Bare Acts Live

Punjab Manufactured Drugs Rules, 1959

Central Act 2 of 1930

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(A) - Definitions

(1) "Act" means the Dangerous Drugs Act, 1930 (II of 1930) ;

(2) "Civil Surgeon" means the civil surgeon or other principal medical officer of a district ;

[(3) "State Drugs Controller" means an officer who is the head of the Drugs Control Administration in the State of Punjab appointed by the State Government;

(5) "Drugs Inspector" means an Inspector appointed under section 21of the Drugs and Cosmetics Act, 1940 (Central Act No. XXIII of 1940);]

(6) [ - ]

(7) "Form" means a form appended to these rules ;

[(8) "Licensed Chemist" means a person who has obtained a licence for the possession, compounding, manufacture and sale of Coca Derivatives, Opium alkaloidal Derivatives and Drugs declared to be manufactured drugs in pursuance of sub-clause (ii) of clause (g) of section 2 of the Dangerous Drugs Act, 1930 (Central Act 2 of 1930), under these rules;]

(9) "Licensed Druggist" means a person who has obtained a licence for the possession, compounding, manufacture and sale of medicinal hemp or medicinal opium intended for use as medicine under these rules.]

(10) "medical practitioner" means a person holding a qualification granted by an authority specified or notified under section 3 of the Indian Medical Degrees Act, 1916 (VII of 1916) or the Patiala Medical Degrees Act, 1999 BK., or specified in the Schedules to the Indian Medical Council Act, 1956 (Parliament Act No. 102 of 1956) and the Dentists Act, 1948 (XVI of 1948) or a person registered or eligible for registration in a medical register of the State meant for registration of persons practising allopathic or Unani or Ayurvedic system of medicine;

(11) "Opium alkaloidal derivatives" means -

(i) morphine, that is, the principal alkaloid of opium having the chemical formula C17 H19 No. 3 and its sale ;

(ii) diacetyl-morphine, that is, the alkaloid, also known as diamorphine or herein, having the chemical formula C21 H23 No. 5 and its salts;

(iii) all preparations, official and non-official, containing more than 0.2 per cent of morphine or containing any diacetyl-morphine;

(12) "prescription" means prescription given by a medical practitioner for the supply of medicinal opium or coca derivatives or opium alkaloidal derivatives to a patient ;

(13) "State Government" means the Government of the State of Punjab;

(14) " to export" means to export inter-state as defined in clause (l) of section 2 of the Dangerous Drugs Act, 1930; and

(15) "to import" means to import inter-state as defined in clause (j) of section 2 of the Dangerous Drugs Act, 1930.

(B) - Possession, Import, Export and Transport

(a) only parcel post may be used;

(b) the parcel shall be accompanied by a declaration stating the name or designation of the consignee and consignor, the contents of the parcel in detail and the indent number and date covering the transaction;

(c) the consignee shall show distinctly in his account books the name or designation of the consignor, and the quantity of the drugs sent to him from time to time by post.

Note. - A pass shall remain in force only for the period specified therein/

(C) Medical Practitioners

[(i) Morphine (In all forms) : 6 Gms]

[(ii) Codeine (In all forms) : 10 Gms]

(iii) Cocaine (In all forms) : 2 Gms

(iv) Methadone (In all forms) : 1 Gm

[(v) Pethidine (In all forms) : 6 Gms]

(vi) Opium : 30 Gms

(vii) Other dangerous drugs : A quantity equivalent to 100 average doses, as fixed by the Drug Controller (India) from time to time ;

(b) All other issues of the manufactured drugs by a medical practitioner from his dispensary will amount to sale.

(ii) A separate register or a separate part of the register shall be assigned to each of the following classes of drugs and preparations :-

(1) Cocaine and ecgonine and preparations containing cocaine or ecogonine,

(2) morphine, and preparations containing morphine;

(3) diacetylmorphine and containing its preparations;

(4) medicinal opium;

(5) dihydrohydrooxycodeinone (commonly known as eucodal) and preparations containing dihydrohydrooxrcodeinone;

(6) dihydrcodeinone (commonly known as dicodide) and its preparations;

(7) extracts or tinctures of Indian hemp;

(8) dihydromorphinone (commonly known as dilaudide) and preparations containing dihydromorphinone.

