(4)     Notwithstanding the audit provided by in sub-section (3) the Auditor General shall have the power to audit or cause to be audited the accounts of the Authority.

(5)     A copy of the audit report shall be sent to the Federal Government along with the comments of the Authority.

(6)     The Authority shall take the requisite steps for the rectification of any objection raised by the Auditor-General of Pakistan.

CHAPTER-IV

RULES AND REGULATIONS

23.     Power to make rules.–The Authority may, with the approval of the Federal Government, by notification in the official Gazette, make rules for carrying out the purposes of this Act.

24.     Power to make regulations.–The Authority may, by notification in the official Gazette, with the approval of the Board, make regulations, for its internal working and terms and condition of employees not inconsistent with the provisions of the Act or the rules, for the carrying out of its functions under ityis Act.

CHAPTER-V

MISCELLANEOUS

25.     Submission of annual reports and returns.–(1) Within three months of the conclusion of each financial year, the Authority shall submit an annual report to the Federal Government in respect of the activities of the Authority including the status of its existing programs, projects and further plans formulated in furtherance of its aims and objectives.

(2)     The Federal Government may require the Authority to furnish:-

(a)     any return, statement, estimate, statistics or other information regarding any matter under the control of the Authority;

(b)     a report on any subject related to the Authority; and

(c)     a copy of any document in the custody of the Authority;

(3)     The Authority shall expeditiously comply with such directions.

26.     Power to call for information.–The Authority may call for any person, involved directly or indirectly, and reasonably believed to having such information in his control or possession which is required for carrying out the purposes of this Act. The person so called upon to provide such information shall do so within the period prescribed by the Authority and in case of failure to do so he shall be punished by imposition of such penalty which may not exceed one hundred thousand rupees.

27.     Offences, penalties etc.–(1) The offences shall be such as specified in Schedule-III.

(2) The prohibition specified in Schedule-II shall be punished in accordance with Schedule-III.

28.     Offences by companies etc.–Where the person guilty of an offence under this Act or the Drugs Act, 1976 (XXXI of 1976), is a company, corporation, firm or institution, every director, partner and employee of the company, corporation, firm or institution with whose knowledge or consent the offence was committed shall be guilty of the offence.

29. Cognizance of offences.–Cognizance of offences shall be taken by the Inspector in the manner specified in Schedule-IV.

30.     Complaints.–(1) Any aggrieved person may file a written complaint with the Authority against contravention of any provision of this Act or any law specified in Schedule-VI.

(2)     The Authority shall, on receipt of a complaint cause it to be investigated as may be prescribed and provide an opportunity to the complainant as well as the person against whom such complaints has been made. The Authority may, on completion of investigation, take any action as may be prescribed under this Act or as the case may be subject to the provisions of any law specified in the Schedule-VI.

(3)     Appeals against the decisions of the Authority shall be referred to the Board, which shall formulate an Appellate Board from among its members, who shall decide the case on merit.

31.     Confidential information.–(1) Except as provided under the regulations, no person shall communicate, or allow to be communicated, any record or information obtained under this Act to a person not legally entitled to that record or information or allows any person not legally entitled to that record or information to have access to any record obtained under this Act.

(2) A person who knowingly receives records or information obtained under this Act shall hold the record or information subject to the same restrictions under sub-section (1) as apply to the person from who the records or information were received.

32.     Act not to override other laws.–(1) The provisions of this Act shall be in addition to and not in derogation of the provisions made in the Drugs Act, 1976 (XXXI of 1976) and any other law for the time being in force.

(2) In case of inconsistency between the provisions of this Act and any other law for the time being in force, the provisions of this Act shall prevail.

33.     Recovery of arrears.–All amounts due to the Authority may be recovered as arrears of land revenue.

34.     Indemnity.–No suit prosecution or other legal proceeding shall lie against any person for anything which is in good faith done or intended to be done under this Act or any rules or regulations made there under.

35.     Power to amend Schedule.–The Federal Government may, by notification in the official Gazette, amend the Schedule so as to add any entry thereto or modify or omit any entry therefrom on the recommendation of the Board.

