33B. Application of Chapter IVA.—This Chapter shall apply only to 4
[Ayurvedic, Siddha and
Unani] drugs.
33C. Ayurvedic and Unani Drugs Technical Advisory Board. —(1) The Central Government
shall, by notification in the Official Gazette and with effect from such date as may be specified therein,
constitute a Board (to be called the 6
[Ayurvedic, Siddha and Unani Drugs Technical Advisory Board]) to
advise the Central 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 officio;
(ii) the Drugs Controller, India, ex officio;
7
[(iii) the principal officer dealing with Indian systems of medicine in the Ministry of Health,
ex officio];
(iv) the Director of the Central Drugs Laboratory, Calcutta 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;
1. Ins. by Act 26 of 2008, s. 14 (w.e.f. 10-8-2009).
2. Sub-section (3) ins. by Act 35 of 1960, omitted by Act 13 of 1964, s. 24 (w.e.f. 15-9-1964).
3. Ins. by Act 13 of 1964, s. 25 (w.e.f. 1-2-1969).
4. Subs. by Act 68 of 1982, s. 2, for certain words (w.e.f. 1-2-1983).
5. Ins. by Act 13 of 1964, s. 26 (w.e.f. 1-2-1969).
6. Subs. by Act 68 of 1982, s. 30, for certain words (w.e.f. 1-2-1983).
7. Subs. by s. 30, ibid., for cl. (iii) (w.e.f. 1-2-1983).
30
1
[(viii) four persons to be nominated by the Central Government, two from amongst the members
of the Ayurvedic Pharmacopoeia Committee, one from amongst the members of the Unani
Pharmacopoeia Committee and one from amongst the members of the Siddha Pharmacopoeia
Committee;]
(ix) one teacher in Darvyaguna, and Bhaishajya Kalpana, to be nominated by the Central
Government;
(x) one teacher in ILM-UL-ADVIA and TAKLIS-WA-DAWASAZI, to be nominated by the
Central Government;
2
[(xi) one teacher in Gunapadam to be nominated by the Central Government;
(xii) three persons, one each to represent the Ayurvedic, Siddha and Unani drug industry, to be
nominated by the Central Government;
(xiii) three persons, one each from among the practitioners of Ayurvedic, Siddha
and Unani Tibb systems of medicine to be nominated by the Central Government.]
(3) The Central Government shall appoint a member of the Board as its Chairman.
(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 regulating its own procedure and conduct of all business to be tran -
sacted by it.
(6) The functions of the Board may be exercised notwithstanding 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.
3
[33D. The Ayurvedic, Siddha and Unani Drugs Consultative Committee.—(1) The
Central Government may constitute an Advisory Committee to be called the Ayurvedic,
Siddha and Unani Drugs Consultative Committee to advise the Central Government, the State
Governments and the Ayurvedic, Siddha and Unani Drugs Technical Advisory Board on any
matter for the purpose of securing uniformity throughout India in the administration of this
Act in so far as it relates to Ayurvedic, Siddha or Unani drugs.
(2) The Ayurvedic, Siddha and Unani Drugs Consultative Committee shall consist of two
persons to be nominated by the Central Government as representatives of that Government
and not more than one representative of each State to be nominated by the State Government
concerned.
(3) The Ayurvedic, Siddha and Unani Drugs Consultative Committee shall meet when
required to do so by the Central Government and shall regulate its own procedure.
1. Subs. by Act 68 of 1982, s. 30, for cl. (viii) (w.e.f. 1-2-1983).
2. Subs. by s. 30, ibid., for cls. (xi) and (xii) (w.e.f. 1-2-1983).
3. Subs. by s. 31, ibid., for sections.33D and 33E (w.e.f. 1-2-1983).
31
33E. Misbranded drugs.—For the purposes of this Chapter, an Ayurvedic, Siddha or Unani drug
shall be deemed to be misbranded—
(a) if it is so coloured, coated, powdered or polished that damage is concealed, or if
it is made to appear of better or greater therapeutic value than it really is; or
(b) if it is not labelled in the prescribed manner; or
(c) if its label or container or anything accompanying the drug bears any statement,
design or device which makes any false claim for the drug or which is false or misleading in
any particular.
