Shelf life and Labeling according to D&C Act

1. SHELF LIFE / DATE OF
EXPIFY OF AYURVEDIC
FORMULATIONS
Dr. Amit Bhatt
M.D. Scholar, Deptt. Of R.S. & B.K.
Rajiv Gandhi Govt. PG Ayurvedic College, Paprola (H.P.)
E mail ID: dr.amit98390@gmail.com

2. Drugs and Cosmetics
(Amendment) Rules, 1945
NOTIFICATION ON
the 24th November, 2005

3. Rule: 161-BRule: 161-B
The date of expiry of Ayurveda, Siddha
and Unani (ASU) medicines shall be
conspicuously displayed on the label of
container or package of an Ayurvedic,
Siddhas and Unani drugs, after which
they shall not be in circulation. Shelf-life
for Ayurveda, Siddha & Unani (ASU)
medicines shall be as follows:

4. Arka / Eye Drops
1 Year

5. Churna / Kwath Churna / Ghrita /
Varti, Shwet Parpati
2 Years

6. Gutika containing Kasth
aushadhi (Vati-Guti, Pills,
Tablets except Gutika with Rasa)
3 Years

7. Ghan vati / Avaleha / Taila /
Oral Liquid Syrup /
Khand / Pak / Grannules
3 Years

8. Lepa Churna & Guti /Capsules /
Lepa malahar (Ointments) /
Liniment / Gels / Lotions / Creams
3 Years

9. Capsules made of soft gelatin
containing Kashtha aushadhi
3 Years

10. Capsules made of hard gelatin
containing Kashtha aushdhi with
Rasa, Bhasma, Parada-Gandhak
5 Years

11. Gutika / Tablet containing Kasth
aushadhi and Rasa, Uprasa,
Metallic Bhasma & Guggulu
5 Years

12. Guggulu / Dravaka /
Lavana / Kshara /
Nag, Vang & Tamra Bhasma
5 Years

13. Mandura - Lauha
10 Years

14. Rasaushadhis / Parpati /
Kupipakva Rasayana /
Pisti & Bhasma /Asava – Arista
No Expiry Date

15. Svarna Bhasma / Rajata Bhasma /
Abhraka Bhasma /
Godanti / Shankha Bhasma
No Expiry Date

16. LABELINGLABELING

17. Drugs and Cosmetics
(Amendment) Rules, 1945
Rule: 161 (3)

18.  The name of the Drug as approved
by the Licensing authority.
 A correct statement of the nett
contents in terms of weight, measure
or number expressed in the metric
system and in accordance with the
approval given by the Licensing
authority.

19.  The name and full address of the
Manufacturer.
 The number of the License under
which the drug is manufactured.
 A distinctive batch number with the
date of manufacture.

20.  The words “Ayurvedic medicine” or
“Siddha medicine” or “Unani
medicine” as the case may be.
 The words “FOR EXTERNAL USE
ONLY” if the medicine is for
external use.

21.  The word “Not to be sold” and
“Govt. Supply” which shall be
overprinted.
 Date of Expiry as has been fixed by
Govt. of India

22. THANKSTHANKS