Source: http://peractolegal.com/the-drugs-and-cosmetics-act-1940/
Timestamp: 2019-04-20 20:52:06+00:00

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(1) This Act may be called the Drugs 1[and Cosmetics] Act, 1940.
(2) It extends to the whole of India 2[***].
1. Ins. by Act 21 of 1962, sec. 3 (w.e.f. 27-7-1964).
2. The words “except the State of Jammu and Kashmir” omitted by Act 19 of 1972, sec. 2 (w.e.f. 31-5-1972).
3. 1st April, 1947; see Notification No.F. 28(10) (3) 45H(I), dated 2nd September, 1946, Gazette of India, 1946, Pt. I, p. 1349.
Chapter IV came into force in the States of Delhi, Ajmer and Coorg on 1st April, 1947, see Notification No. F. 28 (10)(3) 45H(I), Chapters III and IV came into force in the States of Himachal Pradesh, Bilaspur, Kutch, Bhopal, Tripura, Vindhya Pradesh and Manipur on 1st April, 1953, vide Notification No. S.R.O. 663, dated 30th March, 1953, Gazette of India, Pt. II, Sec. 3, p. 451.
Chapter IV came into force in the Union Territory of Dadra and Nagar Haveli w.e.f. 1st August, 1968, see Notification No. ADM/Law/117(74), dated 20th July, 1968, Gazette of India, Pt. III, Sec. 3, p. 128. The Act is extended to Dadra and Nagar Haveli by Reg. 6 of 1963, sec. 2 and Sch. I; to Pondicherry by Reg. 7 of 1963, sec. 3 and Sch. I; to Goa, Daman and Diu by Reg. 11 of 1963, sec. 3 and Sch. and to Laccadive, Minicoy and Amindivi Islands by Reg. 8 of 1965, sec. 3 and Sch.
4. Added by Act 19 of 1972, sec. 2 (w.e.f. 31-5-1972).
5. 24th August, 1974, vide Notification No. S.O. 2185, dated 9th August, 1974, published in the Gazette of India, 1974, Pt. II, Sec. 3(ii), p. 2331.
The provisions of this Act shall be in addition to, and not in derogation of, the Dangerous Drugs Act, 1930, and any other law for the time being in force.
(i) It is not necessary that the article should be applied to the whole body. If it is applied to a part of the body and if it beautifies or promotes attractiveness or alters appearance then also it will be a cosmetic within the meaning of the Drugs and Cosmetics Act, 1940; State of Bombay v. Zahid Hussain, 1975 Mah LJ 455.
(ii) ‘Gandh’ and ‘nail polish’ are ‘cosmetics’ within the meaning of the Act; State of Bombay v. Zahid Hussain, 1975 Mah LJ 455.
(i) The definition of ‘drug’ is an inclusive one. It includes all medicines for external or internal use of human beings or animals or any substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of diseases in human beings or animals; Langamurti v. State of Orissa, (1973) 1 CWR 368.
(ii) The appropriate meaning of the expression ‘substances’ in the section is things; Chimanlal J. Sheth v. State of Maharashtra, AIR 1963 SC 665.
(iii) Water meant to be used for dissolving other medicines for injection into human body is ‘drug’; R.C. Sundarka v. State of West Bengal, 1971 Cr LJ 1369: 77 CWN 437.
2.Subs. by Act 68 of 1982, sec. 2, for “Ayurvedic (including Siddha) or Unani” (w.e.f. 1-2-1983).
3.Subs. by Act 68 of 1982, sec. 3, for “disease in human beings, mentioned in, and processed and manufactured” (w.e.f. 1-2-1983).
4.Subs. by Act 68 of 1982, sec. 3, for “Ayurvedic (including Siddha) and Unani (Tibb) system of medicine” (w.e.f. 1-2-1983).
5.Original clause (a) relettered as clause (aa) and subs. by Act 13 of 1964, sec. 2 (w.e.f. 15-9-1964).
7.Clause (aa) ins. by Act 21 of 1962, sec. 4 (w.e.f. 27-7-1964) and relettered as clause (aaa) by Act 13 of 1964, sec. 2 (w.e.f. 15-9-1964).
8.The words “, but does not include soap” omitted by Act 68 of 1982, sec. 3 (w.e.f. 1-2-1983).
9.Subs. by Act 11 of 1955, sec. 2, for clause (b) (w.e.f. 15-4-1955).
10.Subs. by Act 68 of 1982, sec. 3, for sub-clause (i) (w.e.f. 1-2-1983).
11.Subs. by Act 13 of 1964, sec. 2, for “vermins” (w.e.f. 15-9-1964).
12.Ins. by Act 68 of 1982, sec. 3 (w.e.f. 1-2-1983).
13.Subs. by Act 13 of 1964, sec. 2, for clause (c) (w.e.f. 15-9-1964).
14.Subs. by Act 68 of 1982, sec. 2, for “Ayurvedic (including Siddha) or Unani” (w.e.f. 1-2-1983).
15.Clause (d) omitted by Act 19 of 1972, sec. 3 (w.e.f. 31-5-1972).
16.Subs. by Act 13 of 1964, sec. 2, for clause (e) (w.e.f. 15-9-1964).
18.Ins. by Act 21 of 1962, sec. 4 (w.e.f. 27-7-1964).
20.Subs. by Act 21 of 1962, sec. 4, for “or packing of any drug”.
21.Clauses (c), (d) and (e) relettered as clauses (g), (h) and (i) respectively by Act 35 of 1960, sec. 2 (w.e.f. 16-3-1961).