33EE. Adulterated drugs.—For the purposes of this Chapter, an Ayurvedic, Siddha or
Unani drug shall be deemed to be adulterated,—
(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 contaminated with filth or whereby it may have been rendered injurious to
health; or
(c) if 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 it contains any harmful or toxic substance which may render it injurious to
health; or
(f) if any substance has been mixed therewith so as to reduce its quality or strength.
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
substance is the result of any natural decomposition of the drug:
Provided that such decomposition is not due to any negligence on the part of the manufac -
turer of the drug or the dealer thereof and that it does not render the drug injurious to health.
33EEA. Spurious drugs.—For the purposes of this Chapter, an Ayurvedic, Siddha or Unani drug
shall be deemed to be spurious—
(a) if it is sold, or offered or exhibited for sale, under a name which belongs to another
drug; or
(b) if it is an imitation of, or is substitute for, another drug or resembles another drug in
a manner likely to deceive, or bears upon it or upon its label or container the name of
another drug, unless it is plainly and conspicuously marked so as to reveal its true chara cter
and its lack of identity with such other drug; or
(c) if the label or container bears the name of an individual or company purporting to be the
manufacturer of the drug, which individual or company is fictitious or does not exist; or
(d) if it has been substituted wholly or in part by any other drug or substance; or
(e) if it purports to be the product of a manufacturer of whom it is not truly a product.
33EEB. Regulation of manufacture for sale of Ayurvedic, Siddha and Unani drugs.—No
person shall manufacture for sale or for distribution any Ayurvedic, Siddha and Unani drug except
in accordance with such standards, if any, as may be prescribed in relation to that drug.
32
33EEC. Prohibition of manufacture and sale of certain Ayurvedic, Siddha and Unani
drugs.—From such date as the State Government may, by notification in the Official Gazette,
specify in this behalf, no person, either by himself or by any other person on his behalf, shall—
(a) manufacture for sale or for distribution—
(i) any misbranded, adulterated or spurious Ayurvedic, Siddha or Unani drug;
(ii) any patent or proprietary medicine, unless there is displayed in the prescribed
manner on the label or container thereof the true list of all the ingredients contained in it;
and
(iii) any Ayurvedic, Siddha or Unani drug in contravention of any of the
provisions of this Chapter or any rule made thereunder;
(b) sell, stock or exhibit or offer for sale or distribute any Ayurvedic, Siddha or Unani drug
which has been manufactured in contravention of any of the provisions of this Act, or any rule made
thereunder,
(c) manufacture for sale or for distribution, any Ayurvedic, Siddha or Unani drug except under,
and in accordance with the conditions of, a licence issued for such purpose under this Chapter by the
prescribed authority :
Provided that nothing in this section shall apply to Vaidyas and Hakims who manufacture Ayurvedic,
Siddha or Unani drug for the use of their own patients :
Provided further that nothing in this section shall apply to the manufacture, subject to the prescribed
conditions, of small quantities of any Ayurvedic, Siddha or Unani drug for the purpose of examination,
test or analysis.
33EED. Power of Central Government to prohibit manufacture, etc., of Ayurvedic,
Siddha or Unani drugs in public interest.—Without prejudice to any other provision contained in
this Chapter, if the Central Government is satisfied on the basis of any evidence or other material
available before it that the use of any Ayurvedic, Siddha or Unani drug is likely to involve any risk
to human being or animals or that any such drug does not have the therapeutic value claimed or
purported to be claimed for it and that in the public interest it is necessary or expendient so to do
then, that Government may, by notification in the Official Gazette, prohibit the manufacture, sale
or distribution of such drug.]
33F. Government Analysts.—(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 Government 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 (1), neither the Central Government nor
a State Government shall appoint as a Government Analysts any official not serving under it
without the previous consent of the Government under which he is serving.
1
[(3) No person who has any financial interest in the manufacture or sale of any drug shall be
appointed to be a Government Analysts under this section.]
33G. Inspectors.—(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 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.
1. Ins. by Act 68 of 1982, s. 32 (w.e.f. 1-2-1983).
33
(3) No person who has any financial interest in the manufacture or sale of any drug shall be appointed
to be an Inspector under this section.
