ANNEXURE-1

LIST OF AYURVEDIC DRUGS TO BE MANUFACTURED BY (COMPANY NAME) UNDER

MANUFACTURING LICENSE NUMBER (LIC. NO.) IN FORM 25 D/26 D

PRODUCT NAME : XYZ

TYPE OF PRODUCT : AYURVEDIC PROPRIETARY/CLASSICAL MEDICINE
CATEGORY : TABLET/ CAPSULE/ CHURNA/ ETC……
SUB CATEGORY : BALYA/POSHYA/SONDARYAPRASADHAK (If required)
COMPOSITION :
EACH ……………………………………………..CONTAINS;
SR. NAME OF FORM OF REFERENCE PART BOTANICAL NAME QTY
NO. INGRIDIENTS INGRIDIENTS USE

ACTIVE INGRIDIENTS
1
2
EXCIPIENTS/ BASE (IF ADDED)
1
2
PRESERVATIVE (IF ADDED)
1
COLOUR/ FLAVOUR/ PERFUME/ OTHER INERT (IF ADDED)
1

1.CAUTION: TO BE TAKEN UNDER MEDICAL SUPERVISION ONLY (IF REQUIRED)

2.SPECIAL INSTRUCTION (IF REQUIRED)

UNDERTAKING
I/We will manufacture this Ayurvedic medicine as per above listed contents only. We will not change
any contents in above composition without prior permission of State License authority (Ayurveda).

FOR (COMPANY NAME)

AUTHORIZED SIGNATURE

STATE LICENCE AUTHORITY (AYURVEDA) DATE OF APPROVAL

SIGNATURE WITH STAMP

(SPACE FOR SIGNATURE & STAMP) (SPACE FOR DATE OF APPROVAL)

 ANNEXURE-2.1

AYURVEDIC CLASSICAL MEDECINE LABEL

COMPOSITION: PRODUCT NAME  Caution:- To be taken
Each…………….. of; WITH DOSAGE under medical supervision
Name of Part use Botanical Qty Measurement FORM (Both in Hindi & English)
ingredients name unit mg / ml (In case of Schedule E1)
with form / % (w/w, [REF: Book  For External use Only (if
of v/v, v/w Name] required)
ingredients etc.)  Limit of Self-generated
(An Ayurvedic alcohol (if required)
Classical
Medicine) Indication:- (As per
Classical Text)
Packing Size
Dose:-
Excipients:- Name of all Excipients if used. Mfg Lic No.:-
Preservative: - if used Batch No.:-
Mfg Date :- MM/YYYY
Exp. Date :- MM/YYYY
Special instruction for storage conditions. Name & Full Address of
Special instruction for use of Direction of Medicine. Manufacturer with Contact
details.
 ANNEXURE-2.2

AYURVEDIC PROPRIETORY MEDECINE LABEL

COMPOSITION: PRODUCT NAME  Caution:- To be taken
Each…………….. of; WITH DOSAGE under medical supervision
Name of Part use Botanical Qty Measurement FORM (Both in Hindi & English)
ingredients name unit mg / ml (In case of Schedule E1)
with form (An Ayurvedic  For External use Only (if
of Proprietary required)
ingredients Medicine)  Limit of Self-generated
alcohol (if required)
Packing Size
Indication:-
Sub Category
(if required) Dose:-
Excipients:- Name of all Excipients if used. Mfg Lic No.:-
Preservative: - if used Batch No.:-
Permitted Color:- if used Mfg Date :- MM/YYYY
Artificial Sweetener:- if used Exp. Date :- MM/YYYY
Inert material:- if used
Special instruction for storage conditions. Name & Full Address of
Special instruction for use of Direction of Medicine. Manufacturer with Contact
details.
 ANNEXURE - 3
MASTER FORMULA CARD

Company Name & Address MFC No.