36.     Removal of difficulties.–If any difficulty arises in giving effect to any of the provisions of this Act, the Federal Government may make such Order by notification in the Official Gazette, not inconsistent with the provisions of this Act, for the purpose of removing the difficulty.

37.     Employment under the Authority to be employment under the Federal Government.–Every employment under the Authority shall, for the purpose of Pakistan Essential Services (Maintenance) Act, 1952 (LIII of 1952), be deemed to be employment under Federal Government and the said Act shall have effect accordingly.

38.     Act X of 2012 not to apply to the Authority.–Nothing contained in the Industrial Relation Act (X of 2012), shall apply to or in relation to the Authority or any of the officers and employees of the Institute.

39.     Co-operation with international organizations.–The Authority may, subject to the prior approval of the Federal Government, co-operate with any foreign authority or international organization in the field of health on the terms and conditions of any program or agreement for co-operation to which such authority or organization is a party, or pursuant to any other international agreement made or after the commencement of this Act.

40.     Repeal and Savings.–(1) The Drug Regulatory Agency of Pakistan Ordinance, 2012 (Ordinance I of 2012) is hereby repealed.

(2) Notwithstanding the repeal of the Drug Regulatory Agency of Pakistan Ordinance, 2012 (Ordinance I of 2012) by sub-section (1),–

(a)     any license to manufacture or any registration or maximum retail price fixed for sale issued thereunder to any person, or for the revalidation of an license or registration issued earlier under the Act, for which an application has been made to the Licensing Board, Registration Board, and Drug Pricing Committee as the case may be within the specified time, shall continue to be valid;

(b)     any license for import or export or sale of drugs issued thereunder to any person, shall, unless it expires earlier under the terms thereof, continue to be valid for such periods as the Federal Government, may by notification in the official Gazette, specify in this behalf.

(3)     All such actions of the Federal Government as mentioned in sub-section (2) since 20th April, 2010 shall be deemed to have validly made under this Act.

41.     Policy Directive of Federal Government.–(1) The Federal Government may issue policy directives in accordance with the law and Constitution to the Board in respect of any of its activities, powers and functions and whose compliance shall be binding on the Authority, within a stipulated time.

(2) Notwithstanding anything contained in sub-section (1) if there is any difficulty in implementation of the directions and guidelines of the Policy Board or the Federal Government, the Authority shall refer the case back to the Federal Government for its review specifying reasons for non-implementation, within the stipulated time, whose decision in this respect shall be final.

42.     Winding up of Authority.–No provision of any law relating to winding up of bodies corporate shall apply to the Authority. The Authority shall only be wound up by the law to be enacted by the Parliament for winding up of the Authority).

SCHEDULE-I

[See Section 2 (v, xii, xviii, xix, & xxviii)]

1.       BIOLOGICALS includes,–

(1)     Biological drugs produced by biological systems and which require standardization by biological assays according to the relevant and updated recommendations of the World Health Organization published in Technical Report Series and Biological Standardization Report and includes–

          (a)      blood products including Plasma, Albumin, Clotting Factors, Factors VIII, IX, Mixed Clotting Factors Tractions, Fibrinogens, Immunoglobulins:

          (b)     immunological products including Antisera, Antitoxins, specific Immunoglobulins;

          (c)      in vivo diagnostics including Tuberculins, Lepronin, Histoplasmin, Coccidioidin, Allergens, Allergens Extracts, Antibodies conjugated with isotopes for imaging studies;

          (d)     antigens, cytokines/antibodies/eells injected to elicit a biological response;

          (e)      vaccines, including:–

                   (i)      bacterial vaccines including live, killed whole cell, protein sub-unit, polysacchrid or glyco-conjugate, toxin derivatives, and rDNA biotechnology developed.

                   (ii)     viral vaccines including live, inactivated, sub-unit, rDNA, conjugated;

                   (iii)    polyvalent combinations of vaccines containing combination of vaccines defined in e (i) and d(ii).

          (f)      toxins and venoms including snake venoms, scorpion venoms etc;

          (g)      immunostimulanls of biological origin including BCG vaccine for immunothcrapy;

          (h)     biotechnology products which are primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology or other processes involving site specific genetic manipulation techniques.

