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THE DRUGS ACT (XXXI OF 1976)
[llth May, 1976]

An Act to regulate the import, export, manufacture, storage, distribution and sale of drugs
Preamble : Whereas it is expedient to regulate the import, export, manufacture, storage, distribution and sale of drugs:
It is hereby enacted as follows:--

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.".
COMMENTS
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.
COMMENTS
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-doesnot 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.
COMMENTS
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.

COMMENTS
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.
LIST OF DE-REGISTERED DRUGS
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,


SI. No.

Regn No.

Name of the Drug(s)

Name of Manufacturer

Date

1.

2.

3.

4.

5.

 

003312

Nikethamide Drops.

M/s. Anglo French (Pak) Ltd., Karachi.

18-10-1984

2

003822

Vitamin A. & D Capsules.

M/s. Scherer, Australia

31-10-1984

3

003609

Surgical Silk Suture with or without Needles (4/0, 3/0, 2/0, 0, 1, 2).

M/s. J. Primmer, W. Germany.

Do.

4

003610

Surgical Catgut with or without Needles(4/0, 3/0, 2/0, 0, 1, 2).

M/s. J. Primmer, W. Germany.

Do.

5

002525

Seven Seas Cod Liver Oil..

M/s. British Cod Liver Oils, U.K.

Do.

6

002526

Seven Seas Cod Liver Oil Capsules.

Do.

Do.

7

002822

Silk Suture with or without Needles(4/0, 3/0, 2/0, 0, 1,. 2).

M/s. Ledelre, U.K.

Do.

8.

004123

Cod Liver Oil Capsules.

M/s. Takeda, Japan

Do

9.

003585

Gentamycin Sulphate Injection

M/s. Shanghai Pharma, China.

5-11-1984

10.

004131

Kimotab Tablets.

M/s. Mochida, Japan.

Do.

11.

001849

Gentamycin Injection.

M/s. Dai Han Chong, Korea.

5-11-1984

12.

004167

Chymotrypsin Tablets

Do.

Do.

13.

001280

Catgut Plain with or without Needles(4/0, 3/0, 2/0, O, 1, 2, 3).

M/s. Euro Sutures, W Germany.

6-11-1984

14.

000814

Phisohex Cream.

M/s. Sterling, U.S.A.

11-11-1984

15.

000815

Weprowin Tablets.

Do.

Do

16.

002109

Phillips Gripe Medicine.

Do.

Do.

17.

002890

Fergon Tablets

Do.

Do.

18.

004098

Netroferol Plus Syrup.

Do.

Do.

19.

004099

Intergrin Capsules.

Do.

Do.

20.

004179

Izal Germicide

Do.

Do.

21.

004513

Rocal Liquid.

Do.

Do.

22

004600

Franol Syrup.

Do.

Do.

23

002562

Fish Liver Oil Capsules.

M/s. Changhai Pharma, China

Do.

24.

001030

Theodrex Tablets

M/s. Riker, England

20-10-1984

25.

005124

Tandalgesic Capsules.

M/s. Caba-Geigy (Pak) Limited, Karachi.

18-9-1984

26.

000638

Irgapyrin Tablets

Do.

Do.

27.

001370

Tanderil Cream.

Do.

7-1-1985

28.

001014

Gentamycin Injection.

M/s. Dong Shin, Korea.

16-4-1985

29.

001180

Vitamin A & D Capsules.

M/s. Polfa, Poland.

12-2-1985

30.

002558

Tetracycline Eye Ointment.

M/s. Shanghai Pharma, China.

5-2-1985

31.

000128

Bendryl Capsules.

M/s. Parke Davis & Co., Karachi.

31-3-1985

32.

000129

Taka-Combex Capsules.

Do.

Do.

33.

000209

Elec Capsules.

Do.

Do.

34.

000207

Abdec Capsules.

Do.

Do.

35.

005309

Anethol Trithion Tablet.

M/s. Ferozsons, Nowshera.

26-6-1985

36.

007292

Vibramycin Paediatric Drops.

M/s. Pfizer Laboratories, Karachi.

14-7-1985

37.

000475

Terramycin Paediatric Drops.

Do.

Do.