Version
Effective Date
Page No.
Name of Product Packing Size
License No. Category
Batch Size: Type of Product

PART-1 – Raw Material Details

Form of Part Label
Sr. No. Name of Ingredients Qty/Batch
Ingredient Used claim
Active Ingredients
1
2
Base Material [If Any]
1
2
Excipients [If any]
1
Preservatives [If any]
1
Color/Flavor/Perfume/Others [If Any]
1
2
Others [If Any]
1

Prepared By Checked By
Name
Date

Sign
 ANNEXURE - 3
MASTER FORMULA CARD

PART-2 – Packing Material Details

Sr.
No. Name of Material Qty. [Approx.]
1
2
3
4
5

Prepared By Checked By
Name
Date

Sign
 ANNEXURE - 3
MASTER FORMULA CARD

PART-3 Standard Operating Procedure

In SOP Following points are considered

Scope This procedure is applicable to Manufacturing of [Name of Product]

Name
Responsibility
Designation

Manufacturing Explain Manufacturing Process in Simple Terms

Procedure

Reference If Any particular for the special manufacturing instructions.

Flow Chart Process Flow Chart

Step 1

Step 2

Step 3

Step 4

Step 5

Declaration
I hereby declare that the details furnished above are true and correct to the best of my knowledge and belief and I undertake to
inform you of any changes therein, immediately. In case any of the above information is found to be false or untrue or
misleading or misrepresenting, I am aware that I may be held liable for it.

Name
Designation

Signature with Stamp

 ANNEXURE - 4
Quality Control Specifications

Company Name & Address QCS No.

Version
Effective Date
Page No.
Name of Product Category
Self-Life Packing Size

PART-1 [Composition Details]

As per Label Claim [It must not defer from the Product Approval]

PART-2 [Testing & Specifications]

Sr. No. Name of Parameter Specification Reference
1 Description
1.1 Color
1.2 Odor
1.3 Taste
1.4 Others [Specify]
2 Physico-Chemical Parameters
2.1 Category Specific
2.2 Category Specific
2.3 Category Specific
3 Microbial Content
3.1 Staphylococcus aureus/g
3.2 Salmonella sp./g
3.3 Pseudomonas aeruginosa/g
3.4 Escherichia coli
3.5 Total microbial plate count (TPC)
3.6 Total Yeast & Mould
 ANNEXURE - 4
Quality Control Specifications

PART-2 [Testing & Specifications]

Sr. No. Name of Parameter Specification Reference
4 Heavy Metal
4.1 Lead
4.2 Arsenic
4.3 Cadmium
4.4 Mercury
5 Identifications [If Require]
5.1 TLC/HPTLC
5.2 Others
6 Any Other [if required]

Checked By Approved By
Name
Date

Sign

NOTE: If Company performing In-House Quality Control testing methods other than API than they must
provide their method of analysis [MoA].

Undertaking
I hereby declare that the details furnished above are true and correct to the best of my knowledge and belief and I
undertake to inform you of any changes therein, immediately. In case any of the above information is found to be
false or untrue or misleading or misrepresenting, I am aware that I may be held liable for it.

Name
Designation

Signature with Stamp

 ANNEXURE - 5
Proof Of Effectiveness

Company Name & Address Date

Page No.

Name of Product Category

Indication Claim

Dose
Direction of Use
Special
Instructions
Side Effect

PART-1 [Product Details]

Overview of Product with respect to their Claimed Indication

PART-2 [Overview of Disease – as per indication]

2.1 Overview of the disease as per Ayurveda
2.2 Overview of the Disease as per Modern Terminology
 ANNEXURE - 5
Proof Of Effectiveness

PART-3 [Product Mechanism of Action]

Mechanism of Action
Sr. Name of Ingredient
Ayurvedic Aspect Modern Aspect
1
2
3
4
5
6
7
8
9
10

PART-4 [Purpose of Excipients/Inert/Any Other Material]

Name of Excipient/Inert/Any Purpose Reference [Page Attachment]
Sr.
Other Material
1
2
3
4
5

Declaration

I hereby declare that the Excipients used in the Products are pharmacologically inactive
materials and under the best of my knowledge not affecting the APIs. The Amount of
excipient in the dosage are under the prescribed limit or in controlled manner. The
Excipients used in the formulation are Non-Toxic and having No Side Effect.
 ANNEXURE - 5
Proof Of Effectiveness

PART-5 [Conclusion]

Explain the Scientific Reason of formulation with their claimed indication

PART-6 [Bibliography]

List of sources used.

Checked By Approved By
Name
Date

Sign

Undertaking
I hereby declare that the details furnished above are true and correct to the best of my knowledge and belief and I
undertake to inform you of any changes therein, immediately. In case any of the above information is found to be
false or untrue or misleading or misrepresenting, I am aware that I may be held liable for it.

Name
Designation

Signature with Stamp