If the new Bill is approved by Parliament, a proposed chapter '4K' to be included on clinical trials, may see any company manufacturing cosmetics with a jail time of up to five years, or a fine three times the value of the cosmetics confiscated.
In India, a 'cosmetic' refers to any article intended to be rubbed, poured or sprayed on for cleansing, promoting attractiveness, or altering the appearance, and includes any article intended for use as a component of a cosmetic.
While clinical trials refers to a dermatological study of any new cosmetic on human participants to generate data for discovering or verifying its adverse effects with the objective of determining safety or efficacy of the cosmetic.
Section 4K
India's Department of Health and Family Welfare is behind the new draft guidelines which states; "Whoever, having been convicted under section 4K, shall be punishable with imprisonment for a term which shall not be less than three years but which may extend to five years and shall also be liable to fine which shall not be less than Rs 15 lakh."
The notice goes on to outline that if put in place, any officer authorised by the Central Licensing Authority shall; "have the power to enter with or without prior notice into any premises related to clinical trial to inspect the facilities, record, data, documents, books, notified category of medical devices and cosmetics."
The new Bill also empowers the Central Government to suspend or cancel any permission, licence or certificate issued by the Central Licensing Authority or a State Licensing Authority, in public interest among other reasons.
Industry representatives meet to discuss the impact
In regards to these new guidelines, representatives from industry Associations including cosmetics, met on January 21st to discuss the Bill.
According to the minutes of that meeting; professionals called for a sufficient implementation time for the amended rules, so that the transition "will be smooth and appropriate training of human resources could also be arranged for regulators as well as industry in order to adapt to the new provisions of the Rules."
Dr. Sudipta of global cosmetics player Oriflame was present on behalf of the cosmetics industry.