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Cosmetics licences may come with product composition details to enhance safety; new clause proposed in Cosmetics Rules 2018

Arun Sreenivasan, New Delhi
Tuesday, February 26, 2019, 08:00 Hrs  [IST]

In a bid to allay safety concerns about cosmetic products sold across the country and bring uniformity in licensing procedures, the Central government may soon insist on listing the complete composition of products in the approval certificate issued by the licensing authority. The proposal was deliberated at length by the Drug Consultative Committee (DCC) at its recent meeting and the clause could be incorporated in the final version of the Cosmetics Rules 2018, it is learnt.

Currently, there is no specific provision or guideline under the Drugs and Cosmetics (D&C) Act regarding the approval of cosmetic products by the licensing authority. In many states, the permission is given only on the name of the product and the detailed composition or ingredient list is not mentioned in the licence issued to manufacturers. During investigation of complaint or sample analysis, drug inspectors often detect many harmful ingredients that should not be a part of cosmetics. When enquiry begins, manufacturers state that they have submitted the composition to licensing authority while getting product permission. But on the licence submitted by these firms, only the name of cosmetics without its composition would be mentioned, and the investigation officer would be in dilemma about appropriate punitive action.

According to official sources, substances such as phenol and trichloroacetic acid are often found in licenced beauty products during sample analysis. While these products have displayed efficacy in treating acne scars, numerous new studies have shown that their usage can result in severe health hazards. Since the final product will have a valid licence and the composition won’t be mentioned in the approval certificate, many unscrupulous elements escape through the regulatory loophole.

The health ministry notified the draft Cosmetics Rules 2018 containing 71 Articles in December as the existing legislation focuses predominantly on drugs, with only seven of the 169 rules referring to cosmetics.

While welcoming the move to introduce separate regulations for cosmetics sector, industry representatives criticise some of the propositions as too stringent, particularly for the small and medium enterprises. “Certain clauses, for instance listing of the applicable Bureau of Indian Standards (BIS) norms, are constructive. However, plan to conduct Centre-state joint inspections of manufacturing sites will only delay the licensing process. The officials coming from the Centre will be unaware of local issues and sensitivities. This will increase corruption and create additional bottlenecks,” immediate past president of All India Cosmetic Manufacturers’ Association (AICMA) Kajal Anand told Pharmabiz.

Industry experts point to another inadequacy in the present law concerning percentage of ingredients mentioned on cosmetics labels. Though there is provision to mention the ingredient list on packets in the descending order of their content, their percentage is not mandatory. Under BIS 4707 Part ll, certain ingredients are allowed in cosmetics with restrictions on their percentages. Some are allowed for only a particular class of cosmetics.

To resolve this anomaly, drug controllers from Maharashtra had suggested a provision to mention the percentage of restricted ingredients on product labels to make it easier for the field officer to detect violations. But the suggestion was rejected by the drug consultative panel. “DCC deliberated the proposal and did not feel it necessary for the proposed provisions as the composition of ingredients is reviewed as per prescribed standards while granting the manufacturing licence,” the minutes of the meeting show.

The ministry is presently reviewing comments from stakeholders on the new cosmetics regulations. Once implemented, the new norms will amend and supersede the D&C Rules and if there is any inconsistency, the provisions of the new regulations will prevail over the existing legislation.


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