DRUG LICENSE

Prepared By :- Rishabh Agnihotri

 FLOW OF THE PRESENTATION
• Present status of Ayurveda Industry.
• Approval of plan of premises.
• Documents required for Approval of plan.
• General requirements of manufacturing unit & machineries.
• Inspections.
• Documents required for application of fresh & Renewal of license to manufacture Ayurveda
Drugs.
• Loan license & Documents required for Fresh & Renewal loan license to manufacture Ayurveda
drugs.
• Documents required for Additional product permission of Ayurveda Drugs.
• Qualification & Role of technical person.
• Schedules in drug and cosmetics act.
• Reference Books.
 Ayurveda in demand…..
• 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.
• 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.
 Ayurveda manufacturing Units

ASU manufacturing units

Total GMP Compliance None GMP

4517
10088 5402
 Approval of premises
• Approval of plan is the basic requirements for obtaining license to manufacture
Ayurveda drugs.
• A plan in 4 copies is to be submitted for approval along with a original challan of
Rs-50/- to the joint commissioner (Ayurveda), F.D.CA (Food & Drug Control
Administration) , block no-08 , Dr. jivraj Mehta bhavan Gandhinagar.
• Documents required for approval of plan of premises is as follows…..
Affidavits & Documents
• Approval of plan [ layout plan, key plan, area table with total arc ] from civil
engineer
• Land proof
• Company Name
• Company registration ( Watt & Tin number )
• Registration certificate
• Detail plan of premises
• Loan papers
• Propritary / partnership
• If proprietary- names and address of owner along with government I.D proof &
degree of the owner.
• If partnership- names and address along with government I.D proof + power of
attorney declaring the names of signatory.
• Forwarding letter to joint Commissioner F.D.C.A
General requirements of manufacturing units
SECTION TOTAL AREA SQ.FT
1- Raw material store room 100 sq.ft
2- Finished product store room 100 sq.ft
3- Packing material store 100 sq.ft

4- packing labelling room 100 sq.ft , if more than 2 categories 150 sq.ft
5- Office Adequate
6- Rejection/Recall store Adequate
7- Retain sample room 80 sq.ft with Q.C laboratory 150 sq.ft
8- Glass/Bottle washing and Adequate
drying
9- Worker room with toilet block Male- 80 sq.ft Female- 80 sq.ft
Documents required for application of fresh license
to manufacture A.S.U Drugs.
1. Covering letter addressed to joint commissioner (Ayurveda) , F.D.CA along with mention of categories of
product proposed to be manufactured.
2. Application in form no 24-D duly filled in and signed by proprietor/ authorized signatory / all partners.
3. Original challan of rupees 1000-/ paid under Head 0210 Medical & Public Health.
4. Additional information performa as prescribed by department.
5. True copy / self certified copy of partnership deed in case of partnership firm. OR True copy / self certified
copy of proprietor OR True copy / self certified copy Registered Trust deed + list of trustees.
6. Copies of ID proofs of Proprietor/Partners/Trustees.
7. True copy or self certified copy of resolution or power of attorney in favour of Authorized Signatory of the
company + ID proofs of the Authorized Signatory .
8. Copy of Approved plan.
9. Copy of ownership documents of premises with photo ID of owner.
10. Category wise list of Manufacturing Equipments / Machineries.
11. Quality Control Laboratory Instruments.
12. Consent letter of Government Approved Laboratory , in case of outside Laboratory testing of Raw and Finish
products.
13. List of Technical person for Quality Control Laboratory, if any (T.P form, Degree certificate, Appointment letter,
consent letter).
14. List of Technical person for manufacturing section, if any (T.P form, Degree Certificate , Appointment letter,
consent letter).
15. List of product in 4 copies on Firm letter head and duly signed by the authorized signatory.
16. Draft label (1-copy)
17. Master card ( 1-copy)
18. Standard Operating Procedures for each product.
19. Copy of Reference, in case of classical formula.
20. Any other documents asked by licensing authority.
 MASTER CARD
• List of proprietary/ Generic product to be manufactured by us in at our premises Form No. 25-D.
Bearing lic.no. GA/……
• PRODUCT NAME :
(1) TRIPHALA TABLET ( AN AYURVEDIC CLASSICAL MEDICINE)

