The Drugged Cosmetics Act

If it is there in the market, it is safe. That is the common reflection consumers of cosmetics and personal care products carry. But what is sadly shocking is that this is not even half the truth.

Most cosmetics on the market shelves, and subsequently on yours, are far from being what they are flaunted as. Now that is one thing many would plainly agree with.

What may get a raised eyebrow is the fact that the Drugs and Cosmetics Act, 1940, is a slipshod when it comes to regulating the safety of these cosmetics in India.

Given the enormous size and favorable demographics, the cosmetics market in India has an annual growth of 15-20%, twice as that of the US and the EU. Yet, the regulations, which must be rope-tight in our country, are a no match put against the developed world.

The Drugs and Cosmetics Act was formulated with the idea of providing safe and regulated drugs to consumers in India, along with keeping a strict check on the manufacture, sale and import of cosmetics. It was to be a balanced endeavor between the two, which has shown more than just signs of weakness in its implementation.

The act comes under the Ministry of Health and Family Welfare which, in collaboration with the Drugs and Cosmetics Rule, 1945, looks into the proper channelizing of cosmetics and drugs in India.

The integral flaw with the act is the distributed responsibility between the Centre and the States. The safety and standards for cosmetics are regulated and laid down by the Central Drugs Safety Control Organization (CDSCO), headed by the Drugs Controller General of India (DCGI), advised by the Drugs Technical Advisory Board (DTAB) and Drugs Consultative Committee (DCC). At the state level, the State Drug Control Organizations play the regulator. This creates lack of integration in the laws and variations in standards.

Adding to the precarious pile, the act nonchalantly emphasizes more on drugs and the least on cosmetics.

“The act has an 80 per cent focus on drugs. Cosmetics have only a meager 20 per cent, and even that is not efficiently formulated. Let us not even comment upon enforcement”, Ashok Kanchan, Technical Advisor, Consumer Voice, said.

Unlike EU’s massively elaborate Cosmetics Directives and US FDA’s separate chapters on cosmetics, The Drugs and Cosmetics Act houses only two schedules for cosmetics. The list of prescribed standards for permissible limits for chemicals, which must be clearly outlined, is far from exhaustive.

For instance, Petrolatum, more commonly known as petroleum-jelly, a petroleum by-product doesn’t find a mention under the Drugs and Cosmetics Act.  Although approved by the US FDA, it is banned in the EU for its potential carcinogenic properties.

There are no indigenous studies available to support the claim whether the use of petrolatum is as safe as it is being touted by the US FDA or is EU justified in calling for a ban and that if India too should follow suite.

The act also states that in case of unavailability of prescriptions for various chemicals, the international laws and rules are to be followed. But which international body’s rule, that is not clearly described.

“Ours is a very naïve act. It does not even qualify to be compared to the EU and the US regulations which are much progressive. When there is no understanding of the issues at hand, there can never be a firm law in the land”, feels Rajeev Betne of Toxics Link.

The rules for labeling and packaging of cosmetics are no less dismal, both in formulation and execution. As per the laid down conditions, a cosmetic product being sold in India must carry an ingredient label defining the percentage of each ingredient used. But there are hardly any labels carrying the percentage composition. Even if the ingredients are mentioned, a lay person seldom understands what health risks they might pose.

Ashim Sanyal, COO & Secretary, Consumer Voice, feels that the laws governing cosmetic regulations in India are dangerously vague. “A law must be tight in its enforcement. Enforcement comes when the parameters defining the law are clear. Our law lacks luster because it is loosely-stitched. One can not expect powerful enforcement of a weak foundation.”

What’s worse, the act exempts products weighing less than 30 gms from mandatory labeling on the premise that they are too small in size to accommodate such elaborate information.

“The point here is that all these products easily accommodate frivolous information which aids their marketing scheme, but when it comes to labeling of ingredients, they cite the act and the rules as their savior and make profits selling sub-standard products”, says Director, IITR Lucknow, K.C. Gupta.  

“There are numerous ways of ensuring that a product carries a label. A string of paper may be attached to the product, howsoever small the product may be.”

Such glaring loopholes in the law demonstrate the unwillingness at the hands of designated authorities to further polish the law.

Even the manufacturers in the organized cosmetics market are vying for a stricter check and control policy. “Manufacturers also want integrated standards because their market is being threatened by the unchecked, unorganized section of cosmetic products sellers. It is the government authorities who need to wake up to the reality of a frail law governing a booming cosmetics market”, a source from the Himalayan Drug Company said.

It is highly advocated by various consumer interest groups that chemicals linked to cancer and birth defects should not belong in cosmetics, regardless of the concentration of the chemicals being used.

Despite the potential carcinogenic properties in various chemicals like Paraben, Formaldehyde, 1, 4-dioxane and nitrosamines (produced as a side reaction), among many, they are rampantly used as ingredients in cosmetic products. However small the concentration, these chemicals do get ingested in the body, causing bio-accumulation in the long-run.

 Permissible limits assume safe levels for some synthetic chemicals. But in several types of chemicals such as lead or EDC, new research has shown that there may be no safe level.  Thus safer alternatives are the answer”, says Ravi Agarwal, the man behind the environmental watchdog Toxics Link.

Mr. B.P. Srinivasan, Director, DIPSAR, feels that poor regulation and a weak Drugs and Cosmetics Act stand as lacunae to incorporating nontoxic substitutes. “FMCG companies vehemently promote cosmetics, the claims of which are unsupported by scientific data. Marketers and promoters leave no scope for inclusion of safer alternatives because they sell the harmful ones as safe already!”

All these concerns must be addressed fully and fairly by the Ministry of Health and Family Welfare, India, but the DCGI has been unavailable for comments on the issue.

Narendra Sharma, Drugs Inspector, CDSCO, said that the act is under review and the authorities have submitted some amends in the act to the parliament.

Till the new amends are made, the legal statutory body is happy avoiding sensitizing the masses, content with playing the game of spurious economics and reaping profits from dubious supplies and unhealthy manufacturing practices.


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