A survey for labeling compliance of Ayurvedic medicines containing Schedule E1 drugs mentioned in the Drugs and Cosmetics Act

Abstract BACKGROUND: Poisonous substances under the Ayurvedic System of Medicine are listed in Schedule E1 of the Drugs and Cosmetics Act (D and C Act), 1940, and Rules, 1945, which mandates caution in their use. Furthermore, Part XVII, Rule 161 of the act specifies labeling requirements for Ayurvedic drugs, ensuring consumer safety and regulatory compliance. In this context, the present study was undertaken to evaluate the labeling information provided on containers of Ayurvedic drugs containing Schedule E1 substances and to examine the extent of compliance with the provisions of the D and C Act, 1940. METHODS: Labels of Ayurvedic classical, as well as Ayurvedic proprietary medicines, containing an ingredient of Schedule E1, were collected from the 26 Ayurvedic retailers/pharma companies based on the convenience sampling method. Their contents were checked against a checklist of quality criteria given in the act. The results are expressed as percentages. RESULTS: A literature review of the Ayurvedic Formulary of India showed that a total of 372 Ayurvedic classical formulations are reported as any of the ingredients of Schedule E1 drugs. In this study, a total of 318 labels were observed, comprising 161 (51%) classical formulations and 157 (49%) proprietary formulations. In the classical formulation, 14% of labels did not comply with a list of ingredients, botanical name, and quantity of each ingredient. A caution warning for schedule E1 drug-containing medicines was missing on 11% of classical as well as 45% proprietary medicines. CONCLUSION: This study provides scientific information on the labeling of Schedule E (1) containing drugs, and the data obtained may prove helpful for policy decisions towards improving patient safety and labeling of Ayurvedic drugs.