IMPORT AND REGISTRATION OF DRUGS

1. IMPORT AND REGISTRATION OF DRUGS AND
COSMETICS
(Drugs and cosmetics act,1945)
FACILITATED BY –DR.BALAMURALIDHARA V PREPARED BY – KAUSHIK DEVARAJU
ASST.PROFESSOR 1ST M. PHARM
DEPT. OF PHARMACEUTICS PHARM. REGULATORY AFFAIRS
REGULATORY AFFAIRS GROUPS JSSCP, MYSORE
JSSCP, MYSORE
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2. INTRODUCTION
 IMPORT-Bring (goods or services) into a country from abroad for sale.
 REGISTRATION-The action or process of registering or of being registered.
EX-“The registration of births, marriages, and deaths”.
 DRUG-A medicine or other substance which has a physiological effect when
ingested or otherwise introduced into the body.
 COSMETICS-A preparation applied to the body, especially the face, to
improve its appearance. The range covers everything from the latest
cosmetics to skin and hair care.
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3. WHY ?
Drugs & Cosmetics Act 1940 and Rules 1945
 To Regulate the import, manufacture and sale or distribution of drugs and
cosmetics through Licenses and permits etc.
 Manufacture, distribution and sale of drugs and cosmetics by qualified persons
only.
 To prevent substandard of drugs, presumably for maintaining high standards of
medical treatment.
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4. History
 British misrule-providing poor healthcare system to Indian citizens.
 Observation made by –Drugs enquiry committee, Indian medical
association
 Reports in-Indian medical Gazzette during 1920-1930.
 1940-Drugs and cosmetics
 1945-Rules under the act.
Extended to whole of India
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5. 5
Appoint an India Authorized Agent to interact with the Central Drugs Standard Control
Organization (CDSCO) on your behalf. Your Agent must have a valid wholesale license
(Forms 20B and 21B).
Grant Power of Attorney to your India Authorized Agent to manage your registration in India.
Apply for Import License using Forms 8 and 8-A available from CDSCO. You must identify your
chosen distributors on these forms as well.
Obtain Import License (Form 10) from CDSCO. License valid for up to 3 years, or until the
Registration Certificate expires.
Register
Import
Market
You are
now
authorized
to market

6. PHASES
 PHASE 1
 REGISTRATION CERTIFICATE
 PHASE 2
 IMPORT LICENSE
 MARKETING
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7. 7
PHASE 1

8. Form and process of application for
Registration Certificate
Application for registration
certificate to LA in
FORM 40
It should satisfy
the Schedules
D-1 and D-II
Name & address of authorized
agent in India, power of
attorney
Fee of 1500
US $ for
manufacturing
premises &
1000 US $ for
each drug
The applicant should pay sum of 5000 US $ as expenditure that is required for
inspection, visit by licensing authority
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LA – Licensing Authority
PHASE 1
Free Sale
Certificate

