The document discusses India's drug regulatory system. The Drug Controller General of India regulates drugs and medical devices in the country to ensure quality, safety and efficacy. New drugs require approval through a New Drug Application process which involves submitting documentation on manufacturing, non-clinical studies, and clinical trials for review. It takes about a year to review an NDA and various forms and fees are involved in the approval and import license application processes.

1. New Drug Approval
[NDA]

2. DRUG REGULATION SYSTEM IN INDIA
The
that
and
Objective of a Drug Regulatory Authority is to ensure
of medicinal products are of acceptable Quality, Safety
Efficacy which are Approved, Manufactured and
Imported.
Drug Controller General of India is the head of Central Drug
Standard Control Organization , which regulates
Drugs in India.
Devices &

3. Functions of CDSCO
 Approval of new drugs and clinical trials
 Import Registration and Licensing
 Licensing of Blood Banks, LVPs,Vaccines, r-DNA
 products & some Medical Devices
 Amendment to D &C Act and Rules
 Banning of drugs and cosmetics
 Grant ofTest License, Personal License, NOCs for
Export
 Testing of Drugs

4. Approval of Clinical Trials, Import, &
Manufacture of New Drugs
Requirements and Guidelines - ScheduleY
 Rule 122 A -: Permission to import and market new drug
 Rule
 Rule
 Rule
122
122
122
B -: Permission to manufacture new drug
DA -: Permission of Clinical trials/IND
E -: Definition of New Drugs*
• New substance having therapeutic
indication
• Modified or new claims, new route
administration for already approved
• Fixed Dose Combination
of
drug

5. FLOW C
Biologica
Co
• Veterinary Pr
HART FOR New Drug Approval
(NDA)
ls Vaccines New drugs/Devices
mmon Technical documents
(Modules 1-5)
[CTD]
oduct - CTD Modules 1-4
- Noc from Animal Husbandry

6. Common Technical Documents
MODULE-1: Administrative Information
MODULE- 2: Quality Overall Summary
MODULE-3: Quality
MODULE-4: Non- Clinical Studies
MODULE-5: Clinical Studies

7. New Drug Approval
Form 45 Form 45 A
(Bulk
Substance)
Form 46
(Manufactur
ing)
(Finished Formulation)
Registration
Form 41
Import License
Form 10

8. TIME LINE & FEES FOR NDA
It generally takes about one year 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 theApproval.
TR Challan of
application.
TR Challan of
application.
Rs 50,000 is required for the fresh
Rs 15,000 is required for subsequent

9. FLOW CHART FOR REGISTRATION
Legal Documents Regulatory documents Technical Documents
Form 40 POA, DI & DII PMF DMF Labels/Inserts

10. LEGAL DOCUMENTS
DocumentsTo be submitted by Indian agent
 Form 40- It should be signed and stamped by Indian
agent.
DocumentsTo 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 IndianAgent.
 Schedule DI & DII- They should be signed and stamped by
Manufacturer (Need not to be notarized)

11. REGULATORY DOCUMENTS
 Notarized
 Notarized
 Notarized
Plant Registration Certificate
Manufacturing & Marketing
Free Sale Certificate
License
 GMP/COPPCertificate Notarized

12. 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









13. B). Drug master file:Should include the
following points.
Manufacturing process/Flow Chart
Quality Assurance procedures/process controls
The provision to control contamination & cross contamination
the final product


 in
Process control, control of critical steps
Container Closure System
RiskAssessment as per ISO 14971.
Process validation/verification
Stability data
Biocompatibility andToxicological data
Clinical Studies & report
and intermediates.







14. Post marketing Surveillance- It is the part
of Device Master File, should include following points:
 Procedures for distribution of
 Complaint handling.
 Adverse incident reporting
 Procedure for product recall
 CorrectiveActionTaken
records

15. C). LABELSAND INSERTS
Product labels should show the address of
Manufacturer.

Product inserts should describe the brief description
of the product and its intended use.

16. 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 DataAssociates/Drug inspectors of CDSCO
and during this period clarification if any, required
them are answered and thereafter we get the
Registration Certificate (RC) in Form 41.
by

17. 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
get Form 10 (Import license).
 Form 8
 TR Challan- (Rs 1000 for Ist product then Rs 100 for each
additional product)
 Form 9
 Copy ofWholesale License (Indian agent)-Notarized
 Copy of Registration Certificate-Notarized
to

18. 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
byTechnical 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 applicationTR Challan of Rs 1000 for Ist
product then Rs 100 for each additional product is required.