(4) Every Inspector shall be deemed to be a public servant within the meaning of section 21
of the Indian Penal Code (45 of 1860) and shall be officially subordinate to such authority as
the Government appointing him may specify in this behalf.
33H. Application of provisions of sections 22, 23, 24 and 25.—The provisions of
sections 22, 23, 24 and 25 and the rules, if any, made thereunder shall, so far as may be, apply in
relation to an Inspector and a Government Analyst appointed under this Chapter as they apply in
relation to an Inspector and a Government Analyst appointed under Chapter IV, subject to the
modification that the references to “drug” in the said sections, shall be construed as references to
1
[Ayurvedic, Siddha or Unani] drug.
2
[33-I. Penalty for manufacture, sale, etc., of Ayurvedic, Siddha or Unani drug in contravention
of this Chapter.—Whoever himself or by any other person on his behalf—
(1) manufactures for sale or for distribution, —
3
[(a) any Ayurvedic, Siddha or Unani drug—
(i) deemed to be misbranded under section 33E,
(ii) deemed to be adulterated under section 33EE, or
(iii) without a valid licence or in violation of any of the conditions thereof, as required
under section 33 EEC,
shall be punishable with imprisonment for a term which may extend to one year and with fine which
shall not be less than twenty thousand rupees or three times the value of the drugs confiscated,
whichever is more;]
(b) any Ayurvedic, Siddha or Unani drug deemed to be spurious under
section 33EEA, shall be punishable with imprisonment for a term which shall not be
less than one year but which may extend to three years and with fine which shall not be
less than 4
[fifty thousand rupees or three times the value of the drugs confiscated, whichever is
more]:
Provided that the Court may, for any adequate and special reas ons to be mentioned
in the judgment, impose a sentence of imprisonment for a term of less than one year
and of fine of less than 4
[fifty thousand rupees or three times the value of the drugs
confiscated, whichever is more]; or
5
[(c) any Ayurvedic, Siddha or Unani drug in contravention of the provisions of any
notification issued under section 33EED shall be punishable with imprisonment for a term which
may extend to three years and with fine which may extend to fifty thousand rupees or three times
the value of the drugs confiscated, whichever is more.]
(2) Contravenes any other provisions of this Chapter or of section 24 as applied by
section 33H or any rule made under this Chapter, shall be punishable with imprisonment for a
term which may extend to 6
[six months and with fine which shall not be less than ten thousand
rupees].
33J. Penalty for subsequent offences.—Whoever having been convicted of an offence,—
(a) under clause (a) of sub-section (1) of section 33-I is again convicted of an offence
under that clause, shall be punishable with imprisonment for a term which may extend to
two years and with fine which shall not be less than 7
[fifty thousand rupees or three times the
value of the drugs confiscated, whichever is more];
(b) under clause (b) of sub-section (1) of section 33-I is again convicted of an offence
under that clause, shall be punishable with imprisonment for a term which shall not be less
than two years but which may be extend to six years and with fine which shall not be less
1. Subs. by Act 68 of 1982, s. 2, for certain words (w.e.f. 1-2-1983).
2. Subs. by s. 33, ibid., for sections 33-I and 33J (w.e.f. 1-2-1983).
3. Subs. by Act 26 of 2008, s. 15, for clause (a) (w.e.f. 10-8-2009).
4. Subs. by s. 15, ibid., for “five thousand rupees” (w.e.f. 10-8-2009).
5. Ins. by s. 15, ibid. (w.e.f. 10-8-2009).
6. Subs. by s. 15, ibid., for “three months and with fine which shall not be less than five hundred rupees” (w.e.f. 10-8-2009).
7. Subs, by s. 16, ibid., for “two thousand rupees” (w.e.f. 10-8-2009).
34
than1
[one lakh rupees or three times the value of the drugs confiscated, whichever is more]:
Provided that the Court may, for any adequate and special reasons to be mentioned in
the judgment, impose a sentence of imprisonment for a term of less than two years and of
fine of less than 1
[one lakh rupees or three times the value of the drugs confiscated, whichever is
more;]
(c) under sub-section (2) of section 33-I is again convicted of an offence under that
sub-section, shall be punishable with imprisonment for a term which may extend to 2
[one
year and with fine which shall not be less than twenty thousand rupees or three times the value of the
drugs confiscated, whichever, is more].
