cosmetics registration in india
TRANSCRIPT
Accredited Consultants Pvt. Ltd.D-29, Acharya Niketan, Mayur Vihar Phase I, Delhi-110091
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.
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Central Drug Standards Control Organization is the Regulatory authority for the approval of New Drug, Import Registration of Drugs, Medical Devices and Cosmetics.
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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.
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FLOW CHART FOR REGISTRATION OF FLOW 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
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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.
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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 REQUIREMENTS FOR IMPORT OF COSMETICSOF COSMETICS
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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.
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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
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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.
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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.
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After ensuring all documents correctly as per therequirements of FDA, they are submitted. It generallytakes about 2-3 months to scrutinize these documentsby Technical Data Associates/Drug inspectors ofCDSCO. During this period clarification if any,required by them are answered and thereafter we getthe Registration Certificate (RC) in Form 43.
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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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OUR HEARTFUL THANKS
WE BELIEVE OUR CLIENTS ARE OUR KINGS!!!
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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: [email protected], [email protected],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: [email protected], [email protected],prasad_bhat@hotmail.
Accredited Consultants Pvt. Ltd. Accredited Consultants Pvt. Ltd.