S R O. 890 (I)/76. In exercise of the powers conferred by Section 43 of the Drugs Act, 1976 (XXX! of 1976), the Federal Government is pleased to make the following rules, the same having been previously published as required by sub-section (3) of the said. section) namely :--

1. Short title and commencement. (1) These rules may be called the Drugs (import and Export) Rules, 1976.
(2) They shall come into force at once.
2. Definitions. In these rules unless there is anything repugnant in the subject or context :-
(a) "Act" means the Drugs Act, 1976 ('XXXI of 1976); and
(b) "form" means form appended to these rules.

17. Export of finished drugs: Finished drugs may be exported subject to the condition that the exporter possesses a licence to manufacture or sell by way of retail sale or wholesale.

18. Licences for export drugs: A licence to export drugs shall be required in Form 9 for the export of drugs other than the finished drugs.

19. Licences for export of drugs manufactured by one manufacturer: A Single application shall be made, and a single licence shall be required in respect of the export of more than one drugs or class of drugs manufactured by the same manufacturer:
Provided that if a manufacturer has two or more premises manufacturing the same or different drugs, a separate application shall be made, and a separate licence shall bc required, in respect of the drugs manufactured in each such premises.

20. Application for licence to export drugs: (1) An application for licence to export drugs shall be made to the licensing authority in Form 10 alongwith an undertaking on Form 11 signed by the manufacturer and shall be accompanied by a fee of fifty rupees:

Provided that in the case of a subsequent application by the same exporter for addition to the export licence of any drug manufactured by the same manufacturer, the fee to accompany each such application shall be twenty-five rupees.

(2) A fee of twenty-five rupees shall be paid for a duplicate copy of licence issued under this Chapter if the original is defaced, damaged or lost.

(3) An application for a licence to export small quantity of drugs, including drugs the export of which is otherwise prohibited under the Act, for the purpose of clinical trial, examination, teat or analysis shall be made to the licensing authority in Form 12; and the licensing authority may require such other particulars to be supplied as it may consider necessary.

(4) Any fee deposited under sub-rule (I) or sub-rule (2) shall in no case be refunded.

21. Duration of a licence to export drugs: A licence to export drugs, unless earlier suspended or cancelled, shall be valid for two years:

Provided that if application for a fresh licence, is made three month, before the expiry of the existing licence, the current licence shall continue to be in force until orders are passed on the application

22. Licensing Authority: For the purpose of this Chapter. "licensing authority" means the authority appointed by the Federal Government to issue export licences and includes any person subordinate to it to with such authority may, with the approval of the Federal Government by an order in writing, delegate the power to sign licences and such other powers as may be prescribed in the order.

23. Grant of export licence: On receipt of on application for an export licence, the licensing authority shall, on being satisfied that, if granted, the conditions of the licences will be observed, issue an export licence.

24. Conditions of licence to export drugs: A licence to export drugs other than finished drugs shall be subject to the following conditions, namely :-

(i) the licensee shall allow any person authorised by the licensing authority in this behalf to enter, with or without prior notice, any premises where the drug to be exported is stocked to inspect the means, if any employed for testing the drug and to take samples;

(ii) the licensee shall on request furnish to the licensing authority from every batch of each drug or from such batch or batches as the licensing authority may from time to time specify samples in such quantity as the licensing authority may consider adequate for any examination, test or analysis required to be made and the licensee shall, if so required furnish full protocols of the tests, if any, which have been applied;

(iii) if the licensing authority so directs, the licensee shall not export or offer for export any batch in respect of which a sample is, or protocols are, furnished under clause (ii) until a certificate authorising the export of the batch has been issued to him by or on behalf of the licensing authority:

(iv) the licensee shall, on being informed by the licensing authority that any part of any batch of a drug has been found by the licensing authority not to conform to the required specifications and on being directed so to do, withdraw the remainder of that batch from export and, so far as may, in the particular circumstances of the case, be practicable, recall the issues already made from that batch;

(v) the licensee shall maintain a record of all exports made by him of each drug showing particulars of the drug and of the person to whom exported and such further particulars, if any, as the licensing authority may specify, and such record shall be open to the inspection of any inspector authorised in that behalf by the licensing authority and such records shall be preserved for three years from the date of the export of the drug;

(vi) the licensee shall cause the drugs to be packed and labelled in conformity with the requirements of the consignee;

(vii) the licensee shall ensure proper storage facilities for preserving the properties of the drugs to be exported during storage;

(viii) the licensee shall comply with such further requirements, if any, applicable to the holders of export licenses, as may be specified in any rules subsequently made under the Act in this behalf and of which the licensing authority has given to him not less than three months’ notice.

