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REGISTERED No. D. 221

of India Th Gazette

EXTRAORDINARY

FART II—Section 1

PUBLISHED BY AUTHORITY

No. I6] NEW DELHI, TUESDAY, MAY 12, 1964/VAISAKHA22,1886

Separate paging is given to this Part in order that it may be filed as a separate compilation

MINISTRY OF LAW

(Legislative Department)

New Delhi, the 12th may, 1964/Vaisakha 22, 1886 (Saka)

The following Acts of Parliament received the assent of the Pre- sident on the 12th May, 1964, and aie hereby published for general information: —

THE INDIAN RAILWAYS (AMENDMENT) ACT, 1964

No. 12 OF 1964

[12th May, 1964]

An Act further to amend the Indian Railways Act, 1890.

BE it enacted by Parliament in the Fifteenth Year of the Republic of India as follows : —

1. This Act may be called the Indian Railways (Amendment) Short title.

Act. 1964.

2. In section 66 of the Indian Railways Act, 1890 (hereinafter 9 of 18901

Amendment of M"ion6fi.

referred to as the principal Act), in sub-section (1), after the words "be supplied with a ticket", the words "by a railway servant Or an agent authorised by the railway administration in this behalf" 'hall be inserted.

109 Gof I Ex—1.

f60 THE GAZETTE OF INDIA EXTRAORDINARY [PART II

3. For section 70 of the principal Act, the following section shall be substituted, namely: —

Substitution, of new scftion for section 70. Pr"hibhio" agttost trans- fer "f certain tickets.

"70- A ticket against which reservation of a seat or berth has been made, or a return ticket or season ticket, shall not be transferable and may be used only by the person for whose journey to and from the places specified thereon it was issued:

Provided that nothing herein shall prevent mutual transfer of seats or berths reserved against proper tickets by passengers travelling by the same train.".

4- For section 114 01 the principal Act, the following section shall be substituted, namely: —

Substitution of new section for section 1144

Penalty for transfer of tickets.

"114. (1) If a person, not being a railway servant or an agent authored by the railway administration in this behalf,—

(a) sells or attempts to sell any ticket or any half of a return ticket, or

(b) parts or attempts to part with the possession of a ticket against which reservation of a seat or berth has been made, or any half of a return ticket, or a season ticket,

in order to enable any other person to travel therewith, he shall be punishable with imprisonment for a term which may extend to three months, or with fine which may extend to two hundred and fifty rupees, or with both, and shall also forfeit the fare which he may have paid and the ticket which he may have sold or attempted to sell.

(2) If a person purchases any ticket referred to In clause (a) of sub-section (1), or obtains the possession of any ticket referred to in clause (b) of that sub-section, from any other person, not being a railway servant or an agent authorised by the railway administration in this behalf, he shall be punishable with imprisonment for a term which may extend to three months, or with fine which may extend to two hundred and fifty rupees, or with both, and if the purchaser or holder of any ticket aforesaid travels or attempts to travel therewith, he shall forfeit the ticket which he may have purchased or obtained and shall be deemed to be travelling without having a proper ticket with him, and shall be liaMe to be dealt with under section 113.".

Sac. 1] THE GAZETTE OF INDIA EXTRAORDINARY ifil

THE DRUGS AND COSMETICS (AMENDMENT)

ACT, 1964

No. 13 OF 1964

[12t/i May, 1964]

An Act further to amend the Drugs and Cosmetics Act, 1340.

BE it enacted by Parliament in the Fifteenth Year of the Republic of India as follows:—

Shwrttiik 1. (1) This Act may b<* called the Drugs and Cosmetics (Amend- ment) Act, 1964.

memt.

(2) It shall come into force on tuch date as the Central Govern- ment may, by notification in the Official Gazette, appoint, and differ- ent dates may be appointed for different provisions of this Act.

2. In section 3 of the Drugs and Cosmetics Act, 1940 (hereinafter 23 of 1940.

referred to as the principal Act),—

Amend- ment of section S

(a) clauses (a) and (act) shall be re-lettered as clauses (aa) and (aaa) respectively, and—

(1) before clause (aa) "s so re-lettered, the following clause Khali h? inserted, namely:—

'(") "Ayurved;c (including Siddha) or Unani drug" includes all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention oi disease in human beings, mentioned in, and processed and manufactured exclusively in accord- ance with the formulae described in, the authoritative books of Ayurvedic (including Siddha) and Unani (Tibb) systems of medicine, specified in the First Schedule;';

(zi) for clause (aa) as so re-lettered, the following clause shall be substituted, namely:-—

' (aa) "the Board" means—

(i) in relation to Ayurvedic (including Siddha) or Unani drug, the Ayurvedic and Unani Drugs Tech- nical Advi-orv Board constituted under section 33C; and

