A simple and essential guide to obtain a drug manufacturing license for ayurvedic medicine. It covers procedure, minimum requirements, documents & affidavits and all other necessities.

1. dr.surendra.chaudhary@gmail.com, +91-9810004259

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Present status of manufacturing industry
About Ayurveda manufacturing license
The Drugs and Cosmetics Act and Rules
Essential requirements for drug license
The state and district drug authorities
GMP and other accreditations
dr.surendra.chaudhary@gmail.com, +91-9810004259

3. 
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Ayurveda, the ancient healing science is gaining popularity day by
day at domestic as well as international level. Herbal medicines are
the back bone for treating a patient. Quality medicine is in great
demand and so many small as well big commercial houses are
entering in the Ayurveda manufacturing field.
Presently so many pharmaceuticals companies are manufacturing
Ayurvedic patent as well as classical drugs like Chavyanprash.
Ayurveda drugs and herbs industry has an estimated Rs.35,00 Crore
turnover.
There is huge demand of herbal medicine and cosmetics in
developed countries. Europe and erstwhile Russian countries along
with U.S. are the main area for export. Other developing countries
completely depend upon export from India.
dr.surendra.chaudhary@gmail.com, +91-9810004259

4. All the requirements and suggestions in this
presentations are out of my personal
experience as expert of this field based
upon Drugs and Cosmetics act& rules.
Any discrepancies with the state drugs
authorities are subject to verification and
rectification with consultation of any
expert of the subject.
dr.surendra.chaudhary@gmail.com, +91-9810004259

5. ASU manufacturing units
Total
10088
GMP Compliance None GMP
5402
http://indianmedicine.nic.in/showfile.asp?lid=315
4517
accessed on 11-10-2013

6. 
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It is necessary to obtain a drug
manufacturing licenses for the
sale of Ayurvedic medicine
and/or cosmetics in India and
for export
Equally applicable across the
country
dr.surendra.chaudhary@gmail.com, +91-9810004259

7. 
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Ayurvedic manufacturing industry
covered by this act
Has provision for new license, renewal,
definition regarding manufacturing
Guidelines for GMP etc
dr.surendra.chaudhary@gmail.com, +91-9810004259

8. 
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For the purpose of this Part the State
Government shall appoint such
Licensing Authorities and for such
areas as may be specified in this
behalf by notification in the Official
Gazette. (Part XVI rule 152)
In most of the state, Director
Ayurveda/ Ayush is the Licensing
authority
dr.surendra.chaudhary@gmail.com, +91-9810004259

9. Application on Form 24-D (3 Copies)
http://www.scribd.com/doc/105970847/FORM-24D
 Blue print as per specification of Rule 157
( dedicated to GMP)
 List of technical staff with qualification and
registration certificate( AyurvedacharyaBAMS or B.Sc with two years experience in a
reputed registered manufacturing firm are
the eligibility for manufacturing chemist/
technical staff)
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dr.surendra.chaudhary@gmail.com, +91-9810004259

10. 
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List of medicines for which license is
applied with name and reference book
in case of classical drugs
Full detailed ingredient, quantity, uses
and method of preparation for
proprietary medicine. Each product
must have separate sheet.
List of machinery and equipments
including laboratory apparatus and
equipments
dr.surendra.chaudhary@gmail.com, +91-9810004259

11. 
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Fee- a sum of Rs. 1000(check for any
change in your state)
Treasury chalan in original with two
photo copies (proof of required fee. Fees
will be deposit in a particular code
assigned for this purpose by the state
government and code dully verified by
the competent authority)
dr.surendra.chaudhary@gmail.com, +91-9810004259

12. dr.surendra.chaudhary@gmail.com, +91-9810004259

13. Ownership- if proprietary, name
and address of the owner.
 Partnership- partnership deed,
power of attorney declaring the
name of signatory
 Premises -Rent agreement if is
rented
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dr.surendra.chaudhary@gmail.com, +91-9810004259

14. Technical officer- Appointment
letter showing full time nature of
the technical staff
 Consent letter- agree to work
 Others-Photo copies of Degree
and registration
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dr.surendra.chaudhary@gmail.com, +91-9810004259

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Owner/Proprietor –Affidavit 1
The address
Use of premise for the purpose
manufacturing of drugs.
That the premise not for residential purpose.
About raw drugs testing
Finished drugs testing
Maintenance of testing record of raw &
finished good
Following all norms of Schedule ‘T’
The owner and partner non-conviction
dr.surendra.chaudhary@gmail.com, +91-9810004259

16. 
Owner/Proprietor –Affidavit 2
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Manufacturing only approved product
No resemblance with other products
regarding their name, formulations,
packing and labeling
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dr.surendra.chaudhary@gmail.com, +91-9810004259

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Technical Officer
Non resemblance with other companies
product with the best of his knowledge.
Preparation of drugs under direct
supervision
Bound to follow the rules and regulations
as laid down by the licensing authority
dr.surendra.chaudhary@gmail.com, +91-9810004259

18. As per drug act Bachelor of Ayurvedic Medicine and
Surgery-B.A.M.S.
 B.Sc. With two years Ayurvedic drug
manufacturing experience from any
reputed unit.
dr.surendra.chaudhary@gmail.com, +91-9810004259

19. 
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Office space 100 sq feet
Raw drug store 150 sq feet
Finished medicine store 150 sq feet
Laboratory 150 sq feet
Rejected drug store 100 sq feet
Churn room 200sq feet sq feet
Furness 200 sq feet- Bhatti/ Furness may have a
tin shade
Packaging area –
› Packaging and other space should be as per
kalpnas (dosages forms) to use during manufacturing
dr.surendra.chaudhary@gmail.com, +91-9810004259

20. As per requirements related to number
of kalpnas and volume of drugs
http://www.scribd.com/doc/105970430/Space
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dr.surendra.chaudhary@gmail.com, +91-9810004259

21. 
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Director Ayurveda of the respective
state
Application can be filed through District
Ayurvedic Officer or direct to the Drugs
cell of the directorate as case may be.
Some of the procedure differs from state
to state
dr.surendra.chaudhary@gmail.com, +91-9810004259

22. 
Classical Ayurvedic drugs
› Based on classical text of ayurveda
mentioned in first schedule of Drugs &
Cosmetics act
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Proprietary Ayurvedic drugs
› Based upon personal experience and/or
research
dr.surendra.chaudhary@gmail.com, +91-9810004259

23. 
No change is allowed
› Name of the product
› Ingredients
› Indications
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No proof of evidence required
Application format› S.N.
› Name of medicine
› Reference book with adhikar
dr.surendra.chaudhary@gmail.com, +91-9810004259

24. 
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Reference of ingredients only from the
books mentioned in first schedule of
Drugs & cosmetics act
Proof of efficacy required
Clinical trial reports may require in many
indications
Clinical trials are accepted from
government hospitals in most of cases
dr.surendra.chaudhary@gmail.com, +91-9810004259

25. Name of the product followed by “Proprietary Ayurvedic medicine”
Each (pharmaceutical forms) containsS.N.
Ingredient
Botanical Name
Part used
Quantity
Reference
Preservatives, additives, binding agents, base materials etc if any
Manufacturing process
Indications
Doses
packing
dr.surendra.chaudhary@gmail.com, +91-9810004259

26. 
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It is advisable to get Good
Manufacturing Practice Certificate and
other accreditation certificates for better
acceptance from the domestic & export
market.
Technical help –contact
dr.surendra.chaudhary@gmail.com
dr.surendra.chaudhary@gmail.com, +91-9810004259

27. .
dr.surendra.chaudhary@gmail.com
+91-9810004259