- In these rules, unless there is anything repugnant in the subject or context-(a)"the Act" means the Drugs and Cosmetics Act, 1940 (23 of 1940), as amended from time to time;(aa)[ "biopharmaceutical classification system" means a system used to classify drugs on the basis of solubility and permeability, classified as category I-high solubility and high permeability, category II- low solubility and high permeability, category III- high solubility and low permeability, and category IV- low solubility and low permeability;] [Inserted by Notification No. G.S.R. 327(E), dated 3.4.2017 (w.e.f. 21.12.1945).](b)[ "Central License Approving Authority" means the Drugs Controller, India, or the Joint Drugs Controller (India) or the Deputy Drugs Controller (India) appointed by the Central Government;] [Substituted by G.S.R. 579(E), dated 20.9.2006 (w.e.f. 26.9.2006).](c)"Director" means the Director of the Central Drugs Laboratory;(d)"Form" means a form set forth in Schedule A;(dd)[ "Homeopathic medicines" include any drug which is recorded in Homeopathic proving or therapeutic efficacy of which has been established through long clinical experience as recorded in authoritative Homeopathic literature of India and abroad and which is prepared according to the techniques of Homeopathic pharmacy and covers combination of ingredients of such Homeopathic medicines but does not include a medicine which is administered by parenteral route;] [Substituted by S.O. 4816, dated 19.11.1969 (w.e.f. 6.12.1969).](e)"Laboratory" means the Central Drugs Laboratory;(ea)[ "registered Homeopathic medical practitioner" means a person who is registered in the Central Register or a State Register of Homeopathy;] [Inserted by G.S.R. 680(E), dated 5.12.1980 (w.e.f. 5.12.1980).](i)holding a qualification granted by an authority specified or notified under section 3 of the Indian Medical Degrees Act, 1916 (7 of 1916), or specified in the Schedules to the Indian Medical Council Act, 1956 (102 of 1956); or(ii)registered or eligible for registration in a medical register of a State meant for the registration of persons practicing the modern scientific system of medicine [excluding the Homeopathic system of medicine] [Inserted by S.O. 2139, dated 5.6.1972 (w.e.f. 12.8.1972).]; or(iii)[ registered in a medical register [Added by S.O. 1196, dated 9.4.1960 (w.e.f. 14.5.1960).] [other than a register for the registration of Homeopathic practitioners] [Inserted by S.O. 2139, dated 5.6.1972 (w.e.f. 12.8.1972).] [of a State, who although not falling within sub-clause (i) or sub-clause (ii) is declared by a general or special order made by the State Government in this behalf as a person practicing the modern scientific system of medicine for the purposes of this Act; or [Added by S.O. 1196, dated 9.4.1960 (w.e.f. 14.5.1960).](iv)registered or eligible for registration in the register of dentists for a State under the Dentists Act, 1948 (16 of 1948); or(v)who is engaged in the practice of veterinary medicine and who possesses qualifications approved by the State Government;](eb)[ "Phyto-pharmaceutical drug" includes purified and standardized fraction with defined minimum four bio-active or phyto-chemical compounds (qualitatively and quantitatively assessed) of an extract of a medicinal plant or its part, for internal or external use of human beings or animals for diagnosis, treatment, mitigation or prevention of any disease or disorder but does not include administration by parenteral route.] [Inserted by Notification No. G.S.R. 918(E), dated 30.11.2015 (w.e.f 21.12.1945).](ee)[ "Registered medical practitioner" means a person- [Added by S.O. 1196, dated 9.4.1960 (w.e.f. 14.5.1960).](f)[ "retail sale" means a sale [Substituted by Notification No. F. 1-3/51-D.S., dated 15.10.1954.] [(whether to a hospital, or a dispensary, or a medical, educational or research institute or to any other person)] [Inserted by G.S.R. 681(E), dated 6.6.1988 (w.e.f. 6.6.1988).] [other than a sale by way of wholesale dealing;] [Substituted by Notification No. F. 1-3/51-D.S., dated 15.10.1954.](g)[ "sale by way of wholesale dealing" means sale to a person for the purpose of selling again and includes sale to a hospital, dispensary, medical, educational or research institution;] [Substituted by Notification No. F. 1-16/57-D, dated 15.6.1957.](h)[ "Schedule" means a Schedule to these rules;] [Substituted by Notification No. F. 28-10/45-H(1), dated 31.3.1957.](i)[ State Government in relation to a Union Territory means the Administrator thereof;] [Substituted by Notification No. F. 1-16/57-D, dated 15.6.1957.](j)[ "Poisonous substance" means a substance specified in Schedule E.] [Added by S.O. 2092, dated 27.7.1963.]
