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Laxmi Yadav, Mumbai December 17 , 2018
The cosmetic industry and experts have welcomed draft Cosmetics Rules, 2018 released by the Union health ministry to make manufacturers and importers more accountable for safety and efficacy of cosmetics being sold in the country.

At present, there is a gap in Drugs and Cosmetics Act governing testing and regulatory aspects of cosmetics. The draft rules laid down regulations for testing, manufacturing, packaging of cosmetics and imported cosmetics which will strengthen the safety and efficacy of products to be sold in India. It is a step in the right direction, said Emami spokesperson. Emami is one of the leading FMCG companies in India operating in beauty and healthcare spaces.

The draft once notified will help regulate cosmetic industry in a more stringent way.

Cosmetic market has been dramatically improving around the world. The time has come to amalgamate regulations with current needs of Indian cosmetic industry be it globalization, flexible and output oriented methods adoption or emergence of sustainable cosmetic industries. It will play a pivotal role in harnessing the real potential of Indian cosmetic industry, said Dr Priya Digarse, Dean, School of Fashion Design and Beauty Cosmetology, Sandip University, Nashik.

Calibration of stringent cosmetic regulations to meet the needs of globalization, removal of outdated and unnecessary collection of records by introducing online platform is the need of hour, Dr Digarse said.

Current trends like globalization demands regularization of common platform to streamline the quality of cosmetic products sold online. Recently cases of selling of spurious, adulterated and unapproved cosmetics through e-commerce are on rise.

Appreciating health ministry's draft cosmetic regulations for safety and efficacy of cosmetic products, she said, “The regulations need to specify timeframe for procedures like obtaining remanufacturing license by state FDA and also for procuring import registration at central FDA. It should be shortened to 15 days to meet technological advances of other countries like Korea and Japan. License approval should be uniform in all states and should be in line and support for cosmetic entrepreneurs. An amalgamated committee of administrative and technocrats should consider the license according to need of current marker situation. Such infusion will hasten the delay in product launches.”

Natural and environmental friendly cosmetic business should be prioritized. With the rise in multifunctional cosmetic product, the definition of cosmetics should also focus on multifunctional use and their secondary therapeutic claims. Also GMP must be updated with reference to reuse, reduce and recycle concept in cosmetic manufacturing plants thereby pitching ecological based scrutiny should also be introduced, she added.

Sandip University dean said “Bureau of Indian Standards (BIS) of raw materials focuses solely on quality and safety, its environmental impact should also be taken into consideration. Along with heavy metal test, presence or release of any hazardous nondegradable metabolite in atmosphere should also be included.”

She emphasized the need for stringent post surveillance method to countercheck compliance of regulations as already carried out in EU nation.

Welcoming the draft, Kunal Bijlani, Partner, Eterno, an importer & distributor of premium derma-cosmetic products, said, “We appreciate the draft aiming to ensure that consumers are not misled and quality & safety are of utmost importance.” The provision to register ‘new cosmetics’ when the safety and efficacy is proved is a very welcome move so that Indian consumers can enjoy and benefit from some of the global innovation in this field, he added.

However he expressed concern over a steep rise in the proposed registration fee, currently it is US$ 250 per category which is proposed to be increased to US$ 1,000 per category, plus US$ 50 per variant (currently no extra charge for this), plus US$ 500 per manufacturer (currently no extra charge for this) – which makes the new fees ~ minimum 6x higher or more depending on a few clarifications.

As an importer, we feel the proposed registration fee is a very steep and fast jump, said Bijlani.

Moreover he sought clarification over exact safety data required for ‘new’ cosmetic products, the US$ 500 charge per manufacturer is applicable on the legal manufacturer or each site.

Some companies have 15 or more manufacturing sites – these kind of registrations will suddenly become very expensive if charges are based on number of manufacturing sites, he said.

Komal Saini, a Chandigarh based research scholar also welcomed the draft rules, saying, cosmetic products will quickly have to comply with strict regulatory norms to ensure safety and efficacy.

Presently, cosmetic products are protected by strong federal safety regulations by the US Food and Drug Administration. The new guidelines will help to comply with the entire standard related to packaging and manufacturing. As per norms, the testing will not be performed on the animals because many companies torture and slaughter animals to allegedly protect customers. But there should be other alternative for replacing the testing on animals, she added.

As per the draft, cosmetics will have to comply with packaging standards prescribed by the BIS.

Appreciating this, Saini said “It is important to ensure that product will be sold in India with suitable standard quality and comply with BIS.”

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