Download - New Drug Approval in India
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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)
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
Approval of Clinical Trials, Import, & Manufacture of New Drugs
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Requirements and Guidelines - Schedule YRule 122 A -: Permission to import and market new drugRule 122 B -: Permission to manufacture new drugRule 122 DA -: Permission of Clinical trials/INDRule 122 E -: Definition of New Drugs*• New substance having therapeuticindication• Modified or new claims, new route ofadministration 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
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 agentForm 40- It should be signed and stamped by the Indian agent.
Documents To be submitted by ManufacturerPoA- 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 DocumentsA) 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 recordsComplaint handling.Adverse incident reportingProcedure for product recallCorrective Action Taken
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C). LABELS AND INSERTS1.Product labels should show the address
ofManufacturer.
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 isrequired by them, these are answered.
Thereafter we get the Registration Certificate (RC) in Form 41.
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IMPORT PROCESSINGAfter 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 9Copy of Wholesale License (Indian agent)-NotarizedCopy 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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