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WELCOME
Accredited
Consultants Pvt.
Ltd.
29 Acharyaniketan, 1st
. Floor,
Mayur Vihar Phase 1,
New Delhi 91,
India.
DRUG
REGULATORY
AFFAIRS
Government of
India
Accredited Consultants Pvt. Ltd.
Accredited Consultants Pvt . Ltd.
DRUG REGULATION SYSTEM IN
INDIA
1.Drug Manufacturing Licences are issued by
State Drug Authorities.
2.New Drug Approvals are issued by Drug
Controller General of India.
3.Clinical Trial permissions by Drug Controller
General of India.
LEGAL DOCUMENTS
Documents To be submitted by Indian agent
Form 40- It should be signed and stamped by Indian agent.
Documents To be submitted by Manufacturer
POA- Power of Attorney should be Appostilised or
Consularized from Indian embassy of the country of origin,
and should be co-jointly signed by both the parties
i.e Manufacturer and Indian Agent.
Schedule DI & DII- They should be signed and stamped by
Manufacturer (Need not to be notarized)
Accredited Consultants Pvt. Ltd.
REGULATORY DOCUMENTS
Notarized Plant Registration Certificate
Notarized Manufacturing & Marketing License
Notarized Free Sale Certificate
GMP Certificate Notarized
COPP Notarized
Whole Sale License (20B & 21B) of Indian Agent
Accredited Consultants Pvt . Ltd.
Accredited Consultants Pvt. Ltd.
Technical Documents
A) Plant master file: Should include the
following points.
 Sketch of the Plant
 Profile of the company
 Organogram of the Company
 Plant & Machinery
 Hygienic & Sanitary measure details
 IQPQDQOQ
 HAVAC System
 MEN MATERIAL MOVEMENT
B). Device master file: Should include the
following points.
 Manufacturing process/Flow Chart
 Quality Assurance procedures/process controls
 Final product testing report
 Functionality Test protocol and report
 Sterilization process and validation report
 Stability data
 BA/BE Study Report and Toxicological data
Accredited Consultants Pvt . Ltd.
Post marketing Surveillance- It is the part
of Device Master File, should include
following points:
Procedures for distribution of records
Complaint handling.
Adverse incident reporting
Procedure for product recall
Accredited Consultants Pvt. Ltd.
C). LABELS AND INSERTS
 Product labels should show the
address of Drug Name &
Ingredients, Manufacturer, Importers
Address, provision for Import
Licence No. Mfg. Date, Expiry
Date, Lot No.
 Product inserts
Accredited Consultants Pvt. Ltd.
PROCESSING PROCEDURE
After ensuring all documents correctly as per the
requirements of FDA, they are submitted.
It generally takes about 2-3 months to scrutinize
these documents by Technical Data
Associates/Drug inspectors of CDSCO.
During this period clarification if any, required by
them are answered and thereafter we get the
Registration Certificate (RC) in Form 41.
Accredited Consultants Pvt. Ltd.
IMPORT PROCESSING
After getting the registration certificate from CDSCO, the
Indian agent can import the products from the
manufacturer. Following documents are further required to
get Form 10 (Import license).
1. Form 8
2. TR Challan- (Rs 1000 for Ist. product then Rs 100 for
each additional product)
3. Form 9
4. Copy of Wholesale License (Indian agent)-Notarized
5. Copy of Registration Certificate-Notarized
Accredited Consultants Pvt. Ltd.
TIME LINE FOR IMPORT LICENSE
1. The Importer (Indian agent) is not authorized to
import the products from foreign manufacturer
unless he obtains Import license (Form 10) form
CDSCO.
2. It generally takes about one month to scrutinize these
documents by Technical Data Associates/Drug
inspectors of CDSCO.
3. During this period clarification if any, are required by
them are answered and thereafter the importer gets the
Import license.
4. For Import license application TR Challan of Rs 1000
for Ist. product then Rs 100 for each additional product
is required.
Accredited Consultants Pvt . Ltd.
Accredited Consultants Pvt .Ltd.
THANK YOU
ALWAYS AT OUR CLIENT’S SERVICE!
Contact Details:
Accredited Consultants Private Limited,
D-29, First Floor, Acharya Niketan,
Mayur Vihar Phase-I, Delhi-110091.
Phones: 011-22758204,
(M) +91-9310040434, +91-9266665201
Fax: 011-22758994
Email:
info@acplgroupindia.com,
info@acplgroupindia.co.in,
prasad_bhat@hotmail.