38.

000502

Nardelazine Tablets.

M/s. Warner Lambert (Pak) Ltd., Karachi

16-7-1985

39.

000142

Peritrate S.A Tablets.

M/s. Warner Lambert (Pak) Ltd., Karachi.

16-7-1985

40.

000144

Peritrate Tablets,

Do.

Do.

41

000520

Isokin T. Forte Tablets.

Do.

Do.

42

000334

B.G. Phos Elixir

M/s. Merck Sharp & Dhome (Pak) Ltd., Karachi,

31-7-1985

43.

000307

Cyroheptadine S/R Capsules.

Do

Do.

44.

000319

Indocid Suppositories.

Do

Do.

45.

004547

Periactin Vita Tablets.

Do.

Do.

46.

001682

Predinisolone Tablets.

M/s. Merck Sharp & Dhome (Pak) Ltd., Karachi

Do.

47.

000333

Injection Redisol.

Do.

Do.

48.

001605

Tetracycline Capsules.

Do.

Do.

49.

001606

Tetracycline Syrup.

Do.

Do.

50.

000316

Tryptanol Syrup.

Do.

Do.

51.

002815

Haemostate Tablets.

M/s. Consolidate Chemical Labs., Lahore.

25-8-1985

52.

002816

Haemostate Injection.

Do.

Do.

53.

001951

Haemostop Tablets

M/s. The Schazo Laboratories Ltd., Lahore.

Do.

54.

001498

Styptobion Injection.

M/s, Marker Alkaloids, Quetta

Do.

55.

001499

Styptobion Tablets

Do.

Do.

56.

003985

Hepahionta Tablets

Do.

Do.

57.

001939

Anaroxyl Tablets25 mg.

M/s. Hormone Laboratories (Pak) Ltd., Karachi,

Do.

58.

001620

Guanimycin Suspension,

M/s, Glaxo Laboratories (Pak) Ltd., Karachi,

Do.

59.

001173

Phthalylsulphathiazole Tablets.

M/s. Polfa, Poland.

Do.

60.

000951

Intestine Euvernil Tablets.

M/s. Von Hyden, West Germany.

Do.

61.

001843

Alkaselzer Effervescent Tablets.

M/s. Miles Laboratories, Australia

Do.

62.

005029

Pentafen Tablets.

M/s. Lab. Chemico, Italy.

Do.

63.

005165

Heomex Tablets25 m.g.

M/s. Opel Laboratories, Karachi.

25-8-1985

64.

002767

Hemestine Tablets 25 m.g.

M/s. Pakistan Pharmaceutical Products Ltd., Karachi.

Do.

65.

003182

Noxyl Tablets 25 m.g.

M/s. Popular Chemical Works Ltd., Lahore.

Do.

66.

001115

Phthalylsulphathiazole Tablets.

M/s. Shanghai, China.

Do.

67.

004259

Rutin Compound Tablets.

M/s. Regent Laboratories, Karachi.

Do.

68.

003230

Rutin K. Tablets.

M/s. Chas A Mendoza, Karachi.

Do.

69.

002662

Fernidol Tablets.

M/s. Lepetit, Italy.

Do.

70.

003385

Clotin Tablets.

M/s. Hakimsons Chemical Indus. Ltd., Karachi.

Do.

71.

003906

Rutin Compound Tablets.

M/s. Dosaco Laboratories, Lahore.

Do.

72.

005270

Kagulin C Tablets.

M/s. Geofman Pharmaceuticals, Karachi

Do.

73.

004436

Lomofen Suspension.

M/s. Searle (Pak) Ltd., Karachi.

Do.

74.

003558

Phthatylsulphathiazole Tablets.

M/s. Medexport, USSR.

Do.

75

004182

Rutin Compound Tablets.

M/s. Cyrus Pharma, Lahore.

Do.

76.

004749

Rutin Compound Tablets.

M/s. Harman Pharmaceutical, Lahore.

Do.

77.

006190

Intestopen Q.A. Tablets.

M/S. Sandoz (Pak) Ltd., Karachi.

9-9-1985

78.

000127

Adroxyd Tablets.

M/s. Parke Davis & CO., Karachi.

