e-commerce business in Ayurveda - legal issues

Ayurvedic system of medicine is making a dramatic comeback. Ayurvedic renaissance is not an Indian subject, but it is blooming across the globe.  Several big guns of the pharma industry are investing in this emerging business. Ayurvedic practitioners are adopting the path of e-commerce for reaching patients across the globe. The retail business in the ayurvedic drug industry is the buzz word.

Ayurvedic products promoted via internet
Personal care product: These may include medicated oils, skin creams and hair-oils.
Beverages: These include confections, syrups, and packaged teas.
OTC:  Products for constipation, cough and pain (balms ad liniments).

Legal formalities
If practitioners of Ayurveda and speciality ayurvedic clinics adopt e-commerce as a tool for reaching the masses, they need to fulfil other legal formalities too. M-health is an abbreviation for mobile health, a term used for the practice of medicine and public health supported by mobile devices. E-Health is a relatively recent term for healthcare practice supported by electronic processes and communication, dating back to at least 1999. Telemedicine, online pharmacies, online sale of prescribed drugs and medicines and e-ayurveda are some other modes for promoting herbal, ayurvedic and nutraceutical business.

Ayurveda retail biz
India’s retail market is expected to cross 1.3 trillion USD by 2020 from the current market size of 500 billion USD. Modern retail with a penetration of only 5% is expected to grow about six times from the current 27 billion USD to 220 billion USD, across all categories and segments. Recently, we have witnessed that retail business in Ayurveda is blooming and it is rather unregulated. In order to open ayurvedic chemist shop, there is no requirement of the licensing process and we have witnessed mushroom growth of sub-standard ayurvedic pharmacies and stores including online. Further, companies are setting up clinics across the country in shops/stores.

Provisions of D&C Act 1940 applicable to ASU drugs

• 33C. ASU Drugs Technical Advisory Board
• 33D. ASU Drugs Consultative Committee
• 33E. Misbranded drugs
• 33EE. Adulterated drugs
• 33EEA. Spurious drugs
• 33EEB. Regulation of manufacture for sale of ASU drugs
• 33EEC. Prohibition of manufacture and sale of certain ASU drugs
• 33EED. Power of Central govt to prohibit manufacture, etc, of ASU drugs in public interest
• 33F. Government analysts
• 33G. Inspectors
• 33H. Application of provisions of sections 22, 23, 24 and 25
• 33-I. Penalty for manufacture, sale, etc, of ASU drugs in contravention of this Chapter
• 33J. Penalty for subsequent offenses
• 33K. Confiscation
• 33L. Application of provisions to govt departments
• 33M. Cognizance of offenses
• 33N. Power of Central govt to make rules
• 33O. Power to amend first Schedule

Magic Remedies Act (Objectionable Advertisements) Act, 1954 and Ayurveda
An Act to control the advertisement of drugs in certain cases, to prohibit the advertisement for certain purposes of remedies alleged to possess magic qualities and to provide for matters connected therewith.

Drugs and Magic Remedies:  A medicine for the internal or external use of human beings or animals; Any substance intended to be used for or in the diagnosis, cure, mitigation, treatment or prevention of disease in human beings or animals; Any article, other than food, intended to affect or influence in any way the structure or any organic function of the body of human beings or animals; Any article intended for use as a component of, any medicine, substance or article, referred to in sub-clauses (i), (ii) and (iii); (i). The definition of drug under the Act is comprehensive and even the machine which is an article and covered by the definition. The definition of ‘drug’ in Section 2 is very comprehensive and exhaustive. Unlike definition of the drug under D&C Act 1940, it brings within its ambit, medicines of all systems including Ayurvedic drugs.

Magic remedy includes: A talisman, mantra, kavacha and any other charm of any kind which is alleged to possess miraculous powers for or in the diagnosis, cure, mitigation, treatment or prevention of any disease in human beings or animals or for affecting or influencing in any way the structure or any organic function of the body of human beings or animals;

‘Taking any part in the publication of any advertisement’ includes: (i) The printing of the advertisement; After consultation with the DTAB constituted under the D&C Act 1940 (23 of 1940) and, if the Central govt considers necessary, with such other persons having special knowledge or practical experience in respect of ayurvedic or unani systems of medicines as that govt deems fit.

