Informatics Publishing Limited

Nutan Nabar ¹, Rama Vaidya ², D. B. A. Narayana ³, Ashwinikumar Raut ⁴, Sanjiv Shah ⁴, Bhushan Patwardhan ⁵, Ashok Vaidya ⁴

Affiliations
1 Symbiosis International University, Pune, IN
2 Kasturba Health Society's Medical Research Centre, ICMR Advanced Centre for Reverse Pharmacology in Traditional Medicine Medical Research Center-KHS, 17, Khandubhai Desai Road, Vile Parle (West), Mumbai 400 056, IN
3 Ayurvidye Trust, Bangalore, IN
4 Kasturba Health Society's Medical Research Centre, Mumbai, IN
5 The Interdisciplinary School of Health Sciences, Pune, IN

Abstract

Diabetic patients, in India are known to take one or more Marketed Ayurvedic Antidiabetic Formulations (MAAF) alone or with the conventional drug/s as over the counter or through self medication. The labeling information is crucial for patient information and safety besides fulfilling the regulatory needs. for drugs from any system of medicine. The present study was aimed at to study MAAF for patient information, regulatory compliance and patient safety.

The labels of 180 MAAF were analysed as to the details of brand names, dosage forms, ingredients, composition, dosage schedule and precautions. Package inserts of additional fifty three MAAFs were reviewed for the compliance.

The ingredients used in the products varied widely, as to the plants' identity, parts and extracts used and their concentrations. The dosage of the ingredients ranged from a few mgs to 2-3 gms, depending on raw herbs or extracts used. The current labels, studied for the composition details, did not clearly indicate the quantity of each ingredient to the original raw herb quantum. There was a wide variation in the way composition was printed on the label. The study shows a need for improvement in compliance to labeling regulations. There was no information about the suitability of these drug's administration in pregnancy and/or lactation.,or specific dose and drug formulation for paediatric and geriatric groups.

Brand names studied have chiefly reflected antidiabetic/Madhumehaghna activity. However, some of the brand names like Sugar Knocker, Sugar balance etc convey exaggerated claims. Drug regulators may continue to license MAAF with brand names but sanction those that could be misleading. Ayurvedic manufacturers need to consider and register their trade names under Trade Mark Registration Act to avoid duplicity and misuse of same names, across the state of India.

Keywords

Ayurvedic Antidiabetic Medicine, Ayurvedic Pharmacoepidemiology, Drug Regulation, Brand Names, Labeling and Package Inserts, MAAF.

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