22.Subs. by Act 3 of 1951, sec. 3 and Sch., for “the States”.
23.Clause (d) relettered as clause (h) by Act 35 of 1960, sec. 2 (w.e.f. 16-3-1961) and subs. by Act 68 of 1982, sec. 3 (w.e.f. 1-2-1983).
24.Clause (e) subs. by Act 11 of 1955, sec. 2 (w.e.f. 15-4-1955) and relettered as clause (i) by Act 35 of 1960, sec. 2 (w.e.f. 16-3-1961).
25.Clause (f) ins. by the A.O. 1950 and omitted by Act 3 of 1951, sec. 3 and Sch.
(v) I.V. Cannulac (x) Internal Prosthetic Replacements.
1[3A. Construction of references to any law not in force or any functionary not in existence in the State of Jammu and Kashmir.
Any reference in this Act to any law which is not in force, or any functionary not in existence, in the State of Jammu and Kashmir, shall, in relation to that State, be construed as a reference to the corresponding law in force, or to the corresponding functionary in existence, in that State.
1. Ins. by Act 19 of 1972, sec. 4 (w.e.f. 31-5-1972).
Any substance specified as poisonous by rule made under Chapter III or Chapter IV 1[or Chapter IVA] shall be deemed to be a poisonous substance for the purpose of Chapter III or Chapter IV 1[or Chapter IVA], as the case may be.
(4) The Board may, subject to the previous approval of the Central Government, make bye-laws fixing a quorum and regulating its own procedure and the conduct of all business to be transacted by it.
(5) The Board may constitute sub-committees and may appoint to such sub-committees for such periods, not exceeding three years, as it may decide, or temporarily for the consideration of particular matters, persons who are not members of the Board.
(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.
1. Subs. by Act 13 of 1964, sec. 4, for sub-section (2) (w.e.f. 15-9-1964).
2. Subs. by Act 13 of 1964, sec. 4, for the Proviso (w.e.f. 15-9-1964).
Provided that, if the Central Government so prescribes, the functions of the Central Drugs Laboratory in respect of any drug or class of drugs 1[or cosmetic or class of cosmetics] shall be carried out at the Central Research Institute, Kasauli, or at any other prescribed Laboratory and the functions of the Director of the Central Drugs Laboratory in respect of such drug or class of drugs 1[or such cosmetic or class of cosmetics] shall be exercised by the Director of that Institute or of that other Laboratory, as the case may be.
(f) the matters necessary to be prescribed for the purposes of the proviso to sub-section (1).
1. Ins. by Act 21 of 1962, sec. 5 (w.e.f. 27-7-1964).
2. Clauses (b) and (c) omitted by Act 11 of 1955, sec. 4 (w.e.f. 15-4-1955).
3. Subs. by Act 13 of 1964, sec. 5, for “under Chapter IV” (w.e.f. 15-9-964).
(1) The Central Government may constitute an advisory committee to be called “the Drugs Consultative Committee” to advise the Central Government, the State Governments and the Drugs Technical Advisory Board on any matter tending to secure uniformity throughout 1[ India] in the administration of this Act.
(2) The Drugs Consultative Committee shall consist of two representatives of the Central Government to be nominated by that Government and one representative of each State Government to be nominated by the State Government concerned.
(3) The Drugs Consultative Committee shall meet when required to do so by the Central Government and shall have power to regulate its own procedure.
1. Ins. by Act 3 of 1951, sec. 3 and Sch., for “the States”.
1. Ins. by Act 13 of 1964, sec. 6 (w.e.f. 15-9-1964).
2. Subs. by Act 68 of 1982, sec. 2, for “Ayurvedic (including Siddha) or Unani” (w.e.f. 1-2-1983).
(2) 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 2[the Second Schedule], for the purposes of this Chapter, and thereupon 2[the Second Schedule] shall be deemed to be amended accordingly.
1. Subs. by Act 21 of 1962, sec. 6, for sub-section (1) (w.e.f. 27-7-1964).
2. Subs. by Act 13 of 1964, sec. 7, for “the Schedule” (w.e.f. 15-9-1964).
1. Subs. by Act 68 of 1982, sec. 5, for section 9 (w.e.f. 1-2-1983).
(f) If any substance has been mixed therewith so as to reduce its quality or strength.
1. Section 9A ins. by Act 21 of 1962, sec. 7 and subs. by Act 68 of 1982, sec. 6 (w.e.f. 1-2-1983).
(e) If it purports to be the product of a manufacturer of whom it is only truly a product.
1. Section 9B ins. by Act 13 of 1964, sec. 8 (w.e.f. 15-9-1964) and subs. by Act 68 of 1982, sec. 6 (w.e.f. 1-2-1983).
(c) If the label or container or anything accompanying the cosmetic bears any statement, which is false or misleading in any particular.
1. Ins. by Act 68 of 1982, sec. 6 (w.e.f. 1-2-1983).
Provided further that the Central Government may, after consultation with the Board, by notification in the Official Gazette, permit, subject to any conditions specified in the notification, the import of any drug or class of drugs not being of standard quality.
Any import of goods, of which the importation is prohibited by law, cannot be a valid import under the Act. So, goods so imported cannot be treated to be lawfully ‘imported goods’; S. Mohammed v. Asstt. Collector, Customs, AIR 1970 Cal 134.
2.Ins. by Act 21 of 1962, sec. 8 (w.e.f. 27-7-1964).