30-9-1985

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.

 

 

 

8. Pakistan National Formulary: The Federal Government shall compile and publish in the official Gazette Pakistan National Formulary comprising all drugs allowed to be imported, manufactured or sold and such Formulary may be reviewed and modified from time to time.

9. Appellate Board : (1) The: Federal Government shall, in accordance with the rules, constitute an Appellate Board for the disposal of appeals preferred by persons aggrieved by any decision of the Central Licensing Board or the Registration Board or the Licensing Authority or a Board or Authority to which the powers of 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.

(2) The Appellate Board shall consist of such representatives of the Federal Governments and the Provincial Governments, including a Chairman, as the Federal Government may from time to time appoint.

(3) Subject to sub-section (4), the Chairman and other members of the Appellate.-Board shall hold office for the prescribed period.

(4) The Chairman or any other member of the Appellate Board may, 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) The members of the Appellate Board shall exercise such powers, including the powers of an Inspector, as may be prescribed.

(6) The Appellate Board may appoint experts for the purposes of detailed study of any specific matter before it.

(7) The Appellate 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.

(8) The Appellate Board shall meet at least every month and shall decide any appeal preferred to it within sixty days of receipt of appeal unless the Board is prevented from doing so for sufficient cause to be recorded.
COMMENTS
Constitutional jurisdiction, invoking of : The constitutional jurisdiction of the High Court, could not be invoked where order of the authority was based on facts within the exclusive domain of such authority. The alternate remedy of appeal having not been availed of by affected person, constitutional jurisdiction could not be resorted to. 1986 C L C 1610.

9A Appeals to the Provincial Appellate Authority:-
(1) Any person aggrieved by any decision of the licensing authority may prefer appeal to the Provincial Appellate Authority.
(2) The Provincial Government shall constitute in Provincial Appellate Authority for the disposal of appeal preferred under sub-section (1) as may be prescribed.

10. Expert Committees: (1) The Federal Government may constitute committees of experts on Drugs Evaluation, on Pakistan Pharmacopoeia, on Advertising and on such other matters as may be necessary for the purposes of this Act.

(2) Each committee constituted under sub-section (1) shall consist of such members as the Federal Government may appoint from time to time and each such member shall hold office during the pleasure of the Federal Government.

11. Provincial Quality Control Board: (1) Each Provincial Government shall set up a Provincial Quality Control Board consisting (3f such members, including a Chairman, as that Government may appoint from time to time.

(2) The Chairman and other members of the Provincial Quality Control Board shall hold office during the pleasure of the Provincial Government, on such terms and conditions as that Government may determine.

(3) 'The provincial Government shall appoint a person to be the Secretary of the Provincial Quality Control Board and provide the Board with such staff as the Provincial Government may consider necessary.

(4) The Provincial Quality Control 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.

(5) The following shall be the powers and functions of the Provincial Quality Control Board, namely:--

(a) to inspect any premises where any drug is being or is to be, manufactured or sold and to recommend to the appropriate authority the cancellation or suspension of the licence to manufacture or sell drugs granted to any person who is found to be contravening, or to have contravened, any of the provisions of this Act, or the rules;

(b) to scrutinize the reports of Provincial Inspectors in respect of contraventions of this Act and 'reports of the Government Analysts in respect of drugs Sent to them by the Provincial Inspectors for test and analysis and issue instructions to the Inspectors to the action to be taken on such reports:

Provided that the Provincial Quality Control Board may specify the class of cases in which a Provincial Inspector may make a complaint to the Drug Court, or take any other action, without the specific instructions of the Board;

(c) to exercise all the powers of an Inspector under this Act and the rules; [.]

(d) to advise the Provincial Government on ways and means to ensure quality control of drugs manufactured in the Province; and

(e) to ascertain the names of such directors, partners and employees of the company, corporation, firm or institution who are prima facie responsible for the commission of any offence under this Act or the rules and allow an Inspector in institute prosecution only against such persons;

(f) to conduct annual validation of all instruments in the provincial drug testing laboratories and to recommend measures to upgrade such laboratories, if required;

(g) identify and accredit on payment of fee other laboratories in the Province with suitable facilities and expertise;

(h) to conduct training programs to update Government Analysis and for improving their knowledge according to latest analytical method and technology; and

(i) to submit and monthly report of decisions and activities to the Federal Government

(6) The Provincial Quality Control Board may entrust any of its powers or functions under sub-section (5) to any one or more of its members.

