Drugs Act, 1976 (Pakistan)

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Questions and Answers

Under the Drugs Act, 1976, what does the term 'adulterated drug' refer to?

  • A drug that lacks the proper labeling.
  • A drug with the correct ingredients but in improper proportions.
  • A drug that is sold past its expiry date.
  • A drug containing filthy, putrid, or decomposed substances. (correct)

According to the Drugs Act, 1976, which of the following best describes a 'counterfeit drug'?

  • A drug that contains an incorrect dosage of the active ingredient.
  • A drug whose label or packaging imitates that of another manufacturer to deceive. (correct)
  • A drug that is sold without proper registration.
  • A drug that has been imported or exported illegally.

What is the key purpose of the 'batch number' on a drug label, as defined in the Drugs Act, 1976?

  • To indicate the expiry date of the drug.
  • To show the retail price of the drug.
  • To trace and review the production history of the batch. (correct)
  • To identify the manufacturer of the drug.

According to the Drugs Act, 1976, what is the role of the Federal Government regarding the import and export of drugs?

<p>The Federal Government regulates import and export in a prescribed manner and issues directions to importers and exporters. (B)</p> Signup and view all the answers

Under what conditions can the Federal Government prohibit the import or export of a drug according to the Drugs Act, 1976?

<p>When it deems necessary in the public interest, by notification in the official Gazette. (D)</p> Signup and view all the answers

Which authority is responsible for regulating the grant of licenses to manufacture drugs, according to the Drugs Act, 1976?

<p>The Central Licensing Board. (A)</p> Signup and view all the answers

What role do Provincial Governments play in the sale of drugs, according to the Drugs Act, 1976?

<p>They regulate the sale of drugs in the prescribed manner and issue directions to dealers. (D)</p> Signup and view all the answers

According to the Drugs Act, 1976, what constitutes a 'misbranded drug'?

<p>A drug that is not labeled in the prescribed manner or bears false claims on its label. (C)</p> Signup and view all the answers

What does the term 'expiry date' signify on a drug label, as per the Drugs Act, 1976?

<p>The date after which the drug is not expected to retain its efficacy, safety, quality, or potency. (C)</p> Signup and view all the answers

What is the primary function of the Provincial Quality Control Board under the Drugs Act, 1976?

<p>To ensure the quality control of drugs manufactured in the province. (C)</p> Signup and view all the answers

What is the primary purpose of the Pakistan National Formulary as defined in the Drugs Act, 1976?

<p>To compile and publish a list of all drugs allowed to be imported, manufactured, or sold in Pakistan. (A)</p> Signup and view all the answers

According to the Drugs Act, 1976, what is the role of the Appellate Board?

<p>To handle appeals from those aggrieved by decisions of the Central Licensing Board or Registration Board. (B)</p> Signup and view all the answers

Who appoints the members of Expert Committees related to drug evaluation and other matters under the Drugs Act, 1976?

<p>The Federal Government. (C)</p> Signup and view all the answers

According to the Drugs Act, 1976, under what condition can the Federal Government delegate its power to fix maximum drug prices?

<p>To any board or authority, by notification in the official Gazette. (D)</p> Signup and view all the answers

According to the Drugs Act, 1976, what is the role of a Government Analyst?

<p>To test and analyze drug samples and deliver reports to inspectors. (C)</p> Signup and view all the answers

Under the Drugs Act, 1976, what action should an Inspector take if they seize a drug and suspect it contravenes the Act?

<p>Inform the Board concerned or its Chairman and take order as to the custody of the stocks of the drug seized by him. (C)</p> Signup and view all the answers

What is the significance of Section 30 of the Drugs Act, 1976, concerning cognizance of offenses?

<p>It specifies which authorities are authorized to institute prosecutions under the Act. (D)</p> Signup and view all the answers

According to the Drugs Act, 1976, what is the role of a Drug Court?

<p>To try offenses punishable under the Act. (B)</p> Signup and view all the answers

Under what circumstances can the Registration Board cancel or suspend the registration of a drug according to the Drugs Act, 1976?

<p>If there's a violation of the conditions under which the drug was registered. (A)</p> Signup and view all the answers

According to the Drugs Act, 1976, what constitutes an 'adulterated drug'?

<p>A drug that is manufactured in an unhygienic environment. (B)</p> Signup and view all the answers

When does the Drugs Act, 1976, come into force?

<p>It shall come into force at once. (C)</p> Signup and view all the answers

According to the Drugs Act, 1976, which drugs does the Registration Board registers?

<p>Single-ingredient drugs by their generic names while compound drugs shall be registered generally by their proprietary names. (B)</p> Signup and view all the answers

Whom should the Inspector restore one portion of a sample so divided or one container, as the case may be, to?

