While the Indian beauty and cosmetics market is booming, thanks to the rising demand for personal care products from the youth, the sector is largely operating in a vacuum in terms of regulations and safety, raising concerns among public-health advocates.
At present, most of the personal care products, categorised as hair care, skin care, bath and shower products, makeup and colour, fragrances and deodorants, are regulated under the provisions of the Drugs and Cosmetics (D&C) Act, which, according to industry experts, are absolutely inadequate. Though the health ministry had notified a draft regulatory framework for cosmetics towards the end of 2018 in view of the current laws’ ineffectualness, the ‘Cosmetics Rules, 2018’ is yet to see the light of the day and remain snarled in red tape.
The upshot — numerous products, many of them containing potentially toxic chemicals, are sold in the market without any regulatory watch.
The problem with lack of regulations
The new regulations were proposed as the D&C Act focuses mainly on medications. Only seven of the 169 sections in the existing Act refer to cosmetic products. In the absence of separate rules, the safety of many of the cosmetics products sold in the domestic market is now up to the discretion of manufacturers and importers.
All cosmetic products that are manufactured or imported for sale in India need to be registered with the state or central licensing authority. But owing to the absence of regulations, numerous products, many potentially hazardous, are sold in the market with abandon. “For instance, imported beauty products such as artificial nails, adhesives for hair fixing, certain products for hair straightening and artificial eyelashes don’t come under the existing rules and are sold without effective oversight. The government will soon classify these products as cosmetics and regulate them under the provisions of the D&C Act. We are now reviewing inputs from various stakeholders,” a health ministry official said on condition of anonymity.
Products like these are imported and sold without checks. “The government’s intention seems to be to regulate these products under the existing legislation as the Cosmetics Rules are not yet finalised,” Federation of Pharma Entrepreneurs (Fope) co-chairman Vinod Kalani told CNBC-TV18.
Beauty might be only skin-deep, but the maxim has no bearing on the Indian cosmetics market, which is expected to touch $20 billion by 2025. Despite a slowdown in the consumption of consumer goods, the country’s per capita spending on personal care items is rising quickly and the market is projected to grow at a compounded annual growth rate of over 18 percent in the coming years, according to industry estimates.
What happens on the ground: A reality check
While the move to classify more unregulated products as cosmetics and regulate them under the D&C Act is a welcome step, the truth is that there is no specific provision under the Act for the approval of personal care items. Even now, 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.
According to a former drug controller, substances such as phenol and trichloroacetic acid are often found in even licensed 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 without facing any punitive action,” he said.
As more women are opting for hair extensions and men look for imported hair patches to cover bald spots, concerned health experts call for steps to regulate rampant use of hair adhesives. Latex is a common ingredient in most wig adhesives, which can cause itching, burning and irritation to the scalp. Another common chemical in hair glue is opropanol, which is harmful to eyes, throat and nose.
Earlier this year, the government banned the over-the-counter sales of ointments containing hydroquinone, a bleaching agent for reducing skin pigmentation, and steroid-laced formulations for topical application to curb their indiscriminate use by beauty parlours and quacks. Hydroquinone — also termed Benzene 1,4-diol or quinol on product packages — is usually found in bleaching creams, skin lighteners, pigment gels, spot treatments and many popular anti-aging products. The chemical is added to work as a primary ingredient in skin lightening products.
“Many of these creams are often used without medical guidance for fairness, and even beauticians prescribe them,” says Dr Ramesh Bhatt, eminent skin specialist and former president of Indian Association of Dermatologists, Venereologists and Leprologists.
Industry experts point to another inadequacy in the existing rules concerning percentage of ingredients mentioned on cosmetics labels. Though there is provision to mention the ingredient list on packets, their percentage is not mandatory.
Under BIS 4707, certain ingredients are allowed in cosmetics with restrictions on their percentages and some are allowed for only a particular class of cosmetics. But without a detailed sample analysis, the regulators find it tough to ascertain the percentage of ingredients.
The new draft regulations propose stringent measures to ensure safety of cosmetics and they also cover imported items. Companies launching new products have to submit safety data to the regulator for getting approvals.
There are provisions for inspecting manufacturing facilities, sampling of products and confiscation in case of violations. The companies also have to keep details of product batches and raw materials for at least three years. The manufacturers have to follow strict labelling norms and can’t make false or misleading claims.
But industry representatives term some of the propositions as too rigid, particularly for the small enterprises. “Certain clauses, for instance listing of the applicable Bureau of Indian Standards norms, are constructive. However, plan to conduct Centre-state joint inspections of manufacturing sites will only delay the licensing process. This could create additional bottlenecks,” said a representative of the All India Cosmetic Manufacturers’ Association.
