The document summarizes the drug registration and regulation process in India. It explains that the Drug Controller General of India heads the Central Drug Standard Control Organization and regulates drugs. It outlines the fees required for site registration and product registration. It also provides details on the regulatory authorities and documents required at various stages of the process, including legal documents, regulatory documents, technical documents, labels, and inserts. It describes the processing procedure and timeline for registration and import license.
How to apply for COPPs (Certificate of Pharmaceutical Products)?ambitbiomedix12
The certificate of a pharmaceutical products (COPPs) is a certificate issued in the format recommended by the World Health Organization (WHO), which establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country. Read More: https://bit.ly/31cfTYl
How to apply for COPPs (Certificate of Pharmaceutical Products)?ambitbiomedix12
The certificate of a pharmaceutical products (COPPs) is a certificate issued in the format recommended by the World Health Organization (WHO), which establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country. Read More: https://bit.ly/31cfTYl
To import Diagnostics into India, the Site of manufacturing & products are to be registered.We give Services in getting manufacturing licences
ACCREDITED CONSULTANTS PVT.LTD
info@acplgroupindia.co.in
+919310040434
To import Cosmetics into India, the Site of manufacturing & products are to be registered.We give Services in getting manufacturing licences
ACCREDITED CONSULTANTS PVT.LTD
info@acplgroupindia.co.in
+919310040434
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.
To import Drug into India, the Site of manufacturing & products are to be registered.We give Services in getting manufacturing licences
ACCREDITED CONSULTANTS PVT.LTD
info@acplgroupindia.co.in
+919310040434
To import Diagnostics into India, the Site of manufacturing & products are to be registered.We give Services in getting manufacturing licences
ACCREDITED CONSULTANTS PVT.LTD
info@acplgroupindia.co.in
+919310040434
To import Cosmetics into India, the Site of manufacturing & products are to be registered.We give Services in getting manufacturing licences
ACCREDITED CONSULTANTS PVT.LTD
info@acplgroupindia.co.in
+919310040434
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.
To import Drug into India, the Site of manufacturing & products are to be registered.We give Services in getting manufacturing licences
ACCREDITED CONSULTANTS PVT.LTD
info@acplgroupindia.co.in
+919310040434
To import Drug into India, the Site of manufacturing & products are to be registered.We give Services in getting manufacturing licences
ACCREDITED CONSULTANTS PVT.LTD
info@acplgroupindia.co.in
+919310040434
Indian regulatory requirements - industrial pharmacy 2Jafarali Masi
Indian Regulatory Requirements: Central Drug Standard Control Organization (CDSCO) and State Licensing Authority: Organization, Responsibilities, Certificate of Pharmaceutical Product (COPP), Regulatory requirements and approval procedures for New Drugs
For more information:
Email: info@arqon.com
LinkedIn : ARQon - Asia Regulatory and Quality Consultancy for Medical Device and Drugs
Twitter: @ARQonSG
Medical device regulatory & registration in Asia/ASEAN: Australia, Cambodia, China, Hong Kong, India, Indonesia, Japan, Malaysia, Myanmar, Nepal, New Zealand, Philippines, Singapore, South Korea, Taiwan, Thailand, Vietnam
-ARQon Service-
ARQon (Asia Regulatory & Quality Consultancy) is a regulatory consultancy firm for medical devices and drug companies. We assist our clients in areas of regulatory and quality from product development to product registration to attain market approval in ASIA, ASEAN, EU, US, and the Rest of the World.
ASIA - Austria TGA, Taiwan FDA, New Zealand Medsafe, Japan MHLW, South Korea MFDS, Hong Kong MDCO, Pakistan DRA, Bangladesh DGDA, China FDA, India CDSCO Approvals
ASEAN - Singapore HSA, Cambodia DDF, MOH Indonesia, Malaysia MDA, Myanmar FDA, Philippines FDA, Thai FDA, Vietnam DMEC Approvals
AMERICAS - Brazil ANVISA, Health Canada, Colombia INVIMA, Costa Rica MOH, Mexico COFEPRIS, Peru DIGEMID, US FDA Approvals
EUROPE - Notified Bodies Approval
MIDDLE EAST - Egypt CAPA, Emirates MOH, Saudi Arabia FDA Approvals
3. Accredited Consultants Pvt. Ltd.
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.
DRUG REGULATION SYSTEM IN INDIA
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.
Legal Documents Regulatory documents Technical Documents
Form 40 POA, DI & DII PMF DMF Labels/Inserts
FLOW CHART FOR REGISTRATION
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)
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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
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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 dataAccredited Consultants Pvt. Ltd.
10. Post marketing Surveillance- It is the
part of Device Master File and should
include following points:
Procedures for distribution of records
Complaint handling.
Adverse incident reporting
Procedure for product recall
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11. C). LABELS AND INSERTS
Product labels should show the address of Drug
Name & Ingredients, Manufacturer, Importers
Address, provision for Import Licence No.
Manufacturing Date, Expiry Date, Lot No.
Product inserts
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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.
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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 1000.00 for Ist product then Rs 100.00
for each additional product)
Form 9
Copy of Wholesale License (Indian agent)-Notarized
Copy of Registration Certificate-Notarized
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14. TIME LINE FOR IMPORT LICENSE
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 1000.00
for Ist. product then Rs 100 for each additional product is
required.
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