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: dr.amit98390@gmail.com

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