General Definitions according to CDSCO guidance

General Definitions according to CDSCO guidance
Ayurvedic, Siddha or Unani drug includes 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;] 

 “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 

 “drug” includes— 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; 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;] 2 [(iii) all substances intended for use as components of a drug including empty gelatin capsules; and 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;] 

“Government Analyst” means—in relation to [Ayurvedic, Siddha or Unani] drug, a Government Analyst appointed by the Central Government or a State Government under section 33F; in relation to any other drug or cosmetic, a Government Analyst appointed by the Central Government or a State Government under section 20; 

“Inspector” means— in relation to [Ayurvedic, Siddha or Unani] drug, an Inspector appointed by the Central Government or a State Government under section 33G; and Source Drug and cosmetic act 1940 in relation to any other drug or cosmetic, an Inspector appointed by the Central Government or a State Government under section 21;] 

“manufacture” in relation to any drug 14[or cosmetic] includes any process or part of a process for making, altering, ornamenting, finishing, packing, labelling, breaking up or otherwise treating or adopting any drug 8 [or cosmetic] with a view to its 15[sale or distribution] but does not include the compounding or dispensing 10[of any drug, or the packing of any drug or cosmetic,] in the ordinary course of retail business; and “to manufacture” shall be construed accordingly;] 

“patent or proprietary medicine” means,-— in relation to Ayurvedic, Siddha or Unani Tibb systems of medicine all formulations containing only such ingredients mentioned in the formulae described in the authoritative books of Ayurveda, Siddha or Unani Tibb systems of medicine specified in the First Schedule, but does not include a medicine which is administered by parenteral route and also a formulation included in the authoritative books as specified in clause (a); in relation to any other systems of medicine, a drug which is a remedy or prescription presented in a form ready for internal or external administration of human beings or animals and which is not included in the edition of the Indian Pharmacopoeia for the time being or any other Pharmacopoeia authorised in this behalf by the Central Government after consultation with the Drugs Technical Advisory Board constituted under section 5;] 

Misbranded drugs.— For the purposes of this Chapter, a drug shall be deemed to be misbranded, if it is so coloured, coated, powdered or polished that damage is concealed or if it is made to appear of better or greater therapeutic value than it really is; or if it is not labelled in the prescribed manner; or if its label or container or anything accompanying the drug bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular.] 

Adulterated drugs.—For the purposes of this Chapter, a drug shall be deemed to be adulterated, if it consists, in whole or in part, of any filthy, putrid or decomposed substance; or if it has been prepared, packed or stored under insanitary conditions whereby it may have been contaminated with filth or whereby it may have been rendered injurious to health; or if its container is composed in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or if it bears or contains, for purposes of colouring only, a colour other than one which is prescribed; or if it contains any harmful or toxic substance which may render it injurious to health; or if any substance has been mixed therewith so as to reduce its quality or strength.] 

Spurious drugs.—For the purposes of this Chapter, a drug shall be deemed to be spurious, if it is imported under a name which belongs to another drug; or if it is an imitation of, or is a substitute for, another drug or resembles another drug in a manner likely to deceive or bears upon it or upon its label or container the name of another drug unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug; or if the label or container bears the name of an individual or company purporting to be the manufacturer of the drug, which individual or company is fictitious or does not exist; or if it has been substituted wholly or in part by another drug or substance; or if it purports to be the product of a manufacturer of whom it is not truly a product.] 

Misbranded cosmetics.—For the purposes of this Chapter, a cosmetic shall be deemed to be misbranded if it contains a colour which is not prescribed; or if it is not labelled in the prescribed manner; or if the label or container or anything accompanying the cosmetic bears any statement which is false or misleading in any particular.] 

Spurious cosmetics.—For the purposes of this Chapter, a cosmetic shall be deemed to be spurious, if it is imported under a name which belongs to another cosmetic; or if it is an imitation of, or is a substitute for, another cosmetic or resembles another cosmetic in a manner likely to deceive or bears upon it or upon its label or container the name of another cosmetic, unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other cosmetic; or if the label or container bears the name of an individual or a company purporting to be the manufacturer of the cosmetic which individual or company is fictitious or does not exist; or if it purports to be the product of a manufacturer of whom it is not truly a product.] 

Prohibition of import of certain drugs or cosmetics.—From such date as may be fixed by the Central Government by notification in the Official Gazette in this behalf, no person shall import any drug ‘[or cosmetic] which is not of standard quality; any misbranded drug 24[or misbranded or spurious cosmetic];] any 25[adulterated or spurious] drug;] any drug ‘[or cosmetic] for the import of which a licence is prescribed, otherwise than under, and in accordance with, such licence;