1. Accredited Consultants Pvt. Ltd.
D-29, Acharya Niketan, Mayur Vihar Phase I, Delhi-110091

2.  The Objective of a Drug Regulatory in India are to ensure the Medicinal,
Medical Devices and Cosmetics products are acceptable on their Quality,
Safety and Efficacy.
 Drug Controller General of India is the head of Central Drug Standard
Control Organisation.[CDSCO] He Regulates Cosmetics, Devices & Drugs
in India.
 The Drugs & Cosmetics Act and Rules are the governing regulations in
India.
Accredited Consultants Pvt. Ltd.

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

4. As in the case of USFDA regulation or any
other country regulation in India, there are
possibilities of categorisation of products in
different ways, depending upon various
parameters.
Accredited Consultants Pvt. Ltd.

5. FLOW CHART FOR REGISTRATION OFFLOW CHART FOR REGISTRATION OF
COSMETICSCOSMETICS
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
Accredited Consultants Pvt. Ltd.

6.  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.
Accredited Consultants Pvt. Ltd.

7.  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 IMPORTREQUIREMENTS FOR IMPORT
OF COSMETICSOF COSMETICS
Accredited Consultants Pvt. Ltd.

8.  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.
Accredited Consultants Pvt. Ltd.

9. 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
Accredited Consultants Pvt. Ltd.

10. 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.
Accredited Consultants Pvt. Ltd.

11.  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.
Accredited Consultants Pvt. Ltd.

12.  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.
 During this period clarification if any,
required by them are answered and thereafter we get
the Registration Certificate (RC) in Form 43.
Accredited Consultants Pvt. Ltd.

13. 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.
Accredited Consultants Pvt. Ltd.

14.  OUR HEARTFUL THANKS
 WE BELIEVE OUR CLIENTS ARE OUR KINGS!!!
Accredited Consultants Pvt. Ltd.

15. Contact Details:
Accredited Consultants Private Limited,
D-29, First Floor, Acharya Niketan,
Mayur Vihar Phase-I, Delhi-110091.
Phones: 011-22758204,
(M) +91-9310040434, +91-9266665201
Fax: 011-22758994
Email:
info@acplgroupindia.com,
info@acplgroupindia.co.in,
prasad_bhat@hotmail.
Contact Details:
Accredited Consultants Private Limited,
D-29, First Floor, Acharya Niketan,
Mayur Vihar Phase-I, Delhi-110091.
Phones: 011-22758204,
(M) +91-9310040434, +91-9266665201
Fax: 011-22758994
Email:
info@acplgroupindia.com,
info@acplgroupindia.co.in,
prasad_bhat@hotmail.
Accredited Consultants Pvt. Ltd.Accredited Consultants Pvt. Ltd.