COMMENTS
No prosecution could be launched without the permission of the Quality Control Board. Permission for prosecution should not be given by the Board in the presence of the negative report of Laboratory. 1989 P Cr. L J 566.

Sanction for prosecution granted by Board without issuing show-cause notice to accused manufacturer would be violatire of requirement of rule 4(3)(4). Complaint lodged before Drugs Court on basis of Such illegal sanction would be null and void. Such violation of R.4(3)(4) is a serious illegality and not merely an omission with result that inception of proceedings before: Drugs Court on basis of such sanction complaint would stand invalidated not nullified. Accused manufacturer in such case would be entitled to discharge by Drugs Court in exercise of its powers under. Section 265 K Cr. P C. N L.R 1994 Cr. J 648.

11A Conflict of interest.-
No person who is a member of the Appellate Board, Central Licensing Board, a Provincial Quality Board, the Registration Board or a member of Expect Committee shall be a member of the any other board or committee of which he is a member to avoid any conflict of interest.

12. Power to fix maximum prices of drug, etc.: (1)
The Federal Government may, by notification in the official Gazette,--

(a)fix the maximum price at which any drug specified in the notification is to be sold; and
(b) specify a certain percentage of the profits of manufacturers of drugs which shall be utilised, in accordance with the rules for purposes of research in drugs.

(2) For the purpose of the exercise of its powers under sub-section (1), the Federal Government may require a manufacturer, stockist, importer, exporter, retailer or other dealer in drugs to furnish such relevant information as may be necessary.

(3) The Federal Government may, by notification in the official Gazette, delegate any of its powers under this section .to any Board or other authority.

13. Directions to Provincial Governments : The Federal Government may give such directions to a Provincial Government as may appear to the Federal Government to be necessary for carrying into execution in the Province of any of the provisions of this Act or of any rule or order made thereunder or for maintaining supplies of drugs of standard quality at reasonable prices or for the achievement of uniformity in respect of any matter in different parts of Pakistan.

14. Federal Drugs Laboratory and institutes etc.: The Federal Government shall, as soon as may be, establish a Federal Drug Laboratory and may also set up such other institutes and drugs testing and research laboratories for the purposes of this Act as may be prescribed.

15. Provincial Drugs Testing Laboratory : Each Provincial Government shall, as soon as may be, set up a Provincial Drugs Testing Laboratory for such purposes as may be prescribed.

16. Government Analysts: The Federal Government or a Provincial Government may, by notification in the official Gazette, appoint such persons as it thinks fit, having the prescribed qualifications, to be the Federal Government Analysts or, as the case may be, Provincial Government Analysts, for such areas and in respect of such drugs or classes of drugs as may be specified in the notification:

Provided that no person who has any financial interest in the manufacture, import, export or sale of drugs shall be so appointed:

Provided further that a person serving under the Federal Government or another Provincial Government shall not be so appointed without the previous consent of that Government.
COMMENTS
Scope : This section is not ultra vires the provisions of the Constitution as it has sufficiently, 3rotacted the basic right of an accused to defend himself. A I R 1958 All. 865. (Under the section it is open to the accused to rebut the report of the Analyst and the Court to reject the report when it is satisfied with the rebuttal).

The report itself when it embodies the protocols of tests applied by the analyst would become conclusive evidence of the results therein. A I R 1959 Cal. 427. (The official statement or account which is the description of the experiment or clinical report is the protocol of test within the meaning of R. 5 of the Drugs Rules.)

A report of the Analyst which simply states the result of the test but does not give the protocols at all is not conclusive evidence of the facts stated in it. A I R 1959 All. 634. Failure to give the protocol would seriously prejudice the accused in his defence and hence his conviction cannot be sustained. A I R 1958 All. 865. Report not containing factual data cannot be treated as conclusive evidence.

The report of the analyst becomes conclusive only when it has not been challenged according to the procedure prescribed in the section. 1955 All. WR (HC) 328.