3.Subs. by Act 21 of 1962, sec. 8, for clause (b) (w.e.f. 27-7-1964).
4.Subs. by Act 68 of 1982, sec. 7, for “or misbranded cosmetic” (w.e.f. 1-2-1983).
5.Ins. by Act 13 of 1964, sec. 9 (w.e.f. 15-9-1964).
6.Subs. by Act 68 of 1982, sec. 7, for “adulterated” (w.e.f. 1-2-1983).
7.Subs. by Act 11 of 1955, sec. 5, for clause (d) (w.e.f. 15-4-1955).
8.Subs. by Act 68 of 1982, sec. 7, for certain words (w.e.f. 1-2-1983).
9.Ins. by Act 21 of 1962, sec. 8 (w.e.f. 27-7-1964).
10.Explanation omitted by Act 68 of 1982, sec. 7 (w.e.f. 1-2-1983).
1[10A. Power of Central Government to prohibit import of drugs and cosmetics in public interest.
Without prejudice to any other provision contained in this Chapter, if the Central Government is satisfied that the use of any drug or cosmetic is likely to involve any risk to human beings or animals or that any drug does not have the therapeutic value claimed for it or contains ingredients and in such quantity for which there is no therapeutic justification and that in the public interest it is necessary or expedient so to do then, that Government may, by notification in the Official Gazette, prohibit the import of such drug or cosmetic.
The Central Government on the basis of the expert advice can indeed adopt an approved national policy and prescribe an adequate number of formulations which would on the whole meet the requirement of the people at large. While laying the guidelines on this score, injurious drugs should be totally eliminated from the market; Vincent Panikurlangara v. Union of India, AIR 1987 SC 990.
1. Ins. by Act 68 of 1982, sec. 8 (w.e.f. 1-2-1983).
(1) The law for the time being in force relating to sea customs and to goods, the import of which is prohibited by section 18 of the Sea Customs Act, 1878 (8 of 1878)1 shall, subject to the provisions of section 13 of this Act, apply in respect of drugs 2[and cosmetics] the import of which is prohibited under this Chapter, and officers of Customs and officers empowered under that Act to perform the duties imposed thereby on a 3[Commissioner of Customs] and other officers of Customs, shall have the same powers in respect of such drugs 4[and cosmetics] as they have for the time being in respect of such goods as aforesaid.
(i) The tainted goods may be confiscated without proceeding personally against any person and without coming to a finding as to who was the smuggler; Shermal Jain v. Collector of Central Excise, AIR 1956 Cal 621.
(ii) Mere unlawful possession of prohibited goods does not lead to conclusion that the goods had been imported unlawfully. Onus is on the custom authorities to prove the breach of prohibition order; Kanungo & Co. v. Collector of Customs, AIR 1965 Cal 248: (1965) 1 Cri LJ 547.
1. Now see the Customs Act, 1962 (52 of 1962).
2. Ins. by Act 21 of 1962, sec. 9 (w.e.f. 27-7-1964).
3. Subs. by Act 22 of 1995, sec. 83, for “Customs Collector” (w.e.f. 26-5-1995).
4. Ins. by Act 21 of 1962, sec. 9 (w.e.f. 27-7-1964).
5. Subs. by Act 11 of 1955, sec. 6, for sub-section (2) (w.e.f. 15-4-1955).
6. Subs. by Act 22 of 1995, sec. 83, for “Customs Collector” (w.e.f. 26-5-1995).
7. Ins. by Act 21 of 1962, sec. 9 (w.e.f. 27-7-1964).
(o) provide for the exemption, conditionally or otherwise, from all or any of the provisions of this Chapter or the rules made thereunder of any specified drug or class of drugs 11[or cosmetics or class of cosmetics].
1. Subs. by Act 68 of 1982, sec. 9, for “after consultation with the Board” (w.e.f. 1-2-1983).
2. Ins. by Act 11 of 1955, sec. 7 (w.e.f. 15-4-1955).
3. Ins. by Act 21 of 1962, sec. 10 (w.e.f. 27-7-1964).
4. Subs. by Act 68 of 1982, sec. 9, for certain words (w.e.f. 1-2-1983).
5. Ins. by Act 13 of 1964, sec. 10 (w.e.f. 15-9-1964).
6. Subs. by Act 68 of 1982, sec. 9 for “section 9B” (w.e.f. 1-2-1983).
7. Subs. by Act 11 of 1955, sec. 7, for “to cure or mitigate” (w.e.f. 15-4-1955).
8. Ins. by Act 21 of 1962, sec. 10 (w.e.f. 27-7-1964).
9. Subs. by Act 3 of 1951, sec. 3 and Sch., for “the States”.
10. Ins. by Act 68 of 1982, sec. 9 (w.e.f. 1-2-1983).
11. Ins. by Act 21 of 1962, sec. 10 (w.e.f. 27-7-1964).
(a) Any drug deemed to be adulterated under section 9A or deemed to be a spurious drug under section 9B or any spurious cosmetic referred to in section 9D or any cosmetic of the nature referred to in clause (ee) of section 10 shall be punishable with imprisonment for a term which may extend to three years and a fine which may extend to five thousand rupees .
(c) Any drug or cosmetic in contravention of the provisions of any notification issued under section 10A, shall be punishable with imprisonment for a term which may extend to three years, or with fine which may extend to five thousand rupees, or with both.
