Introduction to Ayurveda
Allopathic medicine, or modern Western medicine, has always played a dominant role in contemporary healthcare systems and is currently the mainstream practice. Nonetheless, Ayurveda – one of the oldest medical systems dating back thousands of years has stood the test of time, as its followers have reposed trust in its holistic healing properties for centuries. Ayurveda translates to “knowledge/science of life” in Sanskrit and emphasises the interconnectedness of the mind, body, and spirit for optimum health and wellness.
Ayurvedic pharmaceuticals initially used materials available in the natural ecosystem, such as roots, stems, barks, and fruits of plants, as key ingredients. However, as Ayurvedic knowledge advanced, practitioners began incorporating medicinal agents from animals, minerals, and metals, particularly mercury, gold, copper, and sulphur. Years of research and evaluations by early practitioners have culminated in the creation of formulations for a wide range of illnesses and conditions in both humans and animals.
The Drugs and Cosmetics Act, 1940 (“D&C Act”), identifies as Ayurveda, Siddha, and Unani drugs (“ASU Drugs”) only those medicines which are intended for use by humans or animals for the diagnosis, treatment, mitigation, or prevention of diseases/disorders and manufactured “exclusively in accordance with the formulae described in the authoritative books of Ayurvedic, Siddha and Unani Tibb systems of medicine (as specified in the First Schedule of the Drugs Act)”.[1] Hence, this likely disqualifies all natural products, ingredients, or their derivatives as Ayurvedic products. ASU Drugs are formulations stated in the authoritative texts specified in the First Schedule of the D&C Act, whereas, in the context of Ayurvedic, Siddha, or Unani Tibb systems of medicine, “Patent or Proprietary Medicine(s)”[2] are formulations prepared using the ingredients stated in the authoritative texts specified in the First Schedule of the D&C Act and referred to as “Ayurvedic Proprietary Medicines”.
It is imperative to reiterate that any wellness product containing natural/organic ingredients does not qualify as an ASU Drug unless manufactured in terms of the authoritative books of Ayurveda as identified in the D&C Act.
Regulation of ASU Drugs under the D&C Act
Keeping in mind the safety considerations surrounding the manufacture and development of ASU Drugs and Ayurvedic Proprietary Medicines, the Ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homoeopathy (“Ayush”) prescribed the criteria for licensure of ASU Drugs and Ayurvedic Proprietary Medicines under the Drugs Rules, 1945 (“Drugs Rules”). Among other things, the Drug Rules prescribe the specific regulatory provisions for granting license to manufacture ASU Drugs and enforcing Good Manufacturing Practices for their safety, quality, and standards. The Drugs Rules[3] specifically categorises the requirements for developing new ASU Drugs and Ayurvedic Proprietary Medicines and implementing material changes in existing ASU Drugs, including changes to the dosage form and approval for new indications. Following is the summary:
| S. No. | Category | Ingredient (s) | Indication (s) | Safety Study | Experience/Evidence of Effectiveness | |
| Publication Literature | Proof of Effectiveness | |||||
| 1. | New ASU Drug | As per authoritative text | As per authoritative text | Not required | Required | Not required |
| 2. | Any change in dosage form of ASU Drugs | As per authoritative text | As per authoritative text | Not required | Required | Not required |
| 3. | ASU Drugs to be used for new indications | As per authoritative text | New | Not required | If required | Required |
| 4. | New Ayurvedic Proprietary Medicine | As per authoritative text | Textual rationale | Not required | Of ingredients | Pilot study as per relevant protocol for ASU Drugs |
| 5. | Ayurvedic Proprietary Medicines with any of the ingredients stated under Schedule E(1) | As per authoritative text | Existing | Required | Required | Required |
A reading of the D&C Act reveals the dearth of ASU Drugs specific regulations in the D&C Act read with the Drugs Rules in comparison with the requirements prescribed for the development of allopathic medicines under the New Drugs and Clinical Trial Rules, 2019 (“NDCT Rules”). As only Ayurvedic Proprietary Medicines containing any of the ingredients stated under the Schedule[4] requires the applicant to undertake safety studies, it is evident that the stringent standards of safety, efficacy, and testing mandated for allopathic drugs have not been replicated for ASU Drugs/Ayurvedic Proprietary Medicines.
