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[Cites 0, Cited by 1] [Entire Act]

Union of India - Section

Section 64 in The Drugs and Cosmetics Rules, 1945

64. [ Conditions to be satisfied before a license in [Amended by Notification No. F. 1-16/57-D, dated 15.6.1957 and Notification No. F. 1-19/59-D, dated 13.6.1961.] [Form 20, 20-B, 20-F, 20-G, 21 or 21-B] [Substituted by G.S.R. 462(E), dated 22.6.1982 (w.e.f. 22.6.1982).] is [granted [***] [Substituted by G.S.R. 681(E), dated 6.6.1988 (w.e.f. 6.6.1988).]].

(1)A license in [Form 20, 20-B, 20-F, 20-G, 21 or 21-B] [Substituted by G.S.R. 462(E), dated 22.6.1982 (w.e.f. 22.6.1982).] [to sell, stock, exhibit or offer for sale or distribute] [Substituted by G.S.R. 788(E), dated 10.10.1985 (w.e.f. 10.10.1985).] drugs shall not be [granted [*] [Substituted by G.S.R. 681(E), dated 6.6.1988 (w.e.f. 6.6.1988).]] to any person unless the authority empowered to grant the license is satisfied that the premises in respect of which the license is to be [granted [*] [Substituted by G.S.R. 681(E), dated 6.6.1988 (w.e.f. 6.6.1988).]] [are adequate, equipped with proper storage accommodation for preserving the properties of the drugs to which the license applies and are in charge of a person competent in the opinion of the licensing authority to supervise and control the sale, distribution and preservation of drugs:Provided that in the case of a pharmacy a license in Form 20 or 21 shall not be [Amended by Notification No. F. 1-16/57-D, dated 15.6.1957 and Notification No. F. 1-19/59-D, dated 13.6.1961.] [granted or renewed] [Substituted by G.S.R. 681(E), dated 6.6.1988 (w.e.f. 6.6.1988).] [unless the licensing authority is satisfied that the requirements prescribed for a pharmacy in Schedule N have been complied with:[Amended by Notification No. F. 1-16/57-D, dated 15.6.1957 and Notification No. F. 1-19/59-D, dated 13.6.1961.][Provided further that license in Form 20-F shall be [Inserted by G.S.R. 462(E), dated 22.6.1982 (w.e.f. 22.6.1982).][granted or renewed] [Substituted by G.S.R. 681(E), dated 6.6.1988 (w.e.f. 6.6.1988).] [only to a pharmacy and in areas where a pharmacy is not operating, such license may be [Inserted by G.S.R. 462(E), dated 22.6.1982 (w.e.f. 22.6.1982).] [granted or renewed] [Substituted by G.S.R. 681(E), dated 6.6.1988 (w.e.f. 6.6.1988).] [to a chemist and druggist.] [Inserted by G.S.R. 462(E), dated 22.6.1982 (w.e.f. 22.6.1982).][ Explanation. - For the purpose of this rule the term "Pharmacy" shall be held to mean and include every store or shop or other place-(1) Where drugs are dispensed, that is, measured or weighed or made up and supplied; or (2) where prescriptions are compounded; or (3) where drugs are prepared; or (4) which has upon it or displayed within it, or affixed to or used in connection with it, a sign bearing the word or words "Pharmacy", "Pharmacist", "Dispensing Chemist", or "Pharmaceutical Chemist", or (5) which, by sign, symbol or indication within or upon it gives the impression that the operations mentioned at (1), (2) and (3) are carried out in the premises; or (6) which is advertised in terms referred to in (4) above.
(2)In granting [***] [Amended by Notification No. F. 1-16/57-D, dated 15.6.1957 and Notification No. F. 1-19/59-D, dated 13.6.1961.] a license under sub-rule (1) the authority empowered to grant it shall have regard-
(i)[ to the average number of licenses [granted or renewed] [Substituted by Notification No. F. 1-19/59-D, dated 13.6.1961.] [during the period of 3 years immediately preceding, and] [Substituted by Notification No. F. 1-19/59-D, dated 13.6.1961.]
(ii)[ to the occupation, trade or business ordinarily carried on by such applicant during the period aforesaid: [Amended by Notification No. F. 1-16/57-D, dated 15.6.1957 and Notification No. F. 1-19/59-D, dated 13.6.1961.]
Provided that the licensing authority may refuse to grant [***] a license to any applicant or licensee in respect of whom it is satisfied that by reason of his conviction of an offence under the Act or these rules, or the previous cancellation or suspension of any license [granted or renewed] [Substituted by G.S.R. 681(E), dated 6.6.1988 (w.e.f. 6.6.1988).] thereunder, he is not a fit person to whom a license should be [granted or renewed] [Substituted by G.S.R. 681(E), dated 6.6.1988 (w.e.f. 6.6.1988).] under this rule. Every such order shall be communicated to the licensee as soon as possible:[Provided further that in respect of an application for the grant of a license in Form 20-B or Form 21-B or both, the licensing authority shall satisfy himself that the premises in respect of which a wholesale license is to be [Substituted by G.S.R. 681(E), dated 5.12.1980 (w.e.f. 5.12.1980).] [granted or renewed] [Substituted by G.S.R. 681(E), dated 6.6.1988 (w.e.f. 6.6.1988).] are-]
(i)of an area of not less than ten square metres; and
(ii)[ in the charge of a competent person, who-
(a)is a Registered Pharmacist, or;
(b)has passed the matriculation examination or its equivalent examination from a recognized Board with four years' experience in dealing with sale of drugs, or;
(c)holds a degree of a recognized University with one year's experience in dealing with drugs:]
[Provided also that-
(i)in respect of an application for the grant of a license in Form 20 or Form 21 or both, the licensing authority shall satisfy itself that the premises are on an area of not less than 10 square meters, and
(ii)in respect of an application for the grant of a license-
(A)in Form 20 or Form 21 or both, and
(B)in Form 20-B or Form 21-B or both, the licensing authority shall satisfy itself that the premises are of an area not less than 15 square metres:
Provided also that the provisions of the preceding proviso shall not apply to the premises for which licenses have been issued by the licensing authority before the commencement of the Drugs and Cosmetics (1st Amendment) Rules, 1997.] [Inserted by G.S.R. 91(E), dated 25.2.1997 (w.e.f. 25.2.1997).]
(3)[ Any person who is aggrieved by the order passed by the licensing authority in sub-rule (1) may, within 30 days from the date of the receipt of such order, appeal to the State Government and the State Government may, after such enquiry into the matter as it considers necessary and after giving the appellant an opportunity for representing his views in the matter, make such order in relation thereto as it thinks fit.] [Substituted by S.O. 1588, dated 3.7.1961 (w.e.f. 8.7.1961).]