          (i)      human interferons, natural hormones, recombinant antibodies, monoclonal antibodies and derivatives gene therapy products;

(2)     "Biological Drugs (Finished form)", are Biological Drugs that are defined in sub-section (1) above and are manufactured, packed by the manufacturer under his responsibility of quality assurance and is further released by the National Control Authority or the National Control Laboratory of the country of origin under the World Health Organization's Lot Release system of evaluation.

(3)     "Biological Drugs (Ready-to-fill form)", are Biological Drugs that are defined in sub-section (1) above but are manufactured at one site in the form of a "Ready-to-fill Bulk" but are transferred to another site for final filling, labeling, packaging and quality control of the finished form. No further formulation or dilution of the Ready-to-fill bulk is allowed in this case of manufacture. The final product is released by the Pakistan's National Control Laboratory for Biologicals under the World Health Organization's Lot Release system of evaluation.

(4)     "Biological Drugs (Concentrated form)", are Biological Drugs that are defined in sub-section (1) above that are manufactured at one site but are stored in the form of Concentrated-Bulk of the active ingredient at controlled temperatures. Such Concentrated-Bulk may be transferred to any other site under temperature controlled conditions for further dilution, stabilization, filling and packaging. The diluted and stabilized bulk requires its own set of quality control test and the final finished form of such Biological Drugs under go another set of complete quality control tests. The final product is released by the Pakistan's National Control Laboratory for Biologicals under the World Health Organization's Lot Release system of evaluation.

(5)     ''Biological Drugs (Naked vials)", are Biologicals Drugs that are defined in sub-section (1) above that are manufactured and filled at one site but the final containers are neither labeled nor packed in cartons. These drugs are imported in unlabeled vials and are labeled and packed in carton locally. In such cases at least an identity test is required to confirm the positive identification of the required antigen. The final product is released by thePakistan's National Control Laboratory for Biologicals under the World Health Organization's Lot Release system of evaluation.

(6)     Originator Biological Drugs means a biological drug which has been licensed by the national regulatory authorities on the basis of a full registration dossier; i.e. the approved indication(s) for use were granted on the basis of full quality, efficacy and safety data:

          (a)      reference biotherapeutic product (RBP) means an originator biological drug product that was licensed on the basis of a full registration dossier. It does not refer to measurement standards such as international, pharmacopoeial, or national standards or reference standards;

          (b)     biosimilar biological drugs mean Similar Biotherapeutic Product (SBP) which is similar in terms of quality, safety and efficacy to an already licensed reference biotherapeutic product;

          (c)      similarity means absence of a relevant difference in the parameter of interest.

(7)     No human biological drug is allowed sale and use until a "Lot Release Certificate" from the Federal Government Analyst of the National Control Laboratory for Biologicals, Islamabad has been obtained.

(8)     Pharmaceutical dossier includes a set of documents submitted by a Person for the registration of a therapeutic good, containing complete information about–

          (a)      muster formula;

          (b)     all ingredients both active pharmaceutical ingredients and inactive excipients added with their safety profile data;

          (c)      complete manufacturing procedure of the drug, biological or medical device;

          (d)     quality control steps and procedures at each level of raw material selection, in-process testing, finished drug testing, and stability testing;

          (e)      clinical trial data and published reports about the safety and efficacy of the drug;

          (f)      complete details of manufacturing plant and equipment, quality control laboratories and equipment;

          (g)      ware-houses capacities and facilities; details of human resources available and the latest cGMP report shall also be part of this document set;

          (h)     any other information required by the registration board for establishing the safety, efficacy, bioavailability, bioequivalence, or biosimilarity of the drug.

