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State of Punjab - Section

Section 21 in Punjab Manufactured Drugs Rules, 1959

21.

[(a) The State Drugs Controller or any other officer specifically empowered by him in this behalf may on the recommendation of the Divisional Drugs Inspector or the Drugs Inspector, grant to any person a Chemist's licence in Form D.D. 6 on payment of a fee of two hundred rupees subject to the following conditions :Provided that no licence in form D.D. 6 shall be granted to a person who does not hold the requisite licence under the Drugs and Cosmetics Rules, 1945 :Provided further that except with the special sanction of the State Drugs Controller such a licence shall not authorise the chemist to possess a quantity greater than 120 grams of opium alkaloidal derivatives or 120 grams of coca derivatives] [ Substituted by Punjab Government Gazette Legislative Supplement : Part III dated 4.3.1980.];
(1)The licensee shall be bound by the provisions of the Act and these rules and any other rules which may, from time to time, be made under the Act.
(2)The licensee shall be responsible for the acts and omissions of every person employed by him in carrying on his business and of all his servants, as if the said acts and omissions were his own.
(3)[ The licensee shall not permit any manufactured drug, which he is authorised to sell, to be dispensed or handled by any person other than a pharmacist registered under the Pharmacy Act, 1948 (Central Act No. VIII of 1948) or a qualified person as defined under sub-rule (15) of rule 65 of the Drugs and Cosmetics Rules, 1945] [Substituted by Punjab Government Gazette Legislative Supplement : Part III dated 4.3.1980.];
(4)The licensee is authorised to sell the following drugs :
(i)Coca Derivatives,
(ii)morphine,
(iii)all preparations containing more than 0.2 per cent of morphine or containing any diacetylmorphine.
(5)The licensee shall not sell or keep coca derivatives or opium alkaloidal derivatives, hereinafter called the "drugs", in greater quantities than specified in his licence or except in the premises described in the licence.
(6)The licensee shall procure his supplies either from a licensed vendor in Punjab or by importation from a licensed vendor in some other State, after obtaining from the [State Drugs Controller] [Substituted by Punjab Government Gazette Legislative Supplement : Part III dated 4.3.1980.] concerned a permit in Form D.D. 2. The importation of these drugs by post is absolutely prohibited.
(7)The licensee is authorised to compound any preparation containing morphine, diacetylmorphine or cocaine from the materials which he is lawfully entitled to possess. He shall also enter in the prescription the name of a person, firm or body corporate dispensing the prescription, the address of the premises at which, and the date on which it is dispensed. [The licensee shall maintain correct accounts of manufacture and sale of all drugs in Form D.D. 9 and Form D. D. 10] [Added by Punjab Government Gazette Legislative Supplement : Part III dated 4.3.1980.];
(8)In the case of every sale, otherwise than on a prescription, the licensee shall obtain a pass in Form D.D. 3 or D.D. 4 to cover the export or the transport of the consignment to its destination.
(9)The licensee shall maintain correct accounts of all transactions [in form D.D. 8] [Added by Punjab Government Gazette Legislative Supplement : Part III dated 4.3.1980.]. Such accounts shall, in respect of each receipt, the source of supply, and the quantity received, and, in respect of each issue the quantity issued, and the name and address of the person to whom it is issued. He shall file in support of his accounts of receipts, the export or transport passes, and in respect of his account of issues, the original prescription on which they have been issued and in the case of issues made otherwise than on a prescription, receipts from the person to whom the issues were made. Such accounts and documents shall be preserved for not less than two years from the date of the last entry in the accounts.
(10)
(i)In the case of preparations containing cocaine, morphine or diacetylmorphine, the bottles, phials, packages, or other containers of these preparations or the lables affixed to them shall either plainly show the actual quantity of the drugs present in each container, or give sufficient particulars to admit of the ready calculation of such quantity.
(ii)A package or a bottle containing the drugs shall before sale be marked with the quantity of the drugs in the package or the bottle;
(iii)A preparation, admixture, extract or any other substance containing any of these drugs shall be sold only in package or bottle plainly marked -
(a)in the case of a powder, solution or ointment, with the total quantity thereof in the package or bottle, and the percentage of the drugs in the powder, solution or ointment;
(b)in the case of tabloids or other similar forms of preparations, with the quantity of the drugs in each tabloid or other similar forms of preparation, and the number of tabloids or other similar forms of preparation in the package or bottle.
(11)[ All stocks of and all accounts and records of transactions under the licence shall be open to inspection by any officer of the Drugs Control Administration not below the rank of a Drugs Inspector]. [Substituted by Punjab Government Gazette Legislative Supplement : Part III dated 4.3.1980.]
(12)The licensee shall on requisition by the [State Drug Controller] [Substituted by Punjab Government Gazette Legislative Supplement : Part III dated 4.3.1980.] or by any officer duly authorised by him in this behalf deliver up his licence for amendment or for the issue of a fresh licence.
