CHAPTER II
Administration and Enforcement

4. Regulation and prohibition of import, etc., of drugs: (1) The Federal Government shall regulate the import and export. of drugs in the prescribed manner and for that purpose may make such orders and issue such directions to the importers and exporters as it may deem fit.

(2) If in the opinion of the Federal Government the public interest so requires, the Federal Government may, by notification in the official Gazette,--
(a) direct that a drug or a class of drugs specified in the notification, or drugs generally, shall not be imported or exported otherwise than under the authority of 'a licence issued under this Act or except by an importer or exporter or through an indentor registered in accordance with the rules;
(b) direct that a drug or class of drugs specified in the notification shall not be imported except by an agency of Government so specified; or
(c) prohibit the import or export of any drug or class of drugs specified in the notification.

"(3) Subject to sub-section (1) and (2), only such drugs shall be imported which are on safe in the market of any of the western European countries, USA, Japan, Australia or any other country as may be prescribed.".

Scope: This section empowers the Federal Government to allow or disallow the import and export of drugs and if all need to do so in accordance with a prescribed manner and subject to directions as may be issued. The Federal Government may also direct that a licence would be required for the export or import of a certain drug or class of drugs or that as certain drug or class of drugs should not be imported or exported at all or that any drug or class of drugs shall be imported only by a specified agency of Government.

Import and export of drugs is regulated by the Drugs (Import and Export) Rules 1976, printed infra.

5. Regulation of manufacture of drugs: (1) The grant of licences to manufacture drugs shall with the approval of the Federal Government and by notification in the official Gazette be regulated in accordance with such conditions and procedure as may be prescribed, by a Central Licensing Board to be set up by the Federal Government and consisting of such representatives of the Federal Government and the Provincial Governments as may be prescribed.

(2) The members of the Central Licensing Board shall exercise such powers, including the powers of an Inspector, as may be prescribed.

(3) The Central Licensing Board shall make regulations to regulate the conduct of its business.

(4) Any member of the Central Licensing Board may, at any time, by writing under his hand addressed to the Federal Government, resign his office or shall vacate his office if the Federal Government, being of opinion that in the public interest it is necessary so to do, so directs.

(5) Subject to sub-section (4), a member of the Central Licensing Board shall hold office for the prescribed period.

Scope : This section regulates the manufacture of drugs. Manufacture of drugs requires a licence which will be. issued subject to such conditions and procedure as may be prescribed by a Central Licensing Board set up by the Federal Government.

Renewal of Licence-Refusal grounds un-suitable: The renewal of a licence was refused on ground of un-suitability of building. Mere user of a portion of premises or building for residential purpose-Held-does not render the same un-suitable for a Licensed premises and manufacturing place only required to be separate from residential place. P L D 1978 Lah. 445.

Interpretation of section--Presumption: A manufacturer of drugs was prosecuted for offence under section 27 of the Drugs Act, 1940 after a report had been received from the Government Analyst that drug was not of standard quality. No copy of the report was supplied , as required under Section 25(3) of the Act, to manufacturer. It was, therefore, contended that the manufacturer in the circumstances could not be prosecuted for offence under section 27 of the Act. It was held, the effect of the second part of sub-section (3) of Section 25 of the Drugs Act, 1940 is only this that the report of the Government Analyst cannot be treated as conclusive evidence against the person, from whom the sample was taken, where no copy of the report was supplied to him. But under the first part of sub-section, there is presumption that the facts stated in the report are correct. This presumption, unless rebutted 'by contrary evidence, can be a sufficient basis for the conviction of the accused. P L D 1967 Kar. 80.

6. Regulation of sale of drugs : The Provincial Governments shall regulate the sale of drugs in the prescribed manner and may for that purpose make such orders, and issue such directions to the importers, manufacturers, stockists, retailers or other dealers of drugs, as they may deem fit.

Scope: It may be noted that Section 4 regulates the import and export of drugs, section 5 regulates the manufacture of drugs, while this section 6 regulates the sale of drugs. The Federal Government may make such orders and issue such directions to importers, manufacturers, stockists, retailers or other dealers of drugs as it may deem fit in this regard.

Criteria for issuance of Licence should have logical nexus with object of law: Drug Act, 1976 Is an independent enactment and has been promulgated for a specified purpose of regulating the sales etc. of the Drugs, therefore, to require a person to obtain licence under the said Act, for the sale of drugs that he should qualify an examination prescribed for a pharmacist would amount to negation of his fundamental right as guaranteed under Article 18 of the constitution. The criteria for prescribing terms and conditions for issuance of licence to regulate a trade or business should be such which has logical nexus with the object of the law. P L D 1992 Lah. 415.

The provision of Rule 20, Punjab Drugs Rules, 1988, whereby any person who was not registered as a pharmacist under the Pharmacy Act, 1967 was debarred from entering upon trade or business of sale of drugs, was violative of the Fundamental Right under Article 18 of the' Constitution guaranteed to a citizen to enter upon any lawful profession or business. P L D 1992 Lah. 415.

