Former State Drugs Controller |
Food and Drugs Administration, (FDA) Haryana, India |
Email: narendervivek16@gmail.com
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Last Updated on August 20, 2021 by The Health Master
Cosmetics are covered under Drugs and Cosmetics Act and are defined u/s 3(aaa) of Drugs Act.
The definition of cosmetics prescribed under Drugs and Cosmetics Act, 1940 is as “cosmetic means any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting, attractiveness, or altering the appearance, and includes any article intended for use as a component of cosmetic.”
Also read or download Cosmetics Rules 2020, click here
There is no further classification provided for cosmetics as Ayurvedic / herbal cosmetics, allopathic cosmetics or homoeopathic cosmetics. Cosmetic containing any ingredient may be herbal, homoeopathic or any other is a cosmetic only.
Definition of the cosmetic provided under Drugs and Cosmetics Act clearly indicate that there is no further classification.
This fact is evident from the licensing provision also that license to manufacture cosmetics is on Form-32 read with Rule 140 and application for grant or renewal of a license to manufacture cosmetics for sale is prescribed on Form-31 read with Rule 139 and certificate of renewal of license to manufacture cosmetics for sale is prescribed on Form-33 read with Rule 141.
Rule 138 of Part XIV clearly states that application for license to manufacture cosmetics categorized in Schedule M-II is to be made to the Licensing Authority appointed by the State Govt. for the purpose of this part.
Rule 49A prescribes qualification of Licensing Authority to be appointed for the purpose of this part and this clearly shows that Licensing Authority for grant of license to manufacture cosmetics is the Licensing Authority meant for grant of license to manufacture drugs (allopathic drugs).
The provisions relating to Ayurvedic, Sidha and Unani drugs contained under chapter IV-A of Drugs Act are prescribed u/s 33-B to 33-O and in this chapter no where the term cosmetics is neither defined nor mentioned. Rule 152 of Part XVI of Drug Act for manufacture for sale of Ayurvedic, Unani and Sidha drugs clearly indicates that the Licensing Authority for this purpose is different and separate from Licensing Authority for allopathic drugs and cosmetics.
It is more clear from provisions of Rule 153 which states that application for license to manufacture Ayurvedic, Unani and Sidha drugs is required to be made to Licensing Authority appointed by the State Govt. for the purposes of Part XVI, XVII or XVIII of Drug Rules.
These provisions clearly indicate that the regulatory authorities for manufacturing for sale of Ayurvedic drugs and cosmetics are different having different qualifications and under Drugs Act cosmetics are not further divided into Allopathic, Ayurvedic or Homoeopathic cosmetic.
But the question still remained unanswered that how and why the cosmetics are manufactured under the garb of Ayurvedic drugs. Requirements for factory premises for manufacturer of cosmetics including general requirements and requirements of plant and equipments are prescribed under Schedule M-II read with Rule-139 of Drugs Act, whereas Good Manufacturing Practices for Ayurvedic, Sidha and Unani medicines are prescribed under Schedule-T read with Rule 157 of Drugs Act.
These different sets of requirements of factory premises and plants and equipments for both the categories of products cosmetics and Ayurvedic drugs and more stringent requirements for cosmetics is one of the reason for manufacturing of cosmetics under the garb of Ayurvedic drugs.
The other reason is the marketing gimmick and by categorizing the cosmetic as herbal cosmetic manufactured as Ayurvedic drugs claiming to be curing certain ailment/disease also and without side effect. Whereas it is clear from the definition of Ayurvedic, Unani and Sidha drugs given u/s 3(a) of Drugs Act which clearly states that “Ayurvedic, Siddha or Unani drug indicates all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention of [disease or disorder in human beings or animals, and manufactured] exclusively in accordance with the formulae described in, the authoritative books of [Ayurvedic, Siddha and Unani Tibb systems of medicine], specified in the First Schedule;]”
Different set of provisions, Licensing Authorities, requirements for factory premises, requirements for plant and machinery and different definitions under Drugs Act clearly proved beyond doubt that cosmetics and Ayurvedic drugs are different categories of products having different uses.
The forces which lure the manufacturers to manufacture cosmetics under the garb of Ayurvedic drugs are less stringent requirements for manufacturing of Ayurvedic drugs, a marketing gimmick of claiming the cosmetics as herbal and claiming the treatment of some ailment without side effects and less GST on Ayurvedic drugs. 18% GST on cosmetics and 5% GST on Ayruvedic drugs is main driving force for manufacturing of cosmetics under the garb of Ayurvedic drugs and causes loss to the exchequer
Moreover, Ministry of Health & Family Welfare, GOI has issued new Cosmetic Rules 2020 vide G.S.R. No. 763(E) dt 15-12-20 – Cosmetics Rules 2020 and perusal of these Draft Cosmetic Rules further made it clear that Cosmetics and Ayurvedic drugs are different from each other. In my opinion, cosmetics should not be allowed to be manufactured in the name of Ayurvedic Drugs.
Disclaimer: This is the personal opinion of the writer and anyone may have a different opinion about these products and will not attract any legal implication.
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