<p>The person from whom he takes it. (A)</p> Signup and view all the answers

What should the Provincial Inspector do on finding any contravention of this Act?

<p>Always refer the case to the Provincial Quality Control Board and seek orders as to the action to be taken in respect of such contravention. (C)</p> Signup and view all the answers

According to the Drugs Act, 1976, what is the meaning of 'advertise'?

<p>Make any representation by any means whatsoever for the purpose of promoting directly or indirectly the sale or disposal of a drug. (A)</p> Signup and view all the answers

According to the Drugs Act, 1976, what should the federal government establish?

<p>A Federal Drug Laboratory (A)</p> Signup and view all the answers

According to the Drugs Act, 1976, what is the minimum punishment if any does the following himself or by any other person on his behalf: exports, imports, manufactures for sale or sells any spurious drug or any drug which is not registered?

<p>Shall be punishable with imprisonment for a term which shall not be less than five years. (B)</p> Signup and view all the answers

According to the Drugs Act, 1976, what does the Provincial appellate authority deals with?

<p>The disposal of appeals preferred by persons aggrieved by any decision of the licensing authority. (D)</p> Signup and view all the answers

According to the Drugs Act, 1976, under what condition an inspector lock and seal any factory, laboratory, shop, building, store-house or godown?

<p>Where any drug is or is being manufactured, stored, sold or exhibited for sale in contravention of any of the provisions of this Act or the rules. (D)</p> Signup and view all the answers

According to the Drugs Act, 1976, what action shall be taken against the director, partner and employee of a company has committed offence, with whose knowledge or consent?

<p>Shall be liable of the offence. (A)</p> Signup and view all the answers

According to the Drugs Act, 1976, a drug shall not be deemed to be misbranded or adulterated or sub-standard only by reason of following?

<p>There has been added thereto some innocuous substance or ingredient because the same is required for the manufacture or preparation of the drug (D)</p> Signup and view all the answers

According to the Drugs Act, 1976, who does not have the financial interest shall be appointed?

<p>Government Analysts and Inspectors. (B)</p> Signup and view all the answers

According to the Drugs Act, 1976, what types of advertisement are not allowed?

<p>Both A and B. (A)</p> Signup and view all the answers

According to the Drugs Act, 1976, to whom any directions are given?

<p>Provincial Governments. (A)</p> Signup and view all the answers

Flashcards

What is an "Adulterated drug?"

A drug that contains any filthy, putrid, or decomposed substance; or is manufactured, packed, or held under unsanitary conditions.

What is the "Appellate Board?"

The Board constituted under Section 9 of the Drugs Act.

What is a "Batch"?

A quantity of any drug produced during a given cycle of manufacture.

What is a "Batch number?"

A designation printed on the label of a drug that identifies the batch and permits tracing the production history.

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What is the "Central Licensing Board?"

A Board set up under Section 5 of the Drugs Act.

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What is a "Counterfeit drug?"

A drug of which the label or outer packing is an imitation designed to deceive.

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What is a "Drug"?

A substance or mixture of substances for internal or external treatment, mitigation, prevention or diagnosis of diseases

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What is the "Expiry date"?

The date stated on the label after which the drug is not expected to retain its claimed efficacy or is not permissible to sell.

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What is an "Expert?"

A specialist through university education and experience in the relevant field.

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What does "Export" mean?

To take out of Pakistan by sea, land, or air.

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What is a "Generic name?"

The non-proprietary, scientific or official name of a drug as approved by the Federal Government.

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Who is the "Government analyst?"

A Federal Government Analyst or Provincial Government Analyst appointed under Section 16.

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What does "Import" mean?

To bring into Pakistan by sea, land or air.

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Who is an "Inspector"?

A Federal Inspector or a Provincial Inspector appointed under Section 17.

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What is a "Label"?

A display of written, printed or graphic matter upon the immediate container, or the outside container or wrapper of a drug package.

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What is "Labelling?"

All labels and other written, printed or graphic matter accompanying any drug.

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What is "Licensing authority"?

Such authority as may be prescribed

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What is "Manufacture"?

All operations involved in the production of a drug, including processing, compounding, formulating, filling, packing, repacking, altering, ornamenting, finishing and labelling with a view to its storage, sale and distribution

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What is a "Misbranded drug?"

A drug which is not labelled in the prescribed manner or which makes false claims on its labeling

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What does "Prescribed" mean?

Prescribed by rules.

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What is the "Provincial Quality Control Board?"

A Board set up under Section 11 of the Drugs Act.

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What is the "Registration Board?"

