Cosmetics presentation

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.


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Cosmetics presentation