rule 64
A certificate of renewal of a licence in Form 20BB or Form 21BB shall be issued in Form 21-CC.
The Drugs and Cosmetics Act and RulesPart VI Part VI
Conditions to be satisfied before a licence in Form
3[20, 20-B, 20-F,20-G,
21 or 21-B] is granted . __ (1)A licence in Form
3[20, 20-B, 20-F, 20-G, 21 or 21-B]
6[to sell, stock, exhibit or offer for sale or distribute] drugs shall not be
7[granted or
renewed] to any person unless the authority empowered to grant the licence is satisfied that the premises in respect of which the licence is to be
7[granted or
renewed] are adequate, equipped with proper storage accommodation for preserving the properties of the drugs to which the licence 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 licence in Form 20 or 21 shall not be
7[granted or renewed] unless the licensing authority is satisfied that the requirements prescribed for a pharmacy in Schedule N have been complied with:
3[Provided further that licence in Form 20-F shall be
7[granted or renewed] only
to a pharmacy and in areas where a pharmacy is not operating, such licence may be
7[granted or renewed] to a chemist and druggist.]
Explanation. __ For the purpose of this rule the term ‘Pharmacy’ shall be held to mean to 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. ____________________________________________________________________
3 Ins. by G.S.R 462 (E), dt. 22-6-1982.
6 Subs. by G.S.R 788 (E), dt. 10-10-1985.
7 Subs. by No. G.S.R 681(E), dt. 6-6-1988.
Drugs and Cosmetics Rules, 1945 62
- (2) In 1[granting or renewing]a licence under sub-rule (1) the authority empowered to grant it shall have regard ____
1[(i) to the average number of licences granted during the period of 3 years
immediately preceding, and
- (ii) to the occupation, trade or business ordinarily carried on by such applicant during the period aforesaid :] Provided that the licensing authority may refuse to grant or renew a licence 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 licence granted thereunder, he is not a fit person to whom a licence should be granted under this rule. Every such order shall be communicated to the licensee as soon as possible: 2[Provided further that in respect of an application for the grant of a licence 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 licence is to be granted are:-
- (i) of an area of not less than ten square meters; and] 3[(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 recognised Board with four years’ experience in dealing with sale of drugs, or
- (c) holds a degree of a recognised University with one year’s experience in dealing with drugs:] 4[Provided also that,⎯
- (i) in respect of an application for the grant of a licence in Form 20 or Form 21 or both, the licensing authority shall satisfy itself that 5[the premises are of an area] of not less than 10 square meters, and
- (ii) in respect of an application for the grant of a licence⎯
- (A) In Form 20 or Form 21 or both, and
- (B) In Form 20 B or Form 21B or both,
the licensing authority shall satisfy itself that the premises are of an area not less than
1 Subs. by G.S.R 681(E), dt. 6.6.1988.
15 square meters: ____________________________________________________________________
3 Ins. by G.S.R 681(E), dt. 6.6.1988.
5 Ins. by G.S.R 91(E), dt. 25-2-1997.
Drugs and Cosmetics Rules, 1945 63 Provided also that the provisions of the preceding proviso shall not apply to the premises for which licences have been issued by the licensing authority before the commencement of the Drugs and Cosmetics (1st Amendment) Rules, 1997.]
1[(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 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 an order in relation thereto as it thinks fit.]
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