(iii) Entries in the register must be made on the day on which the manufactured drug is received or dispensed. It is not necessary that the medical practitioner should himself enter in the register the particulars of manufactured drugs administered by him or under his supervision but entries must be verified by him on the date of entry or on the following date. Where a medical practitioner practises at more than one premises a separate account of manufactured drugs kept at each premises shall be maintained.

(iv) Every entry required to be made and every correction of such an entry must be made in ink and no cancellation, obliteration or alteration shall be made of any entry in the register and any correction of any entry must be made by way of marginal note or foot-note, which must specify the date on which the correction is made.

(v) The stock of manufactured drugs in the possession of a medical practitioner and the accounts relating thereto shall be open for inspection by any officer of the Health Department not below the rank of Assistant Surgeon or District Medical Officer of Health or an Excise Officer not below the rank of Sub-Inspector. The medical practitioner shall, if required do so by the Deputy Excise and Taxation Commissioner, submit such information relating to the transactions in manufactured drugs as may be demanded from him.

(vi) If messenger is sent by the medical practitioner to take delivery of the manufactured drugs, the messenger must be given an authority in writing signed by him and specifying the messenger by name, to receive the drugs on his behalf. A licensed chemist and druggist is forbidden to deliver drugs to messenger not so authorised. In emergencies, when the medical practitioner is unable to send a signed order the licensee may act on the oral message of a medical practitioner known to him, provided that on delivery of the drugs he receives a signed order from the medical practitioner or an undertaking that the signed order will be furnished within twenty-four hours.

(vii) The medical practitioner shall keep the drugs under lock and key.

(viii) While carrying drugs to the house of a patient the medical practitioner shall take full precautions for the safe custody of manufactured drugs. Thefts and losses of manufactured drugs should be forthwith reported to the nearest excise or police official.

(ix) All records including registers and day books must be kept for not less than two years from the date of the last entry therein.

Note. - A medical practitioner who desires to distribute and sell any manufactured drug must take out a licence under these Rules.

(ii) A medical practitioner of the indigenuous system of medicines may prescribe only those manufactured drugs which are included in the indigenous systems of medicines.

(1) [The State Drugs Controller] may] by general or special order authorise a medical practitioner in managing or supervising charge of a hospital or dispensary to possess, import and transport such quantities of manufactured drugs, other than prepared opium and in such manner as may be specified in that order.

(2) The medical practitioner, mentioned in sub-rule (1) shall send an application showing his annual requirements of manufactured drugs, other than prepared opium in the case of civil hospitals or dispensaries to the Director of Health Services, Punjab, in the case of Military Hospitals, to the Senior Medical Officer-incharge of Military Hospitals, and in the case of veterinary hospitals to the Director of Animal Husbandry, Punjab, who shall forward it to the [State Drugs Controller] with his recommendation.

(3) The [State Drugs Controller], who will issue the necessary sanction authorising the practitioner to possess specified quantities of manufactured drugs, other than prepared opium, during a year.

(4) On receipt of sanction the medical practitioner will obtain his requirements from time to time, within the limits of the quantities of manufactured drugs, other than prepared opium, specified therein, but if at any time, his requirements are likely to exceed the specified quantities, he shall apply for additional quantities in like manner. The annual indent shall be obtained from the same firm, from which the first requirement is obtained and each receipt and issue shall be noted in the register in Form D.D. 7-A to facilitate check.

(D) Licensed Druggists - DD 5 Licenses.

(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 Registered Pharmacist 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;"

(4) The licensee shall be authorised to sell the following drugs for medicinal purposes only -

(i) medicinal hemp;

(ii) medicinal opium;

(iii) preparations containing medicinal hemp or medicinal opium.

(5) The licensee shall not have in his possession any medicinal hemp, medicinal opium or excise opium in quantities in excess of those stated in his license, and shall not keep the same in any place except the premises described in the license. He may also possess such quantity of pure opium as is specified in the license for the manufacture of medicinal opium.