POPULAR NAME BOTONICAL NAME USE OF PART REFERENCE AMOUNT

Amla Embelica officinalis Fruit A.B. 150mg
Harde Terminalia chebula Fruit A.B. 150mg
Baheda Terminalia belerica Fruit A.B. 150mg
EXCIPIENT: Talcum --- I.P. ----

DECLARATION:-
1. We declare that above are the only product to be manufactured by at present. Any addition deletion
there should not be done without the prior permission of Licensing Authority (A.S.U) F.D.C.A ,
Gandhinagar
2. We declare that the product is safe for use in content of active ingredients , vehicle and
pharmaceutical aids used in formulations.
 DRAFT LABEL
PRODUCT NAME:
(1) TRIPHALA TABLET (REF.ARYABHISHAK)
(AYURVEDIC CLASSICAL MEDICINE)
POPULAR NAME BOTONICAL NAME PART USED REFERENCE AMOUNT
Amla Embelica officinalis Fruit A.B. 150mg
Harde Terminalia chebula Fruit A.B. 150mg

Baheda Terminala belerica Fruit A.B. 150mg

EXCIPIENT Talcum --- I.P. ---

MFG DATE MFG BY:-

MRP EXP. DATE
BATCH NO. DOSE
LIC NO: GA/….. CAUTION & INDICATION
 Proprietary Ayurvedic drugs
• 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
 Proprietary Ayurvedic drugs
Name of the product followed by “Proprietary Ayurvedic medicine”

Each (pharmaceutical forms) contains-

Name of the product followed by “Proprietary Ayurvedic medicine”

Each (pharmaceutical forms) contains-

S.N. Ingredient Botanical Name Part used Quantity Reference

Preservatives, additives, binding agents, base materials etc if any

Manufacturing process
Indications
Doses & packing
Documents required for Renewal of license to
manufacture A.S.U Drugs.
1. Application in form No.24-D duly filled in and signed.
2. Original challan of rupees 1000/- paid under Head 0210 Medical & Public Health.
3. List of product in 4 copies on firm letter head and duly signed by the authorized signatory.
4. True copy/self certified copy of partnership deed In case of partnership firm OR True copy /
self certified copy of proprietor OR True copy / self certified copy Registered Trust deed + list
of trustees.
5. List of technical person and copies of their approvals.
6. Copies of approved product.
 LOAN LICENSE

• Definition:
• A person(applicant) who does not have his own arrangements(factory) for
manufacture but who wish to manufacturing facilities owned by another license. Such
licenses are called Loan licenses.
• Loan license can also be issued for manufacturing of A.S.U drugs
• The duration of loan license is five years from the date of issued after that it should be
renewed.
Documents required for fresh loan license to
manufacture A.S.U Drugs.
1. Covering letter along with mention of categories of product proposed to be manufactured.
2. Application in Form No. 24-E duly filled in and signed by authorized signatory / all partners.
3. Original challan of rupees 600/-paid under Head 0210 Medical & Public Health.
4. True copy / self certified copy of partnership deed in case of partnership frim. OR True copy / self certified
copy of proprietor OR True copy / self certified copy Registered Trust deed + list of trustees.
5. Copies of ID proofs of Proprietor/Partners/Trustees.
6. True copy or self certified copy of resolution or power of attorney in favour of Authorized Signatory of the
company + ID proofs of the Authorized Signatory.
7. List of products in 5 copies on firm letter head and duly signed by the authorized signatory.
8. Draft label (1-copy).
9. Master card ( 1-copy).
10. Standard Operating Procedures for each product.
11. Copy of reference, in case of classical formula.
12. Supervisory chemist ( T.P. Form, Degree Certificate, Appointment Letter, Consent
Letter).
13. Loan performa, 1,2,3 as prescribed by the department.
14. List of Technical person for Manufacturing section of the parent firm.
15. List of Technical person for Quality Control Laboratory of the parent firm.
16. Category wise list of Manufacturing Equipments/,achineries of the parent firm.
17. Quality Control Laboratory instruments of the parent firm.
18. List of Loanee firms with the parent Firm.
19. Copy of license in Form No. 25-D of the parent firm and copy of last renewal
certificate in Form no. 26-D of the parent firm, if any.
Documents required for Renewal of Loan license
1. Application in Form No. 24-E duly filled in and signed.
2. Original challan of rupees 600/- paid under Head 0210 Medical & Public Health.
3. Loan performa 1,2 & 3.
4. True copy / self certified copy of partnership deed in case of partnership frim. OR True copy / self certified
copy of proprietor OR True copy / self certified copy Registered Trust deed + list of trustees.
5. Copies of ID proofs of Proprietor/Partners/Trustees.
6. True copy or self certified copy of resolution or power of attorney in favour of Authorized Signatory of the
company + ID proofs of the Authorized Signatory.
7. List of products in 5 copies on firm letter head and duly signed by the authorized signatory.
8. 2 copies of last renewal plan.
9. Copies of approved plan.
10. Additional product S.O.P in 3 copies.
 Documents required for Additional Product
Permission of A.S.U Drugs.
1. Covering letter.
2. List of product in 4 copies on firm Letter Head and duly signed by the authorized signatory, in
case of own unit. 0R List of product in 5 copies on firm Letter Head and duly signed by thee
authorized signatory , in case of Loanee Firm.
3. Draft labels (1-copy).
4. Master Cards (1-copy).
5. Standard Operating Procedures for each product.
6. Additional information performa of each product as prescribed by department.
7. Copy of reference, in case of classical formula.
 Qualification required for Approval of
Technical Person (T.P.)