A Board set up under Section 7 of the Drugs Act.

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What is a "Registered drug?"

Any drug registered under Section 7 of the Drugs Act.

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What are "Rules"?

Rules made under the Drugs Act.

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What is a "Drug Court?"

A Court established under Section 31 of the Drugs Act.

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What are "Specifications?"

When applied to a drug, it means such specifications as may be prescribed.

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What does "Sell" mean?

Sell, offer for sale, expose for sale, have in possession for sale and distribution

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What is a "Spurious drug?"

A drug which purports to be a drug but does not contain the active ingredient; or is not truly a product of the manufacturer

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What is "Storage"?

Storage for sale.

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What is a "Sub-standard drug?"

A drug which is not of specifications.

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What is the purpose of the Drugs Act, 1976?

An Act to regulate the import, export, manufacture, storage, distribution and sale of drugs

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According to the Drugs Act, what can the goverment regulate?

Regulations to control the import and export of drugs.

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What does the Central Licensing Board regulate?

Conditions and processes for licenses to manufacture drugs

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What is the main purpose of the Registration Board?

Ensuring all drugs are registered.

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Study Notes

  • The Drugs Act of 1976 (XXXI of 1976) was enacted on May 11, 1976.
  • The Drug Act aims to regulate the import, export, manufacture, storage, distribution, and sale of drugs within Pakistan.

Short Title, Extent, and Commencement

  • The Act is known as the Drugs Act, 1976.
  • The Drug Act extends to the entirety of Pakistan.
  • The Drug Act came into effect immediately upon enactment.

Application of Other Laws

  • The Drug Act supplements, rather than replaces, the Dangerous Drugs Act of 1930 and other applicable laws.

Definitions

  • "Adulterated drugs" are drugs containing:
    • Filthy, putrid, or decomposed substances.
    • Foreign matter, vermin, worms, rodents, or insects.
    • Contamination from unsanitary manufacturing, packing, or holding conditions, rendering it injurious.
    • Containers releasing harmful substances.
    • Substances not intended as ingredients.
    • Substances mixed or packed to reduce quality, strength, or with any substance substituted.
  • "Appellate Board" is the board constituted under Section 9.
  • "Batch" refers to the quantity of a drug produced in a single manufacturing cycle.
  • "Batch number" refers to a designation on a drug label identifying the batch and its production history thus enabling traceability and review.
  • "Central Licensing Board" means a board set up under Section 5.
  • "Counterfeit drug" refers to a drug whose label or packaging imitates or resembles that of another manufacturer, intending to deceive.
  • "Drug" includes:
    • Substances or mixtures for internal or external use in treating, mitigating, preventing, or diagnosing diseases or abnormal physical states in humans or animals, excluding substances exclusively used in Ayurvedic, Unani, Homeopathic and Biochemic medicine except under prescribed conditions.
    • Abortive/contraceptive substances, agents, devices, surgical materials, disinfectants, bacteriophages, adhesive plasters, gelatin, capsules, and antiseptic solutions.
    • Substances used to destroy or repel vermin, insects, rodents, or other disease-carrying organisms in humans or animals, or for disinfection in residential or food-related areas.
    • Pesticides that may cause health hazards to the public.
    • Any substance or preparation listed in pharmacopoeias or formularies, whether alone or in combination, but not substances exclusively used in Unani, Ayurvedic, Homeopathic or Biochemic systems, when intended for purposes mentioned above.
    • Substances declared as drugs by the Federal Government in the official Gazette.
  • "Expiry date" is the date on a drug label beyond which the drug is not expected to retain its efficacy, safety, quality, or potency, and beyond which it is not allowed to be sold.
  • "Expert" is a specialist with university education and experience in the relevant field.
  • "Export" denotes the act of taking goods out of Pakistan by sea, land, or air, along with its related grammatical variations.
  • "Generic name" is the non-proprietary, scientific, or official name of a drug as approved by the Federal Government.
  • "Government analyst" is a Federal Government Analyst or Provincial Government Analyst appointed under Section 16.
  • "Import" with its grammatical variations and related expressions, means bringing into Pakistan by sea, land, or air.
  • "Inspector" refers to a Federal Inspector or a Provincial Inspector appointed under Section 17.
  • "Label" is any written, printed, or graphic display on a drug's immediate container or outer packaging.
  • "Labeling" encompasses all labels and accompanying written, printed, or graphic material of any drug.
  • "Licensing Authority" is the authority as prescribed.
  • "Manufacture," when referring to a drug, encompasses all operations involved in its production like processing, compounding, and packaging, but excludes dispensing in retail or following a prescription.
  • "Misbranded drug" is one that:
    • Is not labeled as prescribed.
    • Lacks prominent placement of required information on the label.
    • Is missing directions for use or warnings.
    • Has false or misleading claims on the label.
    • Has concealed damage or gives a false impression of therapeutic value.
    • Is manufactured according to a particular document, but the label doesn't bear the name of that document.
  • "Prescribed" means prescribed by rules.
  • "Provincial Quality Control Board" means a Board set up under Section 11.
  • "Registration Board" means a Board set up under Section 7.
  • "Registered drug" means any drug registered under Section 7.
  • "Rules" are those made under this Act.
  • "Drug Court" means a Court established under Section 31.
  • "Specifications" when applied to a drug mean
    • such specifications as may be prescribed; or
    • when the specifications are not prescribed, the specifications as contained in the most recent edition of any of the following publications, namely:-
      • (1) the Pakistan Pharmacopoeia;
      • (2) the International Pharmacopoeia;
      • (3) the European Pharmacopoeia;
      • (4) the United States Pharmacopoeia;
      • (5) the British Pharmacopoeia;
      • (6) the British Pharmaceutical Codex;
      • (7) the United States National Formulary; and
      • (8) such other publication as may be prescribed:
        • Provided that, if the specifications do not appear in the most recent edition of any such publication, the specifications appearing in the next preceding edition of such publication in which the specifications appear shall apply; or
    • if no specifications are either prescribed or contained in any of the publications referred to in sub-clause (ii), the specification approved for the purpose of registration under this Act;
  • "Sell" includes offering or exposing for sale, having possession for sale, and distribution.
  • "Spurious drug" refers to a drug:
    • That purports to be a drug but does not contain the active ingredient of that drug; or
    • That purports to be the product of a manufacturer, place or country of whom or of which it is not truly a product; or
    • That is imported or exported or sold or offered or exposed for sale under a particular name while actually it is another drug; or
    • The label of which bears the name of an individual or company purporting to be its manufacturer or producer which individual or company is fictitious or does not exist;
  • "Storage" is the act of storing for sale.
  • "Sub-standard drug" is a drug that does not meet required specifications.