2.       DRUG includes:—

(a)     any substance or mixture of substances that is manufactured, sold, stored, offered for sale or represented for internal or external use in the treatment, mitigation, prevention or diagnosis of diseases, an abnormal physical state, or the symptoms thereof in human beings or animals or the restoration, correction, or modification of organic functions in human beings or animals, including substance used or prepared for use in accordance with the Ayurvedic, Unani, Homoeopathic, Chinese or biochemic system of treatment except those substances and in accordance with such conditions as may be prescribed;

(b)     abortive and contraceptive substances, agents and devices, surgical ligatures, sutures, bandages, absorbent cotton, disinfectants, bacteriophages, adhesive plasters, gelatin capsules and antiseptic solution;

(c)     such substances intended to be used for the destruction or repulsion of such vermin, insects, rodents and other organism as cause, carry or transmit disease in human beings or animals or for disinfection in residential areas or in premises in which food is manufactured, prepared or kept or stored;

(d)     such pesticides as may cause health hazard to the public;

(e)     any substance mentioned as monograph or as a preparation in the Pakistan Pharmacopoeia or the Pakistan National Formulary or the International Pharmacopoeia or the British Pharmacopoeia or the British Pharmaceutical Codex or the United States Pharmacopoeia or the National Formulary of the United States, whether alone or in combination with any substance exclusively used in the Unani, Ayurvedic, Homoeopathic, Chinese or Biochemic system of treatment, and intended to be used for any of the purposes mentioned in sub-Clauses (a), (b) and (c); and

(f)      any other substance which the Federal Government may by notification in the official Gazette, declare to be a drug for the purpose of this Act.

3.       MEDICAL DEVICES include,—

(a)     instruments, medical equipment, implants, disposables and software, used mainly for the purpose of diagnosis, monitoring and treatment of disease, or

(b)     any other item which the Federal Government may, by notification in the official Gazette, declare as medical device;

4.       MEDICATED COSMETICS include,—Cosmetics containing drugs and are defined as articles containing active drug ingredients intended to be rubbed, poured, sprinkled, or-sprayed on, or introduced into, or otherwise applied to human body or part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and articles intended for use as a component of any such articles; except that such term shall not include soap.

SCHEDULE-II

[See Section 2(xxx)]

PROHIBITIONS

A.      Import, manufacture and sale of therapeutic goods:

(1)     No person shall himself or by any other person on his behalf,—

          (a)      Export, import or manufacture for sale or sell,—

                   (i)      any spurious therapeutic good;

                   (ii)     any counterfeit therapeutic good;

                   (iii)    any misbranded therapeutic good;

                   (iv)    any adulterated therapeutic good;

                   (v)     any substandard therapeutic good;

                   (vi)    any therapeutic good after its expiry date;

                   (vii)   any therapeutic good which is not registered or is not in accordance with conditions of registration as disclosed in the registration dossier and that has undergone pharmaceutical evaluation;

                   (viii)  any therapeutic good 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;

                   (ix)    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

                   (x)     any therapeutic good in contravention of any of the provisions of this Act or rules made thereunder;

          (b)     manufacture for sale any therapeutic good except under, and in accordance with the condition of a license issued under this Act;

          (c)      sell any therapeutic good except under, and in accordance with the conditions of a license issued under this Act;

          (d)     import or export any therapeutic good the import or export of which is prohibited by or under this Act;

          (e)      import or export any therapeutic good drug for the import or export of which a license is required, except under, and in accordance with the conditions of, such license;

          (f)      supply an incorrect, incomplete or misleading information, when required to furnish any information under this Act or the rules;

          (g)      peddle, hawk or offer for sale any therapeutic good in a park, or public street or on a highway footpath or public transport or conveyance;

          (h)     import, manufacture for sale, or sell any substance, or mixture of substances, which is not a therapeutic good but is presented in a form or a manner which is intended or likely to cause the public to believe it to be a therapeutic good;

          (i)      sell any therapeutic good without having warranty in the prescribed form bearing the name and batch number of the therapeutic good issued–

                   (i)      in the case of a therapeutic good manufactured in Pakistan, by the manufacturer holding a valid license to manufacture therapeutic good and permission to manufacture that therapeutic good or by his authorized agent;

                   (ii)     in the case of an imported drug, by the manufacture or importer of that therapeutic good or if the therapeutic good is imported through an indenter by such indenter; and

                   (iii)    apply an incorrect batch number to a therapeutic good.

