Survey on The Label of Ayurvedic Classical and Proprietary Medicines in Accordance with The Drugs and Cosmetics Act

1940
Arindam Mallick*, Anirban Roy, Amartya Bose. Department of Ayurvedic Pharmaceutical Sciences, Lovely Faculty of Applied Medical Sciences, Lovely Professional University, Punjab.
Abstract
Ayurvedic drugs falls under the strict supervision of The Drugs And Cosmetics Act 1940. The labels provided on Ayurvedic drug containers must fulfill the requirements specified in this act (part XVII). Ayurvedic Medicines were selected by random sampling method and a list was developed. Compared the contents of those medicines label with the check list prepared in accordance with the Drugs & Cosmetics Act 1940. Total 50 labels were reviewed out of which 27 were classical medicines and 23 were proprietary medicines. Amongst the label of 27classical medicines 63% had the reference mentioned on it, the label of 48.15% where not in compliance, of which 14.8%did not have the expiry date, ingredients were not mentioned on the label of classical medicine i.e. 33.33%, labels of 29.63% did not bear the dose & direction of use, and labels of 3.7% did not have indication mentioned on the label, 51.85% complied with Drugs & Cosmetics Act 1940. In case of proprietary medicine 8.69% were not in compliance as they did not have the indication mentioned on the label.

Importance of a Label
Labels have all the information that we need to choose medicine correctly, and use it safely. "Ingredient" and the scientific name of the plants gives an idea to the doctors or the pharmacists about the information of that particular medicine. "Indications" provide with the name of disease or health problems that the medicine will treat. "Warning" tells who should not use this medicine. It also tells what we should and should not do when we take this medicine. If we take this medicine, we should be careful or we should ask the doctor before using this. "Direction" explains, how to use this medicine. Medicine have toxic effect in children then an auxiliary label, Keep away from children is mentioned.

Complied

Check List
No Indication

A standard checklist will be accumulated from The Drugs & Cosmetics Act 1940 1. References from standard authoritative texts to be considered in case of classical formulations. 2. Net content of the formulation . 3. Ingredient list with quantity. 4. License number( Manufacturing License Number/ Mfg. Lic. No/M.L). 5. Batch number (by words like lot. number, Batch no.). 6. Manufacturing date and Expiry date. 7. It should be mention Ayurvedic Medicine or Siddha Medicine or Unani Medicine. 8. Formulation which are made for external use should have the caption specified as For External Use Only. 9. CAUTION should be mentioned if poisonous substance (drug specified in Schedule E) is present in the formulation. 10. Indication mentioned. 11. Dose mentioned.

Aim
To study and evaluate the diagrammatic representation of Ayurvedic classical and proprietary medicine by developing a check list in accordance with Drugs & Cosmetics Act 1940 and Rule 1945

Recent Status
Now a days there are two types of Ayurvedic formulation available in market one is classical medicine that are prepared or manufactured as described in Ayurvedic Samhitas, and another is patent and proprietary medicines prepared by plant extract or by further modification of method of preparation. So, there are some regulation mentioned in The Drugs and Cosmetics Act, 1940. According to the act , labels should displayed the following information's, viz. reference should always be mentioned in the label of Ayurvedic classical medicine, percentage of alcohol should be mentioned in case of medicine contains alcohol (Asavas, Aristas) there should be mentioned net weight of formulation, name and quantity of Ingredients, caution or warning, manufacturing date, expiry date, license number, batch number. The survey was pursued to ascertain that whether the Ayurvedic drug labels were in accordance with The Drugs & Cosmetics Act, 1940, with respect to their contents.

No Reference

Result
Classical Medicine Total Number Compliance
Complied

Percentage (%)

Proprietary Medicine 23

Percentage (%)

27 14 13 10 4 8 1 9 51.85 48.15 37.04 14.81 29.63 3.7 33.33

21 2 0 0 0 2 0

91.3 8.7 0 0 0 8.69 0

Non Compliance Reference Mentioned No Exp. Date No Dose/Direction No Indication No Ingredient

Methodology
Review of Literature (Study The Norms As Mentioned In The Drugs And Cosmetics Act 1940) Create A Check List Congregating Ayurvedic Classical And Proprietary Medicines From Market

Figure A and B shows the compliance and non compliance of classical and proprietary medicines

(Fig: A) Classical Medicine

Complience Non Compliance

Conclusion
From this survey we can conclude that the label of all the Ayurvedic medicines doesnt comply with the regulations mentioned in The Drugs and Cosmetics Act 1940, which should be mentioned in each and every medicine. Government organization should take interest in supervising it.

(Fig: B) Proprietary Medicine

Complience

Acknowledgement
At first we grab to thank our H.O.D., Dr. Sorabh Lakhanpal for guiding us through out the survey. We are also very grateful to our respected teachers Dr. Vikas Saroch and Ms. Amrinder Kaur for helping us to complete the work. Last but not the least we would like to convey our thanks to all the members of Department of Ayurvedic Pharmaceutical Sciences for granting us the permission to carry out the survey.

Compare The Medicines with Respect To The Check List

Non Compliance

Develop The Final Data (Result)

National Seminar on Recent Advances and Future Challenges in Ayurveda, Date & Venue : 26 March 2012 at Banaras Hindu University, Rajiv Gandhi South Campus, Barkachha, Mirzapur (UP) - 231001.