Regulation and Prohibition of Import

  • The Federal Government is responsible for regulating the import and export of drugs.
  • The Federal Government can issue orders and directions to importers and exporters.
  • The Federal Government may issue notifications in the official Gazette to:
    • Regulate drug import/export through licensing or registered indentors.
    • Restrict import to government agencies.
    • Prohibit the import or export of specific drugs or drug classes.
  • Import of drugs allowed for sale in Western European countries, USA, Japan, Australia or similarly prescribed countries only.

Regulation of Manufacture of Drugs

  • The grant of licenses to manufacture drugs is regulated by the Central Licensing Board under conditions and procedures as prescribed.
  • The Central Licensing Board is established by the Federal Government and includes representatives of the Federal and Provincial Governments.
  • The Central Licensing Board has powers of an Inspector.
  • The Central Licensing Board, with the approval of the Federal Government and by notification in the official gazette, shall make regulations to regulate the conduct of its business.
  • A Central Licensing Board member may resign or be removed from office by the Federal Government.
  • Central Licensing Board members shall hold office for a prescribed period.

Regulation of Sale of Drugs

  • Provincial governments regulate the sale of drugs and may issue orders and directions to importers, manufacturers, stockists, retailers, and other drug dealers.

Registration of Drugs

  • Drugs must be registered by the Federal Government as per prescribed conditions and procedures.
  • The Federal Government establishes a Registration Board with qualified members.
  • In this section, "drugs" means drugs which are in the finished form ready for use.
  • The Registration Board members exercise powers and the powers of an Inspector.
  • The Registration Board makes regulations, with Federal Government approval, to conduct its business.
  • A Registration Board member may resign or be removed from office by the Federal Government.
  • Registration Board members hold office for a prescribed period.
  • The Federal Government fixes a date after which unregistered drugs cannot be exported, imported, manufactured, stored, distributed, or sold.
  • Applicants for drug registration must provide information about the drug's efficacy, safety, and quality.
  • Single-ingredient drugs are registered by generic names, while compound drugs are registered by proprietary names.
    • Single-ingredient drugs contain one active ingredient
    • Compound drugs contain more than one active ingredient
  • Drug registration is subject to prescribed conditions.
  • The Registration Board informs the applicant and Provincial Governments of successful registration and any conditions applied.
  • The Registration Board can cancel or suspend registration if:
  • Registration was obtained by fraud/misrepresentation.
  • The circumstances of registration no longer exist.
  • There has been a violation of registration conditions.
  • It is necessary for public interest.
  • The Provincial Governments take steps to ensure compliance with drug registration conditions and prevent the manufacture/sale of unregistered or suspended drugs.

