PRAGNA BHARATI Vs. UNION OF INDIA

JUDGEMENT

(1.) We have persued the affidavit of Sri DP. Sharma, Assistant Drug Controller posted at Sub-Zonal office, Andhra Pradesh, Hyderabad on behalf of respondent Nos.1 to 3 in response to the notice issued by us in the writ petition. Petitioner claiming to be an Organizing Secretary of Pragna Bharathi, a non-governmental organization has in this petition, filed as PIL sought direction against respondent Nos.1 to 3 declaring their action in permitting fairness products to be marketed as cosmetics without bringing them within the purview of drugs to be violative of rule 106 (1) of the Drugs and Cosmetics Rules, 1945 (hereinafter referred to as "the Rules") read with Schedule J and Section 3 (b) of the Drugs and Cosmetics Act, 1940 (hereinafter referred to as "the Act". Petitioner's claim is that such fairness products manufactured by respondent Nos.5 and 6 deserve to be classified as 'drugs' and not as cosmetics' under the relevant provisions of the Act. 'Cosmetic' is defined under Section 3 (aaa ) of the Act to mean: "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 patterns, and includes any, article intended for use as a component of cosmetic. Similarly, definition of 'drug' in Section 3 (b) of the Act is an inclusive definition which is as under:

(2.) Rule 106 in Part IX-A of the Rules lays down the manner of labelling of homeopathic medicines and Chapter XV deals separately with labelling, packing and standards of cosmetics. Schedule J to the Rules notifies the diseases and ailments by whatever name described which a drug may not purport to prevent or cure or may claim to prevent or cure. Item 18 therein is fairness of skin. This Schedule J referred to in Rule 106 of the Rules is to the effect that no drug may purport or claim to prevent or cure or may convey to the intending user thereof any idea that it may prevent or cure one or more of the diseases or ailments specified in the said schedule. In the instant case we are concerned with the fairness creams manufactured by respondent Nos.5 and 6 which fall in definition of 'cosmetics' under the provisions of the Act and have to be dealt with as such and it is the stand of the respondents that any article rubbed on human body for beautifying or promoting attractiveness or altering the appearance shall be considered as cosmetics. This definition contained in Section 3 (aaa) is as a result of amendment carried out in the Act by the Drugs and Cosmetics (Amendment) Act. 1955 which came into force with effect from 16-4-1955.

(3.) Respondent Nos.1 to 3 in the counter affidavit stated that: .......Claims made on the label of the cosmetics, State Licensing Authorities are required to take into consideration the authenticity of the claims made on the product at the time of granting the licence for the manufacture of the cosmetic..........it is required that the raw materials used are such that in the concentration in which they would be present in the finished skin creams, after interaction with other raw materials used in the formulation, are free from any harmful effects. It is the responsibility of the manufacturers of cosmetics to satisfy, themselves of the dermatological safety of their formulation or its efficacy claimed before releasing the product for sale. .......the classification of the products referred to in the affidavit filed in support of the above writ petition as cosmetic is therefore, within the four corners of the Drugs and Cosmetics Act, 1940.......