Chemical Examiner's opinion--Evidentiary value: The Chemical Examiner's opinion is sought for the aid and assistance of the Court Court is, however, competent to disbelieve such report if no plausible reasons have been put forth by the expert in support of his opinion. P L D 1992 Quetta 67 (c).

17. Inspectors : The Federal Government or a Provincial Government may, by notification in the official Gazette, appoint such persons as it thinks fit, having the prescribed qualifications, to be Federal Inspectors, or, as the case may be, Provincial Inspectors for the purposes of this Act within such local limits as it may assign to them respectively:

Provided that no person who has any financial interest in the manufacture, import, export or sale of any drug shall be appointed:

Provided further that a person serving under the Federal Government or another Provincial Government shall not be .so appointed without the previous consent of such Government.
COMMENTS
Drug Inspector not notified effect: Prosecution for offences under Sections 23(1), (b), 23(1)(a) (vii) launched by an Inspector who is not notified within meaning of Section 17 should not be allowed to sustain, such prosecution being incompetent under Section 30. 1984 Cr. L J 492.

Requirement of Drug/Inspector: Requirement about appointment of a person as Drug Inspector is mandatory proceedings from stage of taking test upto filing of complaint by a person who is not notified as Drug Inspector would be unwarranted. N L R 1993; Cr. L J 102(a).

A notification appointing all District Medical Officers as inspectors under the Act can be in general terms. Failure to state in the Notification that such Medical Officers should possess qualifications laid down in the rules will not render the notification invalid. 1955 All. WR (HC) 328.

An officer of the Public Health Department who is also a registered medical practitioner can be appointed as ex officioinspector for the purposes of inspecting retail shops. Such an appointment is justified by R 49, Proviso 3. AIR 1958 All, 163.

Record showing no order of' appointment of the Drugs Inspector haying been produced before the trial Court at all and Notification issued in this behalf not indeed a notification as stipulated by section 17 of the Act. Since no prosecution can be instituted except by a properly appointed Drug Inspector, conviction and sentence awarded to appellant, were set aside, in circumstances. 1982 P Cr. L J 48.

Complaint lodged by Inspector whose notified appointment did not conform with section 17, the recovery not witnessed by two respectable persons of locality as required by section 103, Cr.P.C. Circumstances not suggesting any probability of accused being convicted of any offence in the long run. The Drug. Court accepted accused's application under section 149-A, Cr.P.C. and ordered their acquittal. N L R 1985 Cr. L J 264.

Drug Inspectors appointment Improper--Sentence set aside :. Record showing no order of appointment of Drug Inspector having been produced before Trial Court at all and Notification issued in this behalf not indeed a notification as stipulated by Section 17 of Act. Since no prosecution can be instituted except by a properly appointed Drugs Inspector, Conviction and. sentence awarded to appellant, set aside in (circumstances. 1982 P. Or. L J 48.

18. Powers of, Inspectors : (1) Subject to the provisions of section 19 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,-

(a) inspect any premises-wherein any drug is manufactured, the plant and process of manufacture, the means employed for standardising and testing the drugs and all relevant records and registers;

(b) inspect any premises wherein any drug 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 drug 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 drug 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:

Provided that where the contravention is such which can be remedied, the stocks shall not be seized upon undertaking in writing of the person not to sell drug without remedying the defect, under institution to the Board concerned;

(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 an offence under this Act or the rules:

Provided that the exemptions 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 Clause;

(h) lock and seal any factory, laboratory, shop, building, store-house or godown, or a part thereof, 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;

(i) forbid for a reasonable period, not exceeding [two] 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 Central Licensing Board, the Registration Board, or the licensing authority, as the case may be, specify, any person in charge of any premises
from removing or dispensing of any drug, 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 causes (f) to (j) shall be exercisable only by an Inspector specifically authorised in this behalf, by an order in writing, by the Government appointing him, subject to such conditions as may be specified in such order:

(2) The provisions of the Code of Criminal Procedure, 1898 (Act V of 1898), in so far as they are not inconsistent with the provisions of this Act, shall apply to searches and seizures made under this Act.
COMMENTS
Powers of Inspectors : The duties entrusted to the Inspectors conveniently called "Inspectors for the purpose of inspection of retail shops" cover a wider range than mere inspection of retail shops. Such an Inspector can, therefore, search any premises (such as the dwelling house and not only the retail shop) in order to detect any sale of drugs in contravention of the Act, A I R 1958 All. 163.

