Product Registration Guidlines

PRODUCT REGISTRATION
GUIDLINES
SAGAR BAGUL
SAGAR BAGUL
13/31/2019

CONTENT
 Introduction
 Overview
 IND
 NDA
 Documents for registration
 Fee structure
 Processing registration process
 Suspension of registration
 Validity of suspension
 Renewal
SAGAR BAGUL 23/31/2019

INTRODUCTION
 Central Drug Standard Control Organization (CDSCO)
• It is the regulatory authority for the approval of new drug,
import registration of drug, medical device & cosmetics.
• The CDSCO works under Directorate general of Health
Service, Ministry Of Health And Family Welfare Government
Of India.
• CDSCO has six zonal offices, four sub-zonal offices, thirteen
port offices and seven laboratories under its control.
• Minister responsible :J.P.Nadda
• Drug Controller General Of India: Dr.G.N.Singh

OVERVIEW

Investigational New Drug
Application (INDA):
 Under the Food Drug and Cosmetics Act as amended,
the sponsor of new drug is required to file with the
FDA as IND before the drug may be given to human
subject.
 This is to protect the right and safety of the subjects
and to ensure that the investigational plan is sound
and is designed to achieve the sated objective.
 After the submission of the IND, the sponser must
delay the use of the drug in human subject for not less
than 30 days from the date of the FDA acknowledges
the receipt of the application .

Pre-IND Meetings
 On request, the FDA will advise a sponsor on
scientific, technical, or formatting concerns related to
the preparation and submission of an IND.
 This may include advice on the adequacy of data to
support an investigational plan, the design of clinical
trial, or whether the proposed investigation is likely to
produce the data needed to meet the requirement of
the next step, the filing of an NDA to gain approval for
marketting.

Review Of IND Application
 The FDA’s objectives in reviewing an IND are to
protect the safety and right of the human subject and
to help ensure that the study allows the evaluation of
the drugs safety and effectiveness .
 When received by the FDA, the IND submission is
stamped with the date of receipt, assigned an
application number, and forwarded to either CDER or
CBER.

The New Drug Application(NDA)
 After the successful demonstrate of sufficient drug
safety and therapeutic efficacy during clinical testing
phases of the IND period , the sponsor files an NDA
with FDA.
 This filing may preceded by an pre-NDA meeting
between the sponsor and the FDA to discuss the
content and the format of NDA.
 The purose of NDA is to gain the permission to market
the drug product.

NDA Review;
 The completed NDA is carefully reviewed by the FDA,
which decides whether to allow the sponser to market
the drug, to disallow marketing, or to require
additional data before rendering a judgment.
 By, regulation FDA must respond within 180 days of
receipt of an application.
 This 180 day period is called the review clock.
 The NDA is reviewed by the same FDA division that
reviewed the sponsor’s original IND.

CDSCO
Documents for registration
LEGAL DOCUMENTS REGULATORY DOCUMENTS TECHNICAL DOCUMENTS
Form 40 Notarized plant reg. certificate PMF
POA Notarized mfg & marketing license DMF
Schedule D-I, D-II Notarized free sale certificate Labels/Inserts
Notarized GMP certificate
Whole sale license

FORM 40
 A dully filled form40 as per the proforma prescribed
in the D &C rule signed and stamped by the local
authorized agent/ manufacturer along with name
and designation and date.
 Details to be captured in form 40.
• Authorized signatory.
• The address of mfg premises.
• The drug name, packing size, strength.

ANNEXURE-I
FORM 40
(See rule 24-A)
Application for issue of Registration Certificate for import of drugs into India under the Drugs and Cosmetics Rules 1945
I/We*____________________________________________________________________________________ (Name and full
address) hereby apply for the grant of Registration Certificate for the manufacturer, M/s.___________________(full address
with telephone, fax and E-mail address of the foreign manufacturer) for his premises, and manufactured drugs meant for
import into India.
1. Names of drugs for registration.
1 * * *
2. I/We enclose herewith the information and undertakings specified in Schedule D
(I) and Schedule D (II) duly signed by the manufacturer for grant of Registration Certificate for the premises stated below.
3. A fee of_______________for registration of premises, the particulars of which are given below, of the manufacturer has been
credited to the Government under the Head of Account "0210-Medical and Public Health, 04-Public Health, 104-Fees and
Fines‖ under the Drugs and Cosmetics Rules, 1945-Central vide Challan No.________ dated__________________(attached
in original).
4. A fee of__________________for registration of the drugs for import as specified at Serial No. 2 above has been credited to the
Government under the Head of Account "0210-Medical and Public Health, 04-Public Health, 104-Fees and Fines" under the
Drugs and Cosmetics Rules, 1945-Central vide Challan No._______, dated___________. (attached in original).
5. Particulars of premises to be registered where manufacture is carried on: Address (es) ___________
Telephone No.___________ Fax__________________ _
E-mail_______________
I/We* undertake to comply with all terms and conditions required to obtain Registration Certificate and to keep it valid during its
validity period.
Place: __________
Date: ___________
Signature__________
Name____________
Designation_______
Seal/Stamp of manufacturer or his authorised Agent in India.
(Note: In case the applicant is an authorized agent of the manufacturer in India, the Power of Attorney is to be enclosed).
*Delete whichever is not applicable.

