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.
Highlights
In the age of modern technology, scientific advancements, consumer awareness and the advent of evidence based medicine, attention has been given towards the quality control and marketing of the Ayurveda drugs
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%
The present study was undertaken to evaluate the impact of Drugs & Cosmetics Act and its implementation pertaining to the labelling standards of Ayurvedic drugs
Summary
In the age of modern technology, scientific advancements, consumer awareness and the advent of evidence based medicine, attention has been given towards the quality control and marketing of the Ayurveda drugs. In India, there are about 14 well-recognized and 86 medium scale manufactures of herbal drugs. Manufacture and quality control of Ayurvedic, Siddha and Unani (ASU) medicines come under the purview of Drugs & Cosmetics Act, Published online in http://ijam.co.in ISSN: 0976-5921. Drugs & Cosmetics Act, 1940 has a separate chapter IV- A(3) which states all the guidelines to be followed for manufacturing, packaging & labelling of ASU drugs. The latest amendments in this chapter were done on 22 March 2013 vide a Gazette notification by the Central Government(4) This notification laid certain new guidelines for labelling of the ASU drugs. 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. Conclusions: It was inferred that potentially large number of the Ayurvedic drugs being marketed in India are misbranded
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