Powers of search and seizure given to the Drugs Inspectors under Section 18(1) is not restricted to such officers. Searches and seizures in respect of offences under section 27(1), could also be made by the Police Officers. Police Officers in such cases, was not required to follow procedure laid down in section 19 but to follow procedure prescribed under the Code of Criminal Procedure, 1898, Section 109. 1979 P Cr. L J Note 6 at p. 4.

Sanction of competent authority--Violation of licensing conditions--Sealing of premises: Shop sealed by the Drugs Inspector for violation of licensing conditions for more than four weeks. Effect of no sanction from competent authority obtained for sealing premises beyond four weeks, sealing of premises beyond four weeks, was in contravention of provisions of section 18-H (1) and without lawful authority, under these circumstances premises ordered to be desealed. 1988 P Cr. L J 1328.

Effect of repeal : Object of enacting section 6 of the General Clauses Act is to protect rights and liabilities already accrued or incurred under repealed law. Drugs Act of 1976, while repealing Act of 1940 has not provided a saving clause. Complaint not made regarding alleged offence under section 18 of Act of 1940 before repeal of Act was a vested right or liability as envisaged under section 6, could not be deemed to have accrued for enforcing same under the repealing enactment. P L D 1980 Lah. 195.

Sample of drugs was submitted by the Inspector of Drugs to Government Analyst for test and analysis. Report of the Analyst was not received within the prescribed period of sixty days and necessary permission of the Quality Control Board not obtained for extension of time and Inspector was not communicating about submission of testing method to manufacturers. Report was received after prescribed period, not conclusive and the Drugs Analyst committed violation of relevant provision of law by submitting report without obtaining extension of time from the Board. 1984 P Cr. L J 1580.

 

19. Procedure for Inspectors: Where an Inspector seizes any drug or any other article under section 18, he shall tender a receipt therefor in the prescribed form.

(2) Where an Inspector takes a sample of a drug 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 wilfully absents himself, shall divide the sample into [five] portions and effectively seal and suitably 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 drug is made up in containers of small volume, instead of dividing a sample as aforesaid, the Inspector may, and if the drug 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 further 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 restore 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 :-

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

(ii)the second he shall send to the chairman, Provincial Quality Control Board or the Central Licensing Board or the Registration Board, as the case may be; [.]

(iii)the third, where taken, he shall send to the warrantor, if any, named under the proviso to sub-section (3) of Section 32; and

(iv) the fourth, where taken, he shall send to the person purporting to be its manufacturer or importer, as the case may be.

(4) Where an Inspector seizes any drug 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 drug to add his own seal, if any, and mark to it and shall produce the same before the Drug Court or the Central 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 18,--

(a) he shall as soon as practicable ascertain whether or not the drug 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 drug 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 Inspectors not competent to take action under section 30, 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.

(6) The Provincial Inspector on finding any contravention of this Act 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 contravention.

(7) The Federal Inspector on finding any contravention of this Act for which he is authorised shall, unless otherwise directed, always refer the case to the Central 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.

COMMENTS
Analyst Report received after prescribed period not conclusive: Sample of drugs submitted by Inspector of Drugs to Government Analysis for test and analysis. Report of analyst not received within prescribed period of sixty days and necessary permission of Quality Control Board not obtained for extension of time and Inspector not communicating about submission of testing method to manufacturers. Report received after prescribed period, held, not conclusive and Drugs Analyst committed violation of relevant provisions of law by submitting report without obtaining extension of time from Board. 1984 P Cr. L J 1580.

