The document discusses the regulatory status of herbal drugs in India. It outlines that herbal drugs are regulated under the Drug and Cosmetic Act of 1940 and Rules of 1945. The Department of AYUSH is the regulatory authority that requires manufacturing and marketing licenses. It also discusses definitions, licensing procedures, good manufacturing practices, labeling requirements, and guidelines set by AYUSH.

1. REGULATORY STATUS OF HERBAL
DRUGS IN INDIA
NAME: RICHA PATEL

2. CONTENT:
 Regulation in India
 Definition
 Ayurvedic drug manufacturing license approval
 Approval of plant of premises
 Submission of plant of premises to LA for approval
 Application submission to LA
 Inspection of premises by inspectorate and report
submitted to LA
 Procedure for obtaining loan license
 Schedule T
 AYUSH guideline
 Labelling requirement

3. REGULATION IN INDIA:
 Herbal drugs are regulated under the Drug and
Cosmetic Act (D and C) 1940 and Rules 1945 in
India, where regulatory provisions for Ayurveda,
Unani, Siddha medicine are clearly laid down.
 Department of AYUSH is the regulatory authority
and mandate that any manufacture or marketing of
herbal drugs have to be done after obtaining
manufacturing license, as applicable.

4.  The D and C Act extends the control over licensing,
formulation composition, manufacture, labelling,
packing, quality, and export.
 Schedule “T” of the act lays down the good
manufacturing practice (GMP) requirements to be
followed for the manufacture of herbal medicines.
 The official pharmacopoeias and formularies are
available for the quality standards of the medicines.

5. DEFINITION
 As per Drugs and Cosmetics Act 1940 amended in
1964,
“Ayurvedic, Siddha or Unani drug” includes all
medicines intended for internal or external use for or in
the diagnosis, treatment, mitigation or prevention of
disease or disorder in human beings or animals, and
manufactured exclusively in accordance with the
formulae described in, the authoritative books of
Ayurvedic, Siddha and Unani (Tibb) systems of
medicine, specified in the First Schedule.

6.  Indian system of registration of herbal medicinal
products has provision in each state via state drug
licensing authority of Ayurvedic, Sidha and Unani
drugs.

7. Ayurvedic drug manufacturing license
approval:
 (1)Approval of Plan of Premises
 (2)Submission of Application with documents to LA
for grant of License
 (3)Inspection of Premises by Inspector & reporting to
LA for taking action
 (4)Grant of license by LA
 (5)Appeal in case of rejection of application
 (6) Renewal of License
 (7) Additional Product Permission
 (8) Addition of new Category in License
 (9) Technical Person approval

8. Approval of plant of premises (area
requirement)
1) Manufacturing areas- As per Sch-T ( areas are in sq.feets)
2) Office- 100 SFt
3) Workers Room-80 SFt/Each sex
4) Raw material store-100 SFt
5) Finish Product store-100 SFt
6) Quarantine Room-100 SFt
7) Packaging material store-100 SFt
8) Bottle washing Room-100 SFT
9) Bottle drying Room-100 SFT
10) Packing & labeling Room-100 SFt
11) Q.C.Laboratory-100-150 SFt- (Chemistry & Cognosy Lab.)
 For PTL-800SFt-in (i) Chemistry, (ii) Pharmacognosy,
 (iii) Ayurveda, Siddha and Unani, (iv) Microbiology, (v) Sample Room,
 (vi) Office-cum-Record Room-Rule-160B-List of Equipments given

9. Submission of plant of premises to LA
for approval (document required)
1) Forwarding letter address to LA
2) Original challan for Fee-Rs.50
3) 4 Copies of Plan- It includes the following
-Key plan,
-plan,
-elevation,
-end view,
-Address of Premises & Sign. Of Auth. Person
4) Plan is scrutinized by Plan Committee & approved for
construction of premises.
5) Premises is to be constructed as per approved plan, Machineries
and equipments are to be installed, Technical Persons are to be
employed, all documents are to be prepared and than application
is to be submitted to LA for issuing License.

10. Application submission to LA
1) Forwarding letter address to LA for obtaining License.
2) Application Form. No.-24D dully filled & signed by Auth. Person.
3) Form of Firms details dully filled & signed by Auth. Person
4) Original challan for lic. Fee as per requirements-Rs.1000/- +Rs. 500/-GMP certi. Fee.
5) Original plan of premises -1 copy
6) Document regarding possession of the premises
7) Document regarding constitution of the Firm(P/D,MOAA,TD etc)
8) List of Products-category wise-4 copies along with product details Form-with similar product
9) Draft label of each product-3 copies
10) List of Machineries & Equipments-1 copy
11) List of Laboratory equipments-1 copy
12) List of approved Technical persons with their degree & experience certificates, appointment letter, acceptance
letter, forms -4 copies
13) Detail of method of analysis of products & Raw materials
14) Consent letter of Public Testing Laboratory
15) List of SOP
16) Master Formula card of each product
17) Xerox copy of Ref. Book for product’s ingredient

11. Inspection of premises by inspector
and report to LA
 Inspection of Premises by Inspector is carried out for verification of-
1) Areas of Premises
2) Documents
3) Machineries & Equipments
4) Laboratories Equipments
5) Technical Persons requirements
6) Other requirements if any as per law
- Detail report of inspection is submitted to LA by Inspector along with his recommendations
for grant/rejection/compliance of License.
-LA grant/reject application for License.( Lic.Form.No.-25D)
- License granted is valid for 5 years from the date of grant.
-License granted in Form No. 25D is to be renewed for another period of 5 years.
-New License is to be obtained in case of change in constitution of the Firm within three
months.
-Separate License is to be obtain for change of Premises.