(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] a permit in Form D.D. 2. The importation of his supplies by post is absolutely prohibited.

(7) The licensee is authorised to manufacture medicinal opium and to compound any preparation containing medicinal hemp or medicinal opium from the materials which he is lawfully entitled to possess. [The licensee shall maintain correct accounts of manufacturing and sale of all drugs in Form D.D. 9 and Form D.D. 10]..

(8) The licensee shall maintain correct accounts of all transactions. [in Form D.D. 8]. Such accounts shall show, in respect of each receipt, the source of supply and the quantity received, and in respect of issues, the quantity issued each day, the original prescriptions on which they have been issued and in the case of issues made otherwise than on a prescription, receipts from the persons to whom the issues were made. Such accounts shall be preserved for not less than two years from the date of the last entry in the accounts, and should be signed by any [Drugs Inspector] who inspects the licensed premises.

(9) Any package or bottle containing drugs shall before sale be marked with the quantity of the drugs in the package or bottle.

(10) A preparation, admixture, extract or other substance containing drugs shall be sold only in a package or bottle plainly marked -

(i) 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; and

(ii) in the case of tablets or other articles, with the quantity of drugs in each article, and the number of articles in the package or bottle.

[(11) All stocks of pure opium, medicinal hemp and medicinal opium 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]".

(12) The licensee shall on requisition by the [State Drugd Controller] or 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 pure opium, medicinal hemp and medicinal opium received by him during the quarter, the quantity sold by him and the quantity remaining in his possession to the [Divisional Drugs Inspector or Drugs Inspector] and the Drugs Inspector of the Drugs Control Department, Punjab.

[(14). If on the expiry or cancellation of the licence, any stocks of pure opium, medicinal hemp, medicinal opium or any other manufactured 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 stocks 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 forthwith 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;].

(15) If any portion of the drugs is fit for human consumption, [Divisional Drugs Inspector or the Drugs Inspector] shall make over such opium, medicinal hemp or medicinal opium 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 these to the [Divisional Drugs Inspector or the Drugs Inspector] 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] any portion of excise opium, medicinal hemp and medicinal opium, which in the opinion of the [Divisional Drugs Inspector or the Drugs Inspector] does not amount to more than two months' supply, at such a price as shall be determined by the [Divisional Drugs Inspector or the Drugs Inspector] The price shall be paid to the previous licensee, if he has surrendered the drugs in question to the [Divisional Drugs Inspector or the Drugs Inspector].

(17) A licensed druggist may import, export or transport such quantity of medicinal hemp and medicinal opium as may be specified in his license.

(b)(1) The [State Drug Controller] shall in respect of each license fix and shall record in the license the maximum quantity of medicinal hemp or medicinal opium which the licensee may possess at any one time for the purpose of vend or the manufacture of medicinal opium.

(2) A licensed druggist may, subject to the conditions of his license, sell medicinal hemp or medicinal opium for medicinal purposes only and to the undermentioned persons :-

(i) a medical practitioner, who (i) is either known to the licensed druggist, or (ii) 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 drug; provided that the licensee is satisfied with the medical practitioner of the order and on the delivery he receives from the genuineness of the order the signed order or an undertaking that the signed order will be furnished within twenty-four hours. If such signed order is not received within twenty-four 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];

(ii) a druggist licensed under these rules or under any rules for the time being in force in any other State;

(iii) any other person authorised under these rules;

(iv) any person holding the prescription of a medical practitioner.

(3) All prescriptions for the dispensing of such drugs shall be written out in Form D.D. 7 and the licensee shall be responsible that the prescriptions on the authority of which such drugs are to be sold, are made out in that form.

(4) The licensee shall sell the drugs in such quantities and for the use of such persons only as may be specified in the prescription.

(E) Licensed Chemists - D.D. 6 Licensees

(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];

(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] 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];

(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]. 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].

(12) The licensee shall on requisition by the [State Drug Controller] 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.]