33K. Confiscation.—Where any person has been convicted under this Chapter, the stock of
the 3
[Ayurvedic, Siddha or Unani] drug, in respect of which the contravention has been made,
shall be liable to confiscation.
4
[33KA. Disclosure of name of manufacturer, etc. — Every person, not being the manufacturer
manufacturer of any Ayurvedic, Siddha or Unani drug or his agent for the distribution thereof, shall, if so
required, disclose to the Inspector the name, address and .
other particulars of the person from whom he
acquired the Ayurvedic, Siddha or Unani drug.
33KB. Maintenance of records and furnishing of information. — Every person holding a licence
under clause (c) of section 33EEC shall keep and maintain such records, registers and other documents as
may be prescribed and shall furnish to any officer or authority exercising any power or discharging any
function under this Act such information as is required by such officer or authority for carrying out the
purposes of this Act.]
33L. Application of provisions to Government departments.—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 3
[Ayurvedic, Siddha or Unani] drug by any department of
Government as they apply in relation to the manufacture for sale, sale, or distribution of such
drug by any other person.
33M. Cognizance of offences.—(1) No prosecution under this Chapter shall be instituted
except by an Inspector 5
[with the previous sanction of the authority specified under
sub-section (4) of section 33G].
(2) No Court inferior to that 6
[of a Metropolitan Magistrate or of a Judicial Magistrate
of the first class] shall try an offence punishable under this Chapter.
33N. Power of Central Government to make rules.—(1) The Central Government may,
7
[after consultation with, or on the recommendation of, 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:
Provided that consultation with the Board may be dispensed with if the Central Government is of
opinion that circumstances 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 suggestions which the Board may make in relation
to the amendment 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 3
[Ayurvedic, Siddha or
Unani] drugs;
1. Subs. by Act 26 of 2008 s. 16, for “five thousand rupees” (w.e.f. 10-8-2009).
2. Subs. by s. 16, ibid., for “six months and with fine which shall not be less than one thousand rupees ”
(w.e.f. 10-8-2009).
3. Subs. by Act 68 of 1982, s. 2, for certain words (w.e.f. 1-2-1983).
4. Ins. by Act 26 of 2008, s. 17 (w.e.f. 10-8-2009).
5. Ins. by Act 68 of 1982, s. 34 (w.e.f. 1-2-1983).
6. Subs. by s. 34, ibid., for “of a Presidency Magistrate or of a Magistrate of the first class” (w.e.f. 1-2-1983).
7. Subs. by s. 35, ibid., “after consultation with the Board” (w.e.f. 1-2-1983).
35
(b) prescribe the qualifications and duties of Government Analysts and the
qualifications of Inspectors;
(c) prescribe the methods of test or analysis to be employed in determining whether any
1
[Ayurvedic, 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 1
[Ayurvedic, Siddha or
Unani] drugs 2
[and for sale of processed Ayurvedic, Siddha or Unani drugs,] the form of
application for such licences, the conditions subject to which such licences may be issued,
the authority empowered to issue the same and the fees payable therefor; 2
[and provide for
the cancellation or suspension of such licences in any case where any provision of this
Chapter or rules made thereunder is contravened or any of the conditions subject to which
they are issued is not complied with];
3
[(f) prescribe the conditions to be observed in the packing of Ayurvedic, Siddha and
Unani drugs including the use of packing material which comes into direct contact with the
drugs, regulate the mode of labelling packed 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 1
[Ayurvedic, Siddha
or Unani] drugs may be manufactured for the purpose of examination, test or analysis;
and
4
[(gg) prescribe under clause (d) of section 33EE the colour or colours which an
Ayurvedic, Siddha or Unani drug may bear or contain for purposes of colouring;
(gga) prescribe the standards for Ayurvedic, Siddha or Unani drugs under
section 33EB;]
5
[(ggb) prescribe the records, registers or the documents to be kept and
maintained under section 33KB; and]
(h) any other matter which is to be or may be prescribed under this Chapter.
33-O. Power to amend First Schedule.—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.