162 THE GAZETTE OF TNDIA EXTRAORDINARY LPAHT II

(ii) in relation to any other drug or cosmefic, the Drugs Technical Advisory Board constituted under section 5;';

(b) in clause (b),—

(i) in sub-clause (7), 1he words "other th?n medicines and substances exclusively u^ed or prepared for use in ac- cordance with the Ayurvedic or Unnni systems of medicine" shall be omitted;

(ii) in sub-clause (if), for the word "verrrrins", the word "vermin" shall he substituted;

(c) for clause (c), the following clau^f shall be substituted, namely:—

'(c) "Government Analyst" means—

(i) in relation to Ayurvedic (including Siddha) or Unani drug, a Government Analyst appointed by the Central Government or a State Government under sec- tion 33F; nnd

(ii) in relation to f"ny other drug or cosmetic, a Government Analvst appointed by the Central Govern- ment or a State Government under section 20;';

(d) for clause (e), the following clause shall be substituted, namely;—

'(p) "Inspector" means—•

' (7) in relation to Ayurvedic (including Siddba) or Unani drug, an Iirpector appointed by the Cen+ral Gov- ernment or a State Government under section 33G; and (ii) in relation to any nther drug or cosmetic, an Inspector appointed by the Central Government or a State Government under section 21;';

(e) for clause (h), the following clause shall be substituted, namely:—

'(h) "patent or proprietary medicine" means a drug which is n remedy or prescription pre ented in a form ready for internal or external administration of human beings or animals and which is not included in the edition of the Indian pharmacopoeia for the time being or in any other pharmacopoeia authorised in this behalf by the Central Government after consuliation with the Board;1.

SEC. 1] THE GAZETTE OF INDlA EXTRAORDINARY 163

Amend- ment of section 4.

3. In section 4 of th" principal Art, nfter the word ;iml figures "Chapter IV" wherever they occur. 1hc words, fl^nr^* • tvnl letter "or Chapter IVA" shall he inserted.

4. In section 5 of thp principal Act,—

Amend- ment of sretion 5 (a) for sub-section (2), the following aih >--(iftion -hnll bo substituted, namely:—

" (2) The Board shall consist of the following members, namely: —

(i) the Director General of Health Services, ex officio, who shall be Chairman;

(ij) the Drugs Controller, India, ex officio;

(Hi) the Director of the Central Drugs Laboratory, Calcutta, ex officio;

(iv) the Director of thp Central Research Institute, Kasauli, ex officio;

(v) the Director of the Indian Veterinary Research Institute, Izatnagar, ex officio;

(vi) the President of the Medical Council of India, ex officio;

(vii) the President of the Pharmacy Council of T":iia, ex officio;

(viii) the Director of the Central Drup X?esenrch Institute, Lucknow, er officio;

(ix) two persons to be nominated by the Central Government from among persons who are in charge of drugs control in the States;

(x) one person, to be elected by the Executive °nm- mittee of the Pharmacy -Council of India, from among teachers in pharmacy or pharmaceutical chemistry or pharmacognosy on the staff of an Indian University or a college affiliated thereto;

(on) one person, to be elected by the Executive Com- mittee of the Medical Council of India, from among teachers in medicine or therapeutic, on fhe staff of an Indian university or a college affiliated thereto;

164 T HE GAZETTE OF INDlA EXTRAORDINARY [PART II

(xii) one person to be nominated by the Central

Government from the pharmaceutical industry;

(xiii) one pharmacologist to be elected by the Governing Body of the Indian Council of Medical Research;

(xiv) one person to be elected by the Central Coun-

cil of the Indian Medical Association;

(xv) one person to be elected by the Council of the

Indian Pharmaceutical Association;

(xvi) two persons holding the appointment of Gov- ernment Analyst under this Act, to be nominated by the Central Government;

(b) in sub-section (3), for the proviso, the following proviso

shall be substituted, namely: —

"Provided that the person nominated or elected, as the case may be, under clause (ix) or clause (re) or clause (xi) or clause (xvi) of sub-section (2) shall hold office for so long as he holds the appointment of the office by virtue of which he was nominated or elected to the Board,".

Amend- ment of section 8,

5, In section 6 of the principal Act, in clause (d) of sub-section (2), for the words and figures "under Chapter IV", the words, figures and letter "under Chapter IV or Chapter IVA" shall be substituted.

ft. In Chapter II of the principal Act, after section 7, the following

section shall be Inserted, namely:—

insertion of new section 7A.

"7A. Nothing contained in sections 5 and 7 shall apply to

Ayurvedic (including Siddha) or Unani drugs.".

sections o and 7 not to apply to Ayurvedic (Including Siddha) or Unani

drugs. 7. In section 8 of the principal Act, for the words "the Schedule wherever they occur, the words "the Second Schedule" shall be substituted.

Amend- ment of section B.

