CDSCO Regulatory Approval Process India

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

The Objective of a Drug Regulatory in India are to ensure the
medicinal, Medical Devices and Cosmetics products are acceptable on
the of Quality, Safety and Efficacy.
Drug Controller General of India-the head of Central Drug Standard
Control Organisation, regulates Cosmetics, Devices & Drugs in India.
The Drugs & Cosmetics Act and Rules are the governing regulations in
India.
Accredited Consultants Pvt. Ltd.

Central Drug Standards Control
Organization is the Regulatory
authority for the approval of New
Drug, Import Registration of Drugs,
Medical Devices and Cosmetics.

As in the case of USFDA regulation or
any other country regulation in India
also there are possibilities of
categorisation of product in different
ways, depending upon various
parameters.

FLOW CHART FOR REGISTRATION
OF COSMETICS
Legal Documents Regulatory documents Technical Documents
Form 42 POA, DIII Product Testing
(From Indian Agent) Specification Method, COA,
Label/IFU
Manufacturing License, GMP, Free Sale Certificates, Standards

 Drugs & Cosmetic Act defines “cosmetic” means any article intended
to be rubbed, poured, sprinkled or sprayed on, or introduced into, or
otherwise applied to, the human body or any part thereof for
cleansing, beautifying, promoting attractiveness, or altering the
appearance, and includes any article intended for use as a component
of cosmetic.

 Domestic Manufacturing of Cosmetic already regulated in India
 As per Notification GSR 426(E) in 2010 the Drugs & Cosmetics
Act amended required Registration prior to importation of
Cosmetics to India.
 Though it is extended for some time now it is mandatory from
1st April 2013
REQUIREMENTS FOR IMPORT OF
COSMETICS

 Other Documents required are Manufacturing License, GMP if any,
Free Sale Certificate, etc.
 The products should not contain prohibited items (such as mercury,
lead & prohibited colors) & it should comply to the standards of
either Bureau of Indian Standards or of International Cosmetics
Standards.
 Government Fee by TR Challan as applicable.

Labels and inserts
 Product labels should show the address of manufacturer, manufacturing &
expiry date, importer name and address, import license no., indications &
cautions or contra indications (if any)
Product inserts should describe the brief description of the product and its
intended use.
 Company Profile
 Product specification and testing protocol
 List of Ingredients with details of strength of each ingredient used in the
products to be registered

Documents To be submitted by Indian agent
 Form 42- 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 in the given format.
 Schedule DIII- They should be signed and stamped by
Manufacturer in the given format.

 The total fee depends upon the no. of brands. The cosmetics must
be categorized into brands.
 A "Brand" will mean each category of cosmetic products as
mentioned in Column 3 of Annexure (enclosed in “Guidelines on
Registration of Import of Cosmetics”).
 Government Fees as TR Challan of USD 250 or its equivalent Indian
rupees is required for each brand.

 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 43.

State Drug authorities of Respective States are responsible to issue
manufacturing Licenses.
Application in Form 31 with Govt. Fees of Rs3500.
List of Equipments, Manufacturing Facility details with minimum area
of 15 Sq. Meters, Technical Competent personnel details, Relevant
Sops are required for obtaining manufacturing permissions. The
specifications should comply the BIS standards if applicable or else
acceptable International Standards. Presently Trials are not required.
A proposal to include the definition of New cosmetics are on cards.

 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

CDSCO Regulatory Approval Process India

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