Since they are marketed as dietary supplements standards of efficacy and safely are largely based on their established use as food additives, food supplements or functional foods. India does not have a legislation equivalent to US DSHEA.
Based on reported efficacy of these products for similar disease conditions in classical texts, anecdotal reports and patient perceptions, dozens of such preparations in modern galenic forms of tablets, capsules, powders, ointments, liquid orals etc are being promoted for indications such as asthma, musculoskeletal disorders (osteoarthritis, osteoporosis), immune disorders (rheumatoid arthritis), skin diseases (psoriasis, leucoderma), metabolic diseases (diabetes) or even cancer. No available scientific data is peer reviewed and/or published, nor are they put through rigorous clinical evaluation to provide evidence of safety and efficacy. Since the majority of claims are for diseases for which modern medicine has little to offer by way of cure, the public is enticed to use these drugs without referring to any specialist.
Examples of premature claims Cow urine therapy
Two examples of this practice, both resulting from publically funded research (CSIR Labs) in which this author’s opinion was sought would suffice to establish the lacunae in this approach. In 2002, the US patent office granted a patent to one of the CSIR Labs for the use of distillate of cows urine as a bio-enhancer of drugs, which according to the discoverers was an endorsement of the utility of cow’s urine as a therapeutic agent mentioned in ayurvedic texts.
The then Minister of Health Government Of India, Dr Murali Manohar Joshi held a press conference to announce that India’s rich heritage and use of cows urine in Indian Systems of Medicine has been vindicated by this grant of a US patent. In an article published in Hindu in 2002, I refuted this conclusion since the grant of a patent does not necessarily guarantee the validity of the claims and in addition the experimental evidence provided by the inventors lacked scientific credibility and was technically flawed. I did not question the potential use of cow’s urine for this or other indications; all I said was that the available experimental evidence and the grant of the US patent by no means warranted such a conclusion.
John Esterbrook of CBS News reporting on this case quoted my statement and suggested that only after further investigations, the veracity of the claims made in the patent can be confirmed. Not unexpectedly, the patent itself out was never licensed or commercially exploited. However the ministers press conference served its purpose; bottled cow’s urine has ever since been marketed in India for its use as a bio-enhancer and for other claimed uses. No further efforts were deployed by CSIR or any other agency to validate the experimental evidence.
Very recently government has announced the setting up of a research centre for carrying out research on Panchagavya which is a combination of cow’s milk, curd, ghee, urine and dung claimed in ancient Indian Systems of Medicine for a variety of indications including cancer. Hopefully, unlike in the past, appropriate pre clinical and clinical studies will be carried out on a suitable formulation of Panchakavya before it is considered for human use the product is shown to be effective and safe.
BGR 34 and Ayush 82
Diabetes as a medical condition of inability to handle glucose and its varied consequences broadly classified as metabolic syndrome, is emerging as an epidemic notably in India and China. Over one third of the global diabetic population estimated at over 350 million reside just in these two countries and the incidence is growing in high double figures across the world.
Apart from insulin, around six different classes of synthetic drugs have been in the market with different structural and pharmacological characteristics. There is increasing evidence that the synthetic oral hypoglycemics have the potential to lead to unacceptable adverse reactions on chronic use and it is therefore but natural that alternative approaches are being sought to manage this condition.
However acute that need is, any new product regardless of the system of origin should be developed and marketed only on the basis of its established safety and efficacy. After several decades of research on Diabetes carried out in publically funded Institutions such as the CSIR Labs and CCRAS (Central Council For Research In Ayurveda, Siddha and Unani) medicinal plant based anti diabetic drugs such as BGR 34 (by CSIR Labs) and Ayush 82 (by CCRAS) have been launched with much publicity in the media.
Both drugs are marketed as ‘ AYUSH DRUGS’ a term not mentioned in the Drugs and Cosmetics Act, the prevailing statutory legal arm for the approval of any drug. The former was endorsed as a major discovery by the Prime Minister and the latter by the Ministry of Ayush, Government of India. Through Press Conferences and advertisements in public audio and visual media they were promoted and licensed for manufacture and marketing to commercial houses.
Online (amazon) sales promoting the usefulness as anti-diabetic drugs has brought in more brickbats than bouquets from consumers in many parts of the world who had access to the drugs online. The validity of the claims are still under challenge in view of absence of scientific publications and presentations at professional conferences. Record of outcomes of clinical trials are not available and the trials have not been registered with the Clinical Trial Registry of India or the NIH sponsored clinicaltrials.com.
In the absence of any verifiable scientific evidence, many experts including Dr M S Valiathan an Ayurvedic Expert and Chairman of the task force on Ayurbiology, Dr Nityanad Former Director Of CDRI Lucknow, Dr Bhushan Patwardhan, of Pune University, Dr Y K Gupta of All India Institute of Medical Sciences, Dr A B Vaidya of Kasturba Medical Centre Mumbai, Ms Shailaja Chandra former Secretary of the Department of Ayush, D B ANarayana, veteran researcher, Dr Narendra Bhatt, clinician and research scientist and many others who have years of experience in this line have deplored the approach of promoting these products directly to the patients through lay press and visual media as ayurvedic drugs without valid experimental and clinical data.
In response to a query on the subject by a correspondent, I mentioned that “such populistic and market driven approaches will undermine the credibility of the CSIR and lack of transparency in the approval and marketing of BGR 34 will lead to exposing our populations to a drug not properly and scientifically validated”. While some companies have stopped advertising the drugs in lay press under pressure from the Government, both drugs are still being actively promoted and marketed worldwide through the online route in addition to making them available ‘Over The Counter’.
In response to these concerns expressed in many quarters about BGR 34, the Ministry of Ayush claimed that it was the responsibility of CSIR since it was their discovery. In addition, most of these agencies emphasise the fact that under the constitution, health being a States subject, the authority to approve Ayurveda products rests with the State.
This is a debatable point since standards of safety and efficacy of any drug for human consumption should rest squarely with the Central Drug Control Agency and not with Ayush, CSIR or States. These are just two examples of how unprofessionally we are promoting our ancient systems of medicine for short term gains. Unfortunately this trend continues with several such new cases surfacing every day which need to be prevented through legislative measures, if Ayurveda is to attain its legitimate place in providing healthcare.
Statutory provisions to achieve prescribed standards for approval of new drugs need to be urgently put in place. Considering the long track record of use of drugs from traditional systems, the protocols for evaluation of efficacy and ways of establishing safety of ayurvedic drugs may be different and may be even less stringent. The ICMR has come out with guidelines for clinical evaluation of traditional products, so too the WHO and US FDA. Taking all these into account, we need to take a realistic view and prepare a road map for promotion of our systems of medicine in the world scene for the overall benefit of ailing patients.
(The author is a senior research scientist and industry expert)