[(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.]

(15) If any portion of the drugs is fit for human consumption, [Divisional Drugs Inspector or the Drugs Inspector] 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] 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] any portion of the drugs which in the opinion of the [Divisional Drugs Inspector or the Drugs Inspector] 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.] 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] 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];

(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

(G) Appeal and Revision

Form D.D. 1

Application for Permit to Import Manufactured Drugs other than Prepared opium into the State of Punjab

1. Name and address of the applicant_____________________________________

2. Licence No._____________________ Date up to which valid _______________

3. The above named being a Licensed Druggist/Licensed Chemist in .......... District, is licensed to possess Medicinal hemp/Medicinal opium/Coca derivatives/Opium derivatives/Any other manufactured drug.

4. Name, designation of the officer and address of Government department requiring the manufactured drugs other than prepared opium in official capacity.

5. Stock in hand of manufactured drugs other than prepared opium :

6. Name and address of the firm from whom manufactured drugs other than prepared opium is to be imported :

Signature and address of the Licensee.

Note. - The application should be submitted to the Divisional Drugs Inspector/Drugs Inspector of his area in duplicate who will after verification submit the same to the State Drugs Controller.

Divisional Drugs Inspector/Drugs inspector,

Form D.D. 2

(See rule 14)

Permit and Pass (on the reverse) for the Import/Permit for the transport of manufactured Drugs other than prepared Opium in the Punjab State

Note. - The permit must be used within ........... months from the date of its issue. One copy of the permit and the pass on the reverse shall be delivered on arrival of the consignment noted above and its destination to ........ (c) The bulk of the consignment shall not be broken in transit.

State Drugs Controller, Punjab.

(a) Here state the name and the designation of the consignee.

(b) Here state the locality and district.

(c) Here state that the official designation of the person to whom this is to be delivered.

Form D.D. 2 (Duplicate)

(To be given to the Importer)

Permit and Pass (on the reverse) for the Import/Permit for the transport of manufactured Drugs other than prepared Opium in the Punjab State

Note. - The permit must be used within ____________ months from the date of its issue. One copy of the permit and the pass on the reverse shall be delivered on arrival of the consignment noted above and its destination to _______________ (c) the bulk of the consignment shall not be broken in transit.

State Drugs Controller, Punjab.

(a) Here state the name and designation of the consignee.

(b) Here state the locality and district.

(c) Here state the official designation of the person to whom the pass is to be delivered.

Form D.D. 2 (Triplicate)

(To be sent to the Collector of Exporting District)

Permit and Pass (on the reverse) for the Import/Permit for the transport of manufactured Drugs other than prepared Opium in the Punjab State

Note. - The permit must be used within ____________ months from the date of its issue. Once copy of the permit and the pass on the reverse shall be delivered on arrival of the consignment noted above and its destination to _______________ (c) the bulk of the consignment shall not be broken in transit.

State Drugs Controller, Punjab.

(a) Here state the name and designation of the consignee.

(b) Here state the locality and district.

(c) Here state the official designation of the person to whom the pass is to be delivered.

Form D.D. 2 (Reverse)

(Foil)

Pass for the export of Medicinal hemp/Medicinal opium/Opium alkaloidal derivatives/Coca derivatives/Any other manufactured drug.

District _________

(a) Here specify date and hour.

(b) Here state route and mode of conveyance.

(c) Here give name of person, if any.

(d) Here state description and number of packages.

Form D.D. 2 (Reverse)

(Duplicate)

Pass for the export of Medicinal hemp/Medicinal opium/Opium alkaloidal derivatives/Any other manufactured drug.

Collector of Customs, Collector,

District _________

(a) Here specify date and hour.

(b) Here state route and mode of conveyance.

(c) Here give name of person, if any.

(d) Here state description and number of packages.

Form D.D. 2 (Reverse)

(Triplicate)

Pass for the export of Medicinal hemp/Medicinal opium/Opium alkaloidal derivatives/Any other manufactured drug.

Collector of Customs Collector,

District _________

(a) Here specify date and hour.

(b) Here state route and mode of conveyance.

