The move was based on the recommendation that it may complicate the cosmetics regulation and add regulatory burden on stakeholders.
In its 86the meeting held on April 13, the DTAB was apprised that the DTAB in its 79th meeting held on May 16, 2018 agreed to the proposal for mandating the indication of green, red or brown dot on every package of cosmetics for vegetarian and non-vegetarian respectively in the Drugs and Cosmetics (D&C) Rules.
The DTAB also suggested taking opinion from stakeholders and the public before taking action in the matter.
Accordingly, a draft notification for amending Rule 148 of D&C Rules, 1945 was prepared for consideration of the union health ministry.
In the meantime, separate Rules, named as the Cosmetic Rules 2020 for regulation of import and manufacture of cosmetics was published vide GSR 763 (E) dated December 15, 2020.
DTAB after detailed deliberation emphasized that there is no clarity and system to certify vegetarian and non-vegetarian ingredients in the country. Hence, the DTAB did not agree to mandate the indication of green, red or brown dots on every package of cosmetics as it may increase regulatory burden.
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DTAB also opined that it can be voluntary and left to the company’s own decision. It further stated that accordingly advisory may be issued for labeling red, brown or green dots on packages of cosmetics for non-vegetarian or vegetarian origin.
The Union health ministry, through a gazette notification, notified the Cosmetics Rules, 2020 to separately codify rules relating to cosmetics for effective compliance.
The ministry issued the notification in exercise of the powers conferred by Section 12 and Section 33 of the D&C Act, 1940 (23 of 1940). These rules shall be applicable to the cosmetic as defined in clause (aaa) of Section 3 of the D&C Act, 1940 (23 of 1940).
In these rules, unless the context otherwise requires, Act means the D&C Act, 1940 (23 of 1940) (b) actual manufacturer in relation to import of cosmetics, means a person who manufactures cosmetics at his own manufacturing site in a country other than India approved by national regulatory authority or any authorised competent authority in that country for that purpose, by whatever name called for the purpose of this clause, person includes a company or a unit or a body corporate or any other establishment.
As per the notified Rules, authorised agent means a person in India authorised by the manufacturer.
The authorised agent shall be responsible for the business activities of the manufacturer in India including compliance to the provisions of the D&C Act and rules made thereunder for the purpose of this clause.
Bureau of Indian Standards (BIS) means the Bureau of Indian Standards established under Section 3 of the Bureau of Indian Standards Act, 2016 (11 of 2016).
No cosmetic shall be imported into India unless the product has been registered in accordance with these rules by the Central Licensing Authority (CLA) or by any officer to whom such powers may be delegated under sub-rule (1) of Rule 5.
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