Registration to be made mandatory for all cosmetic imports from April 2011.

The health ministry has issued notification to bring the fourth amendment of the Drugs and Cosmetics Rules, 2010 into force from April, 2011 which seeks to make mandatory the registration of all imported cosmetics with the approved licensing authority.

"Registration of cosmetic products imported into the country:- 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 a person to whom such powers may be delegated under Rule 22,'' according to the changed Rule 129 of the Drugs and Cosmetics Rules, 1945. Besides, sub-sections to Rule 129 have been included to detail the procedure and formalities for the registration of the cosmetics.

The heading in Part XIII of the D&C Rules also has been changed as 'Import and Registration of Cosmetics' instead of the previous 'Import of Cosmetics.' Earlier the Rule said only "Statement to accompany imported cosmetics.-All consignments of cosmetics sought to be imported shall be accompanied by an invoice or statement showing the name and quantities of each article of cosmetic included in the consignment and the name and address of the manufacturer."

The health ministry had proposed the amendment to the rule to this effect long back and the draft had been published in February 2007 for inviting suggestions from the public and the concerned stakeholders. The objections and suggestions received from the public were then considered by the government and finally, in consultation with the Drugs Technical Advisory Board (DTAB), the amendment has been incorporated now. It will come into effect from April 1, 2011, according to official sources.

Rule 129A is about the form and manner of application for registration certificate while Rule 129B says about registration certificate for the import of cosmetics manufactured by one manufacturer. The registration authority will issue the certificate in Form 43 subject to the conditions, as per Rule 129C. The registration is being given for a period of three years, according to Rule 129D while Rule 129E says about the suspension and cancellation of the certificate.

Prohibited cosmetics cannot be imported, as per Rule 129F while Rule 129 G talks about the standards for imported cosmetics and the next sub-section about the labelling and packaging rules.


Source : Pharmabiz