(2)     Nothing in Paragraph (1) shall apply to the manufacture of small quantities of any therapeutic good for the purpose of clinical trial examination, test, analysis or personal use in small quantities.

B.      Control of advertisement:—

No person shall himself or by any other person on his behalf advertise, except in accordance with such conditions as may be prescribed,—

(a)     any therapeutic good;

(b)     any substance used or prepared for use in accordance with the Ayurvedic, Unani, Homoeopathic, Chinese or Biochemic system of treatment or any other substance or mixture of substances as may he prescribed;

(c)     any remedy, treatment or offer of a treatment for any disease.

                   Explanation.–For the purpose of this entry "Advertise" means to make any representation by any means whatsoever for the purpose of promoting directly or indirectly the sale or disposal of therapeutic good, a substance or a mixture of substances, a remedy or a treatment except the display of sign boards for a clinic, a dispensary or a hospital or such other institution offering treatment.

C.      Control of samplings:—

No person shall distribute or cause to be distributed any therapeutic good as a sample except in accordance with such conditions as may be prescribed.

D.      Control of printing of labeling:—

No person shall print any label in respect of any therapeutic good which is required to be registered under this Act but is not so registered after the date fixed by the Federal Government under sub-section (6) of Section 7 of Act, or for a person who does not possess a license under that Act to manufacture that therapeutic good.

SCHEDULE-III

[See Section 27]

OFFENCE

(1)     Whoever himself or by any other person on his behalf,—

(a)     exports, imports, manufactures for sale or sells any spurious therapeutic good or any therapeutic good which is not registered;

(b)     manufactures for sale any therapeutic good without a license;

(c)     imports without license any therapeutic good for the import of which a license is required;

                   Shall be punishable with imprisonment for a term which shall not be less than three years or more than ten years and with fine which may extend to ten lakh rupees:

                   Provided that the Drug Court may, for any special reasons to be recorded, award a sentence of imprisonment for a term of less than three years.

(2)     Whoever himself or by any other person on his behalf,–

(a)     imports, manufactures for sale or sells any counterfeit therapeutic good; or

(b)     gives to the purchaser a false warranty in respect of any therapeutic good sold by him that the therapeutic good does not in any way contravene the provisions of Schedule II and is not able to prove that, when he gave the warranty, he had good and sufficient reason to believe the same to be true; or

(c)     applies or permits to be applied to any therapeutic good sold, or stocked or exhibited for sale, by him, whether the container or a label or in any other manner, a warranty given in respect of any other therapeutic good; or

(d)     imports, manufactures for sales or sells any therapeutic good under a name other than the registered name; or

(e)     exports, imports, manufactures for sale or sells any therapeutic good with which any substance, which should not actually be its component, or has been mixed or packed it so as to reduce its quality or strength or for which any such substance has been substituted wholly or in part,

shall be punishable with imprisonment for a term which may extend to seven years, or with fine which may extend to five lakh rupees or with both.

(3)     Obstruction of Inspector.–Whoever obstructs an Inspector in the exercise of any power conferred upon him by or under this Act, or disobeys the lawful authority of any Inspector, shall be punishable with imprisonment for a term which may extend to one year, or with fine which may extend to one lakh rupees, or with both.

(4)     Contravention of rules.–Subject to the provisions of Clauses (1), (2) and (3), whoever himself or by any other person on his behalf contravenes any of the provisions of this Act or any rule shall be punishable with imprisonment for a term which may extend to five years, or with fine which may extend to one lakh rupees, or with both.

(5)     Penalty for subsequent offence.–Whoever having been convicted of an offence under Clause (1) of Schedule-Ill is convicted for a subsequent offence under that section shall be punishable with imprisonment for life or with imprisonment which shall not be less than five years and with fine which may extend to five hundred thousand rupees.

(6)     Penalty for violating the prohibitions.–Whoever himself or by any other person on his behalf violates any prohibitions specified in Schedule-II shall be punished with imprisonment for a term up to five years and with fine up to five hundred thousand rupees.