Accredited Consultants Pvt. Ltd.

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Biological Products in India

  • 1. WELCOME Accredited Consultants Pvt. Ltd. 29 Acharyaniketan, 1st . Floor, Mayur Vihar Phase 1, New Delhi 91, India.
  • 3. Accredited Consultants Pvt . Ltd. DRUG REGULATION SYSTEM IN INDIA 1.Drug Manufacturing Licences are issued by State Drug Authorities. 2.New Drug Approvals are issued by Drug Controller General of India. 3.Clinical Trial permissions by Drug Controller General of India.
  • 4. LEGAL DOCUMENTS Documents To be submitted by Indian agent Form 40- It should be signed and stamped by Indian agent. Documents To be submitted by Manufacturer POA- Power of Attorney should be Appostilised or Consularized from Indian embassy of the country of origin, and should be co-jointly signed by both the parties i.e Manufacturer and Indian Agent. Schedule DI & DII- They should be signed and stamped by Manufacturer (Need not to be notarized) Accredited Consultants Pvt. Ltd.
  • 5. REGULATORY DOCUMENTS Notarized Plant Registration Certificate Notarized Manufacturing & Marketing License Notarized Free Sale Certificate GMP Certificate Notarized COPP Notarized Whole Sale License (20B & 21B) of Indian Agent Accredited Consultants Pvt . Ltd.
  • 6. Accredited Consultants Pvt. Ltd. Technical Documents A) Plant master file: Should include the following points.  Sketch of the Plant  Profile of the company  Organogram of the Company  Plant & Machinery  Hygienic & Sanitary measure details  IQPQDQOQ  HAVAC System  MEN MATERIAL MOVEMENT
  • 7. B). Device master file: Should include the following points.  Manufacturing process/Flow Chart  Quality Assurance procedures/process controls  Final product testing report  Functionality Test protocol and report  Sterilization process and validation report  Stability data  BA/BE Study Report and Toxicological data Accredited Consultants Pvt . Ltd.
  • 8. Post marketing Surveillance- It is the part of Device Master File, should include following points: Procedures for distribution of records Complaint handling. Adverse incident reporting Procedure for product recall Accredited Consultants Pvt. Ltd.
  • 9. C). LABELS AND INSERTS  Product labels should show the address of Drug Name & Ingredients, Manufacturer, Importers Address, provision for Import Licence No. Mfg. Date, Expiry Date, Lot No.  Product inserts Accredited Consultants Pvt. Ltd.
  • 10. PROCESSING PROCEDURE After ensuring all documents correctly as per the requirements of FDA, they are submitted. It generally takes about 2-3 months to scrutinize these documents by Technical Data Associates/Drug inspectors of CDSCO. During this period clarification if any, required by them are answered and thereafter we get the Registration Certificate (RC) in Form 41. Accredited Consultants Pvt. Ltd.
  • 11. IMPORT PROCESSING After getting the registration certificate from CDSCO, the Indian agent can import the products from the manufacturer. Following documents are further required to get Form 10 (Import license). 1. Form 8 2. TR Challan- (Rs 1000 for Ist. product then Rs 100 for each additional product) 3. Form 9 4. Copy of Wholesale License (Indian agent)-Notarized 5. Copy of Registration Certificate-Notarized Accredited Consultants Pvt. Ltd.
  • 12. TIME LINE FOR IMPORT LICENSE 1. The Importer (Indian agent) is not authorized to import the products from foreign manufacturer unless he obtains Import license (Form 10) form CDSCO. 2. It generally takes about one month to scrutinize these documents by Technical Data Associates/Drug inspectors of CDSCO. 3. During this period clarification if any, are required by them are answered and thereafter the importer gets the Import license. 4. For Import license application TR Challan of Rs 1000 for Ist. product then Rs 100 for each additional product is required. Accredited Consultants Pvt . Ltd.
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  • 14. Contact Details: Accredited Consultants Private Limited, D-29, First Floor, Acharya Niketan, Mayur Vihar Phase-I, Delhi-110091. Phones: 011-22758204, (M) +91-9310040434, +91-9266665201 Fax: 011-22758994 Email: info@acplgroupindia.com, info@acplgroupindia.co.in, prasad_bhat@hotmail. Accredited Consultants Pvt. Ltd.