The Hindu Business Line : Should `dream' products attract disclosure norms?

THE possibility of the Maharashtra Food and Drug Administration (FDA) putting companies that sell "dreams" under the scanner appears to have stirred a hornet's nest. While every company dealing with cosmetics, claims its products are safe and adhere to quality norms, it seems that many may not be following the mandated disclosure norms while listing out ingredients of product packaging.

In India, as per existing rules under the Drugs and Cosmetics Act, companies manufacturing and selling cosmetics are allowed a certain degree of freedom in terms of disclosure. They have to disclose ingredients but not necessarily the exact percentage of each. Most often ingredients are mentioned in a general list, without giving specific quantities.

"This allows companies to focus on a certain ingredient - say henna or protein - and market the product on this basis without specifically saying how much of this particular ingredient is present in each 100 ml of a shampoo," said a senior official with a leading FMCG company.

But if a company claims that its cosmetic product also contains therapeutic properties and is thus a medicinal product, it has to seek clearance from the Drug Controller General of India (DCGI). As per the rules, companies have to mandatorily disclose each ingredient and its weight.

According to pharmaceutical industry sources, "Normally pharma companies manufacturing products that offer medicinal benefits approach the DCGI for clearances. The onus is on the companies to get regulatory approvals. The Government can take penal action in case of violations. However, in the case of dream products there is an ambiguity that needs to be addressed."

Also, companies are free to take up either a drug or a cosmetic license for the products. "The tax structure for a product would depend on the license granted to it. Therefore, companies choose to classify their product according to the tax benefits," said officials.

The norms in India are not as stringent as in the US, where cosmetic labelling falls under the Food, Drug and Cosmetic Act (FD&C Act) and the Fair Packaging and Labelling Act (FPLA). It stipulates that all cosmetics, whether they are sold on a retail basis to consumers or marketed exclusively for salon or workplace use, are subject to the FD&C Act.

Also, special rules apply to the ingredient declaration on products that are both cosmetics and over-the-counter drugs in the US. "An example of such a product is an anti-dandruff shampoo: A shampoo is a cosmetic, while an anti-dandruff treatment is a drug. Regulations enacted in 1999 require such combination products to have the drug ingredients listed separately as `active ingredients' in alphabetical order, followed by the cosmetic ingredients, which are listed as `inactive ingredients' in descending order of predominance.

In India, the industry appears to be divided over whether the disclosure norms should be tightened. While one section feels that existing regulations are good enough, some people say a stricter disclosure framework is called for.

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