(c) Here give name of person, if any.

(d) Here state description and number of packages.

Form D.D. 3

(See rule 15)

(Foil)

(To be retained in the Office of the Issue)

Form D.D. 3

(Duplicate)

(To be given to the Exporter)

Form D.D. 3

(Triplicate)

(To be sent to the Controller of the District of Destination)

Form D.D. 4

(See rule 15)

(Foil)

(To be retained in the office of issue)

Dated _______________

Note. - One copy of this pass shall be carried with the consignment of the drugs, the transport of which it is intended to cover, and is valid uptil _____

Form D.D. 4

(Duplicate)

(To be given to the transporter)

Dated _______________

Note. - One copy of this pass shall be carried with the consignment of the drugs, the transport of which it is intended to cover, and is valid uptil _____

Form D.D. 4

(Triplicate)

(To be sent to the Drugs Inspector of the District of Destination)

Dated _______________

Note. - One copy of this pass shall be carried with the consignment of the drugs, the transport of which it is intended to cover, and is valid uptil _____

Form D.D. 5

[See rule 20(a)]

Druggists Licence

(1) The Licensee shall be bound by the provisions of the Dangerous Drugs Act, 1930 (Central II of 1930), and the Punjab Manufactured Drugs Rules, 1959, and any other rules which may from time to time be prescribed under the said Act.

(2) The licensee shall be responsible for the acts and omissions of every person employed by him in carrying on his business, and all of his servants, as if the said acts and omissions were his own.

(3) The Licensee shall not permit any drug, which he is authorised to sell, to be dispensed or handled by any person other than pharmacists registered under the Pharmacy Act, 1948 (Central Act No. VIII of 1948), or a qualified person as defined under rule 65(15) of the Drugs and Cosmetics Rules, 1945.

(4) The Licensee shall not at any time have in his possession the drugs in greater quantities than the following and keep the same in the premises described above (Quantity to be entered here by the State Drugs Controller).

(5) The Licensee shall obtain the drugs 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, the necessary permit in the Form D.D. 2. The importation of his supplies by post is absolutely prohibited.

(6) The Licensee is authorised to manufacture medicinal opium and to compound any preparation containing medicinal hemp or medicinal opium from the materials which he is lawfully entitled to possess. He shall maintain correct record of manufacture and sale of all drugs in Form D.D. 9 and Form D.D. 10.

(7) The Licensee shall maintain correct accounts of all transactions in Form D.D. 8. Such accounts shall show in respect of each receipt, the source of supply and the quantity received, and in respect of issue, the quantity issued each day. Such accounts shall be preserved for not less than two years from the date of the last entry in the accounts and should be signed by any officer of the Drugs Control Administration of or above the rank of the Drugs Inspector who inspects the Licensed premises.

(8) Any package or bottle containing the drugs shall before sale be marked with the quantity of the drug in the package or bottle.

(9) A preparation admixture extract or other substance containing the drugs shall be sold only in a package or a bottle plainly marked (i) in the case of powder, solution or ointment with the total quantity thereof in the package or bottle and the percentage of the drug in the powder, solution or ointment, (ii) in the case of tablets or other articles, with the quantity of the drugs in each article and the number of articles in the package or the bottle.

(10) All stocks of drugs, all accounts and records of transactions under this Licence shall be open to inspection by any Officer of the Drugs Control Administration of or above the rank of a Drugs Inspector.

(11) The Licensee shall, on requisition by the State Drugs Controller 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.

(12) The licensee shall on the first day of every quarter, submit a correct quarterly statement in Form D.D. 11 to the Divisional Drugs Inspector or Drugs Inspector of his area showing the quantity of the drugs received by him during the quarter the quantity sold by him and the quantity remaining in his possession.

(13) If on the expiry or cancellation of the licence, any stocks of pure opium, medicinal hemp or medicinal opium remain in the possession of the licensee, he shall at once surrender these stocks to the Divisional Drugs Inspector or Drugs Inspector. If any portion of these stocks is declared by the Drugs Control Administration to be unfit for human consumption, the Divisional Drugs Inspector or Drugs Inspector shall forthwith cause that portion to be destroyed and the licensee shall not be entitled to claim any compensation for loss resulting from destruction of such a portion of the drugs.