The accused was charged for offence of the manufacturing drugs without obtaining registration of such drugs in the name of firm. Action was initiated against firm only within half an hour of expiry of date for the manufacture of drugs without registration and possibility that workers were cleaning machines when premises raided was not ruled out. Seizure of drugs also not strictly in accordance with law as no receipt after seizure passed on to accused in the prescribed form as required by Section 19 of the Drugs Act. All preparations to raid premises complete before mid-night of the date when firm still was within the permissible limits of the manufacturing drugs without registration. Deliberate efforts were made to harass the accused in circumstances. The conviction and sentence were set aside. 1982 P Cr. L J 175.

Directions in regard to making and submission of test reports, held, not directory but mandatory and the Drug Court could not convict accused if directions not strictly observed and reports not submitted in the prescribed manner. 1985 P Cr. L J 281.

20. Persons bound to disclose place where drugs are manufactured or kept: Every person for the time being in charge of any premises whereon any drug is being manufactured or is kept for sale or distribution shall, on being required by an Inspector so to do, disclose to the Inspector the place where the drug is being manufactured or is kept, as the case may be.

21. Disclosure of the name of the manufacturer: Every person, not being the manufacturer of a drug or his agent for the distribution thereof, shall if so required by an Inspector, disclose to him the name, address and other particulars of the manufacturer or other person from whom he acquired the drug.

22. Reports of .Government Analysts : (1) The Government Analyst to whom a sample of any drug has been submitted for test and analysis under sub-section (3) of section 19 shall deliver to the Inspector submitting it a signed report in quadruplicate in the prescribed form and forward one copy thereof to the authority as may be prescribed.

(2) The Government Analyst, as far as may be, shall submit the report referred to in sub-section (1) within sixty days of the receipt by him of the sample of the drug and, if he is not able to do so for reasons beyond his control, shall communicate the reasons to the Inspector in writing and shall endorse its copy to the [Central Licensing Board or, as the case may be, the Registration Board or the Provincial Control Board] who shall have the sample tested from the same or any other Government Analyst or a Government Drug Testing Laboratory or any other Laboratory and shall ensure the receipt of results of such test and analysis within a further period as may be prescribed and shall make the test report available to the Inspector for further action.

(3) On receipt of the report, the Inspector shall--
(a) deliver one copy thereof to the person from whom the sample was taken;
(b) forward one copy to the warrantor, if any, named under the proviso to sub-section (3) of Section 32;
(c) forward one copy to the [Central Licensing Board or, as the case may be, the Registration Board or the Provincial Quality Control Board] for its directions as to the action to be taken on the report; and
(d) retain the fourth copy for use in any prosecution or for any other purpose.

(4) Notwithstanding anything contained in any other law for the time being in force, any document purporting to be a report signed by a Government analyst shall be admissible as evidence of the facts stated therein without formal proof and such evidence shall be conclusive unless the person from whom the sample was taken or the said warrantor has, within thirty days of the receipt of a copy of the report notified in writing to the Inspector or [Provincial Quality Control Board" or, as the case may be, the Central Licensing Board or the Registration Board or the Drug Court] before which any proceedings in respect of the sample are pending that he intends to adduce evidence in controversion of the report.

(5) Where a person has, under sub-section (4), notified his intention of adducing evidence in controversion of a Government Analyst's report, [Provincial Quality Control Board" or, as the case may be, the Central Licensing Board or the Registration Board or the Drug Court] may, of its own motion or in its discretion at the request either of the complainant or the accused, cause the sample of the drug lying with the Board concerned under sub-section (3) of section 19 to be sent for test or analysis to the Federal Drug Laboratory or any other laboratory specified for the purpose by the Federal Government which shall make the test or analysis and report in writing signed by, or under the authority of the person for the time being incharge of the Federal Drug Laboratory, or, as the case may be, such other laboratory, the result thereof and such report shall be conclusive evidence of the facts stated therein.

(6) The cost of a test or analysis made by the Federal Drug Laboratory or other laboratory under sub-section (5) shall be paid by the complainant or accused as the Drug Court or the Board concerned shall direct.
COMMENTS
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 the 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 that 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 (3) 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.

Substandard drugs : Record not showing that after purchasing drugs from manufacturer whether the same were stored under the conditions Paid down or stated on carton. Reasonable possibility of sample obtained by the Drug Inspector and subsequently sent to the National Health Laboratory having been deteriorated due to its improper storage after purchase from the manufacturers not ruled out Accused, held, entitled to the benefit of doubt and the conviction and sentence were set aside. 1985 P Cr. I. J 281.

