Union government has postponed the implementation of the notification of the rule requiring importers of cosmetics to register with the office of Drugs Controller General of India (DCGI) before marketing them in India.
The government notification via No. GSR, 426 (E) dated May 19, 2010 published in Part II, Section 3, Sub-Section 1 on pages 1-22 of the Gazette of India was to be implemented from April 1, 2011 but it was now decided that the rule will come into effect from October 1, 2011.
“The notification on imported cosmetics is now hanging in fire. Going by the large number of imported cosmetics being marketed and manufactured in India, the DCGI has been insisting to look at the contents and the production processes of the products for skin and hair care with greater caution. The cosmetic industry has worked out with the DCGI to devise a set of clear cut guidelines. The drug regulatory authority continues to work with stake holders to come out with the guidelines giving lucid details on the how the regulation would be enforced” stated s, Dr DBA Narayana, Consultant, Regulatory Issues, told Pharmabiz.
“There seems to be some confusion on certain aspects of the guidelines and now the Ministry of Health & Family Welfare would have taken a decision to defer its implementation by six months giving it ample time to revise the regulation,” he added.
Among the clauses of the guidelines which are viewed to be complicating and need clarity include the registration fee of the cosmetic fixed at US$ 250 per brand. Currently, there can be as high as around 100 products and their packs, marketed under one brand name in India. There are also a couple of other aspects which require some more information and these have led to difficulties in its implementation on April 1, 2011.
Now the government of India will have to re-evaluate the notification with much more clarity and apply the revision per product or bring in more comprehension about the details required in production plant from which the products are developed and imported to India. Just like in drug manufacture, where clear cut areas of production of capsules and liquids are defined, in the case of imported cosmetics too, the DCGI wants the information of the premises overseas, among others to ensure control on quality along with details of the ingredients used to produce skin and hair care products, he said.
So far India had no regulations on cosmetics and the need for a regulation, was suggested by the Mashelkar Committee. This was to ensure curbing and importing of spurious, counterfeit and poor quality cosmetics in the interest of the consumer safety. Going by the over 200 imported international cosmetics companies and the traders, there was a need for comprehensive guidelines. “Now we feel that since guidelines seem to have more grey areas and have been found to be weak in content, the government has extended its implementation by six months to iron out the issues and review the contents properly”, pointed out Dr Narayana.
Leading imported cosmetics available in India are Mabelline, Body Shop. Lush Cosmetics, Garnier, Sante Mernaud to name a few. The size of the cosmetic industry in India according to estimates is Rs.5,200 crore.