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Insight

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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Strategy

NDAC meeting Support

The success of any new drug or FDC largely depends on the rationale and justification for using it.

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Feature

MEDICAL WRITING

Standard Operating Procedures (SOPs) in clinical trials are essential to support compliance with the regulations that govern the conduct of clinical research.

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News

Clarification and requirements related to Post approval changes as per CDSCO Guidance for Industry for Biological Products

In order to update the Quality information of already licensed products in a systemic approach it has been decided to submit the updated PPD of all approved Biological Product on yearly basis having all changes compiled in Quality information.

Regulation/Guidelines

Guidelines on “Similar Biologics: Regulatory requirements for Market Authorization in India” will be implemented from 15th September 2012.

The “Guidelines on Similar Biologics” prepared by Central Drugs Standard Control Organization (CDSCO) and the Department of Biotechnology (DBT) lay down the regulatory pathway for a similar biologic claiming to be similar to an already authorized reference biologic.

Regulation/Guidelines

Fourth Amendment in Drugs & Cosmetics Rules, 2013

Following are the rules to amend the Drugs & Cosmetics Rules, 1945, namely-These rules may be called the Drugs & cosmetics (Fourth Amendment) Rules, 2013