Pakistan National Formulary

  • The Federal Government publishes the Pakistan National Formulary of drugs allowed to be imported, manufactured, or sold and can review and modify its contents.

Appellate Board

  • The Federal Government constitutes an Appellate Board to address appeals from decisions made by:
    • Central Licensing Board
    • Registration Board
    • Licensing Authority
    • Authorities delegated powers under the Federal Government under section 12 have been delegated under sub-section (3) of that section and for revision of any such decision on its own motion.
  • The Appellate Board includes representatives from Federal and Provincial Governments, with a Chairman appointed by the Federal Government.
  • The Chairman and members hold office for a prescribed term.
  • Any member may resign or be removed from office by the Federal Government.
  • The Appellate Board has powers of an Inspector.
  • Appellate Board may appoint experts for detailed study of cases before it.
  • The Appellate Board makes regulations to conduct its business with Federal Government approval.
  • The Appellate Board must meet monthly and decide appeals within 60 days.

Appeals to the Provincial Appellate Authority

  • Individuals aggrieved by a licensing authority decision may appeal to the Provincial Appellate Authority.
  • The Provincial Government forms this authority to handle such appeals.

Expert Committees

  • The Federal Government may form expert committees.
    • Drugs Evaluation
    • Pakistan Pharmacopoeia
    • Advertising
    • Other matters related to the Drug Act.
  • Committees include members the Federal Government appoints.
    • Each member holds office at the Federal Government's pleasure.

Provincial Quality Control Board

  • Each Provincial Government establishes a Provincial Quality Control Board.
  • Membership includes a Chairman appointed by the Provincial Government.
  • The Chairman and members serve at the pleasure and under the terms determined by the Provincial Government.
  • The Provincial Government appoints a Secretary and provides staff to the Board.
  • The Provincial Quality Board makes regulations with Provincial Government approval.
  • The Provincial Quality Control Board's powers and functions are:
    • Inspecting premises and recommending license cancellation or suspension for violations;
    • Reviewing reports from Provincial Inspectors and Government Analysts, issuing instructions;
    • Exercising the powers of an Inspector;
    • Advising on quality control;
    • Ascertaining responsible parties for offenses and allowing inspector to institute prosecution only against such persons.
    • Conducting annual validation of drug testing instruments, recommending upgrades;
    • Identifying/accrediting qualified laboratories;
  • Conducting Government training programs;
  • Submitting monthly reports to the Federal Government.
  • The Provincial Quality Control Board may delegate powers to its members.

Conflict of Interest

  • Prohibits membership on multiple boards/committees simultaneously to avoid conflicts of interest. The affected boards are: Appellate Board, Central Licensing Board, Provincial Quality Board, and Registration Board.

Power to Fix Maximum Drug Prices

  • The Federal Government publishes the maximum sale price of drugs in the official Gazette.
  • It specifies the percentage of drug manufacturers' profits to research drugs.
  • The Federal Government may require information from manufacturers, stockists, importers, exporters, retailers, or other dealers.
  • The Federal Government may delegate powers under this section to any Board/authority.

Directions to Provincial Governments

  • The Federal Government can direct Provincial Governments to enforce the Drug Act to maintain drug supplies, quality, and uniform standards across Pakistan.

Federal Drugs Laboratory and Institutes

  • The Federal Government may establish a Federal Drug Laboratory.
  • The Federal Government may establish other institutes and drug testing/research labs.
  • The Institutes should fulfill purposes as may be prescribed.

Provincial Drugs Testing Laboratory

  • Each Provincial Government must establish a Provincial Drugs Testing Laboratory.
  • Drugs must be tested for prescribed purposes.

Government Analysts

  • The Federal or Provincial Government may appoint qualified individuals as Government Analysts in the official Gazette for specific areas and drugs.
  • Those with financial interests in drug manufacture, import, export, or sale cannot be appointed.
  • Government employees from other areas cannot be appointed without prior consent.

Inspectors

  • The Federal or Provincial Government may appoint qualified Federal or Provincial Inspectors in the official Gazette for specific local limits.
  • Individuals with financial interests in drug manufacture, import, export, or sale cannot be appointed.
  • Government employees from other areas cannot be appointed without prior consent.