25. Export of drugs for the purposes of clinical trial, examination, test analysis or personal use: Small quantities of drugs, including drugs the export of which is otherwise prohibited under the Act, may be exported for the purposes of clinical trial examination, test, analysis or personal use with the written permission of the licensing authority.

26. Statement to accompany drugs for export: All consignments of drugs sought to be exported shall be accompanied by an invoice or other statement showing the name and address of the manufacturer and the names and quantities of the drugs.

27. General provisions regarding export: An exporter of drugs, except where such export is for personal use, shall comply with the following general provisions, namely:-

(a) The exporter shall allow any person authorised in this behalf to enter with or without prior notice, any premises where the drugs to be exported are stocked, in inspect the storage facilities and take samples for testing.

(b) The exporter shall, on being informed by the Registration Board or the licensing authority or an officer authorised by it in this behalf or the Chairman of the Provincial Quality Control board that any part of any batch of a drug has been found in contravention of any of the provisions of the Act or the rules made thereunder and on being directed so to do, withdraw the remainder of that batch from export and so far as practicable, recall the issues already made from that batch and dispose of it in such manner as the Board, or, as the case may be, the licensing authority, may direct.

(c) The exporter shall maintain a record of all exports of drugs made by him and such record shall be open to inspection by any person authorised in this behalf.

(d) the exporter shall maintain an inspection book on which a member of the Registration board or the licensing authority or an Inspector shall record proceedings of each of his visits, his impressions, and the defects noticed by him and such inspection book shall be signed by him as well as the licensee or his authorised agent.

28. Procedure at customs port: (1) If the Collector of Customs or an officer authorised by him has reason to suspect that any drug does not comply with the provisions of the Act or the rules make thereunder, he may, and if requested by an officer appointed for this purpose by the Federal Government shall, take samples of any drugs from the consignment and forward them to the officer-in-charge of the laboratory appointed for the purpose by the Federal Government and may detain the drugs from the consignment of which samples have been taken until the report of the officer-in-charge of the said laboratory on such samples is received:

Provided that if the exporter gives an undertaking in writing not to export or dispose of the drugs without the consent of the Collector of Customs and to return the consignment or such portion thereof as may be required, the Collector of Customs shall make over the consignment to the exporter.

(2) If an exporter who has given an undertaking under the proviso to sub-rule (I) is required by the Collector of Customs to return the consignment or any portion thereof, he shall return the consignment or portion thereof within ten days of the receipt of the notice.

(3) If the officer in-charge of the laboratory appointed for the purpose by the Federal Government reports to the Collector of Customs that the samples of any dug in a consignment do not conform to the specifications or that the drug contravenes in any other respect the provisions of the Act or the rules made thereunder and that the contravention is such that it cannot be remedied by the exporter, the Collector of Customs shall communicate the report forthwith to the exporter who shall cause them to be destroyed or surrender them to the Federal Government for disposal in such manner as it may deem fit:

Provided that the exporter may, within fifteen days of the receipt of the report, make a representation against the report to the Collector of Customs who shall forward the representation with a further sample to the licensing authority or, as the case may be, the Registration Board which after obtaining, if necessary, the report of the officer-in-charge of the Federal Drugs Laboratory, shall pass orders thereon which shall be final.

(4) If the officer-in-charge of the laboratory appointed for the purpose by the Federal Government reports to the Collector of Customs that the samples of any drug contravene in any respect the provisions of the Act or the rules made thereunder and that the contravention is such that it can be remedied by the exporter, the Collector of Customs shall communicate the report forthwith to the exporter and permit him to withdraw the drug on his giving an undertaking in writing not to export that drug without remedying the said contravention.

29. Suspension and cancellation of license to export drugs: If the manufacturer or licensee fails to comply with any of the conditions of license to export drugs or violates any of the provisions of the Act or the rules made thereunder, the licensing authority may, after giving the licensee an opportunity of being heard, by an order in writing stating the reasons therefor, suspend or cancel it for such period as it thinks fit or cancel for all times, either wholly or in respect of some of the drugs, to which it relates or, if the nature of offense is so serious that it is likely to endanger the public health, may prohibit the export of all other drugs of the said manufacturer:

Provided that a person who is aggrieved by the suspension or cancellation of his license, may within sixty days of the receipt of such order, appeal to the Appellate Board.

I/We...................................of..................................have established the letter of credit to conduct import of drug(s) details of which are as follows:--

FORM 2
[See rule 6 (1)]
APPLICATION FOR LICENSE TO IMPORT DRUG(S)

I/We -------------------------hereby apply for import of drug(s) specified below manufactured by--------------------- of--------------------------.