 B.A.M.S or B.PHARM (AYURVEDA).

B.Sc (chem/Botony)with 2 years Experience in Ayurvedic Drugs Manufacturing.
B.Pharm with 2 years Experience in Ayurvedic Drugs Manifacturing.
Diploma in Ayurveda with 8 years Experience in Ayurvedic Drugs Manufacturing.
 Documents required for T.P. Approval of
A.S.U DRUGS

1. Covering letter
2. T.P. Form
3. Appointment Letter
4. Consent Letter
5. Degree certificate
6. Experience Letter
 SCHEDULES
• SCHEDULE ‘E’ :- LIST OF POISONOUS SUBSTANCES UNDER THE A.S.U
MEDICINE.
• SCHEDULE ‘H’ :- PRESCRIPTION DRUGS.
• SCHEDULE ‘L’ :- GOOD LABORATORY PRACTICES .
• SCHEDULE ‘N’ :- LIST OF MINIMUM EQUIPMENTS FOR THE EFFICIENT
RUNNING OF PHARMACY.
• SCHEDULE ‘T’ :- GOOD MANUFACTURING PRACTICES FOR A.S.U MEDICINES.
• SCHEDULE ‘S’ :- STANDARD FOR COSMETICS.
• SCHEDULE ‘C’ :- BIOLOGICAL &SPECIAL PRODUCTS.
 REFERENCE BOOK [1 ST SCHEDULE]
1. Arogya kalpadruma
2. Arka Prakasha
3. Arya Bhishak
4. Ashtang Hridaya
5. Ashtang Sanghraha
6. Ayurveda Kalpadruma
7. Ayurveda Prakasha
8. Ayurveda Samgraha
9. Bhaishajya Ratnavali
10. Brihat Nighantu Ratnakara
11. Brihat Bhaishajya Ratnakara
12. Bhava Prakasha
13. Charaka Samhita
14. Chakra Datta
15. Gadanigraha
16. Kupi Pakva Rasayana
17. Nighantu Ratnakara
18. Rasa Chandanshu
19. Rasa Raja Sundara
20. Rasaratna Samuchaya
21. Rasatantra Sara Va Siddha Prayoga Sangraha –part 1
22. Rasa Tarangini
23. Rasa Yoga Sangraha
24. Rasa Yoga Ratnakara
25. Rasa Yoga Sangraha
26. Rasendra Sara Sangraha
27. Rasa Pradipika
28. Sahasrayoga
29. Sarvaroga Chikitsa Ratnam
30. Sarvaroga chikitsa
31. Sharangdhar samhita
32. Siddha Yoga Sanghraha
33. Siddha Bhaishajya Manimala
34. Sushruta Samhita
35. Vaidya Chintamani
36. VaidyakaShabda Sindu
37. Vaidyaka Chikitsa Sara
38. Vidya Jiwan
39. Vasava Rajeeyam
40. Yoga Ratnakaram
41. Yoga Tarangini
42. Yoga Chintamani
43. Kashyapsamhita
44. Bhelasamhita
45. Vishwanathachikitsa
46. Vrindachikitsa
47. Ayurvedachintamani
48. Abhinavchintamani
49. Ayurved Ratnakara
50. Yogaratnasangraha
51. Rasamrita
52. Dravyaguna Nighantu
53. Rasamanjari
54.(A) Bhangsena
54.(B) A.F.I
(C) A.P.I