(14) If any portion of drugs is fit for human consumption, the Divisional Drugs Inspector or Drugs Inspector shall make over such medicinal hemp or medicinal opium in any quantity not exceeding that which the transferee is likely to sell within two months to the in-coming licensed vendor who is taking place of the previous licensee or to any other licensed vendor if the latter has surrendered the drugs in question to the Divisional Drugs Inspector or Drugs Inspector.

(15) The Licensee shall be bound to accept from the Divisional Drugs Inspector or Drugs Inspector any portion of the Drugs which in the opinion of the Divisional Drugs Inspector or Drugs Inspector does not amount to more than two months' supply, at such a price as shall be determined by the Divisional Drugs Inspector or Drugs Inspector. The price shall be paid to the previous licensee, if he has surrendered the drugs in question to the Divisional Drugs Inspector or Drugs Inspector.

1. Street and house number or other particulars.

2. Bounded on the :- North _________ East _________ South _________ West __________

State Drugs Controller, Punjab.

Form D.D. 6

(See rule 21(a)]

(a) Coca derivatives.

(b) Morphine.

(c) Diacetylmorphine (heroin).

(d) all preparations containing more than 0.2 per cent of morphine or containing diacetylmorphine

(e) Manufactured drugs excluding medicinal hemp and medicinal opium.

(1) The licensee shall be bound by the provisions of the Dangerous Drugs Act, 1930 (Central Act No. II of 1930), the Punjab Manufactured Drugs Rules, 1959 and any other rules which may from time to time be made under the said 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 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 defined under sub-rule (15) of rule 65 of the Drugs and Cosmetics Rules, 1945.

(4) The licensee is authorised to sell the following drugs (here mention the name(s) of the Drug(s) to -

(a) a medicinal practitioner.

(b) a chemist licensed under these rules or under any rules for the time being in force in any State.

(c) Any person authorised under rule 21 of the Punjab Manufactured Drugs Rules, 1959, or any other corresponding rule for the time being in force.

(d) Any person holding the prescription of form D.D. 7 of a medical practitioner.

(5) The licensee shall not sell or keep the drugs in any other place except in the premises described above.

(6) The Licensee shall not at any time have in his possession the drugs in greater quantities than the following :-

(7) The licensee shall obtain his supplies of drugs either by direct importation from another State or from another licensed vendor in Punjab after obtaining from the State Drugs Controller necessary permit in Form D.D. 2. The importation of the drugs by post is absolutely prohibited.

(8) The licensee is authorised to manufacture any preparation containing morphine, diacetylmorphine, cocaine or to manufacture another "Manufactured drug" so listed in this licence from the materials which he is lawfully entitled to possess.

He shall maintain correct record of manufacture and sale of all drugs on Forms D.D. 9 and D.D. 10.

(9) The name of the person, firm or body corporate dispensing the prescriptions, the address of the premises at which and the date on which it is dispensed must be entered in the prescription.

(10) All prescriptions for the dispensing of such drugs shall be written out in the Form D.D. 7 and the licensee shall be responsible that the prescriptions on the authority of which such drugs are to be sold, are made out in this form.

(11) (i) The licensee shall sell the drugs in such quantities and for the use of such persons only as may be specified in the prescription.

(ii) If the prescription does not bear a superscription by any 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 drugs once only on such a prescription and shall retain the prescription.

(iii) If the prescription bears the requisite superscription he shall enter in the prescription the date of sale, and shall sign and seal the prescription, giving particulars as laid down in condition 9.

(12) In the case of every sale, otherwise than on 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.

(13) The licensee shall maintain correct accounts of all transactions in Form D.D. 8. Such accounts shall show 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 made up, and in the case of issue made otherwise than on the 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 last entry in the accounts.

(14) All stocks of drugs and all accounts and records of transactions under this licence shall be open to inspection by any officer of the Drugs Control Administration of or above the rank of Drugs Inspector.