Safety/Efficacy and Clinical Evaluation of Ayurvedic Formulations
The practice of conducting experiments to guarantee the safety of food and drugs dates back centuries. Evidentiary documents, such as “Vishanna/Virudhanna Pareeksha” or trials on animal, prove the existence of preclinical testing in Ayurvedic practices. The Central Council for Research in Ayurvedic Sciences (“CCRAS”), a division of the Ministry of Ayush, Government of India, has issued guidelines prescribing the necessary steps/phases in Ayurvedic drug development (including safety/toxicity[5] and clinical evaluations[6] of Ayurvedic formulations). The new-drug development process has a series of steps that include assessing the safety and efficacy data related to both humans and animals. The general objectives of the non-clinical safety study are to characterise the toxic effects on target organs, dose dependence, relationship to exposure, and, when appropriate, potential reversibility. The purpose of the data is to help determine the parameters for clinical surveillance for any side effects and an initial safe starting dose and dose range for human trials. The goal of clinical evaluation of ASU Drugs/ Ayurvedic Proprietary Medicines is to find or confirm any adverse effects – be it clinical, pharmacological (including pharmacodynamics and pharmacokinetics), or both – and assess the drug’s safety and/or effectiveness.
The clinical evaluations for ASU Drugs differ from the clinical trial of allopathic drugs, as required under the NDCT Rules. The CCRAS guidelines have prescribed four phases of clinical trials for ASU Drugs/ Ayurvedic Proprietary Medicines: (i) Phase I: Human Pharmacology; (ii) Phase II: Therapeutic exploratory trials; (iii) Phase III: Therapeutic confirmatory trials; and (iv) Phase IV: Post-marketing trials. In comparison with the clinical trials mandated for allopathic drugs under the NDCT Rules regime, the phases of the clinical evaluation of ASU Drugs/Ayurvedic Proprietary Drugs are rudimentary and not holistic. For example, the objectives of the Phase 1 trials in ASU Drugs do not include pharmacokinetics[7] and pharmacodynamics – objectives considered critical in Phase 1 of clinical trials conducted under the NDCT Rules.
Of late, efforts are underway to carry out further research on Ayush streams, however, such research findings have little or no translational value because only a few have progressed to clinical trials and marketing. Several significant ASU Drugs remain obscure because of the absence of such yardsticks as pharmacology, pharmacokinetics, and pharmacovigilance – all of which are essential to ascertain the efficacy and safety of drugs. Ayurveda desperately needs modern research methodology, which is rooted in the scientific method, to authenticate its fundamental ideas and drugs. Just as validated research and sophisticated methodologies have helped the western medical system become the gold standard and establish deep public trust, improvements in the current research approach are imperative to the growth and acceptance of Ayurveda.
Concluding Thoughts and the Way Forward
Organisations are increasingly leaning towards finding innovative and marketable solutions rooted in ancient medicinal practices. This trend continues to flourish given the current demography’s preference for natural products. The CCRAS has continually tried to draw up comprehensive guidelines for stakeholders that address drug development (standardisation and quality assurance), safety and toxicity, and clinical evaluation. Nonetheless, a detailed assessment of Ayurvedic herbs and herb products in line with current preclinical trial and drug review practices is necessary to ensure more effective therapeutic outcomes in global medicine. In India, allopathic drugs development, conducted under the NDCT Rules, follows globally accepted methodologies; however, Ayurvedic and patent/proprietary Ayurvedic medicines follow a different set of regulatory protocols. This has resulted in the proliferation of sub-standard products with dubious efficacy, negatively impacting public faith in Ayurveda and its global stature.
With the resurgence of global interest in holistic healing modalities placing Ayurveda (along with other complementary and alternative medicinal treatments) under the spotlight, the only way forward towards unlocking the full potential of Ayurveda is to ensure collaborative efforts between traditional practitioners, clinical scientists, policy makers, and healthcare professionals.
For further information, please contact:
Biplab Lenin, Partner, Cyril Amarchand Mangaldas
biplab.lenin@cyrilshroff.com
[1] In terms of section 3(a) of the Drugs and Cosmetics Act, 1940.
[2] Section 3(h) of the Drugs and Cosmetics Act, 1940, stipulates that “patent or proprietary” medicine in relation to Ayurvedic, Siddha, or Unani Tibb systems of medicine are all formulations containing only those ingredients mentioned in the formulae described in the authoritative books of Ayurveda, Siddha, or Unani Tibb systems of medicine specified in the First Schedule, but does not include a medicine administered by the parenteral route and also a formulation included in the authoritative books as specified in Section 3(a).
[3] In terms of rule 158-B of the Drugs Rules, 1945.
[4] Schedule E(1) of the D&C Act
[5] General Guidelines for Safety/Toxicity Evaluations of Ayurvedic Formulations, available at http://www.ccras.nic.in/sites/default/files/viewpdf/Publication/CCRAS_Guideline%20of%20Safety_Toxicity.pdf.
[6] General Guidelines for Clinical Evaluations of Ayurvedic Formulations, available at http://www.ccras.nic.in/sites/default/files/viewpdf/Publication/CCRAS_Guideline%20of%20Clinical_Evaluation.pdf.
[7] Characterisation of a drug’s absorption, distribution, metabolism, and excretion.
