Download - New Drug Approval in India

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New Drug Approval[NDA]


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.


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


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


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


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


Common Technical Documents

MODULE-1: Administrative Information

MODULE- 2: Quality Overall Summary

MODULE-3: Quality

MODULE-4: Non- Clinical Studies

MODULE-5: Clinical Studies


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.


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


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)


REGULATORY DOCUMENTS

1. Notarized Plant Registration Certificate

2. Notarized Manufacturing & Marketing License

3. Notarized Free Sale Certificate

4. GMP/COPP Certificate Notarized


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


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


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


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.


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


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.

Contact Details:

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Download - New Drug Approval in India

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