Registration compulsory for Imported cosmetics from April next, DCGI issues guidelines.

With the Union Health Ministry making the registration of all imported cosmetics compulsory from April 2011, the Drugs Controller General of India has issued guidelines to be followed by the importers in this regard.

The new guidelines issued by the DCGI, who is the appropriate authority for giving permission, follows the notification by the ministry in May effecting amendment in the Drugs & Cosmetics Rules to stipulate mandatory registration of all cosmetics imported.

According to the guidelines, one importer can file single application in Form-42 for different brands and products by the same company. However, registration fee for one brand has been fixed equal to 250 US dollars each. “Brand owner is the manufacturer who can manufacture the product at his own manufacturing site or under contract manufacturing and can provide power of attorney to his authorized agent in India who will be filing import registration application on his behalf,” the guidelines said.

“The brand for import registration purpose can be a mother brand, e.g. Brand XYZ is brand name for range of products coming under this brand. This range of products could be skin creams, skin toner, skin moisturiser cream, vanishing cream etc. under each of these products, there could be many variants. For registration purpose, a fee of 250 US dollars should be paid for registration of Brand XYZ but product details as provided in attached checklist must be included in the dossier for each product within the mother brand,’’ the guidelines said.

Cosmetic products which are imported to India as bulk for repackaging for 100 per cent export to other countries are out of scope of this new regulation and need not require registration. But the details of the products and countries should be intimated to the DCGI office, as per the guidelines.

In May this year, the ministry had issued the notification amending the Rule 129 of the D&C Rules, 1945. 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.

Source : pharmabiz.com