2. CONTENTS
Introduction
D&C Rule 161
Current scenario
Shelf life – revised rule
Estimation of shelf life & stability testing
Discussion
Conclusion
Reference
04-Apr-18Rule 161-B D&C Act
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3. INTRODUCTION
The Drug and Cosmetic act, 1940
An act to regulate to import, manufactures, distribution
and sale of drugs and Cosmetics.
The Drug and Cosmetic Rule 1945
The D&C Rule 1945 are the set of rules under the D&C
Act, 1940 which contains provisions for classification of drugs
under given schedules and there are guidelines for the
storage, sale, display and prescription of each schedule.
D&C rules have been divided into 18 parts each dealing with
a particular subject. There are 2 Schedules in D&C Act act and
26 schedules in D&C rules.
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Rule 161-B D&C Act
4. D&C Rule 161
Labeling, Packing and Limit of Alcohol
1. Labeling
2. Caution : To be taken under medical supervision (both in
Hindi and English)
3. Following particular shall be either printed or written
• Name of the drug
• Name and address of manufactures
• License number
• Batch Number
• Date of Manufacturing
• Ayurveda /Siddha/Unani medicine should be printed
• FOR EXTERNAL USE ONLY
• Physician sample or Not to be sold – shall be over printed
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Rule 161-B D&C Act
5. D&C RULE 161 B
• The amendment of Rule NO.161-B of D&C Act-1940,
specify the maximum shelf life or date of expiry,
unless otherwise determined on the basis of scientific
data of an Ayurvedic medicine defined under clause (a)
of section 3 of the Act.
• The Ayurvedic medicine defined under clause (h) of
section 3 of the drugs and cosmetic act 1940, the
scientific data based shelf life based on the Real-time
stability studies of medicines should be derived in
accordance with the guidelines prescribed in API Part I,
Vol 8.
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Rule 161-B D&C Act
6. CURRENT SCENARIO
Till 2009 – Rule 161 of D&C- dealt with rules applicable for the
o Labeling
o Packing
o Limit of alcohol for ASU medicine
In 2009 Dept. of AYUSH under Ministry of Health and family vide G.S.R
764(E) dated 15th Oct. 2009 the Rule 161-B of D&C act 1940 and Rule 1945
further revised.
The focal points as follows:
1. (1) These Rules may be called the Drug and Cosmetics (5th
Amendment Rules, 2016)
(2) They shall come into force on the date of their publication in the
Official Gazette.
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Rule 161-B D&C Act
7. 2. In the D&C Rules, 1945, for rule 161-B the following rule shall
be substituted, namely
“161 – B. Shelf life or date of expiry of
medicine”
Display of date of expiry
For license/renewal –submission of scientific data based on
stability studies
Guidelines of stability study in API , part 1, vol 8
Ensure of validity of data
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Rule 161-B D&C Act
8. NO NAME OF MEDICINE SHELF
LIFE
1. Anjana
a) Kashta medicines made
b) Rasa/ uparasa/ bhasma + kashta
c) Only rasa/ uparasa/ bhasma made anjana
1 yr
2 yr
3 yr
2. Arka 1 yr
3. Asava & Arishta 10 yrs
4. Avaleha, khanda, paaka, guda 3 yrs
5. Churna, kwatha churna, lepa churna, danta
manjan (Powder & paste)
2 yrs
6. Dhupana 2 yrs
7. Dravaka, lavana, kshara 5 yrs 8
Shelf life of different ayurvedic dosage
forms
revised rule 161 B
04-Apr-18Rule 161-B D&C Act
9. 8. Ghrita 2 yrs
9. Guggulu 5 yrs
10. Gutika/ vati
a) Rasa/ uparasa/ guggulu + kashta
b) Only kashta
c) Only rasa/ uparasa/ bhasma except
naaga, vanga and tamra bhasma
5 yrs
3 yrs
10 yrs
11. Karna/ nasa bindu 2 yrs
12. Kupipakwa rasayna 10 yrs
13. Malahara 3 yrs
14. Mandura- loha 10 yrs
15. Naaga, vanga, tamra bhasma 5 yrs
16. Netra bindu 1 yr
17. Parpati 10 yrs
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Rule 161-B D&C Act
11. 11
ESTIMATION OF SHELF LIFE & STABILITY TESTING
API part 1 vol 8 appendix 3.9
1. Scope and objective
2. General information of stability
3. Selection of batches
4. Container and closure systems
5. Specifications
6. Testing frequency
7. Storage conditions
8. Evaluations
04-Apr-18Rule 161-B D&C Act
12. Carried out to demonstrate the medicine will
remain suitable for consumption during
shelf life period under conditions mentioned
Factors effecting stability – nature,
ingredients, packaging etc
Normal temp – below 300C
Purpose of stability testing – evidence
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GENERAL INFORMATION OF STABILITY
04-Apr-18Rule 161-B D&C Act
13. Should be conducted on at least three primary
batches
New product – pilot batch of 1/10th of
commercial batch size
Quality of batch should represent the
commercial scale
Product preparation using different batch of
ingredients
Stability test on each individual strength and
container size (unless bracketing and matrixing
applied)
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SELECTION OF BATCHES
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14. List of tests, reference to analytical procedure and
proposed acceptance criteria
Test of those attribute that changes quality, purity
and efficacy on time
Should cover physical, chemical, biological and
microbiological attributes
Validating stability indicating analytical procedures
Suitable bioassay
Proposed acceptance criteria specified in
pharmacopoeia
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SPECIFICATIONS
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15. In normal storage conditions;-
for drug of shelf life 12 months;
study in every 6 months for first 2 year, then
annually
In accelerated storage conditions; a min of 3 time
points – 6 months
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TESTING FREQUENCY
Accelerated :- 400C ± 20C for 6
months
Long term :- 300C ± 20C for 12
months
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16. Significant changes for a drug:-
+ /- 20% change from initial assay value (marker)
+ /- 15% change from initial assay value (active
compound)
Appearance of new spots in identification by TLC
Change of beyond 25% in physico-chemical values
Failure to clear acceptance criteria as per
monograph
Failure to clear acceptance criteria for appearence
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EVALUATION
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17. DISCUSSION
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Rule 161-B D&C Act
Saviryata Avadhi is that period during which the Virya
(potency) of a drug remains unchanged/undiminished. In
other words, it is the period during which a formulation/drug
may be safely administered for maximum benefit.
•Main factors affecting Shelf life are:
Dosage forms
Environmental factors (humidity, temp, light etc.)
microbial contamination
storage conditions
Packing systems
18. DOSAGE FORM SH, SAM VANGA
SEN
Y.RATNAKARA
Swarasa 1prahar
Kalka ‘’
Kwata ‘’
Churna 2months 3months
Vati 12months
Leha/guda 12months 12months 6months
Ghrita, taila 16months 6 months 12months
Asaava Infinite
Dhatu ‘’
Rasa ‘’
Anjana 3months
SHELF
LIFE
O
F
A
Y
U
D
O
S
A
G
E
F
O
R
M
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Rule 161-B D&C Act
19. CONCLUSION
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• The D&C Rule 161 B helps to improve
Quality of ASU drugs
Packaging of drugs
Labeling techniques
Storage practices
Need for standards regarding addition of preservatives
Helps to standardize the manufacturing of ASU
medicine
20. REFERENCE
The Gazette of India, Extraordinary Part-II,
Section 3 – Sub-section (i) No.605, New
Delhi
The API, Part I, Vol VIII, Ed.I , Published by
Govt.of India
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