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WELCOME
Accredited
Consultants Pvt.
Ltd.
DRUG REGISTRATION
Accredited Consultants Pvt. Ltd.
Accredited Consultants Pvt. Ltd.
DRUG REGULATION SYSTEM IN INDIA
Drug Controller General of India is the head of
Central Drug Standard Control Organization ,
which regulates Devices & Drugs in India.
TR Challan: Fees of 1500 USD is required for site
registration and 1000 USD for registration of each
product.
Accredited Consultants Pvt .Ltd.
Drug Controller General of India
Deputy Drug Deputy Drug Deputy Drug Deputy Drug
Controller Controller Controller Controller
[New Drug/GCT [Medical Device] [Biologicals & Vaccines] [Drugs]
/FDC/P’ovigilance]
Asst Drug Controller Asst Drug Controller Asst Drug Controller Asst Drug Controller
T.O/D.I (5-15) T.O/D.I (5-15) T.O/D.I (5-15) T.O/D.I (5-15)
TDA (0-10) TDA (0-10) TDA (0-10) TDA (0-10)
Accredited Consultants Pvt. Ltd.
FLOW CHART FOR REGISTRATION
Legal Documents Regulatory documents Technical Documents
Form 40 POA, DI & DII PMF DMF Labels/Inserts
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. Mafg. 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 and 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 is now import the products from the
manufacturer. Following documents are further required
to get Form 10 (Import license).
 Form 8
 TR Challan- (Rs 1000 for Ist product then Rs 100 for each
additional product)
 Form 9
 Copy of Wholesale License (Indian agent)-Notarized
 Copy of Registration Certificate-Notarized
Accredited Consultants Pvt. Ltd.
The Importer (Indian agent) is not authorized to import the
products from foreign manufacturer unless he obtains
Import license (Form 10) form CDSCO.
It generally takes about one month to scrutinize these
Documents by Technical Data Associates/Drug inspectors of
CDSCO and during this period clarification if any, are
required by them are answered and thereafter the importer
gets the Import license.
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.
TIME LINE FOR IMPORT LICENSE
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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Manufacturing of New Drug by Export NOC

  • 3. Accredited Consultants Pvt. Ltd. DRUG REGULATION SYSTEM IN INDIA Drug Controller General of India is the head of Central Drug Standard Control Organization , which regulates Devices & Drugs in India. TR Challan: Fees of 1500 USD is required for site registration and 1000 USD for registration of each product.
  • 4. Accredited Consultants Pvt .Ltd. Drug Controller General of India Deputy Drug Deputy Drug Deputy Drug Deputy Drug Controller Controller Controller Controller [New Drug/GCT [Medical Device] [Biologicals & Vaccines] [Drugs] /FDC/P’ovigilance] Asst Drug Controller Asst Drug Controller Asst Drug Controller Asst Drug Controller T.O/D.I (5-15) T.O/D.I (5-15) T.O/D.I (5-15) T.O/D.I (5-15) TDA (0-10) TDA (0-10) TDA (0-10) TDA (0-10)
  • 5. Accredited Consultants Pvt. Ltd. FLOW CHART FOR REGISTRATION Legal Documents Regulatory documents Technical Documents Form 40 POA, DI & DII PMF DMF Labels/Inserts
  • 6. 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.
  • 7. 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.
  • 8. 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
  • 9. 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.
  • 10. 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.
  • 11. C). LABELS AND INSERTS: Product labels should show the address of Drug Name & Ingredients, Manufacturer, Importers Address, provision for import Licence No. Mafg. Date, Expiry Date, Lot No.  Product inserts Accredited Consultants Pvt. Ltd.
  • 12. 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 and 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.
  • 13. IMPORT PROCESSING After getting the registration certificate from CDSCO, the Indian agent is now import the products from the manufacturer. Following documents are further required to get Form 10 (Import license).  Form 8  TR Challan- (Rs 1000 for Ist product then Rs 100 for each additional product)  Form 9  Copy of Wholesale License (Indian agent)-Notarized  Copy of Registration Certificate-Notarized Accredited Consultants Pvt. Ltd.
  • 14. The Importer (Indian agent) is not authorized to import the products from foreign manufacturer unless he obtains Import license (Form 10) form CDSCO. It generally takes about one month to scrutinize these Documents by Technical Data Associates/Drug inspectors of CDSCO and during this period clarification if any, are required by them are answered and thereafter the importer gets the Import license. 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. TIME LINE FOR IMPORT LICENSE
  • 15. 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.