(b) Under clause (b) of sub-section (1), is again convicted of an offence under that clause, shall be punishable with imprisonment for a term which may extend to one year, or with fine which may extend to one thousand rupees, or with both.
(3) The punishment provided by this section shall be in addition to any penalty to which the offender may be liable under the provisions of section 11.
Oral evidence can be led to prove previous conviction only if the original judgement of previous conviction has been lost; City Board Saharampur v. Abdul Waheed, AIR 1959 All 695.
1. Subs. by Act 68 of 1982, sec. 10, for section 13 (w.e.f. 1-2-1983).
Where any offence punishable under section 13 has been committed, the consignment of the drugs 1or cosmetics] in respect of which the offence has been committed shall be liable to confiscation.
1. Ins. by Act 21 of 1962, sec. 11 (w.e.f. 27-7-1964).
No Court inferior to that 1[of a Metropolitan Magistrate or of a Judicial Magistrate of the first class] shall try an offence punishable under section 13.
1. Subs. by Act 68 of 1982, sec. 11, for certain words (w.e.f. 1-2-1983).
(2) The 3[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 2[the Second Schedule] for the purposes of this Chapter, and thereupon 2[the Second Schedule] shall be deemed to be amended accordingly.
The standards of qualities are fixed by the Government after due deliberation and after consulting a committee of competent men, it is for them to give due allowance for probable errors before fixing a standard. When a standard has been fixed it has to be observed strictly; State of Kerala v. Vasudevan Nair, 1974 KLT 617 (FB): 1975 Cri LJ 97.
1. Subs. by Act 21 of 1962, sec. 12, for sub-section (1) (w.e.f. 27-7-1964).
2. Subs. by Act 13 of 1964, sec. 11, for “the Schedule” (w.e.f. 15-9-1964).
3. Subs. by Act 11 of 1955, sec. 8, for “State Government” (w.e.f. 15-4-1955).
(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.
1. Subs. by Act 68 of 1982, sec. 13, for section 17 (w.e.f. 1-2-1983).
(e) If it purports to be the product of a manufacturer of whom it is not truly a product.
(c) If the label or container or anything accompanying the cosmetic bears any statement which is false or misleading in any particular.
(d) If it purports to be the product of a manufacturer of whom it is not truly a product.
1. Ins. by Act 68 of 1982, sec. 13 (w.e.f. 1-2-1983).
1[18A. Disclosure of the name of the manufacturer, etc. Every person, not being the manufacturer of a drug or cosmetic 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 drug or cosmetic.
On a reading of section 18A and sub-section (4) of section 23 together, it is clear that out of the four portions into which the sample has been divided one portion should be sent to the person, if any, whose name and address and other particulars have been disclosed under section 18A; in re: R. Dayalan, 1978 Cri LJ 1852: (1979) 1 FAC 29.
1. Ins. by Act 13 of 1964, sec. 14 (w.e.f. 15-9-1964).
118B. Maintenance of records and furnishing of information. Every person holding a licence under clause (c) of section 18 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.
1. Ins. by Act 68 of 1982, sec. 15 (w.e.f 1-2-1983).
(1) Save as hereinafter provided in this section, it shall be no defence in a prosecution under this Chapter to prove merely that the accused was ignorant of the nature, substance or quality of the drug 1[or cosmetic] in respect of which the offence has been committed or of the circumstances of its manufacture or import, or that a purchaser, having bought only for the purpose of test or analysis, has not been prejudiced by the sale.
(b) in the process of manufacture, preparation or conveyance some extraneous substance has unavoidably become intermixed with it: provided that this clause shall not apply in relation to any sale or distribution of the drug 4[or cosmetic] occurring after the vendor or distributor became aware of such intermixture.
All that the prosecution is required to prove in order to establish the contravention of section 18 is the fact that the accused had sold or exhibited for sale the drug which was not of standard quality or which was a misbranded drug. If the accused want to get rid of the effect of the prosecution evidence then it is for them to establish the defences which are available to them under sub-section (3) of section 19 of the Act; Public Prosecutor v. Hatambhai, AIR 1969 AP 99.
1. Ins. by Act 21 of 1962, sec. 15 (w.e.f. 27-7-1964).
2. Subs. by Act 13 of 1964, sec. 15, for certain words (w.e.f. 15-9-1964).
3. Subs. by Act 68 of 1982, sec. 16, for “adulterated” (w.e.f. 1-2-1983).
4. Ins. by Act 21 of 1962, sec. 15 (w.e.f. 27-7-1964).
5. Clause (aa) ins. by Act 11 of 1955, sec. 10 (w.e.f. 15-4-1955) and omitted by Act 13 of 1964, sec. 15 (w.e.f. 15-9-1964).
6. Subs. by Act 13 of 1964, sec. 15, for sub-section (3) (w.e.f. 15-9-1964).
1[20. Government Analysts.—(1) The 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 in the State and in respect of such drugs or 2[classes of drugs or such cosmetics or classes of cosmetics] as may be specified in the notifications.
(2) The Central Government may also, by notification in the Official Gazette, appoint such persons as it thinks fit, having the prescribed qualifications, to be Government Analysts in respect of such drugs or 2[classes of drugs or such cosmetics or classes of cosmetics] as may be specified in the notification.
The Director of Central Laboratory is also a Government Analyst; Ram Shankar Misra v. State of U.P., (1980) 1 SCC 255.
