RULE 161 B of D&C Act

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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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

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

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

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

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

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

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

18. Pishti except naga, vanga tamra bhasma 10 yrs
19. Pravahi kwatha 3 yrs
20. Rasa yoga
a) Rasa/uparasa/ bhasma except naga,
vanga and tamra
b) Kashtaushadhi with guggulu rasa/
uparasa/ bhasma
10 yrs
5 yrs
21. Satva 2 yrs
22. Sharkara/panaka/ sharbat 3 yrs
23. Shweta parpati 2 yrs
24. Taila 3 yrs
25. Varti 2 yrs
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Rule 161-B D&C Act

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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

 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

 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

 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

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

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

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

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

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

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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RULE 161 B of D&C Act

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RULE 161 B of D&C Act