8. After section 9A of the principal Act. the following section

shall be inserted, namely:—

"9B. For the purposes of this Chapter, a drug shall be deem-

ed to be adulterated—

insertion of new section 9B. Adulterat- ed dnie^

&cc. 1] TliE GAZETTE OF INDlA EXTRAORDINARY 155

(a) if it consists, in whole or in part, of any filthy, putrid or decomposed substance; or

(b) if it has been prepared, packed or stored under insanitary conditions whereby it may have been contaminat- ed with filth or whereby it may have been rendered injurious to health; or

(c) if its cuntainer is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or

(d) if it bears or contains, for purposes of colouring only, a colour other than one which is prescribed; or

(e) if any substance has been—

(i) mixed or packed therewith so as to reduce its quality or strength; or

(it) substituted wholly or in part therefor.

Explanation.—For the purpose of clause (a), a drug shall not be deemed to consist, in whole or in part, of any decomposed substance only by reason of the fact that such decomposed sub- stance is the result of any natural decomposition of the drug within the period, if any, specified on the label of the drug within which the drug is to be used:

Provided that such decomposition is not due to any negli- gence on the part of the manufacturer of the drug or the im- porter or the dealer thereof and that it does not render the drug injurious to health.".

9. In section 10 of the principal Act, after clause (b), the follow- ing clause shall be inserted, namely: —

Amend- ment of section 10.

"(bb) any adulterated drug;".

10. In section 12 of the principal Act, in sub-section (2), after clause (c), the following clause shall be inserted, namely: —

Amend- ment of section 12.

" (cc) prescribe under clause (d) of section £>B the colour or colours which a drug may bear or contain for purposes of colour- ing;".

Amend- mont of section 16 11. In section 16 of the principal Act, for the words "the Schedule" wherever they occur, the words "the Second Schedule" shall be sub- fltitntAH

loo THE GAZETTE OF INDIA EXTRAORDINARY LPAHT II

12. After section 17A of the principal Act, the following section

.hall be inserted, namely: —

'L17B. For the purposes of this Chapter a drug shall be Insertion of new section 17B. Adultera- ted drugs.

deemed to be adulterated'—

(a) if it consists, in whole or in part, of any filthy, put-

rid or decomposed substance; or

(b) il it has been prepared, packed oi stored under insanitary conditions whereby it may have been contami- nated with filth or whereby it may have been rendered in- jurious to health; or

(c) il its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or

(d) if it bears or contains, for purposes of colouring

only, a colour other than one which is prescribed; or

(e) if any substance has been—

(i) mixed or packed therewith so as to reduce its

quality or strength; or

(ii) substituted wholly or in part therefor.

Explanation.—For -the purpose of clause (a), a drug shall not be deemed to consist, in whole ur in part, of any decomposed .substance only by reason of Lhc fact that such decomposed sub- stance is the result of any natural decomposition of the drug within the period, if any, specified on the label of the drug within which the drug is to be used:

Provided that such decomposition is not due to any negli- gence on the part of the manufacturer of the drug or the dealer thereof and that it does not render the drug injurious to health.".

13. In section 18 of Ihe principal Act, in clause (a), after sub-

rlause (li), the iollowing sub-clause shall be inserted, namely: —

Amend- ment of section 18.

" (iia) any adulterated drug;".

14 After section 18 of the principal Act, tho following section shall

be inserted, namely: —

Inoertion of new section 18A.

"18A. Every por.son, noi being the manufacturer ol a drug or cosmetic or his agent lor tho distribution thereof, shall, if so re- quired, disclose to the Inspector the name, address and other par- ticulars of the porson from whom he acquired the drug or cos- metic".

Disclosui i ol the name of the raanu facturer, etc.

Bfcc. 1] THE GAZETTE OF INDIA EXTRAORtHNAkY 167

15. In section 19 of the principal Act,—

(a) in sub-section (2),—

fcmend- nent of , lection 19,

Amend- ment of section 2 Amend- ment of section 25 11& G of I Ex.—1

i<53 THE GAZETTE OF INDIA EXTRAORDINARY LPART U

and other particulars have been disclosed under section 18A'; shall be substituted.

18. For section 27 of the principal Act, the following section shall

be substituted, namely: —

"27. Whoever himself or by any other person on his behalf manufactures for sale, sells, stocks or exhibits foir sale or dis- tributes-—

(a) any drug—

Substitu- tion of section 27. Penalty for manu- facture, sale, etc., of drugs in contra- vention ci this Chapter.

(i) deemed to be misbranded under clause (a), clause (b), clause (c), clause (d), clause (f) or clause (0) of section 17 or adulterated under section 17B; or

(it) without a valid licence as required under clause

(c) of section 18,

shall be punishable with imprisonment for a term which shall not be less than one year but which may extend to ten yeans and shall also be liable to fine:

Provided that the Court may, for any special reasons to be recorded in writing, impose a sentence of imprisonment of less than one year;

(b) any drug other than a drug referred to in clause (a)

in contravention of any of the provisions of this Chapter or any rule made thereunder shall be punishable with imprison- ment for a term which may extend to three years, or with fine, or with both.".