1. Subs. by Act 35 of 1960, sec. 4, for section 20 (w.e.f. 16-3-1961).
2. Subs. by Act 21 of 1962, sec. 16, for “class of drugs” (w.e.f. 27-7-1964).
3. Ins. by Act 68 of 1982, sec. 17 (w.e.f. 1-2-1983).
1[21. 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, the drugs or 2[classes of drugs or cosmetics or classes of cosmetics] in relation to which 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 3[in the import, manufacture or sale of drugs or cosmetics] shall be appointed to be an Inspector under this section.
Judicial notice can be taken of the fact of a person being appointed as Inspector of Drugs under section 21(1) of the Act when the relevant notification published in the Official Gazette has been referred to; Ramlagun Singh v. State of Bihar, AIR 1960 Pat 243.
1. Subs. by Act 35 of 1960, sec. 4, for section 21 (w.e.f. 16-3-1961).
2. Subs. by Act 21 of 1962, sec. 17 for “class of drugs” (w.e.f. 27-7-1964).
3. Subs. by Act 21 of 1962, sec. 17, for “in the manufacture, import or sale of drugs” (w.e.f. 27-7-1964).
4. Ins. by Act 68 of 1982, sec. 18 (w.e.f. 1-2-1983).
(d) exercise such other powers as may be necessary for carrying out the purposes of this Chapter or any rules made thereunder.
(2) The provisions of 6[the Code of Criminal Procedure, 1973 (2 of 1974)] shall, so far as may be, apply to any search or seizure under this Chapter as they apply to any search or seizure made under the authority of a warrant issued under 7[section 94] of the said Code.
(ii) Since under the Drugs and Cosmetics Act a search or seizure by a Drugs Inspector is equated to a search and seizure under the authority of a warrant, it is not necessary for a Drugs Inspector to record his reasons for making a search; Public Prosecutor v. Mahaveer Prasad, 1972 Cri LJ 1546.
1. Subs. by Act 11 of 1955, sec. 11, for section 22 (w.e.f. 15-4-1955).
2. Subs. by Act 68 of 1982, sec. 19, for clauses (a), (b) and (c) (w.e.f. 1-2-1983).
3. Ins. by Act 35 of 1960, sec. 5 (w.e.f. 16-3-1961).
4. Subs. by Act 68 of 1982, sec. 19, for “in any place mentioned in clause (c)” (w.e.f. 1-2-1983).
5. Ins. by Act 68 of 1982, sec. 19 (w.e.f. 1-2-1983).
6. Subs. by Act 68 of 1982, sec. 19, for “the Code of Criminal Procedure, 1898 (5 of 1898)” (w.e.f. 1-2-1983).
7. Subs. by Act 68 of 1982, sec. 19, for “section 98” (w.e.f. 1-2-1983).
8. Ins. by Act 68 of 1982, sec. 19 (w.e.f. 1-2-1983).
(1) Where an Inspector takes any sample of a drug 1[or cosmetic] under this Chapter, he shall tender the fair price thereof and may require a written acknowledgement therefor.
(2) Where the price tendered under sub-section (1) is refused or where the Inspector seizes the stock of any drug 1[or cosmetic] under clause (c) of section 22, he shall tender a receipt therefor in the prescribed form.
Provided further that where the drug 1[or cosmetic] is made up in containers of small volume, instead of dividing a sample as aforesaid, the Inspector may, and if the drug 1[or cosmetic] 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.
(c) without prejudice to the institution of any prosecution, if the alleged contravention be such that the defect may be remedied by the possessor of the drug 1[or cosmetic], he shall, on being satisfied that the defect has been so remedied, forthwith revoke his order under the said clause.
(i) As required by sub-section (4)(iii) of section 23 read with section 18A, it is the duty of the Drugs Inspector to supply to the person whose particulars are disclosed under section 18A the third portion of the sample; Agarwal Medical and General Stores v. State of M.P., AIR 1973 MP 255.
(ii) The validity of the first proviso to section 23(3) cannot be challenged on the ground that it offends equal protection of law guaranteed by Article 14 of the Constitution as there is no purpose in having an extra portion in cases where the drug is seized from the manufacturer himself; T.Babulal v. Drugs Inspector, Madras, 1969 Cri LJ 699: (1970) 1 MLJ 124.
(iii) When the procedure mentioned in section 23 is not followed in a case, the report of the Government Analyst cannot be treated as conclusive evidence; Dharam Deo Gupta v. State, AIR 1958 All 865: 1958 Cri LJ 1453.
2. Subs. by Act 13 of 1964, sec. 16, for clause (iii) (w.e.f. 15-9-1964).
3. Subs. by Act 68 of 1982, sec. 20, for “a Magistrate” (w.e.f. 1-2-1983).
4. Ins. by Act 35 of 1960, sec. 6 (w.e.f. 16-3-1961).
Every person for the time being in charge of any premises whereon any drug 1[or cosmetic] is being manufactured or is kept for sale or distribution shall, on being required by any Inspector so to do, be legally bound to disclose to the Inspector the place where the drug 1[or cosmetic] is being manufactured or is kept, as the case may be.
(1) The Government Analyst to whom a sample of any drug 1[or cosmetic] has been submitted for test or analysis under sub-section (4) of section 23, shall deliver to the Inspector submitting it a signed report in triplicate in the prescribed form.
(2) The Inspector on receipt thereof shall deliver one copy of the report to the person from whom the sample was taken 2[and another copy to the person, if any, whose name, address and other particulars have been disclosed under section 18A], and shall retain the third copy for use in any prosecution in respect of the sample.