Powers of Inspectors

  • Subject to Section 19, Inspectors can:
    • Inspect premises, manufacturing processes, records, and registers.
    • Inspect premises where drugs are sold, stocked, or distributed, including storage arrangements.
    • Take samples of manufactured, sold, stocked, or distributed drugs.
    • Enter/search buildings, vessels, or places with belief of offense committed.
    • Call witnesses for search/seizure or other matters.
    • Seize drugs, materials, registers, and documents that evidence offenses.
    • Stocks can not be seized if the contraventions can be remedied as long as there is a written undertaking of the person to only sell the drugs after the defect is remedied.
    • Require individuals to appear and provide statements/assistance for investigations.
    • Lock and seal premises used in contravention of the Drug Act/rules.
    • Forbid removal of substances likely to be used for evidence for a reasonable period of two weeks. This period may be extended to three months.
    • Exercise other necessary powers.
  • Powers under (f) to (j) require specific authorization, in writing, from the government, with specific conditions.
  • The Code of Criminal Procedure applies to searches/seizures, where it is consistent with this Act.

Procedure for Inspectors

  • Inspectors must provide a receipt when seizing any drug or article.
  • Inspectors taking samples must:
  • Indicate the purpose in writing;
  • Divide the sample into [five] portions (three if from manufacturing premises);
  • Seal and mark the portions;
  • Allow the person to add their own seal.
  • If the drug is in small containers, inspectors may take three or four containers instead of dividing the sample, if needed. And if the contents of one container is not enough for testing, inspectors may increase the number of containers.
  • One sample is restored, the remainder disposed within seven days:
  • Portion sent to the Government Analyst for testing.
  • Second portion sent to the Chairman, Provincial Quality Control Board, Central Licensing Board, or Registration Board.
  • Third portion sent to the warrantor, if any, named under the proviso to sub-section (3) of Section 32.
  • The fourth portion, where taken, is sent to the person purporting to be its manufacturer or importer, as the case may be.
  • Inspectors seizing visibly contaminated drugs must seal and mark the sample; and produce before the Drug Court, Central Licensing Board or the Registration Board.
  • Inspectors taking action under section 18 must inform the Board concerned or its chairman and take any orders on the custody of the drug seized.
  • Federal Inspectors not competent to act under Section 30 must report to the Provincial Inspector for action.
  • Inspectors must ascertain if the drug does not contravene the Act. If it does not contravene it, the Inspectors shall revoke the order under the said section.
  • Where a Federal Inspectors is incompetent to take action under section 30, the Inspector should report and handover the stock to the Provinicial Inspector for action.

Contravention

  • Provincial Inspectors refer the case to the Provincial Quality Control Board unless directed otherwise, seeking orders for action.
  • Federal Inspectors must refer any contravention to the Central Licensing Board, Registration Board, or specified authority for further orders.

Disclosure

  • Every person managing premises manufacturing, storing, or distributing drugs must disclose the location to an Inspector upon request.

Manufacturers

  • Persons not the manufacturer or manufacturers agent must disclose the manufacturers name, address and details of manufacture as requested by an Inspector.

Government Analysts Reports

  • Government Analysts must provide the Inspector with a signed report in quadruplicate, sending one copy to the prescribed authority, within sixty days.
  • If unable to submit report, inform the Inspector in writing and ensure the Central Licensing Board, Registration Board, or Provincial Quality Control Board receives a copy sent for further testing.
  • On receipt of the report, the Inspector:
    • Delivers a copy to the person from whom the sample was taken.
    • Forwards a copy to the warrantor, if any.
    • Forwards a copy to the Central Licensing Board, Registration Board, or Provincial Quality Control Board, for directions.
    • Retains the fourth copy.
  • Government analyst reports are admissible as evidence without formal proof, unless the person from whom the sample was taken or the said warrantor indicated their intention to adduce evidence to controvert the report.
  • The Drug Court can order a test by the Federal Drug Laboratory, whose report is conclusive.
  • Costs are paid by the complainant or accused, as directed by the Drug Court.