19. if or section 2B ot the principal Act, the following section snail

je substituted, namely: —

"28. Whoever contravenes the provisions of section 18A shall be punishable with imprisonment for a term which may extend to one year, or with fine which may extend to five hundred rupees, or with both.".

Substitu- tion of ] section 28. Penalty for non- disclosure of the name of the manu- facturer,

20- In section 30 of the principal Act,—

(a) in sub-section (1), for the words "five years" wherever Amend- ment of erection 30, they occur, the words "ten years" shall be substituted; .

(b) in sub-section (2) ,—

(i) the words and figures "section 28 or" shall be

omitted;

(ii) for the words "two years", the words "ten years"

shall be substituted.

SEC. 1] THE GAZETTE OF INDIA EXTRAORDINARY 169

21. In section 31 of the principal Act,—

Amend- ment of section 31 (a) in sub-section (1), the following shall be added at the

end, namely: —

"and if such contravention is in respect of—

(£) manufacture of any drug deemed to be mis- branded under clause (a), clause (b), clause (c), clause (d), clause (f) or clause (gr) of section 17 or adulterated under section 17B; or

(il) manufacture for sale, or sale, or stocking or exhibiting for sale, or distribution of any drug with- out a valid licence as required under clause (c) of sec- tion 18,

any implements or machinery used in such manufacture, sale or distribution and any receptacles, packages or cover- ings in which such drug is contained and the animals, vehicles, vessels or other conveyances used in carrying such drug shall also be liable to confiscation";

(b) in sub-section (2), for the words "or is a misbranded drug", the words "or is a misbranded or adulterated drug" shall be substituted.

22. After section 31 of the principal Act, the following sectioi

shall be inserted, namely: —

"31A- The provisions of this Chapter except those contained in section 31 shall apply in relation to the manufacture, sale or distribution of drugs by any department of Government as they apply in relation to the manufacture, sale or distribution of drugs by any other person."-

Insertion of new section 31 A. Applica- tion of provi- sions to Govern- ment depart- mpnt.s

23. After section 32 of the principal Act, the following section shall

be inserted, namely: —

Insertion of new- section 32A. Power of Court to implead the manu- facturer, etc.

3 of 1808.

"32A. Where, at any time during the trial of any offence under this Chapter alleged to have been committed by any per- son, not being the manufacturer of a drug or cosmetic or his agent for the distribution thereof, the Court is satisfied, on the evidence adduced before it, that such manufacturer or agent Is also concerned in that offence, then, the Court may, notwith- standing anything contained in sub-seciion (1) of section 351 of the Code of Criminal Procedure. 1898, proceed against him as

170 THE GAZETTE OF INDIA EXTRAORDINARY LPART II

though a prosecution had been instituted against him under sec- tion 32.".

24. In section 33 of the principal Act,—

Amend- ment of section 33

(i) in sub-section (2),—

(a) after clause (d), the following clause shall be

inserted, namely: —

"(dd) prescribe under clause (d) of section 17B the colour or colours which a drug may bear or contain for purposes of colouring;";

(b) clause (m) shall be omitted;

(c) for clause (p), the following clause shall be substi-

tuted, namely: —

" (?) specify the offences against this Chapter or any rule made thereunder in relation to which an order of confiscation may be made under section 31; and";

(ii) sub-section (3) shall be omitted.

25. In Chapter IV of the principal Act, after section 33, the fol-

lowing section shall be inserted, namely: —

Insertion of new lection 3SA.

"33A. Save as otherwise provided in this Act, nothing con- tained in this Chapter shall apply to Ayurvedic (Including Sid- dha) or Unani drugs.".

unaptex not to apply to Ayurvedic (including Slddha) or Unani drugs.

26. After Chapter IV of the principal Act, the following Chapter

shall be inserted, namely: —

Insertion of new Chapter 1VA.

'CHAPTER IVA

PROVISIONS RELATING TO AYURVEDIC (INCLUDING SIDDHA) AND UNANI

DRUGS

33B. This Chapter shall apply only to Ayurvedic (including

Siddha) and Unani drujfs.

Applica. tion Of Chapter IV A.

SEC. 1] .THTC GAZETTF, OF INDlA EXTRAORDINARY 171

33C. (1) The Ceniral Government shall, by notification in Ayurvedic ind Unani Drugs Fechnical \dvisory Board.

the Official Gazette and with effect from such date as may be ' specified therein^ constitute a Board (to be called the Ayurvedic and Unani Drugs Technical Advisory Board) to advise the Cen- tral Government and the State Governments on technical matters arising out of this Chapter and to carry out the other functions assigned to it by this Chapter.