(3) Any document purporting to be a report signed by a Government Analyst under this Chapter shall be evidence of the facts stated therein, and such evidence shall be conclusive unless the person from whom the sample was taken 3[or the person whose name, address and other particulars have been disclosed under section 18A] 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.
(4) Unless the sample has already been tested or analysed in the Central Drugs Laboratory, where a person has under sub-section (3) notified his intention of adducing evidence in controversion of a Government Analyst’s report, the 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 drug1[or cosmetic] produced before the Magistrate under sub-section (4) of section 23 to be sent for test or analysis to the said Laboratory, which shall make the test or analysis and report in writing signed by or under the authority of, the Director of the Central Drugs Laboratory the result thereof, and such report shall be conclusive evidence of the facts stated therein.
(5) The cost of a test or analysis made by the Central Drugs Laboratory under sub-section (4) shall be paid by the complainant or accused as the Court shall direct.
(i) Section 25 does not offend Article 21 of the Constitution as it has sufficiently protected the basic right of an accused to defend himself; T. Babulal v. Drugs Inspector, Madras, 1969 Cri L J 699: (1970) 1 MLJ 124.
(ii) There can be no prejudice to the accused if the Drugs Inspector, instead of sending the sample to the Government Analyst, sends it to a higher authority namely the Central Drugs Laboratory; Ram Shankar Misra v. State of U.P., (1980) 1 SCC 255.
(iii) The Public Analyst can analyse the sample himself or cause it to be analysed by some other person; Bechan v. State, AIR 1966 All 91: 1966 Cri LJ 122.
(iv) It is not necessary to mention in the analysis report the methods or technological processes adopted by the Analyst; Dhian Singh v. Municipal Board, Saharanpur, AIR 1970 SC 318: (1969) 2 SCC 371.
(v) If accused wants to call the Public Analyst as a witness it is his duty to take appropriate steps; Municipal Corporation of Delhi v. Asa Ram, 1972 Cri LJ 1651 (Del).
2. Subs. by Act 13 of 1964, sec. 17, for certain words (w.e.f. 15-9-1964).
3. Subs. by Act 13 of 1964, sec. 17, for “or the said warrantor” (w.e.f. 15-9-1964).
Any person 1[or any recognised consumer association, whether such person is a member of that association or not] shall, on application in the prescribed manner and on payment of the prescribed fee, be entitled to submit for test or analysis to a Government Analyst any drug 2[or cosmetic] 3[purchased by him or it] and to receive a report of such test or analysis signed by the Government Analyst.
1. Ins. by Act 71 of 1986, sec. 2 (w.e.f. 15-9-1987).
2. Ins. by Act 21 of 1962, sec. 15 (w.e.f. 27-7-1964).
3. Subs. by Act 71 of 1986, sec. 2, for “purchased by him” (w.e.f. 15-9-1987).
4. Added by Act 71 of 1986, sec. 2 (w.e.f. 15-9-1987).
The State’s obligation of enforce production of qualitative drugs and elimination of the injurious ones from the market must take within its sweep an obligation to make useful drugs available at reasonable price so as to be within the common man’s reach; Vincent Panikurlangara v. Union of India; AIR 1987 SC 990.
1. Ins. by Act 68 of 1982, sec. 21 (w.e.f. 1-2-1983).
Provided that the Court may for any adequate and special reasons to be recorded in the judgement impose a sentence of imprisonment for a term of less than one year.
The absence of any comma after the word “stocks” clearly indicates that the clause “stocks or exhibits for sale” is one indivisible whole and it contemplates not merely stocking the drugs but stocking the drugs for the purposes of sale and unless all the ingredients of this category are satisfied, section 27 of the Act would not be attracted; Mohd Shabir v. State of Maharashtra, (1979) 1 SCC 568.
1. Section 27 subs. by Act 13 of 1964, sec. 18 (w.e.f. 15-9-1964) and again subs. by Act 68 of 1982, sec. 22 (w.e.f. 1-2-1983).
(ii) Any cosmetic other than a cosmetic referred to in clause (I) above in contravention of any provisions of this Chapter or any rule made there under shall be punishable with imprisonment for a term which may extend to one year or with fine which may extend to one thousand rupees or with both.
1. Section 27A ins. by Act 21 of 1962, sec. 19 (w.e.f. 27-7-1964) and subs. by Act 68 of 1982, sec. 22 (w.e.f. 1-2-1983).
1. Subs. by Act 13 of 1964, sec. 19, for section 28 (w.e.f. 15-9-1964).
2. Ins. by Act 68 of 1982, sec. 23 (w.e.f. 1-2-1983).
3. Subs. by Act 68 of 1982, sec. 23, for “five hundred rupees” (w.e.f. 1-2-1983).
28A – Penalty for not keeping documents, etc., and for non-disclosure of information.
1. Ins. by Act 68 of 1982, sec. 24 (w.e.f. 1-2-1983).
1[28B. Penalty for manufacture, etc., of drugs or cosmetics in contravention of section 26A. Whoever himself or by any other person on his behalf manufacturers or sells or distributes any drug or cosmetic in contravention of the provisions of any notification issued under section 26A, shall be punishable with imprisonment for a term which may extend to three years and shall also be liable to fine which may extend to five thousand rupees.
Whoever uses any report of a test or analysis made by the Central Drugs Laboratory or by a Government Analyst, or any extract from such report, for the purpose of advertising any drug 1 shall be punishable with fine which may extend to five hundred rupees.
