Misbranding of Ayurvedic pharmaceutical preparations A market survey report

Abstract

Background: The annual turnover of the Indian herbal medicinal industry is about Rs. 7,500 crore as against the pharmaceutical industry’s turnover of Rs. 14,500 crores with a growth rate of more than 15%. Certainly some regulations are required to keep a check on this massive industry. Drugs and Cosmetics Act, 1940 (D& C Act) lays down the regulatory and recommendatory standards for Ayurvedic drugs. Objective: The present survey study was undertaken to assess the compliance of the D & C Act by the Ayurveda drugs manufacturing units. The guidelines laid down by this act formed the basis of the study. Materials & Methods: A total of 100 drug labels from 13 different major pharmaceutical houses were collected from the market and analysed on the basis of guidelines for labelling laid down under D&C Act, 1940. Results: It was found that none of the labels satisfied all the guidelines pertaining to labelling standards of the Ayurvedic drugs. It was observed that 92% drug labels did not mention the API standards of the drugs used while 99% drug labels did not mention the part of the plant used. Conclusions: It was inferred that potentially large number of the Ayurvedic drugs being marketed in India are misbranded.