Clinical trial must for new proprietary AYUSH products – Regulation to promote or isolate?

Many ISM industries are upbeat with the new clarity thrown by the department of AYUSH for obtaining the license for new proprietary AYUSH products. The new guidelines mandate clinical trial at a pilot level for new products that are proprietary in nature. Further the clinical trial although needs to be done only in a small number of patients but must be within the regulatory norms i.e. requires IEC approval, CTRI registration, and other formalities.

The new development although may look positive and progressive but it has its serious side effects as well. The clinical trial requirements can limit the growth and acceptance of AYUSH products.

According to several experts from ISM industry have clearly stated that all AYUSH products are although listed under D&C act but are nonscheduled products meaning there is no bar or restriction on anyone to prescribe such products. Since these products are likely to be used by patients for various health benefits, they are regulated by D&C act to meet some level of safety norms.

ISM industries use this fact about AYUSH products are unscheduled drugs - products that may have some medicinal benefits, to convince the allopathic doctors to prescribe some of their products without any legal hassle. That is how the product liv 50 is quite popular.

The introduction of a clinical trial for new proprietary AYUSH products at least at perception level may make these products appear like ‘drugs’. Although such AYUSH products to meet the complete definition of the drug such as pharmacokinetic details, bioavailability, mechanism of action, target specificity, receptor site etc., may take centuries but still the clinical trial pre-requisite for a license can unnecessarily position them as ‘semi-drugs’. This situation might raise concern over the minds of many allopathic doctors as whether they can prescribe such products or not because allopathic science is fully a scientifically proven, globally accepted science and on the contrary, AYUSH is faith, GOD, and religion based practice.

The point is not against clinical trial or efficacy evaluation of new proprietary AYUSH products. Any half-hearted effort or touch and go namesake reforms cannot help to reform any system.

Due to the confidence that the AYUSH products are ‘commodities’ or ‘products that may have some medicinal value’, many allopathic doctors may be using their discretion and wisdom and prescribe some AYUSH products.

Once the new AYUSH products are introduced in the market with clinical trial proof, the question will be whether allopathic doctors can consider such AYUSH products still as unscheduled products is a big question. Further, the clinical trial data is although available, but the data generated at a pilot level may not be convincing. Further, the active principle, its absorption, its metabolism, evidence for the therapeutic effect only due to the herbs/active principle in the formulation etc., also required to be explained and established for the new AYUSH products. Even all such data are provided, the judgment of Honorable Supreme Court of India in defining the term ‘quacks’ will certainly impede the allopathic doctors from prescribing such new AYUSH products.

Considering all the above limitations, one would naturally ask whether the new initiatives by AYUSH for granting the license for proprietary AYUSH products really do any good to the system. When the unchecked cross pathy by large number of institutionally qualified AYUSH vaidyas continues, how the new initiatives of AYUSH will help the system to grow and expand? Is it not the duty and responsibility of the Ministry of AYUSH and CCIM to facilitate Ghar was of all those institutionally qualified AYUSH vaidyas back to own system to support and develop it? When clinical trial proof is provided by the industry, does it not sufficient for the AYUSH vaidyas trust own system?

The new initiative may limit the ISM industries to get the help of allopathic doctors as per the judgment of Honorable Supreme Court of India with reference to the term ‘quacks’ and ‘quackery’. When many institutionally qualified AYUSH vaidyas engage in quackery and mockery of AYUSH by going after cross pathy, how the system will grow and develop?

Unless we initiate collective steps and use collective wisdom to stop all possible nonsense in the system viz.,

a) False claim and misleading advertisements
b) Hyping pseudo-science
c) Cross pathy

the efforts of Ministry of AYUSH would go futile. AYUSH may be busy since the new Ministry was created like one sitting on a rocking chair that would keep one always busy but lands nowhere.

AYUSH will prosper and progress if the Government of India re-name AYUSH as Indian Traditional Medicine and its products as wellness and health products. Once the system is clearly defined and positioned for paramedical benefits, acceptance of the system become easy. As long as we create confusion in the society by allowing separate Ayurveda, Siddha, Unani, Homeopathy products for the treatment of every disease alongside scientifically proven allopathic system, we are leaving the choice of treating diseases to faith than to science. Such situation only would create medical mockery and health hazard by surrendering our medical care to faith and occultism.

Our society must benefit the best from every system. But unfortunately Government heavily sponsors the AYUSH to convince the world that it is full of science and evidence. It looks like Government never wants to do 5S in AYUSH may be because most of the practices and promises in AYUSH might not even worth to find place in the backyard.

Picking things from here and there and implementing them will not help any system to progress. Before introducing any new change or direction, we must honestly and impartially do deep introspection on the real strength, merit, science and credence of AYUSH in the light of what it has done and how it can benefit the present generation who live in the era of science and evidence at fingertips through google search.

The clinical trial for new proprietary AYUSH products is must and welcome step. But such initiatives should not end up in describing and defining the AYUSH products as drugs. We must promote AYUSH and its products only paramedical practice and products. Once AYUSH is passionately and unequivocally promoted as paramedical practice, its acceptance become easy so shall be the trust on the system.

Dr S Ranganathan