SCHEDULE-IV

[See Section 29]

COGNIZANCE OF OFFENCES

(1)     Subject to the provisions of Schedule-V no prosecution shall be instituted under this Act except,—

(a)     by a Federal Inspector, where the prosecution is in respect of a contravention of Clause (h) of Paragraph (1) of heading A of Schedule-II or any of the provisions of this Act or the rules relating to the import or export of therapeutic goods or the manufacture for sale, or sale, of a therapeutic good 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

(b)     by a Provincial Inspector:

                    Provided that, where the public interest so requires, the Federal Inspector may, with the prior permission of the Registration Board or Licensing Board as the case may be, institute a prosecution for a contravention of any other provision of this Act and The Drugs Act, 1976 (XXXI of 1976).

(2)     Notwithstanding anything contained in the Code of Criminal Procedure, 1898 (Act V of 1898):

(a)     an offence punishable under Schedule-III other than an offence mentioned in Clause (1) of that Schedule shall be non-cognizable, and

(b)     no Court other than a Drug Court established under The Drugs Act, 1976, (XXXI of 1976) shall try an offence punishable under this Act and Drugs Act, 1976 (XXXI of 1976);

(c)     nothing contained in this Schedule shall be deemed to prevent any person from being prosecuted under any other law for any act or omission which constitutes an offence punishable under this Act or The Drugs Act, 1976 (XXXI of 1976) or to require the transfer to a drug Court of any case which may be pending in any Court immediately before the establishment of Drug Court.

SCHEDULE-V

[See Section 2(xvi)]

POWERS OF INSPECTORS

(1) Subject to the provisions of this Schedule and of any rules made in this behalf, an Inspector may, within the local limits for which he is appointed, and in any other area within the permission of the licensing Authority or Licensing Board as the case may be,—

(a)     inspect any premises where in any therapeutic good is manufactured, the plant and process of manufacture, the means employed, for standardizing and testing the therapeutic goods and all relevant records and registers;

(b)     inspect any premises wherein any therapeutic good is sold or is stocked or exhibited for sale or is distributed, the storage arrangements and all relevant records and registers;

(c)     take samples of any therapeutic good which is being manufactured, or being sold or is stocked or exhibited for sale or is being distributed;

(d)     enter and search, with such assistance, if any, as he considers necessary, any building, vessel or place, in which he has reason to believe that an offence under this Act or any rules has been or is being committed or may continue to be committed;

(e)     call any person to be present as witness in the course of search or seizure or in connection with any other matter where the presence of witnesses is necessary;

(f)      seize such therapeutic good and all materials used in the manufacture thereof and any other articles, including registers cash memos, invoices and bills, which he has reason to believe may furnish evidence of the commission of an offence punishable under this Act or any rules;

(g)     require any person to appear before him at any reasonable time and place to give statement, assistance or information relating to or in connection with the investigation of any offence under this Act and the Drugs Act, 1976 (XXXI of 1976) or the rules:

                    Provided that the exemption under Sections 132 and 133 of the Code of Civil Procedure, 1908 (Act V of 1908), shall be applicable to requisitions for attendance under this Schedule;

(h)     lock and seal any factory, laboratory, shop, building, store-hose or godown, or a part thereof, where any therapeutic good is or is being manufactured, stored, sold or exhibited for sale in contravention of any of the provisions of this Act, the Drugs Act, 1976 or the rules;

(i)      forbid for a reasonable period, not exceeding four weeks or such further period, which shall not be more than three months, as the Inspector may, with the approval of the Provincial Quality Control Board, the Licensing Board, the Registration Board, as the case may be, specify, any person in charge of any premises from removing or dispensing of any therapeutic good, article or other thing likely to be used in evidence of the commission of an offence under this Act or the rules; and

(j)      exercise such other powers as may be necessary for carrying out the purposes of this Act or any rules:

                    Provided that the powers under Paragraph (f) to (j) shall be exercisable only by an Inspector specifically authorized in this behalf, by an order in writing, by the Government appointing him, subject to such conditions as may be specified in such order:

                   Provided further that the power under Paragraph (h) may be exercised by an Inspector not authorized as aforesaid where the contravention is of a provision which requires a license to be obtained for the manufacture, storage or sale of drug.