The first and the second or the subsequent offences must all relate to the breaches of the provisions of this Act; Kamal Singh v. State, 1957 All L J 9.
1. Subs. by Act 11 of 1955, sec. 14, for section 30 (w.e.f. 15-4-1955).
2. Subs. by Act 68 of 1982, sec. 25, for sub-section (1) (w.e.f. 1-2-1983).
3. Ins. by Act 21 of 1962, sec. 20 (w.e.f. 27-7-1964).
4. Subs. by Act 68 of 1982, sec. 25, for “one thousand rupees” (w.e.f. 1-2-1983).
5. The words “section 28 or” omitted by Act 13 of 1964, sec. 20 (w.e.f. 15-9-1964).
6. Subs. by Act 13 of 1964, sec. 20, for “two years” (w.e.f. 15-9-1964).
(ii) 5[manufacture for sale, or for distribution, sale, or stocking or exhibiting or offering for sale,] or distribution of any drug without a valid licence as required under clause (c) of section 18, any implements or machinery used in such manufacture, sale or distribution and any receptacles, packages or coverings 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].
1. Section 31 re-numbered as sub-section (1) of that section by Act 35 of 1960, sec. 9 (w.e.f. 16-3-1961).
2. Ins. by Act 21 of 1962, sec. 21 (w.e.f. 27-7-1964).
3. Added by Act 13 of 1964, sec. 21 (w.e.f. 15-9-1964).
4. Subs. by Act 68 of 1982, sec. 26, for clause (i) (w.e.f. 1-2-1983).
5. Subs. by Act 68 of 1982, sec. 26, for certain words (w.e.f. 1-2-1983).
6. Sub-section (2) ins. by Act 35 of 1960, sec. 9 (w.e.f. 16-3-1961) and subs. by Act 21 of 1962, sec. 21 (w.e.f. 27-7-1964).
7. Subs. by Act 13 of 1964, sec. 21, for “or is a misbranded drug” (w.e.f. 15-9-1964).
8. Subs. by Act 68 of 1982, sec. 26, for “misbranded or adulterated drug, or misbranded cosmetic” (w.e.f. 1-2-1983).
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.
1. Ins. by Act 13 of 1964, sec. 22 (w.e.f. 15-9-1964).
(2) No court inferior to that of 2 a Metropolitan Magistrate or of a Judicial Magistrate of the first class] shall try an offence punishable under this Chapter.
(3) Nothing contained in this Chapter shall be deemed to prevent any person from being prosecuted under any other law for any act or omission, which constitutes an offence against this Chapter.
1. Ins. by Act 71 of 1986, sec. 3 (w.e.f. 15-9-1987).
2. Subs. by Act 68 of 1982, sec. 27, for “a Presidency Magistrate or of a Magistrate of the first class” (w.e.f. 1-2-1983).
1[32A. Power of Court to implead the manufacturer, etc.—Where, at any time during the trial of any offence under this Chapter alleged to have been committed by any person, 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, notwithstanding anything contained 2[in sub-sections (1), (2) and (3) of section 319 of the Code of Criminal Procedure, 1973 (2 of 1974)], proceed against him as though a prosecution had been instituted against him under section 32.
The object of the section seems to be that such a power enables speedy trial of the really guilty parties; Bhagwandas v. Delhi Admn., (1975) 1 SCC 866 : 1975 Cri L J 1091.
1. Ins. by Act 13 of 1964, sec. 23 (w.e.f. 15-9-1964).
2. Subs. by Act 68 of 1982, sec. 28, for “in sub-section (1) of section 351 of the Code of Criminal Procedure, 1898 (5 of 1898)” (w.e.f. 1-2-1983).
(q) provide for the exemption, conditionally or otherwise, from all or any of the provisions of this Chapter or the rules made thereunder, of any specified drug or class of drugs 17[or cosmetic or class of cosmetics].
It was obligatory on the part of the rule making authority to satisfy the Court that it was necessary in the facts and circumstances of the case to enhance the fees payable for the renewal of licence in the manner as has been sought to be done; Jaiswal Medical Hall v. Union of India, AIR 1988 Pat 266.
1. Subs. by Act 11 of 1955, sec. 15, for sub-section (1) (w.e.f. 15-4-1955).
2. Subs. by Act 68 of 1982, sec. 29, for “after consultation with the Board” (w.e.f. 1-2-1983).
3. Ins. by Act 21 of 1962, sec. 22 (w.e.f. 27-7-1964).
4. Ins. by Act 13 of 1964, sec. 24 (w.e.f. 15-9-1964).
5. Subs. by Act 68 of 1982, sec. 29, for “section 17B” (w.e.f. 1-2-1983).
6. Subs. by Act 68 of 1982, sec. 29, for “for the manufacture for sale” (w.e.f. 1-2-1983).
7. Ins. by Act 21 of 1962, sec. 22 (w.e.f. 27-7-1964).
8. Ins. by Act 68 of 1982, sec. 29 (w.e.f. 1-2-1983).
9. Subs. by Act 11 of 1955, sec. 15, for “to cure or mitigate” (w.e.f. 15-4-1955).
10. Ins. by Act 21 of 1962, sec. 22 (w.e.f. 27-7-1964).
11. Ins. by Act 68 of 1982, sec. 29 (w.e.f. 1-2-1983).
12. Clause (m) omitted by Act 13 of 1964, sec. 24 (w.e.f. 15-9-1964).
13. Subs. by Act 35 of 1960, sec. 10, for clause (n) (w.e.f. 16-3-1961).
14. Ins. by Act 68 of 1982, sec. 29 (w.e.f. 1-2-1983).
15. Subs. by Act 21 of 1962, sec. 22, for “the drugs or class of drugs” (w.e.f. 27-7-1964).
16. Subs. by Act 13 of 1964, sec. 24, for clause (p) (w.e.f. 15-9-1964).
17. Ins. by Act 21 of 1962, sec. 22 (w.e.f. 27-7-1964).
18. Sub-section (3) ins. by Act 35 of 1960, sec. 10 (w.e.f. 16-3-1961) and omitted by Act 13 of 1964, sec. 24 (w.e.f. 15-9-1964).