9. DETAILS TO BE CAPTURED IN FORM 40:
1. Authorized Signatory.
2. The address of manufacturing premises shall be captured.
3. The drug(s) name shall be captured.
4. Fee structure for Import Registration.
5. Covering Letter.
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10. Authorized Signatory
 The person authorized preferably
 Director
 approved by the Board of Directors in case of company or
 by the proprietor in case of proprietorship firm.
 The application should accompany affidavit in respect of
authorized person or the Power of Attorney in the name of the
authorized person.
 The Form shall detail the Foreign Manufacturer‘s contact person in the
manufacturing site complete address, (i.e. address of the
manufacturing premises), with corporate office address, along with
the Telephone number, Fax number and E-mail address.
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11. The address of manufacturing premises:
 Undertaking on the document contents by the responsible person at the
manufacturing site (contact person in the manufacturing site).
 In respect of import of more than one drug or class of drugs
manufactured by the same manufacturer, provided that drug or the
classes of drugs, are manufactured at one factory or more than one
factory functioning conjointly as a single manufacturing unit.
 If the tablets are manufactured at one location and packed at another
location, Name and Address of both the locations indicating the activity
of each location.
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12. The drug(s) name shall be captured as
below
 The brand name shall be captured.
 Different pack, pack size and/or different strengths of the same brand shall
be captured.
 Importer‘s undertaking letter declaring for the information specified in
Schedule D (I)(for registration of the manufacturing Premises) and Schedule D
(II)(for registration of the drugs), provided by the original manufacturer.
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13. Fee structure for Import Registration under
Form 40:
 Applicant shall make a payment of 1500 USD (or its equivalent to Indian Currency), as
registration fee for the Manufacturing premises.
 Applicant shall make an payment of 1000 USD (or its equivalent to Indian Currency),
as registration fee for a single drug and additional fee of 1000 USD for each additional
drug in case the manufacturing site remains the same.
 Fees shall be paid through a Callan in the Bank of Baroda, Kasturba Gandhi Marg, New
Delhi- 110 001 or any other Bank, as notified, from time to time by the authority.
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14. Details to be captured in the Covering
Letter
 Information of the drugs to be imported
 Manufacturer information like address and contact details.
 Brief information about the application and List of Documents
a) Original Challan and the details of the Challan.
b) Form 40
c) Schedule D(I) documents as provided by the drug(s) manufacturer (Module 1 of CTD
format)
d. Schedule D(II)-documents as provided by the drug(s) manufacturer(Module 2 to 5 of CTD
format) .
e. Power of Attorney issued by the manufacturer .
f. Copy of Whole Sale License of applicant & Copy of Authorization letter of Applicant .
g. An Undertaking shall be submitted by the proprietor of the firm in case of proprietorship
firm and in case of Private limited Company, by the board of Directors.
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15. SCHEDULE D(I)
Information & undertaking required to be submitted by manufacturer of
his authorized agent with the application form for a registration
certificate. The format shall be properly filled in for the each
application in Form 40. The detailed information, secret in nature, may
be furnished on a computer floppy.
SCHEDULE D(II)
Information required to be submitted by the manufacturer or his authorized
agent with the application form for the registration of the
bulk/formulation/special product for its import into India. The format shall
be properly filled in and the detailed information, secret in nature, may be
furnished on the computer floppy. 15
Free Sale Certificate-A document required in certain countries or for
certain commodities (such as pharmaceuticals), certifying that the
specified imported goods are normally and freely sold in the exporting
country's open markets and are approved for export.

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PHASE 2

17. Form and procedure of application for
import licence
 An application for an import licence shall be made to the licensing authority
 In Form 8 for drugs excluding those specified in Schedule X, and in
 In Form 8-A for drugs specified in Schedule X.
 By the manufacturer himself having a valid wholesale licence for sale or distribution
of drugs under these rules, or
 by the manufacturer's agent in India either having a valid licence under the rules to
manufacture for sale of a drug or having a valid wholesale licence for sale or
distribution of drugs under these rules.
 Rs.1000 for a single drug and an additional fee at the rate of 300rps for each
additional drug.
 Any application for import licence in Form 8 or Form 8-A, shall be accompanied
by a copy of Registration Certificate issued in Form 41 under rule 27-A.
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PHASE 2

18. FORM 10
(See rules 23 and 27)
License to import drugs (excluding those specified in Schedule X) to the Drugs and Cosmetic Rules,
1945
License Number.............. Date...…………..
........................................................................................ (Name and full address
of the importer)
is hereby Licensed to import into India during the period for which the License is in force, the
drugs specified below, manufactured by M/s..................................................
(name and full
address) and any other drugs manufactured by the said manufacturer as may from time to time
be endorsed on this License.
2. This License shall be in force from ........................... to ............. unless it is
sooner suspended or cancelled under the said rules.
3. Names of drugs to be imported.
Place : ……….
Date : ………. Licensing Authority
Seal/Stamp
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19. Forms
 Form 9-Form of undertaking to accompany an application for an import
license.
 FORM 12-Application for license to import drugs for purpose of examination,
test or analysis.
 FORM 11- license to import drugs for the purpose of examination, test or
analysis.
 FORM 11A – License to import drugs by a government hospital or autonomous
medical institution for the treatment of patient.
 FORM 12A –Application for the issue of a permit to import small quantities of
drugs for personal use.
 FORM 12B- Permit for the import of small quantities of drugs for personal use.
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,sir