Mere non-compliance with section does not make report inadmissible: Sub-section (2) of section 25 of the Drugs Act. 1940 requires that a copy of the report of the Government Analyst shall be delivered to the person from whom the sample is taken and another copy to the warrantor, if any, named under the proviso to sub-section (3) of Section 19. Then comes sub-section (3) which makes the report evidence of the facts stated therein and furthermore makes it conclusive "unless the person from whom the sample was taken or the said warrantor has, within twenty-eight days of the receipt of a copy of the report notified in writing the Inspector or the Court. before which any proceedings in respect of the sample are pending that he intends to adduce evidence in controversion of the report". It will thus be seen that the contents of the report not only prove themselves but are also considered to be conclusive unless objection is made. Sub-section (3) of section 25 provides the consequence of non-compliance with the provisions of sub-section (2) of the said section. Thus, if no report is supplied all that happens is that the contents of the report do not become conclusive evidence; but they are nevertheless evidence and rebuttable at the stage of the trial. This does not mean that at the trial the contents of the report cannot be utilised as evidence. The intention of the legislature appears to be to merely give an adequate opportunity to the person charged to challenge the correctness of the report. If this has not been done, then the contents of the report become conclusive evidence. If any event, the provisions are clear and leave no room for doubt that if the copy of the report is not supplied to the accused, the report is, nevertheless, admissible in evidence and proves itself but its contents are not conclusive evidence. On the other hand, if a copy has been supplied and the appellant does not raise any objection within the time prescribed, then the report becomes conclusive evidence and cannot even be rebutted. P L D 1973 S C 299.

Report of Public Analyst did not complete with "full protocols of tests" and silent as to how he arrived at conclusion regarding low percentage of Tetracycline hydrochloride in sample. Order of the trial Court rejecting application for summoning Public Analyst as witness was set aside, in circumstances. Court further directed to summon witness to produce full protocols of tests, in the interest of justice. 1977 P Cr. L J 822.

Accused failed to challenge the Government Analyst's report within statutory period of 30 days by notifying to any of the authorities specified in sub-section (4) of Section 22 of the Act, regarding their such intention. Report was conclusive proof of its contents. Contention that report being silent about full protocols was of no consequence. 1984 P Cr. L J 2007.

Potency and the state of certain drugs, was depended to some extent upon conditions in which they were required to be stored and had actually been stored prior to test by the concerned laboratory. 1984 P Cr. L J 1580.

Analyst submitted his report beyond the period prescribed by law without obtaining extension from the Quality Control Board. Drug Analyst committed violation of provisions of law and report sent by him not in the prescribed form. 1985 P Cr. L J 281.

Appeal against acquittal: The accused respondents had a right to request for retesting of samples and Section 22(5) of the Drugs Act, 1976, makes it compulsory for prosecution to send the samples for retesting to the Federal Drugs Laboratory or any other laboratory specified for the purpose by the Federal Government. The accused had not given up their such request and their right could not be brushed aside on basis of their letters which did not amount to unconditional admission of guilt as provisions of law have to be strictly followed. Letters were addressed to the Provincial Quality Control Board and not to proper quarters. The trial Court, held, had rightly given benefit of doubt to the accused in view of clear violation of Section 22(5) of the Drugs Act, 1976. Appeal against the acquittal was dismissed in circumstances. 1990 P Cr. L J 865.

Finding of the Drugs Court that test report was not according to law was correct. Drugs Court had also rightly concluded that the said report would not be conclusive as provided under Section 22(4) of the Drugs Act. Provincial Quality Control Board had sent the sample for retesting in contravention of sub-sections (4) and (5) of Section 22 of the Drugs Act and as such second report was illegal under such circumstances appeal against the acquittal of the accused was dismissed. 1991 P Cr. L J 1363.

After an accused has secured acquittal from a Court, the Appellate Court will not interference until prosecution shows conclusively that inference of guilty is irresistible and indications of error in the judgment are clear and evidence more cogent and convincing in support of prosecution case is available. 1991 P Cr. L J 1363.