(15) The licensee shall on requisition by the State Drugs Controller 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.

(16) The licensee shall on the first day of every quarter submit a correct quarterly statement in Form D.D. 11 to the Drugs Inspector or Divisional Drugs Inspector of his area showing the quantities of drugs received by him during the quarter, the quantity sold by him and the quantity remaining in his possession.

(17) If on the expiry or cancellation of the licence, any stocks of drugs remain in the possession of the licensee, he shall at once surrender the stocks to the Divisional Drugs Inspector or Drugs Inspector. If any portion of these stocks is declared by the Drugs Control Administration to be unfit for human consumption, the Divisional Drugs Inspector or Drugs Inspector, shall forthwith 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 portion of the drugs.

(18) If any portion of the drug is fit for human consumption the Divisional Drugs Inspector or Drugs Inspector shall make over such portion of the drugs, in any quantity not exceeding that the transferee is likely to sell within two months to the in-coming licensed vendor, who is taking the place of the previous licensee if the latter has surrendered the drugs in question to the Divisional Drugs Inspector or Drugs Inspector or to any other licensed vendor.

(19) The licensee shall be bound to accept from the Divisional Drugs Inspector or Drugs Inspector any portion of the drugs which in the opinion of the Divisional Drugs Inspector or Drugs Inspector does not amount to more than two months supply at such a price as shall be determined by the Divisional Drugs Inspector or Drugs Inspector. The price shall be paid to the previous licensee if he has surrendered the drugs in question to the Divisional Drugs Inspector or the Drugs Inspector.

1. Street and house number or other particulars

2. Boundaries on the :- North______East_______South______West_______

Form D.D. 7

[See Rule 20(b)(3)]

Official form of Prescription to be used when Preparations of

1. Name and address of the patient.

2. Age ___________ 3. Sex _______________ 4. Disease _________

5. Name of the drug prescribed alongwith quantity.

(Signature)
Full name, qualification, Registration No. and
complete address of Medical practitioner
(rubber Stamp be affixed here)

Form NO. D.D. 7A

[See rule 16(2)(i)]

Form of the register to be maintained by a Medical practitioner permitted to possess manufactured drugs under the manufactured Drugs Rules

Note. - For manufactured drug, a separate page shall be allotted.

Form D.D. 7-B

[See rule 16(3)]

To be maintained by the State Drugs Controller, Punjab

Form D.D. 7-C

[See rule 16(3)]

1. Dr. ____________ 2. Son of __________ 3. Locality _____________

4. Medical Registration No. _______________ has been registered in accordance with the provisions of the Punjab Manufactured Drugs Rules, 1959, and his registration No. is ___________________ in the register prescribed in Form D.D. 7-B.

State Drugs Controller, Punjab.

Form D.D. 8

[See rule 20(a)(8)]

Register to Maintain Records of Purchase and Sale of Manufactured Drugs by Chemists and Druggists

A. Record of purchase : Name of the drug -

B. Record of sale :- Name of the Drug _________

Note. - A separate page should be allotted to each drug.

Form D.D. 9

[See rule 20(a)(7)]

Register showing particulars of manufactured drugs by a manufacturer :

Note. - For each manufactured drug, a separate page shall be allotted.

Form D.D. 10

[See rule 20(a)(7)]

Register showing particulars about the sale of manufactured drugs by a manufacturer to licensed druggist/chemist

Note. - For each manufacturing drug, a separate page shall be allotted.

Form D.D. 11

[See D.D. 5(12) and D.D. 6(16)]

Proforma regarding quarterly statement to be supplied by D.D. 5/D.D. 6 Licensee

1. Name and complete address of the licensee.

2 (i) Licence No. in Form D.D. 5.

(ii) Licence No. in Form D.D. 6.

3. Name of the manufactured drugs.

4. Opening balance at the beginning of the quarter.

5. Quantity received during the quarter.

6. Total of Serial Nos. 4 and 5.

7. Quantity sold during the quarter.

8. Balance in hand at the end of the quarter.