new drug approval ppt

WELCOME Accredited

Consultants Pvt Ltd

D-29, First Floor, Acharya Niketan, Mayur Vihar Phase-I, Delhi-110091

Ph: 011-22758204, Fax: 011-22758994 (M) +91-9310040434:+91-

9266665201 Email: info@acplgroupindia.com,

info@acplgroupindia.co.in; prasad_bhat@hotmail.com; Web:

www.acplgroupindia.co.in

New Drug Approval [NDA]

Accredited Consultants Pvt Ltd

Accredited Consultants Pvt Ltd

DRUG REGULATION SYSTEM IN INDIA

The Objective of a Drug Regulatory Authority is to ensure

that of medicinal products are of acceptable Quality, Safety

and Efficacy which are Approved, Manufactured and

Imported.

Drug Controller General of India is the head of Central Drug

Standard Control Organization , which regulates Devices &

Drugs in India.

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)

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

Accredited Consultants Pvt Ltd

Approval of Clinical Trials, Import, &

Manufacture of New Drugs

Accredited Consultants Pvt Ltd

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

Accredited Consultants Pvt Ltd

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

Accredited Consultants Pvt Ltd

Common Technical Documents

MODULE-1: Administrative Information

MODULE- 2: Quality Overall Summary

MODULE-3: Quality

MODULE-4: Non- Clinical Studies

MODULE-5: Clinical Studies

Accredited Consultants Pvt Ltd

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

Accredited Consultants Pvt Ltd

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 the Approval.

TR Challan of Rs 50,000 is required for the fresh

application.

TR Challan of Rs 15,000 is required for subsequent

application.

Accredited Consultants Pvt Ltd

FLOW CHART FOR REGISTRATION

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

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)

Accredited Consultants Pvt Ltd

REGULATORY DOCUMENTS

Notarized Plant Registration Certificate

Notarized Manufacturing & Marketing License

Notarized Free Sale Certificate

GMP/COPPCertificate Notarized

Accredited Consultants Pvt Ltd

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

Accredited Consultants Pvt Ltd

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

Accredited Consultants Pvt Ltd

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

Accredited Consultants Pvt Ltd

C). LABELS AND INSERTS

Product labels should show the address of

Manufacturer.

Product inserts should describe the brief description

of the product and its intended use.

Accredited Consultants Pvt Ltd

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.

Accredited Consultants Pvt Ltd

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 for Ist product then Rs 100 for each

additional product)

Form 9

Copy of Wholesale License (Indian agent)-Notarized

Copy of Registration Certificate-Notarized

Accredited Consultants Pvt Ltd

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.

THANK YOU

Accredited Consultants Pvt Ltd

OUR HEARTFUL THANKS

WE BELIEVE OUR CLIENTS ARE OUR

KINGS!!!

D-29, First Floor, Acharya Niketan, Mayur Vihar Phase-I, Delhi-110091

Ph: 011-22758204, Fax: 011-22758994 (M) +91-9310040434:+91-

9266665201 Email: info@acplgroupindia.com,

info@acplgroupindia.co.in; prasad_bhat@hotmail.com; Web:

www.acplgroupindia.co.in