The document summarizes India's drug regulation system. The Drug Controller General of India oversees the Central Drug Standard Control Organisation and regulates medical devices and drugs. New drugs must go through an approval process involving clinical trials and submissions to various departments before gaining an import license and being allowed for manufacture and sale in India. The process can take around one year and involves filing various regulatory, technical and legal documents with fees.

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WELCOME
Accredited
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New Drug Approval
[NDA]

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DRUG REGULATION SYSTEM IN INDIA
 Drug Controller General [DCG] of India is the Head of the Central
Drug Standard Control Organisation [CDSCO] that Regulates
Medical Devices & Drugs in India.
 The Objective of a Drug Regulatory Authority is to ensure that
medicinal products are of acceptable Quality, Safe and Efficient.
 That the medicinal products are Manufactured, Approved, and
Imported.

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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. Functions of CDSCO
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 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 of Test License, Personal License, NOCs for
Export
 Testing of Drugs

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

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FLOW CHART FOR New Drug Approval (NDA)
Common Technical documents [CTD]
(Modules 1-5)
• Veterinary Product - CTD Modules 1-4
Biologicals Vaccines New
Drugs/Devices
NoC from Animal Husbandry

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

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New Drug Approval
Form 45 Form 45 A Form 46
(Finished Formulation) (Bulk Substance) (Manufacturing)
Registration
Form 41
Import License
Form 10

10. TIME LINE & FEES FOR NDA
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1. It generally takes about one year to scrutinize these
documents by Technical Data Associates/Drug
Inspectors of CDSCO.
2. During this period clarifications if any, are required by
them are answered and thereafter the importer gets the
Approval.
3. TR Challan of Rs 50,000 is required for the fresh
application.
4. TR Challan of Rs 15,000 is required for subsequent’
application.

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

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FLOW CHART FOR New Drug Approval (NDA)
Biologicals Vaccines New
Drugs/Devices
Common Technical documents [CTD]
(Modules 1-5)
• Veterinary Product - CTD Modules 1-4
- NoC from Animal Husbandry

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LEGAL DOCUMENTS
Documents To be submitted by Indian agent
Form 40- It should be signed and stamped by the Indian agent.
Documents To be submitted by Manufacturer
PoA- Power of Attorney should be Appostilised or Consularized
by the Indian Embassy from the country of origin. It should be
co-jointly signed by both the parties i.e The Manufacturer and the
Indian Agent.
Schedule DI & DII- They should be signed and stamped by
Manufacturer (Need not to be notarized)

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REGULATORY DOCUMENTS
1. Notarized Plant Registration Certificate
2. Notarized Manufacturing & Marketing License
3. Notarized Free Sale Certificate
4. GMP/COPP Certificate Notarized

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Technical Documents
A) Plant master file:
Should include the following points.
1. Sketch of the Plant
2. Profile of the company
3. Organogram of the Company
4. Plant & Machinery
5. Hygienic & Sanitary measure details
6. IQPQDQOQ
7. HAVAC System
8. MEN MATERIAL MOVEMENT

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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 in the final product
 Process control, control of critical steps and intermediates.
 Container Closure System
 Risk Assessment as per ISO 14971.
 Process validation/verification
 Stability data
 Biocompatibility and Toxicological data
 Clinical Studies & reports

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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
Corrective Action Taken

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C). LABELS AND INSERTS
1.Product labels should show the address
of
Manufacturer.
2. Product inserts should describe the
brief description of the product and its
intended use.

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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 the Technical
Data Associates/Drug Inspectors of CDSCO.
During this period if any clarification is
required by them, these are answered.
Thereafter we get the Registration Certificate
(RC) in Form 41.

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IMPORT PROCESSING
After getting the registration certificate from
CDSCO, the Indian agent can 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 the First Product, thereafter
Rs. 100 for each additional product)
Form 9
Copy of Wholesale License (Indian agent)-Notarized
Copy of Registration Certificate-Notarized

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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 for
Ist. product then Rs 100 for each additional product is
required.

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