12. Procedure for addition of new
category in existing license
 New plan showing old and new category is to be submitted for approval to LA as
discussed earlier. Fee Rs-20 is to be paid by challan.
Plan is approved by plan committee. Premises is to be constructed for new
category as per new plan, Machineries and equipments are to be installed,
Technical Persons are to be employed, all documents are to be prepared and than
application is to be submitted to LA for granting new category of cosmetics. The
following documents are to be submitted to LA.
1) Forwarding letter address to LA
2) Original challan for Fee of products as per requirements-No fees at present
3) Original new plan of premises -1 copy
4) List of Products-category wise-4 copies along with product details Form
5) Draft label of each product-3 copies
6) List of Machineries & Equipments-1 copy
7) List of Laboratory equipments-1 copy
8) List of approved Technical persons-4 copies
9) Detail of method of analysis of products & Raw materials
10) Copy of original License along with list of products

13. Procedure for additional product
permission in existing license
 For additional item –No fee is prescribed.
1) Application is to be made to LA for obtaining
permission for additional items with-
2) List of Products-category wise-4 copies along with
product details Form
3) Draft label of each product-3 copies
4) Detail of method of analysis of products & Raw
materials
5) Copy of original License

14. Approval of technical person by LA
 For getting approval of TP for particular section an
application along with documents is to be made to LA by
concern manufacturer if degree & experience is as per
Rules.
 Documents are-(1) Appointment letter of TP (2) Acceptance
letter of TP (3) Copy of Degree Certificate of TP
(4)Experience Certificate of TP (5) Forms of TP dully filled
with.
 Verification of Degree , experience is carried out by an
Inspector & report is submitted to LA.
 LA is approving TP for concern section if report is OK.
 Approval given by LA is valid for all Manu. Units.

15. Procedure for obtaining loan license
1) Forwarding letter address to LA for obtaining License.
2) Application form-24E along with fee Rs.600/- (challan)
3) Form-1,2,3 Properly filled & sign by applicant
4) Copy of Manu. licences of own firm along with list of approved products.
5) List of loanee firms till date.
6) Form of Firms details dully filled & signed by Auth. Person
7) Document regarding possession of the premises-Wholesale Licence.
8) Document regarding constitution of the Firm(P/D,MOAA,TD etc)
9) List of Products-category wise-4 copies along with product details Form-with similar product
10) Draft label of each product-3 copies
11) Detail of method of analysis of products & Raw materials
12) Consent letter of Public Testing Laboratory
13) List of SOP
14) MFR of each product
15) Documents regarding supervisory chemist
Validity of licence Is for 5 years from the date of grant.
In case of any change in the constitution new license is to be obtained within three months.

16. Schedule T
 The GMP are prescribed as follows in part I and
part II to ensure that:
I. Raw materials used in the manufacture of drugs
are authentic, of prescribed quality and are free
from contamination.
II. The manufacturing process is as has been
prescribed to maintain the standards.
III. Adequate quality control measures are adopted.
IV. The manufactured drug which is released for sale
is of acceptable quality.

17. V. To achieve the objectives listed above, each
licensee shall evolve methodology and
procedures for following the prescribed process
of manufacture of drugs which should be
documented as a manual and kept for reference
and inspection. However, under IMCC act 1970
registered vaidyas, siddhas and hakeems who
prepare medicines on their own to dispense to
their patients and not selling such drugs in the
market are exempted from the purview of GMP.

18. Schedule T
 Part I
 GOOD MANUFACTURING PRACTICES
 Factory premises:
 The manufacturing plant should have adequate space for:
1) Receiving and storing raw material
2) Manufacturing process areas
3) Quality control section
4) Finished goods store
5) Offices
6) Rejected goods/ drug store

19. Schedule T: general requirements
 Location and surroundings
 Buildings
 Water supply
 Disposal of waste
 Container’s cleaning
 Stores
 Raw materials
 Packaging material
 Finished goods stores
 Working space
 Health, clothing, sanitation and hygiene of workers
 Medical services
 Machinery and equipment
 Batch manufacturing record
 Distribution record
 Record of market complaints
 Quality control

20. AYUSH guideline
 AYUSH guideline contains GCP guideline for the
ayurvedic, unani and siddha drugs.
 It contains followings:
 Introduction
 Definitions
 Pre-requisites for the study
 Protocol
 Ethical and safety consideration
 Informed consent process
 Compensation for participation
 Responsibilities of sponsor, monitor and investigator

21.  Record keeping and data handling
 Quality assurance
 Statistics
 Special concerns
 Appendix I: guideline for evaluation of ayurvedic,
unani and siddha medicine
 Appendix II: ethical issues
 Appendix III: investigator’s brochure
 Appendix IV: essential document

22. Labeling requirements
 Label of ayurvedic drug contains:
 List of all ingredients with the botanical names of plant with plant part and
form of ingredients
 Quantity of each ingredients
 Reference to the method of preparation detailed in standard text or books
 Container of a medicine for internal use made up ready for the treatment of
human ailments shall, made up from substance specified in schedule E, be
labeled with the words “caution: to be taken under medical supervision:
both in English and Hindi language.
 Name and address of the manufacturer
 License number
 Batch number, lot number, date of manufacturing
 The word ayurvedic/ siddha/ unani medicines
 For “external use only” if medicine is for external application
 Storage condition
 Dosage instruction

23. Label of product

25. REFERENCE
 Drug and cosmetic act 1945
 AYUSH GCP guideline
 Herbal medicine: regulation and practices in
europe, united states and india; international journal
of herbal medicine
 Current status of regulation for herbal medicines
europe, united states and india;
www.researchgate.net