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Andhra High Court · body

2003 DIGILAW 1440 (AP)

Pragna Bharati v. Union of India, Ministry of Health and family Welfare

2003-11-21

DEVENDER GUPTA, G.ROHINI

body2003
DEVINDER GUPTA, C. J. ( 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:"drug includes- (i) all medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals including preparations applied on human body for the purpose of repelling insects like mosquitoes; (ii) such substances (other than food) intended to affect the structure or any function of the human body or intended to be used for the destruction of vermin or insects which cause disease in human beings or animals as may be specified from time to time by the central Government by notification in the Official Gazette; (iii) all substances intended for use as components of a drug including empty gelatin capsules; and (iv) such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the central Government by notification in the Official Gazette, after consultation with the Board: ( 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. 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. . . . . . . ( 4 ) THE classification of the product referred to by the petitioner as cosmetics is strictly in consonance with the provisions of the Act and is not violative of any provisions of the Act including Rule 106 of the Rules since it is on the basis of the declaration given by respondents about the product. When an article can be classified into two separate definitions the definition in which the product would clearly fall would govern the same and respondents are following the criterion laid down under the Act and thus have not violated any provisions of the Act. Writ petition is dismissed.