(2) The Board shall consist of the following members, namely: —

(i) the Director General of Health Services, ex ojficio;

(ii) the Drugs Controller, India, ex officlo;

(Hi) the Adviser in indigenous systems of medicine, Ministry of Health, ex officlo;

(iv) the Director of the Central Drugs Laboratory, Cal- cutta, ex officio;'

(v) one person holding the appointment of Government Analyst under section 33F, to be nominated by the Central Government;

(vi) one Pharmacognocist to be nominated by the Central Government;

(vii) one Phyto-chemist to be nominated by the Central Government;

(viii) two persons to be nominated by the Central Gov- ernment from among members of the Central Council of Ayurvedic Research;

(ix) one teacher in Dravyaguna and Bhaishajya Kal- pana, to be nominated by the Central Government;

(x) one teacher in IL-MUL-ADVIA and TAKLIS-WA- DAWASAZI, to be nominated by the Central Government;

(xi) two persons, one each to represent the Ayurvedic (including Siddha) and Unani drug industry, to be nomi- nated by the Central Government;

(xii) two persons, one each from among the practitioners of Ayurvedic (including Siddha) and Unani systems of medi- cine, to be nominated by the Central Government.

(3) The Central Government shall appoint a member of the Board as its Chairman,

I72 THE GAZETTE OF INDIA EXTRAORDINARY [PART II

(4) The nominated members of the Board shall hold office

for three years but shall be eligible for renomination.

(5) The Board may, subject to the previous approval of the Central Government, make bye-laws fixing a quorum and regu- lating Its own procedure and conduct of all business to be tran- sacted by it.

(6) The functions of the Board may be exercised notwith-

standing any vacancy therein,

(7) The Central Government shall appoint a person to be Secretary of the Board and shall provide the Board with such clerical and other staff as the Central Government considers necessary.

33D. From such date as may be fixed by the State Govern- ment by notification in the Official Gazette in this behalf, no person shall himself or by any other person on his behalf, manu- facture for sale any Ayurvedic (including Siddha) or Unani, drug—

(") except under prescribed hygienic conditions;

prohibition of manu- facture for sale of Ayurvedic (including Siddha) and Unani drugi.

(b) except under the supervision of a person having the prescribed qualifications;

(c) except under and in accordance'with the conditions of a licence issued for such purpose under this Chapter;

(d) unless the raw materials used in the preparation of such drug are genuine and arc properly identified;

(e) unless such drug is labelled with the true list of all the ingredients contained in it and with such other particu- lars as may be prescribed; and

(f) in contravention of any oi the provisions of this Chapter or any rule made thereunder:

Provided that nothing in this section shall apply to Vaidyas and Hakims who manufacture such drugs for the use of their own patients:

Provided further that nothing in clauses (a), (b) and (c) shall apply to the manufacture, subject to prescribed conditions, of small quantities of anv such drug for the purpose of exami- nation, test or analysis.

SEC. 1] THE GAZETTE OF INDlA EXTRAORDINARY 173

33E. From such date as may be fixed by the State Govern- ment by notification in thi; Official Gazette in this behalf, no person shall himself or by any other person on his behalf, sell, or stock or exhibit for sale, or distribute, any Ayurvedic (includ- ing Siddha) or Unani drug other than that manufactured by a manufacturer licensed under this Chapter.

Restriction on sale, rtc, of Ayurvedic (including Siddha) and Unani drugs.

Govern- ment Analysts.

33F. (1) The Central Government or a State Government may, by notification in the Official Gazette, appoint such persons as it thinks fit, having the prescribed qualifications, to be Gov- ernment Analysts for such areas as may be assigned to them by the Central Government or the State Government, as the case may be.

(2) Notwithstanding anything contained in sub-section (J), neither the Central Government nor a State Government shall appoint as a Government Analyst any official not serving under it without the previous consent of the Government under which he is serving.

Inspectors.

33G. (J) The Central Government or a State Government may, by notification in the Official Gazette, appoint such persons as it thinks fit, having the prescribed qualifications, to be Inspectors for such areas as may be assigned to them by the Central Government or the State Government, as the case may be.

(2) The powers which may be exercised by an Inspector and the duties which may be performed by him and the conditions, limitations or restrictions subject to which such powers and duties may be exercised or performed shall be such as may be prescribed.

(3) No person who has any financial interest in the manu- facture or sale of any drug shall be appointed to be an Inspector under this section.

45 of i860.

(4) Every Inspector shall be deemed to be a public servant within the meaning of section 21 of the Indian Penal Code and shall be officially subordinate to such authority as the Govern- ment appointing him may specify in this behalf.