Several ayurvedic companies involved in e-commerce and internet selling of herbal products is violating norms of Magic Remedies Act. As an instance, several companies are openly claiming permanent cure for cancer, which is gross violation of the norms of the above described Act.

Practitioners of Indian Medicine Regulations 1982
Part 4 of Practitioners of Indian Medicine Regulations 1982, deals with code of ethics. Under section 24, dealing with advertisement, it is mentioned

Solicitation of patients directly or indirectly either personally or by advertisement in the newspaper, by placards or by distribution of circular cards or hand bills by a practitioner of Indian medicine is unethical. A practitioner shall not make use of or aid or permit others to make use of him or his name and/or photograph as subject of any form or manner of advertising or publicity. This provision shall not apply to authors of purely medical literature written for the advancement of the profession and science.

Disciplinary action can be taken if practitioners of Indian Medicine are convicted under the provisions of the D&C Act 1940 or the rules made hereunder.

Problems associated with unregulated sale of ayurvedic products
Heavy metal issues: Ayurvedic theory attributes important therapeutic roles of metals such as mercury and lead. Ayurveda experts estimate that 35% to 40% of the approximately 6000 medicines in the ayurvedic formulary intentionally contain at least 1 metal. Evidence from various countries implies that toxic heavy metals and undeclared prescription drugs in Asian herbal medicines might constitute a serious health problem. Several cases of lead-poisoning, arsenic poisoning and mercury-poisoning have been reported after consumption of ayurvedic formulations.

Genotoxicity: Very little information is available on the genotoxicity potential of Ayurvedic products.

Presence of Aristolochic acid in Ayurvedic formulations: Aristolochic acids are a family of carcinogenic, mutagenic, and nephrotoxic compounds commonly found in the plant family Aristolochiaceae. Chronic interstitial nephropathies in Indians were mentioned to be associated with Aristolochia sp. In Ayurveda, Aristolochia bracteata is known as Kitmari or Dhumapatra. It is a shrub distributed throughout India. In the Ayurvedic system of medicine, the plant is used for the treatment of skin-diseases, inflammation and purgative. Another species is A. indica, known as Jata.

Pyrrolizidine alkaloids: Although, this issue is not so hot, but need to be tackled effectively. More than 500 different PAs are found in over 6,000 plant species. We need to study distribution of pyrrolizidine alkaloids in Ayurvedic formulations and address health hazards associated with their consumption.

Ayurvedic-synthetic drug interactions: Ayurvedic-synthetic drug interactions have been reported in various studies published in journals. Interaction between guggulip and atenolol, impact of trikatu on the bioavailability of rifampicin, diclofenac-sodium, isonaizid, carbamazepine, indomethacin, pefloxacin, ampicillin and norfloxacin has been reported.

Ayush notification on classical ayurvedic medicines
In recent times, Department of Ayush, Ministry of Health and Family Welfare, Govt of India, banned the classical ayurvedic medicines that were being sold in the market with prefixes and suffixes. The purpose of this move was to prevent the alteration in the classical ayurvedic formulations. A number of classical ayurvedic formulations, as an instance, Chyawanprashavleha is sold in the market under various trade names.  The purpose of giving the trade name to classical ayurvedic formulations is to reflect the value addition to the potential buyer. This step is an example of legal compliance that practitioners of ayurveda and clinics need to maintain.

Importance of pharmacovigilance
The goals of Ayurveda’s pharmacovigilance programme are to improve: Patient care and safety when using ayurvedic medicines and related interventions; Public health and safety records of ayurvedic medicines; Assessment of benefit, harm, effectiveness, and risk of medicines; Encouragement of safe, rational, and more effective (including cost effective) use, and promotion of understanding, education, and clinical training in pharmacovigilance for ayurvedic medicines and its effective communication to the public. Many cases have been reported in the recent past regarding ADRs and drug-drug interactions at various national and international forums.

Conclusion
The purpose of this article is not to promote or rebuke the scope of internet-selling or role of e-commerce in the propagation of ayurvedic business across the globe. The companies promoting ayurvedic business should ensure that all legal and regulatory aspects associated with e-commerce are effectively met with. It may be a good mode to reach out masses, but at the same time it is unethical to expose the patient to the word of ADRs.