Import, Manufacture and Sale of Drugs

  • One may not export, import, manufacture for sale or sell:
    • Spurious drug
    • Imitation product
    • Misbranded drug
    • Adulterated drug
    • Substandard drug
    • Any drug after its expiry date;
    • Any drug which is not registered or is not in accordance with the conditions of registration;
    • Any drug which, by means of any statement, design or device accompanying it or by any other means, purports or claims to cure or mitigate any such disease or ailment, or to have any such other effect, as may be prescribed;
    • Any drug if it is dangerous to health when used in the dosage or with the frequency, or, for the duration specified, recommended or suggested in the labeling thereof; or
    • Any drug in contravention of any of the provisions of this Act or any rule;
  • One may not manufacture for sale any drug:
    • Except under, and in accordance with the conditions of, a license issued under this Act;
  • One may not sell any drug:
    • Except under, and in accordance with the conditions of, a license issued under this Act;
  • One may not import or export any drug:
    • The import or export of which is prohibited by or under this Act;
  • One may not import or export any drug for which a license is required. Except under, and in accordance with the conditions of, such license;
  • One may not supply incorrect, incomplete or misleading information, when required to furnish any information under this Act or the rules;
  • One may not peddle, hawk or offer for sale any drug:
    • In a park or public street or on a highway, footpath or public transport or conveyance;
  • One may not import, manufacture for sale, or sell any substance, or mixture of substances,
  • Which is not a drug but is presented in a form or a manner which is intended or likely to cause the public to believe it to be a drug;
  • One may not sell any drug without having a warranty bearing the name and batch number of the drug issued:
  • In the case of a drug manufactured in Pakistan, by the manufacturer holding a valid license to manufacture drugs and permission to manufacture that drug or by his authorized agent;
  • In the case of an imported drug, by the manufacturer or importer of that drug or, if the drug is imported through an indentor by such indentor;
  • One may not apply an incorrect batch number to a drug and
    • Sell or import a drug above the maximum price fixed under this Act on which the drug shall be sold or imported.
  • The aforementioned prohibitions do not apply to the manufacture or subject to prescribed conditions, of small quantities or any drug for clinical examination, test, analysis or personal use.

Control of Advertisement

  • One may not advertise any drug, remedy, treatment, substance or mixture of substance:
    • except in accordance with the conditions as may be prescribed.
  • The act of making any form of representation for the purpose of promoting the sale.
  • The above restrictions don't not include display of sings for a clinic, a dispensary or a hospital or such other institution offering treatment.

Control of Samplings

  • One may not distribute any kind of dug as a sample unless prescribed to.

Control of Printing of Labelling

  • One may not print any labelling in respect of any drug without being registered.
  • Printing of labelling may never occur for a a licensee under this Act to manufacture that drug.

Penalties

  • One may not export, imports, manufactures for or sales any spurious drug which is unregistered or manufactures for sale any drug without a license. or imports, without a license, any dug for which a license is required. Penalty includes 5-10 years of imprisonment or a fine of 500,000 Rupees. The drug court may decrease imprisonment to less than three years for special cases.
  • One may not exports, imports, manufactures for or sales any imitation product or provides a false warranty for any drug sold that the drug does not contravene with the Drug Act (Section 23) or applies or permits to be applied to any drug sold a warranty given in respect of another drug or exports, imports, manufactures for or sales any drug under a name other than its registered name or and exports, imports, manufactures for or sales any drug with any substance which should not actually be component of the drug to either degrade or alter the chemical makeup of the substance. Penalty involves 7 years in imprisonment or a fine of 100,000 Rupees (or both).
  • Penalty for obstructing an inspector in the exercise of any power include 1 years of imprisonment (with a fine which may extend to ten thousand rupees, or with both.)
  • Any other offences or contraventions can be punished with 5 years of imprisonment or a fine of 50,000 Rupees (or with both).

Penalties for Subsequent Offences

  • For repeat offense of either, manufactures for sale any drug without a license. or imports, without a license, any dug for which a license is required: The penalty is imprisonment for life, or imprisonment which shall not be less than five years and with fine which may extend to ten lakh rupees.
  • For repeat offenses of applying or permitting falsely advertised warranty or changing the chemical constituents of the drug: The penalty is imprisonment for a term which shall not be less than two years or more than ten years, or with fine which may extend to two lakh rupees, or with both.
  • For any other repeat offences, the penalty in imprisonment for a term which may extend to seven years, or with fine which may extend to one lakh rupees, or with both.

Forfeiture

  • In a event for contravening any such provisions of this Act or any rule as may be prescribed in this behalf, the Drug Court may order the stock of drug or substanc or other related apparatus which violate any of the offenses with intent of making money for illegal gains. This include any tools used to either sale or manuafcture the illicit items.
  • The drug should be forfeited to either theFederal or Provincial Government and can be disposed as the government sees fit.
  • Inspector must forfeit to the provincial or federal government an illicit drug to make money or continue offences.
  • If the Drug is found to contaven the constitution of this act, the drug court may order the goverment to forfiet the Drug.

Cognizance of Offences

  • No prosecution shall be instituted under this Chapter except: By a Federal Inspector, where the prosecution is in respect of a contravention of clause (h) of sub-section (1) of section 23 or section 24 or any of the provisions of this Act or the rules relating to the import or export of drugs or the manufacture for sale, or sale, of a drug which is not for the time being registered or for the manufacture for sale of which a license is not for the time being in force; or By a Provincial Inspector.
  • The Federal Inspector may, with the prior permission of the Federal Government, prosecute.
  • An offence punishable under this Chapter other than an offence mentioned in sub-section (1) of section 27, shall be non-cognizable (An officer cannot arrest without a warrant) An offence punishable under this Chapter is non-bailable (A bail cannot be automatically rewarded). And only a Drug Court shall try an offence punishable under this Chapter.