I/We--------------------------enclose herewith an undertaking in Form 3 signed by or on behalf of the manufacturer as required by the rule under the Drugs Act, 1976.

Whereas--------------------of----------------------intends to apply for a license under the Drugs (Import and Export) Rules, 1976, for the import into Pakistan of the drug(s) specified below manufactured by us. We-----------------------of-------------------------hereby give this undertaking that:
(1) the said applicant has made a contract with us for import of drug(s) mentioned in the undertaking;
(2) we declare that we are bonafide licensed manufacturer of the drugs covered under this undertaking at the premises specified below and we shall report change, if any, in the said premises;
(3) we shall comply with the conditions imposed on a license by the rules under the Drugs Act, 1976 and such other requirements as may the laid down by the Government of Pakistan in this behalf;
(4) the drug(s) mentioned below conform(s) to the provisions or the Drugs Act, 1976, and the rules made thereunder.

NAME OF THE DRUG(S)
Particulars of the premises where manufacture is carried on.

I/We---------------------------of-------------------------by occupation------------hereby apply for a license to import the drug(s) analysis at----------------and I/We undertake to comply with the conditions applicable to the license under rule 12 of the Drugs (Import and Export) Rules, 1976.

Number of license---------------------------M/s--------------- of----------------------is/are hereby licensed to import into Pakistan during the period for which this license is in force the drug(s) specified below, manufactured by----------------of-------------------------.

2. This license is subject to the conditions prescribed in the Drugs Act, 1976 and shall be in force for a period of two years from the date stated below unless it is sooner suspended or cancelled under the said Rules:

Name of Drug(s) to which this license applied:

No. of license--------------------------M/s----------------of---------------------- is/are hereby licensed to import from---------------------------------the drug(s) specified below for the purpose of clinical trial, examination test or analysis at--------------------or in such other place as the licensing authority may from time to time authorise.

2. This license is subject to the condition prescribed in rule 12 of the Drugs (Import and Export) Rules, 1976, and such other conditions as may be prescribed by the Federal Government in this behalf.

3. This license shall, unless, previously suspended or cancelled, be in force for a period of two years from the date specified below:
Name(s) of drug(s) with quantities which may be imported

It is hereby certified that the above-mentioned drug (s) has/have been manufactured and labelled in conformity with the provisions of the Drugs Act, 1976, and the rules made thereunder.

It is further certified that this/these drug (s) has/have been manufactured under a valid permit/license issued by the competent Health or any other authority to manufacture this/these drug(s).

Intimation of arrival of consignment (s) of imported drug (s) other than those imported for personal use.
Name and address of importer.
Status (whether commercial importer or industrial consumer).
Drugs Manufacturing License No (in case of industrial consumer).
Drug Import License No. (in case of industrial consumer).
C.C.I., &E License No. with date and value of the License.
Import Policy Order applicable.
Name and address of exporter/manufacturer.

Number of licence.............................M/s..............of...........................is/are hereby licensed to export during the period for which this licence is in force the drug specified below manufactured...........................................

(2) This licence is subject to the conditions prescribed in the rules under the Drugs Act, 1976, and shall be in force for a period of two years from the date stated below unless it is sooner suspended or cancelled under the said rules.
Name (s) of drug (s) to which the licence applied:

l/We ....................... of ........................ hereby apply for licence to export the drugs specified below manufactured by................................

Name (s) of drugs

l/We ........................enclose herewith an undertaking in form 11 signed by the manufacturer/exporter as required by rule under Drugs Act, 1976.

Whereas .......................of ..........................intends to apply for licence under the Drugs (Import and Export) Rules, 1976 for the export of the drug (s) specified below manufactured by .......................................

(1) the said applicant has made a contract with use for thc purchase of drug (s) mentioned in the undertaking;

(2) we shall comply with the conditions imposed on a licensee made the Drugs Act, 1976;

(3) we declare that we arc carrying on the manufacture of drug (s) mentioned in this undertaking at the premises specified below and we shall from time to time, report any change of premises on which the manufacture will be carried on and, in cases where manufacture is carried on in more than one factory, any change in the distributions between the factories;

(4) every drug manufactured by us for export under licence shall conform with the provisions of the Drugs Act, 1976 and the Rules made thereunder;

(5) we shall comply with such further requirements if any, as may be specified by rules made by the Federal Government under the Act and of which the licensing authority has given to the licensee not less than three months notice.
List of drug (s)

Particulars of premises where manufacture is carried on.

l/We ............ of .............. hereby apply for permission to export the drug (s) specified below manufactured by of ............ for the purpose of .................. clinical trials, examination, test or 2analysis or for personal use

Name (s) of drug (s)