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Indian Cosmetic Regulation Webinar By Dr. Ashwini Kumar

This video gives a brief understanding of the registration of cosmetic products in India. History – The Drug and Cosmetic Act 1940 is an act of the parliament of India which regulates the import, manufacture and distribution of drugs and cosmetics in India. – The Rules of this act were passed by the India’s parliament in 1945 and has undergone several amendments since then. - The primary objective of this act is to ensure that the drugs and cosmetics sold in India are safe, effective and conform to the quality standards. – In India the cosmetics are regulated by the Central Drugs Standard Control Organization (CDSCO). – The DCGI, is the head of CDSCO, who regulates all the activities in India. – Prior to 2010, the importers were freely importing the cosmetics in India. Then in 2010, there was need felt to regulate cosmetic importation in India. - On May 19, 2010 the Government of India issued a Gazette Notification dated 19th May 2010 for amending the Drugs & Cosmetics Rules, 1945 providing a provision for registration of cosmetics into the Country before import. – When gazette came it remained in suspended state till March 2013 when the govt. finally decided on 1st April 2013 to implement the Cosmetic registration with immediate effect. – Rules were now called as Drugs and Cosmetics (Amendment) Rules, 2010 which came into force from 1st April 2011 and finally were effective from April 1, 2013. – The heading “IMPORT OF COSMETICS” in Part XIII were now called as “IMPORT AND REGISTRATION OF COSMETICS”.

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Cosmetic License Application & Registration in India

An expert approach to resolve technical and non-technical issues regarding Cosmetic License and Cosmetic Registration throughout India

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CDSCO has drafted guidelines for determining Quantum of financial compensation to be paid in case of Clinical Trial related Injury or Death

The Good Clinical Practice (GCP) Guidelines for Clinical Trials of India under para 2.4.7 provides that the research subject who suffers physical injury as a result of their participation in clinical trials are entitled to financial or other assistance

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Insecticide Registration

We help our clients in liaisoning process at Central Insecticides Board and Registration Committee

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Submission of PSUR

DCGI has made it mandatory for all manufacturers and importers who have obtain new drug permission to submit Periodic Safety Update Reports of new drug every six months for the first two year and for the subsequent two years it should be submitted annually

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Cosmetics Registration

No cosmetic shall be imported into India unless the product is registered under the rules by the licensing authority appointed by the Central Government under rule 21 or by any Person to whom such powers may be delegated under rule 22.

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