shelf life of ayurvedic drugs and labeling
TRANSCRIPT
SHELF LIFE / DATE OF EXPIFY OF AYURVEDIC
FORMULATIONS
Dr. Amit BhattM.D. Scholar, Deptt. Of R.S. & B.K.
Rajiv Gandhi Govt. PG Ayurvedic College, Paprola (H.P.)
E mail ID: [email protected]
Drugs and Cosmetics (Amendment) Rules, 1945
NOTIFICATION ON
the 24th November, 2005
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:
Arka / Eye Drops
1 Year
Churna / Kwath Churna / Ghrita / Varti, Shwet Parpati
2 Years
Gutika containing Kasth aushadhi (Vati-Guti, Pills,
Tablets except Gutika with Rasa)
3 Years
Ghan vati / Avaleha / Taila / Oral Liquid Syrup /
Khand / Pak / Grannules
3 Years
Lepa Churna & Guti /Capsules /Lepa malahar (Ointments) /
Liniment / Gels / Lotions / Creams
3 Years
Capsules made of soft gelatin containing Kashtha aushadhi
3 Years
Capsules made of hard gelatin containing Kashtha aushdhi with Rasa, Bhasma, Parada-Gandhak
5 Years
Gutika / Tablet containing Kasth aushadhi and Rasa, Uprasa, Metallic Bhasma & Guggulu
5 Years
Guggulu / Dravaka / Lavana / Kshara /
Nag, Vang & Tamra Bhasma
5 Years
Mandura - Lauha
10 Years
Rasaushadhis / Parpati /Kupipakva Rasayana /
Pisti & Bhasma /Asava – Arista
No Expiry Date
Svarna Bhasma / Rajata Bhasma / Abhraka Bhasma /
Godanti / Shankha Bhasma
No Expiry Date
LABELINGLABELING
Drugs and Cosmetics (Amendment) Rules, 1945
Rule: 161 (3)
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.
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.
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.
The word “Not to be sold” and “Govt. Supply” which shall be overprinted.
Date of Expiry as has been fixed by Govt. of India
THANKSTHANKS