(13)The licensee shall on the first day of every quarter submit a correct quarterly statement showing the quantity of the drugs received by him during the previous quarter, the quantity sold by him and the quantity remaining in his possession to the [Divisional Drugs Inspector or Drugs Inspector.] [Substituted by Punjab Government Gazette Legislative Supplement : Part III dated 4.3.1980.]
(14)[ If on the expiry or cancellation of the licence, any stocks of drugs remain in possession of the licensee, he shall at once surrender these stocks to the Divisional Drugs Inspector or the Drugs Inspector concerned. If any portion of these drugs is declared by the Civil Surgeon to be unfit for human consumption, the Divisional Drugs Inspector or the Drugs Inspector, as the case may be, shall henceforth cause that portion to be destroyed and the licensee shall not be entitled to claim any compensation for loss resulting from the destruction of such a portion of the drugs.] [Substituted by Punjab Government Gazette Legislative Supplement : Part III dated 4.3.1980.]
(15)If any portion of the drugs is fit for human consumption, [Divisional Drugs Inspector or the Drugs Inspector] [Substituted by Punjab Government Gazette Legislative Supplement : Part III dated 4.3.1980.] shall make over such portion of the drugs in any quantity not exceeding that which the transferee is likely to sell within two months, to the incoming licensed vendor, who is taking the place of the previous licensee if the latter has surrendered the drugs drugs in question to the [Divisional Drugs Inspector or the Drugs Inspector] [Substituted by Punjab Government Gazette Legislative Supplement : Part III dated 4.3.1980.] or to any other licensed vendor of the district.
(16)The licensee shall be bound to accept from the [Divisional Drugs Inspector or the Drugs Inspector] [Substituted by Punjab Government Gazette Legislative Supplement : Part III dated 4.3.1980.] any portion of the drugs which in the opinion of the [Divisional Drugs Inspector or the Drugs Inspector] [Substituted by Punjab Government Gazette Legislative Supplement : Part III dated 4.3.1980.] does not amount to more than two months' supply, at such a price as may be determined by the [Divisional Drugs Inspector or the Drugs Inspector.] [Substituted by Punjab Government Gazette Legislative Supplement : Part III dated 4.3.1980.] This price shall be paid to the licensee, who has surrendered the drugs in question to the [Divisional Drugs Inspector or the Drugs Inspector.]
(17)A licensed chemist may import, export or transport such quantity of opium alkaloidal derivatives (excluding prepared opium) and coca derivatives as may be specified in his licence.
(b)
(i)The [State Drugs Controller] [Substituted by Punjab Government Gazette Legislative Supplement : Part III dated 4.3.1980.] shall in respect of each such license fix and record in the licence the maximum quantity of opium alkaloidal derivatives or coca derivatives which the licensee may possess at any one time for the purpose of vend as well as for the manufacture of preparations of morphine, diacetylmorphine and cocaine.
(ii)A licensed chemist may, subject to the conditions of his license, sell opium alkaloidal derivatives or coca derivatives to -
(1)a medical practitioner, who (a) is either known to the licensed chemist, or (b) is introduced by someone known to the licensee, and either signs the register in person or sends a written or signed order stating his name, address and the name and quantity of the article required. In the latter case the licensee must satisfy himself as to the genuineness of the signature and qualification of the medical practitioner. If the drugs are transported by post these shall be sent by registered post. In case of real emergency the licensee may act on an oral message and send the drugs provided that the licensee is satisfied with the genuineness of the order and on the delivery he receives from the medical practitioner the signed order or an undertaking that the signed order will be furnished within 24 hours. If such signed order is not received within 24 hours, the licensee shall forthwith report full details of the transaction to an [Officer of the Drug Control Administration not below the rank of a Drug Inspector] [Substituted by Punjab Government Gazette Legislative Supplement : Part III dated 4.3.1980.];
(2)a chemist licensed under these rules or under the rules for the time being in force in any other State;
(3)any other person authorised under these rules;
(4)any person holding the prescription in Form D.D. 7 subject to the following conditions namely :-
(i)he shall sell the opium alkaloidal derivatives or coca derivatives in such quantity and for the use of such person only as may be specified in the prescription;
(ii)If the prescription does not bear a superscription by a medical practitioner stating that it is to be repeated and at what interval of time it is to be repeated, and how many times it is to be repeated, he shall sell the opium alkaloidal derivatives or coca derivatives once only on such a prescription and shall retain the prescription :
Provided that he shall first warn the person presenting the prescription that unless it bears such a superscription as aforesaid it shall be retained;
(iii)If the prescription bears a superscription as aforesaid he shall enter in the prescription the date of sale and shall sign or seal the prescription.
Provided that if it appears that opium alkaloidal derivatives or coca derivatives have already been sold on the prescription 6 times or such a number of times as the prescription is required to be repeated, or that the interval specified in the prescription has not elapsed since the prescription was last dispensed, he shall not sell the morphia drugs or coca derivatives on such prescription unless it has further been superscribed by the medical practitioner;
(iv)any other condition that may be prescribed in his license.
(F)Grant, Renewal and Cancellation of Licences