Applica- tion of provisions of "ection" 32, 23, 24 33H. The provisions of sections 22, 23, 24 and 25 and the rules, if any, made thereunder shall, so far as may be, apply in rela- tion to an Inspector and a Government Analyst appointed under this Chapter as they apply in relation to an Inspector and a Gov- ernment Analyst appointed under Chapter IV, subject to the

174 T HE GAZETTE OF INDIA EXTRAORDINARY LPART II

modification that the references to "drug" in the said sections, shall be construed as references to "Ayurvedic (including Siddha) or Unani drug".

331. Whoever contravenes the provisions of section 33D or section 33E or section 24 as applied by section 33H or any rule made under this Chapter shall be punishable with imprison- ment for a term which may extend to three months, or with fine which may extend to five hundred rupees, or with both.

Penalty for manli- tacture, sale, etc, of Ayurvedic (including Siddha) and Unani drugs in contraven- tion of this Chapter.

Penalty for sub- sequent offences.

33J. Whoever, having been convicted of an offence under section 33D or section 33E is again convicted of an offence under the said section shall be punishable with imprisonment for a ternv which may extend to six months, or with fine which may extend to one thousand rupees, or with both.

Confisca- tion.

33K. Where any person has been convicted under this Chapter, the stock of the Ayurvedic (including Siddha) or Unani drug, in respect of which the contravention has been made, shall be liable to confiscation.

33L. The provisions of this Chapter except those contained in section 33K shall apply in relation to the manufacture for sale, sale, or distribution of any Ayurvedic (including Siddha) or Unani drug by any department of Government as they apply in relation to the manufacture for sale, sale, or distribution of sucb drug by any other person.

Applica- tion of provisions to Gov- ernment depart- ment*

33M. (1) No prosecution under this Chapter shall be institut-

ed except by an Inspector.

Cognizance of offences.

(2) No Court inferior to that of a Presidency Magistrate or of a Magistrate of the first class shall try an offence punishable under this Chapter.

33N. (1) The Central Government may, after consultation with the Board and after previous publication by notification in the Official Gazette, make rules for the purpose of giving effect to the provisions of this Chapter:

Power ol Central Govern- ment to make rulw.

Sue. 1] THE GAZETTE OF INDIA EXTRAORDINARY 175

Provided that consultation with the Board may be dispens- ed with if the Central Government is of opinion that circum- stances have arisen which render it necessary to make rules without such consultation, but in such a case, the Board shall be consulted within six months of the making of the rules and the Central Government shall take into consideration any sug- gestions which the Board may make in relation to the amend- ment of the said rules.

(2) Without prejudice to the generality of the foregoing power, such rules may,—

(a) provide for the establishment of laboratories for testing and analysing Ayurvedic (including Siddha) or Unani drugs;

(b) prescribe the qualifications and duties of Govern- ment Analysts and the qualifications of Inspectors;

(c) prescribe the methods of test or analysis to be em- ployed in determining whether any Ayurvedic (including Siddha) or Unani drug is labelled with the true list of the ingredients which it is purported to contain;

(d) specify any substance as a poisonous substance;

(e) prescribe the forms of licences for the manufacture for sale of Ayurvedic (including Siddha) or Unani drugs, the form of application for such licences, the conditions sub- ject to which such licences may be issued, the authority empowered to issue the same and the fees payable therefor;

(f) regulate the mode of labelling packed Ayurvedic (including Siddhe) or Unani drugs and prescribe the matters which shall or shall not be Included in such labels;

(g) prescribe the conditions subject to which small quantities of Ayurvedic (including Siddha) or Unani drugs may be manufactured for the purpose of examination, test or analysis; and

(h) any other matter which is to be or may be pres- cribed under this Chapter.

Power to amend First Schedule 33O. The Central Government, after consultation with the Board and after giving, by notification in the Official^ Gazette, not less than three months' notice of its intention so to do, may, by a like notification, add to or otherwise amend the First Schedule for the purposes of this Chapter and thereupon the said Schedule shall be deemed to be amended accordingly.'

119 G of I EX.—3

176 THE GAZETTE OF INDIA EXTRAORDINARY [PART II

27. Section 33A of the principal Act shall be re-numbered as

section 33P.

Amend- ment of section 33A.

28. After section 34 of the principal Act, the following section

shall be inserted, namely: —

Insertion of new section 34 A.

Offences by Gov- ernment depart- ments

"34A. Where an offence under Chapter IV or Chapter IVA has been committed by any department of Government, such authority as is specified by the Central Government to be in- charge of manufacture, sale or distribution of drugs or where no authority is specified, the head of the department, shall be deemed to be guilty of the offence and shall be liable to be proceeded against and punished accordingly:

Provided that nothing contained in this section shall render any such authority or person liable to any punishment provided in Chapter IV or Chapter IVA, as the case may be, if such authority or person proves that the offence was committed with- out its or his knowledge or that such authority- or person exer- cised all due diligence to prevent the commission of such off- ence.".