7. Registration of drugs : (1) The Federal Government shall cause all drugs to be registered in-accordance with such conditions and procedure as may be prescribed and for that purpose set up a Registration Board, consisting of such number of persons, possessing such qualifications, as may be prescribed.

Explanation: In this section, "drugs" means drugs which are in the finished form ready for use.

(2) The members of the Registration Board shall exercise such powers, including the powers of an Inspector, as may be prescribed.
(3) The Registration Board shall with the approval of the Federal Government and by notification in the official Gazette make regulations to regulate the conduct of its business.
(4) Any member of the Registration Board may, at any time, by writing under his hand addressed to the Federal Government, resign .his office or shall vacate his office if the Federal Government, being of opinion that in the public interest it is necessary so to do, so directs.
(5) Subject to sub-section (4), the members of the Registration Board shall hold office for the prescribed period.
(6) The Federal Government shall, by notification in the official Gazette, fix the date after which no drug which is not registered shall be allowed to be exported, imported, manufactured, stored, distributed or sold.
(7) A person applying for the registration of a drug shall furnish such information in respect of the drug as may be prescribed, including information relating to its efficacy, safety, and quality, or as may be required by the Registration Board for the purpose of the evaluation of the drug.
(8) Single-ingredient drugs shall be registered generally by their generic names while compound drugs shall be
registered generally by their proprietary names.

Explanation: In this sub-section,--
(a) "single-ingredient drugs" means drugs containing one active ingredient;
(b) "compound drugs" means drugs containing more than one active ingredient.

(9) The registration of a drug shall be subject to such conditions as my be prescribed.
(10) Where the Registration Board registers a drug, it shall inform the person applying for its registration and the Provincial Governments of its having done so and of the conditions subject to which it has been registered.
(11) If the Registration Board, on the basis of information received or an inquiry conducted by it, is of opinion that--
(a) the registration of a drug was procured by fraud or misrepresentation; or
(b) the circumstances in which a drug was registered no longer exist; or
(c) there has been a violation of the conditions subject to which a drug was registered; or
(d) it is necessary in the public interest so to do;
the Registration Board may, after affording to the person on whose application the drug was registered an opportunity of showing cause against the action proposed to be taken, cancel or suspend the registration or specify any further conditions to which the registration shall be subject and inform such person and the Provincial Governments accordingly.

(12) The Provincial Governments shall take all such steps as may be necessary to ensure compliance with the
conditions subject to which a drug is registered and to prevent the manufacture or sale of a drug-- .
(a) which has not been registered; or
(b) the registration of which has been cancelled or stands suspended.

Registration of drugs: Registration of drugs is not automatic but subject to fulfillment of specified conditions and satisfaction of Registration Board. 1979 P Cr. L J Note 6 at p. 4.

The Federal Government has fixed 15th August, 1977 to be the date after which no drug which is not registered under the said Act would be allowed to be stored, distributed or sold.

Certain steps in the manufacture Of unregistered drug being carried out in the factory of the accused immediately on day following cut-off date. Basically drug in question being manufactured by accused long before cutoff date and even completion certificate in respect of whole consignment of such drug issued by the Directorate of Inspection by that date. Offence committed by the accused was technical in nature, hence nominal fine of Rs. 1,000 was imposed, in circumstances. 1983 P Cr. L J .401.

Notification No. S.R.O. 1069(I)/85, dated 24th October, 1985: Whereas in the opinion of the Registration Board the public interest so requires and in exercise of the powers conferred by clause (d) of sub-section (11) of Section 7 of the Drugs Act, 1976 the said Board is pleased to notify the list of drugs that have been de-registered from time to time,

Drug "Fucidin Leo Interlullo gauze" registered as drug, being not exempt was liable for Customs duty & Sales Tax: It is not disputed that the "Fucidin Leo Interlullo gauze" is a drug within the meaning of Section 3 (g) of the Drugs Act XXXl of 1976. and is also registered as a drug under: Section 7 of the said Act, but the mere registration of substances, mixtures, powders, solutions. bandages, agents, devices as "drugs" under the Drugs Act or any other substances which the Federal Government may be notification in the Official Gazette declare to be "drug" for the purposes of that Act, does not mean that in the classification of medicaments (including veterinary medicaments)" as given in heading 30.03 of the Pakistan Customs Tariff all what comes under the definition of "drug" under the Drugs Act, 1976, will stand included. The classification of drugs for the purposes of the Pakistan Customs Tariff is totally different. 1988 C L C 313.

Registration of a Drug under Drug Act 1976, cannot exempt from claim under Patent Act: The contention that the drug has been registered under Drugs Act, 1976 and registration certificate under Section -7 of the Act has been issued by the Ministry-of-Health Held, mere registration of the Drug with the Ministry of Health under the Drugs Act cannot immunise the Defendants against claims of aggrieved parties under the Patent and Design Act, 1911. 1987 C L C 1571.