POA (Power Of Attorney)
 It is the authorization by manufacturer to his agent in India.
 POA is appostilised or consularized from Indian embassy of
the country of origin & should be co-jointly signed by both
the parties (manufacturer and agent).
 It consist the list of of the names of all the proposed drugs if
possible along with their specific Indication and/or intended
use.
 The authorized agent is responsible for manufacturer’s
business activity, in India.
 It implies that a fresh POA is to be submitted at the time of
renew of registration certificate.

POWER OF ATTORNEY FOR ISSUE OF REGISTRATION CERTIFICATE AND/OR
IMPORT LICENSE FOR IMPORT OF DRUGS IN INDIA
Whereas, M/s……………., having Registered Office at ………….. at…………..,
(Telephone ……………, Fax …, email:….) hereinafter to be known as Authorised Agent/Manufacturer of us
intends to apply for a Registration Certificate and/or Import License under the Drugs and Cosmetics Rules,
1945, for the import, use and marketing into India, the .. (Product name), Manufactured by (Full address/
telephone no., /e-mail) here after to be known as the Manufacturer, having the factory premises at
……………. (Full address/ telephone no., /e-mail), hereby delegate Power of Attorney that for the
duration of the said Registration and /or License period.
PRODUCT (S) INFORMATION
NAME (S) OF THE PRODUCT:
Active Ingredients
Pharmacological Classification
Dosage Form
Signature on behalf of manufacturer, with name, designation, date and place.
Name: …
Place: …………..
Date:
Signature*:
(* Signatory Authority should be authorized by the Board of the Company/Directors)
Signature on behalf of Authorised Agent in India with name, designation, date and place.
Name: …….
Place: ……….
Date:
Signature:

SCHEDULE D-I & D-II
They shouled be signed & stamped by manufacturer (need not to be
notarized).
See rule 21 (d) and rule 24 A)
Information and undertaking required to be submitted by the manufacturer or
his authorized agent with the Application Form for a Registration Certificate.
The format shall be properly filled in for each application in Form 40. The
detailed information, secret in nature, may be furnished on a Computer Floppy.
Schedule D-I
 for registration of the
manufacturing Premises
Schedule D-II
For registration of product
 vaccines
 Diagnostic kit
 Blood product
 Medical Devices

REGULATORY
DOCUMENTS
Notarized plant reg. certificate.
Notarized mfg & marketing license.
Notarized free sale certificate.
Notarized GMP certificate.
Whole sale license.
Notarized certificate of pharmaceutical product
(COPP).

TECHNICAL DOCUMENT
Plant Master File.
Sketch of plant
Profile of the company
Organogram of company
Plant and machinery
Hygienic and sanitary measure details
HAVAC system
Men Material Movement
Device Master File
Manufacturing process/ flowchart
Quality assurance procedure/ process control
Final product testing report
Stability data

Cont...
Marketing Surveillance:- part of DMF
Procedure for distribution of records
Complaint handling
Adverse incident reporting
Procedure for product recall
Labels and Inserts
 Labels:- Product label should show the drug name,
ingredients, manufacturer, license No., mfg date, exp date,
lot No..
 Inserts:- describe the brief description of the product and
its intended use.

Fee Structure For
Registration :
TR6 Challan : fee is paid through challan in Bank of
Baroda, Kasturba Gandhi Marg, New Delhi.
Applicant shall make a payment of 1500US$
(equivalent to Indian Currency) as registered fee for
Mfg premises.
Applicant shall make an payment of 1000US$
(equivalent to Indian Currency) as registration fee for
single drug meant for import into and use in India and
1000US$ for each additional drug in case the Mfg site
remains same.
Applicant has to pay 5000US$ for inspection & visit
Mfg premises.
300US$ for duplicate registration certificate.

Processing Registration
Procedure
 After ensuring all documents correctly as per the
requerments it is submited to the regulatory authority.
 Registration time provided further that if the application
is complete in all respects and information specified in
D (I) & D (II) are in order, the licencing authority shall
within 9 months from the date of receipt of application
issue such Registration Certificate, and in exceptional
circumstances and for the reasons to be recorded in
writing, the Registration Certificate may be issued within
such extended period not exceeding 3 months as the
licencing authority may deemed fit.

Suspension and Cancellation of
Registration Certificate
 If the manufacturer fails to comply with any of the
condition of the Registration Certificate, the
licensing authority may suspend or cancelled the
RC.
Duration Of Registration Certificate
 A registration Certificate, unless, it is sooner
suspended or cancelled, shall be valid for a period
of three from the date of it’s issue.

Renewal of registration or re-
registration
 At the time of application for renewal of registration
or re-registration, the application is to be made 9
months before the expiry of the Registration
Certificate. In addition regulatory documentary
compliance like Form 40, POA, GMP / COPP,
Registration certificate, DMF (soft copy if no
change), License (sale or manufacturing License of
drugs of the agent) etc.

CONCLUSION
 A Successful guidance to provide non binding
guidance in the registration and import of bulk drugs
and finisshed formulation in india.
3/31/2019 SAGAR BAGUL 23

References;
 Guidance Document (Import and Registration
Division) Document No. IMP/REG/200711
 https;//cdsco.nic.in
 https;//cdsco.gov.in
 Loyd V.ALLEN, Ansel’s Pharmaceutical Dosage Forms
And Drug Delivery System, Ninth Edition, wolters
kluwer India Pvt.Ltd.
 Dr.B.S.Kuchekar, A.M.Khadatare, Forensic Pharmacy,
11th edition June 2015, Nirali Prakashan.

Product Registration Guidlines

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