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Unethical issues of ayurveda drug manufacturing - a critical review

Dr. Amritpal Singh
Thursday, August 31, 2017, 08:00 Hrs  [IST]

Ayurveda system of medicine has recently received boost by introduction of various schemes and certifications by Department of Ayush and private certifying organisations accredited by Quality Council of India. Several companies are opting for certifications like Kosher, Halal, HCCAP (Hazard Analysis and Critical Control Points and Ayush mark and many more. Some ayurvedic manufacturing units have been awarded Certificate of Pharmaceutical Product (CoPP) keeping in mind eve-expanding global market of Ayurveda. Several amendments in the Drugs and Cosmetics Act have been done with respect to ayurvedic drugs so as to enhance scientific credibility of the traditional Indian medicine.

Current scenario of unethical ayurvedic manufacturing
Due to revival of interest in Ayurveda at national as well as international level, several groups have entered in ayurvedic business. This has resulted in mushroom growth of substandard ayurvedic manufacturing units across India. It is worthwhile to mention that ayurvedic business has been hijacked by the religious people and genuine utility of Ayurveda has been overlooked or even killed due linking of medicine with religion.

Without having adequate knowledge of pharmacological and toxicological aspects, these ayurvedic manufacturing units are composing and introducing unscientific products exposing the masses to undue risks. Every country has own pharmacopoeia and the manufacturers are supposed to abide by the standards, protocols and standard operative procedures (SOPs) mentioned in the official publication including pharmacopoeia, addendum, formulary or codex.

In case of Ayurveda, one can look for Ayurvedic Pharmacopoeia of India (API) for data on single herbs. For information on polyherbal, herbo-mineral and polymineral for formulations, Ayurvedic Formulary of India (AFI) is the standard guide. Several companies have introduced commercial products incorporating overseas herbal drugs like St. John’s wort (Hypericum perforatum), Milk thistle (Silybum marianum), Saw palmetto (Sereno repens) and Bilberry (Vaccinium myrtillus) in ayurvedic composite formulations.  

Several manufacturers are deliberately mixing herbal extracts with crude drugs so as to cut off the cost involved in manufacturing. This is totally untechical as ethnobotanists often warn about intentional mixing of phytochemicals with crude drugs. The manufacturers are least bothered about batch to batch variability in concentration of active ingredients in finished formulations.

The State Licensing Authorities (SLAs) without taking into consideration of drug-interactions/side-effects arising out from unethical mixing of ingredients are issuing licenses for manufacturing which is a serious matter. Further, this is gross violation of the Essential Drug List issued by Department of Ayush for genuine guidance of the ayurvedic industry.

Herbal drug manufacturing norms in foreign countries
Scenario for registration of herbal/traditional/botanical medicines is well organised and effective. Stringent documentation for the safety and efficacy of the herbal formulation is mandatory while filing for registration. Emphasis is on pharmacological and toxicological aspects of herbal products ensuring safety among consumers. The US Food and Drug Administration (US FDA) and World Health Organization (WHO) policy on traditional medicines clearly throws light on safety issues. Material Safety Data Sheet (MSDS) is to be delivered along with product intended for commercial use. Further, rules related to manufacturing of herbal products are well defined and manufacturer has to ensure coherence between ingredients mentioned on the label and put in the formulation.

Unethical claims by ayurvedic manufacturing cos
Claims by several ayurvedic manufacturing companies for curing incurable diseases have tarnished the image of the genuine manufacturing houses. As per the Objectionable Advertisement Act, one cannot claim cure for 101 incurable diseases including hepatitis, AIDS, cancer, and gall bladder stone. On the contrary, it is shocking to see newspaper loaded with advertisements claiming cure for incurable diseases.

Big guns in the ayurvedic manufacturing sector are aware about the provisions of the Drugs and Cosmetics Act and Objectionable Advertisement Act. However, some pharmacies and quacks are doing justice to the potential of Ayurveda. Either, they are unaware about the provisions of the Drugs and Cosmetics Act and Objectionable Advertisement Act or shot of technical expertise to provide them with mandatory knowledge. Strict action is required from State Licensing Authorities to curb such malpractices so as to enhance the accountability of Ayurveda.

Future strategy
As per the vision of the Indian government, if we want to develop traditional Indian medicine on lines parallel to traditional Chinese medicine, the whole scene needs to be revamped. Myths should be extracted from facts and genuine model/strategy should be formulated to boost commercial utility of ayurvedic drugs. Bringing reforms in the ayurvedic drug manufacturing industry are a perquisite in achieving such an ambitious aim.

Ayurvedic Pharmacopoeia Committee, Siddha Pharmacopoeia Committee & Unani Pharmacopoeia Committee have been constituted by Government of India in order to lay down Pharmacopoeia Standards for Ayush drugs. Ayurveda, Siddha and Unani Drugs Technical Advisory Board (ASUTAB),Ayurveda, Siddha and Unani Drug Consultative Committee (ASUDCC), Ayurveda Drug Manufacturers Association (ADMA) and Ayurvedic Medicine Manufacturers Organization of India (AMMOI) are supposed to play a pivotal role in establishing the credibility of ayurvedic medicine and formulations derived from them.

(Author is herbal consultant based in Mohali)


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