(2) The provisions of the Code of Criminal Procedure, 1898 (Act V of 1898), insofar as they are not inconsistent with the provisions of this Act and The Drugs Act, (XXXI of 1976), shall apply to searches and seizures made under this Act.

PROCEDURE FOR INSPECTORS

(1)     Where an Inspector seizes any therapeutic good or any other article under this Schedule he shall tender a receipt therefore in the prescribed form.

(2)     Where an Inspector takes a sample of a therapeutic good for the purpose of test or analysis, he shall intimate such purpose in writing in the prescribed form to the person from whom he takes it and, in the presence of such person unless he willfully absents himself, shall divided the sample into four portions and effectively seal and suitable mark the same and permit such persons to add his own seal, if any, and mark to all or any of the portions so sealed and marked:

Provided that, where the sample is taken from premises whereon the drug is being manufactured, it shall be necessary to divide the sample into three portions only:

Provided further that, where the therapeutic good is made up in containers of small volume, instead of dividing a sample as aforesaid, the Inspector may, and if the therapeutic good be such that it is likely to deteriorate or be otherwise damaged by exposure shall, take three or four, as the case may be, of the said containers after suitably marking the same and, where necessary, sealing them:

Provided also that if the contents of one container are insufficient for the laboratory test and analysis, the Inspector may increase the number of the containers in order to make the sample sufficient for this purpose.

(3)     The Inspector shall return one portion of a sample so divided or one container, as the case may be, to the person from whom he takes it, and shall retain the remainder and dispose of the same within seven days as follows, namely,—

(a)     one portion of sample he shall send to the Government Analyst concerned for test and analysis;

(b)     the second he shall send to the Chairman, Provincial Quality Control Board or the Licensing Board or the Registration Board, as the case may be; and

(c)     the third, where taken, he shall send to the warrantor, if any, named under proviso to sub-section (3) of Section 32 of The Drugs Act, 1976 (XXXI of 1976).

(4)     Where an Inspector seizes any therapeutic good containing any filthy or putrid substance, vermin, worm, rodent, insect or any foreign matter which is visible to the naked eye, and the sample is such that it cannot or need not be divided, he shall effectively seal and suitably mark the same and permit the person from whom he seizes the therapeutic good to add his own seal, if any, and mark to it and shall produce the same before the Drug Court, or the Provincial Quality Control Board, or the Licensing Board or the Registration Board, as the case may be, before which proceedings are instituted or action is initiated in respect of the drug.

(5) Where an Inspector takes any action under section this Schedule,–

(a)     he shall as soon as practicable ascertain whether or not the therapeutic good contravenes any of the provisions of this Act and, it is ascertained that the drug does not so contravene, he shall forthwith revoke the order passed under the said section or, as the case may be, take such action as may be necessary for the return of the stock seized and payment for the samples taken, under intimation to the Board concerned;

(b)     if he seizes the stock of the therapeutic good he shall, as soon as may be inform the Board concerned and take its order as to the custody thereof:

                   Provided that where a Federal Inspector is not competent to take action under Schedule-IV, he shall as soon as may be, report the matter and hand over the stock, if any, to the Provincial Inspector for further action under this Act or The Drugs Act, 1976.

(6)     The Provincial Inspector on finding any contravention of this Act or the Drugs Act, 1976 (XXXI of 1976) shall, unless the Board otherwise directs, always refer the case to the Provincial Quality Control Board and seek orders as to the action to be taken in respect of such contraventions.

(7)     The Federal Inspector on finding any contravention of this Act or the Drugs Act, 1976 (XXXI of 1976) for which he is authorized shall unless otherwise directed, always refer the case to the Licensing Board or the Registration Board or any other authority as may be specified for the purpose and seek any further orders as to the action to be taken in respect of such contravention.

SCHEDULE-VI

[See Section 2(i)]

 (1)    The Drugs Act, 1976 (XXXI of 1976).

(2)     Rules made under the Drugs Act, 1976 (XXXI of 1976).

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