At present, most of the personal care products, categorised as hair care, skin care, bath and shower products, makeup and colour, fragrances and deodorants, are regulated under the provisions of the Drugs and Cosmetics (D&C) Act, which, according to industry experts, are absolutely inadequate. Though the health ministry had notified a draft regulatory framework for cosmetics towards the end of 2018 in view of the current laws’ ineffectualness, the ‘Cosmetics Rules, 2018’ is yet to see the light of the day and remain snarled in red tape.
The upshot — numerous products, many of them containing potentially toxic chemicals, are sold in the market without any regulatory watch.
The problem with lack of regulations
The new regulations were proposed as the D&C Act focuses mainly on medications. Only seven of the 169 sections in the existing Act refer to cosmetic products. In the absence of separate rules, the safety of many of the cosmetics products sold in the domestic market is now up to the discretion of manufacturers and importers.
All cosmetic products that are manufactured or imported for sale in India need to be registered with the state or central licensing authority. But owing to the absence of regulations, numerous products, many potentially hazardous, are sold in the market with abandon. “For instance, imported beauty products such as artificial nails, adhesives for hair fixing, certain products for hair straightening and artificial eyelashes don’t come under the existing rules and are sold without effective oversight. The government will soon classify these products as cosmetics and regulate them under the provisions of the D&C Act. We are now reviewing inputs from various stakeholders,” a health ministry official said on condition of anonymity.
Products like these are imported and sold without checks. “The government’s intention seems to be to regulate these products under the existing legislation as the Cosmetics Rules are not yet finalised,” Federation of Pharma Entrepreneurs (Fope) co-chairman Vinod Kalani told CNBC-TV18.
Beauty might be only skin-deep, but the maxim has no bearing on the Indian cosmetics market, which is expected to touch $20 billion by 2025. Despite a slowdown in the consumption of consumer goods, the country’s per capita spending on personal care items is rising quickly and the market is projected to grow at a compounded annual growth rate of over 18 percent in the coming years, according to industry estimates.
What happens on the ground: A reality check
While the move to classify more unregulated products as cosmetics and regulate them under the D&C Act is a welcome step, the truth is that there is no specific provision under the Act for the approval of personal care items. Even now, 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.
According to a former drug controller, substances such as phenol and trichloroacetic acid are often found in even licensed 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 without facing any punitive action,” he said.
As more women are opting for hair extensions and men look for imported hair patches to cover bald spots, concerned health experts call for steps to regulate rampant use of hair adhesives. Latex is a common ingredient in most wig adhesives, which can cause itching, burning and irritation to the scalp. Another common chemical in hair glue is opropanol, which is harmful to eyes, throat and nose.
Earlier this year, the government banned the over-the-counter sales of ointments containing hydroquinone, a bleaching agent for reducing skin pigmentation, and steroid-laced formulations for topical application to curb their indiscriminate use by beauty parlours and quacks. Hydroquinone — also termed Benzene 1,4-diol or quinol on product packages — is usually found in bleaching creams, skin lighteners, pigment gels, spot treatments and many popular anti-aging products. The chemical is added to work as a primary ingredient in skin lightening products.
“Many of these creams are often used without medical guidance for fairness, and even beauticians prescribe them,” says Dr Ramesh Bhatt, eminent skin specialist and former president of Indian Association of Dermatologists, Venereologists and Leprologists.
Industry experts point to another inadequacy in the existing rules concerning percentage of ingredients mentioned on cosmetics labels. Though there is provision to mention the ingredient list on packets, their percentage is not mandatory.
Under BIS 4707, certain ingredients are allowed in cosmetics with restrictions on their percentages and some are allowed for only a particular class of cosmetics. But without a detailed sample analysis, the regulators find it tough to ascertain the percentage of ingredients.
The new draft regulations propose stringent measures to ensure safety of cosmetics and they also cover imported items. Companies launching new products have to submit safety data to the regulator for getting approvals.
There are provisions for inspecting manufacturing facilities, sampling of products and confiscation in case of violations. The companies also have to keep details of product batches and raw materials for at least three years. The manufacturers have to follow strict labelling norms and can’t make false or misleading claims.
But industry representatives term some of the propositions as too rigid, particularly for the small enterprises. “Certain clauses, for instance listing of the applicable Bureau of Indian Standards norms, are constructive. However, plan to conduct Centre-state joint inspections of manufacturing sites will only delay the licensing process. This could create additional bottlenecks,” said a representative of the All India Cosmetic Manufacturers’ Association.
First Published: Nov 13, 2019 11:13 AM IST
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