29, In section 36 of the principal Act, the words and figures

"section 32 of" shall be omitted.

Amend- ment Of section 36.

SO. After section 37 of the principal Act, the following section

shall be Inserted, namely: —

Insertion of new section 38.

Rules to be laid before Parlia- ment.

"38. Every rule made under this Act shall be laid as soon aa may be after it is made before each House of Parliament while it is in session for a total period of thirty days which may be comprised In one session or in two or more successive ses- sions, and if before the expiry of the session In which it is so laid or the successive sessions aforesaid, both Houses agree in making any modification in the rule or both Houses agree that the rule should not be made, the rule shall thereafter have effect only in such modified form or be of no effect, as the case may be; so however that any such modification or annulment shall be without prejudice to the validity of anything previously done under that rule-".

SEC. 1] THE GAZETTE OF INDIA EXTRAORDINARY 177

31. For the Schedule to the principal Act, the following Sche-

dules shall be substituted, namely: —

Substitu- tion of Schedule.

"THE FIRST SCHEDULE

[See section 3(a)]

A.—AYURVEDIC (INCLUDING SIDDHA) SYSTEM

Serial No. Name of book.

Ayurveda

1.

2.

3.

Arogya Kalpadruma Arka Prakasha Arya Bhishak

4.

Ashtanga Hridaya

5.

6-

7.

8.

9.

10.

11.

12.

13-

Ashtanga Samgraha Ayurveda Kalpadruma Ayurveda Prakasha Ayurveda Samgraha Bhaishajya Ratnavali Bharat Bhaishajya Ratnakara Bhava Prakasha Brihat Nighantu Ratnakara Charaka Samhita

14.

15.

16.

Chakra Datta Gada Nigraha Kupi Pakva Rasayana

17.

18-

19.

20.

Nighantu Ratnakara Rasa Chandanshu Rasa Raja Sundara Rasaratna Samuchaya

21.

22.

Rasatantra Sara Siddha Prayoga Samgraha Rasa Tarangini

23.

24.

Rasa Yoga Sagara Rasa Yoga Ratnakara

25.

26.

Rasa Yoga Samgraha Rasendra Sara Samgraha

I 78 THE GAZETTE OF INDIA EXTRAORDINARY [PART II

Name of book

Serial No.

27.       Rasa  Pradlpika
28.       Sahasrayoga
29.       Sarvaroga  Chikitsa  Ratnam
30.        Sarvayoga  Chikitsa  Ratnam
31.       Sharangadhara  Samhita
32.       Siddha  Bhaishajya  Manimala
33.       SIddha  Yoga  Samgraha
34.       Sushruta  Samhita
35.        Vaidya  Chintamiani
36.       Vaidyaka  Shabda  Sindu
37.        Vaidyaka  Chikitsa  Sara
88.       Vaidya  Jiwan
39.       Basava  Rajeeyam
40.       Yoga  Ratnakara
41.        Yoga  Tarangini
42.       Yoga  Chintamani
43.        Kashyapasamhita
44.       Bhelasamhita
45.       Vishwanathachikltsa
46.       Vrindachikitsa
47.        Ayurvedachintamani
48.       Abhinavachlntamani
49.       Ayurveda-ratnakar
50.       Yogaratnasangraha
51.        Rasamrita
52.       Dravyagunanighantu
53.       Rasamanjari
54.       Bangasena
                         Siddha
55.       Siddha  Vaidya  Thirattu
56.        Therayar  Maha  Karisal
57.       Brahma  Muni  Karukkadai  (300)
58.       Bhogar  (700)
59.       Pulippani  (500)
60.       Agasthlyar  Paripuranam  (400)
61.        Therayar  Yamagam
62.       Agasthiyar  Chenduram  (300)
63.       Agasthiyar  (1500)
64.       Athmarakshamrutham
65.       Agasthiyar  Pin  (80)
66.       Agasthiyar  Rathna  Churukkam
67.       Therayar  Karisal  (300)
SEC. 1] THE GAZETTE OF INDIA EXTRAORDINARY iyy

Serial No.

Name of book

68. 69. 70. 71. 72.

73. 74.

75. 76.

77. 78. 79. 80. 81. 82. 83.

Veeramamuni Nasa Kandam Agasthiyar (600) Agasthiyar Kanma Soothiram 18 Siddhar's Chillarai Kovai Yogi Vatha Kaviyam Therayar Tharu Agasthiyar Vaidya Kaviyam (1500) Bala Vagadam Chimittu Rathna (Rathna) Churukkam Nagamuni (200) Agasthiyar Chillarai Kovai Chikicha Rathna Deepam Agasthiyar Nayana Vidhi Yugi Karisal (151) Agasthiyar Vallathi (600) Therayar Thaila Varkam

B.—UNANI (TIBB) SYSTEM

Serial No.

Name of book

1.

2.

3.

4.