Drug Courts

  • The Federal Government may, by notification from the offical Gazette, establish drug courts and specify territorial limits.
  • A Drug Court shall consist of a person who is, or has been, or is qualified for appointment as, a Judge consisting of who is responsible for appointment, two members, in the opinion of the Federal Government, are experts in the medical or pharmaceutical fields. May award bail if they see if the charges are not valid.
  • A drug court shall sit in at local places as the Federal Government may direct.
  • A Drug Court shall have all the powers conferred by the Code of Criminal Procedure, 1898 (Act V of 1898), on a Court of Session exercising original jurisdiction.
  • A Drug Court shall not merely by reason of a change in its composition, be bound to recall and rehear any witness who has given evidence, and may act on the evidence already recorded by or produced before it.
  • A Drug Court shall, in all matters with respect to which no procedure has been prescribed by this Act, follow the procedure prescribed by the Code of Criminal Procedure, 1898 (Act V of 1898), for the trial of summons cases by Magistrates.
  • A person sentenced by a Drug Court may prefer an appeal to a Bench of the High Court consisting of not less than two judges.
  • The provisions of sections 5 and 12 of the Limitation Act, 1908 shall be applicable to an appeal (after a thirty-day appeal).

Pleas

  • In a prosecution, there will be no defence if an accused was ignorant of the nature, substance or quality of the drug.
  • A drug shall not be deemed to be misbranded or adulterated or substandard if there is added a harmless substance required for preparation/for transport.
  • Such decomposition is not due to any negligence that does not render the drug of sub standard or injurious.
  • One who is not the manufacturer can be free from conviction If a person did not know if a drug contravened the provision of this act as well as can prove that he was given the drug by a warrant under prescribed form stating the name and bacth signed by the personnel.

Customs and Powers of Officers of Customs

  • The law for the time applies to drugs of which are prohibited.
  • An officer of customs may suspect package of drugs with the import of which is prohibited, detain such and report such detention.

Offences by Companies

  • Offenses by companies, every director or parter or employee shall be held guilty.

Publication of Offender's name

  • If any person is convicted of an offence under this Act, it shall be lawful for the Drug Court to cause the offender's name or offence which he had been charged to be published in form of an announcement across paper.

Power to exempt

  • The federal government may change and exempt drugs in operation with the provisions of this act, for the benefit of the people.

Inspectors to be Public Servants

  • Inspectors are considered public servants within the meening of section 21 of public servants

Indemnity

  • Proceedings shall not lay against government for anything which is done in good faith.

Finnality of Order

  • Every order shall be passed in an accurate way and won't be put into question of either what is called for or in before any Court or other authority.

Publication of Result of Test or Analysis

  • It shall be lawful for the Federal Government to analyze the test of drugs in concern.

Cancellation or Suspension of Licences

  • It may be cancelled if the authority of the central licensing board can endanger the life or health of the public.

Cancellation or Suspension of Registration of Registered Drugs

  • If there have been contraventions of anything that endangered lives, the licensing bored may have full opportunity to cancel.

Power of Federal Government to Make Rules

  • The Federal Government may make rules for the purpose of this Act.
  • These may pertain to:
    • The functions of the Federal Drug Laboratory
    • Specifcations including strength, purity etc for methods of analysis
    • The maximum Proportions for various illegal products that may be added
    • Classes of drugs for import or export
    • The evidence to be presented for imported drugs
    • Forms of licensing
  • Date of manufacture of expiration:
    • Packing for standards.
  • Mode and conditions etc;
    • scientific name to be displayed.
  • requirements for quality and practices in control.
  • How to give samples.
  • Registation boards.
  • conditions for registration. To test if drugs were manufactured inside the specific establishment.
  • specify the offences and relation the stock
  • qualification what so ever power and functions of an inspector. labs used to test To maintain to secure supplies.
  • To give certain conditions.

Power of te provinciial is power to make establisjhemnts or lab to test, what willbe made as report, conditions to distribute or regilate drugs of each.

Power of the Providinvcial government to make files

  • Qualifications to estabalish, what reports may e givieng.
  • Condintions to regilate of what to be sold.

Repeal and Savings

  • The following acts have been repealed: The Drugs Act, 1940 (XXIII of 1940), the Drugs (Generic Names) Act, 1972 (XXIV of 1972), and the Drugs Ordinance, 1976 (IV of 1976).
  • Any license to manufacture issued will follow through the date specified by the Federal Goverenment.

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