Karabadin Qadri Karabadin Kabir Karabadin Azam Ilaj-ul-Amraz

5.

6.

7.

Al Karabadin Biaz Kabir Vol. II Karabadin Jadid

8.

9.

10.

11.

Kitab-ul-Taklis Sanat-ul-Taklis Mifta-ul-Khazain Madan-ul-Aksir Makhzan-ul-murabhat.

12.

l8o THE GAZETTE OF INDlA EXTRAORDINARY [PART H

THE SECOND SCHEDULE

(See sections 8 and 16)

STANDARDS TO BE COMPUED WITH BY IMPORTED DRUGS AND BY DRUG MANUFACTURED FOR SALE, SOLD, STOCKED OR EXHIBITED FOR SALE OR DISTRIBUTED

Class of drug

1. Patent or proprietary medi- cines.

2. Substances commonly known as vaccines, sera, toxine, toxoids, antitoxins, and antigens and biological products of such nature.

Vitamins, hormones and 3.

analogous products.

4. Substances (other than food) intended to affect the structure or any func- tion of the human body or intended to be used for the destruction of ver- min or insects which cause disease in human beings or animals-

Other drugs:

5.

(a) Drugs included in the Indian Pharmacopoeia.

(b) Drugs not included in the Indian Pharmaco- poeia but which are included in any Pharmacopoeia of any other country.

Standard to be complied with

The formula or list of ingre- dients displayed in the pres- cribed manner on the label or container and such other standards as may be pres- cribed.

The standards maintained at the International Laboratory for Biological Standards, Stantans Seruminstitut, Copenhagen and such fur- ther standards of strength, quality and purity as may be prescribed.

The standards maintained at the International Laboratory for Biological Standards, National Institute. for Medical Research, London, and such further standards of strength, quality and purity as may be prescribed. Such standards as may be prescribed.

Standards of identity, purity and strength specified in the edition of the Indian Pharmacopoeia for the time being and such other standards as may be pres- cribed.

Standards of identity, purity and strength specified for the drugs in the edition of such pharmacopoeia for the time being and such other standards as may be pres- cribed."

SEC. 1] THE GAZETTE OF INDIA EXTRAORDINARY 181

Traniitory provision.

32. Until the constitution of the Drugs Technical Advisory Board under section 5 of the principal Act as amended by this Act, the Drugs Technical Advisory Board constituted under section 5 of the princi- pal Act • and functioning immediately before the commencement of this Act shall be deemed to be the Drugs Technical Advisory Board constituted under section 5 of the principal Act as amended by this Act and shall continue to function as if this Act had not been passed.

R. C. S. SARKAR, Secy, to the Govt, of India.

PRINTED IN INDIA BY THE GENERAL MANAGER, GOVERNMENT OF INDIA PRESS,

NEW DELHI AND PUBLISHED BY THE MANAGER OF PUBLICATIONS, DELHI. 1 9 64


  1. tion 18 a drug or cosmetic shall not be deemed to be mis- branded or to be below standard quality", the words and figures "For the purposes of section 18 a drug shall not be deemed to be misbranded or adulterated or to be below standard quality nor shall a cosmetic be deemed to be mis- branded or to be below standard quality" shall be substi» tuted; (it) clause (aa) shall be omitted; (b) for sub-section (3), the following sub-section shall be substituted, namely: — "(3) A person, not being the manufacturer of a drug or cosmetic or his agent for the distribution thereof, shall not be liable for a contravention of section 18 if he proves— (a) that he acquired the drug or cosmetic from a duly licensed manufacturer, distributor or dealer thereof; (b) that he did not know and could not, with reason- able diligence, have ascertained that the drug or cos- metic in any way contravened the provisions of that section; and (c) that the drug or cosmetic, while in his posses- sion, was properly stored and remained in the same state as when he acnuired it". 16- In section 23 of the principal Act, for clause (iii) of sub-sec- tion (4), the following clause shall be substituted, namely:— '. " (iii) the third, where taken, he shall send to the person, if any, whose name, address and other particulars have been dis- closed under section 18A.". 17. In section 25 of the principal Act,— (a) in sub-section (2), for the words, brackets and figures "and another copy to the warrantor, if any, named under the proviso to sub-section (3) of section 19", the words, figures and letter "and another copy to the person, if any, whose name, address and oth^r particulars have been disclosed under section 18A" shall be substituted; (b) In sub-section (3), for the words "or the said warrantor",' the words, figures and letter "or the person whose name, address ↩
Cite this issue. Extraordinary Gazette of India, Government of India, 12 May 1964. Indian Gazettes, https://egazette.servantsofknowledge.in/details/in.gazette.csl_extraordinary.1964-05-12.E-1819-1964-0016-82639/. Archive identifier in.gazette.csl_extraordinary.1964-05-12.E-1819-1964-0016-82639.