1. Ins. by Act 13 of 1964, sec. 25 (w.e.f. 1-2-1969).
This Chapter shall apply only to 1Ayurvedic, Siddha and Unani] drugs.
1. Subs. by Act 68 of 1982, sec. 2, for “Ayurvedic (including Siddha)and Unani” (w.e.f. 1-2-1983).
(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 1Ayurvedic, 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.
(3) The Central Government shall appoint a member of the Board as its Chairman.
but shall be eligible for recombination.
(5) The Board may, subject to the previous approval of the Central Government, make bye-laws fixing quorum and regulating its own procedure and conduct of all business to be transacted by it.
1. Subs. by Act 68 of 1982, sec. 30, for “Ayurvedic and Unani Drugs Technical Adviory Board” (w.e.f. 1-2-1983).
2. Subs. by Act 68 of 1982, sec. 30, for clause (iii) (w.e.f. 1-2-1983).
3. Subs. by Act 68 of 1982, sec. 30, for clause (viii) (w.e.f. 1-2-1983).
4. Subs. by Act 68 of 1982, sec. 30, for clauses (xi) and (xii) (w.e.f. 1-2-1983).
133D. 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, sec. 31, for sections 33D and 33E (w.e.f. 1-2-1983).
Provided that such decomposition is not due to any negligence on the part of the manufacturer of the drug or the dealer thereof and that it does not render the drug injurious to health.
1. Subs. by Act 68 of 1982, sec. 31, for sections 33D and 33E (w.e.f.1-2-1983).
133EEB. Regulation of manufacturer for sale of Ayurvedic, Siddha and Unani drugs.– No person shall manufacture for sale or for distribution any Ayurvedic, Siddha or Unani drug except in accordance with such standards, if any, as may be prescribed in relation to that drug.
(c) Manufacture for sale or for distribution, any Ahyurvedic, 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 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.
(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 Analyst any official not serving under it without the previous consent of the Government under which he is serving.
The opinion of an Analyst, not recognized under section 33F, cannot be relied upon, whatever may be his qualifications; State v. Rajamani, 1982 Cri LJ (NOC) 71.
1. Ins. by Act 68 of 1982, sec. 32 (w.e.f. 1-2-1983).
(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.
(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 and shall be officially sub-ordinate to such authority as the Central Government appointing him may specify in this behalf.
The provisions of sections 22, 23, 24 and 25 and the rules, if any, made there under 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 1Ayurvedic, Siddha or Unani] drug.
1. Subs. by Act 68 of 1982, sec. 2, for “Ayurvedic (including Siddha) or Unani” (w.e.f. 1-2-1983).
(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 three months and with fine which shall not be less than five hundred rupees.
1. Subs. by Act 68 of 1982, sec. 33, for sections 33-I (w.e.f. 1-2-1983).
(c) Under sub-section (2) of section 33I is again convicted of an offence under that sub-section, shall be punishable with imprisonment for a term which may extend to six months and with fine which shall not be less than one thousand rupees.
1. Subs. by Act 68 of 1982, sec. 33, for sections 3J (w.e.f. 1-2-1983).
Where any person has been convicted under this Chapter, the stock of the 1[Ayurvedic, Siddha or Unani] drug, in respect of which the contravention has been made, shall be liable to confiscation.
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 1drug 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.
(1) No prosecution under this Chapter shall be instituted except by an Inspector 1with the previous sanction of the authority specified under sub-section (4) of section 33G].
(2) No Court inferior to that2 of a Metropolitan Magistrate or of a Judicial Magistrate of the first class] shall try an offence punishable under this Chapter.
1. Ins. by Act 68 of 1982, sec. 34 (w.e.f. 1-2-1983).
2. Subs. by Act 68 of 1982, sec. 34, for “of a Presidency Magistrate or of a Magistrate of the first class” (w.e.f. 1-2-1983).
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.
(h) any other matter which is to be or may be prescribed under this Chapter.
1. Subs. by Act 68 of 1982, sec. 35, for “after consultation with the Board” (w.e.f. 1-2-1983).
3. Ins. by Act 68 of 1982, sec. 35 (w.e.f. 1-2-1983).
4. Subs. by Act 68 of 1982, sec. 35, for “clause (f)” (w.e.f. 1-2-1983).
5. Subs. by Act 68 of 1982, sec. 2, for “Ayurvedic (including Siddha) or Unani” (w.e.f. 1-2-1983).
6. Ins. by Act 68 of 1982, sec. 35 (w.e.f. 1-2-1983).
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.
1[2[33P.] Power to give directions.—The Central Government may give such directions to any State Government as may appear to the Central Government to be necessary for carrying into execution in the State any of the provisions of this Act or of any rule or order made there under.
1. Ins. by Act 35 of 1960, sec. 11 (w.e.f. 16-3-1961).
2. Section 33A re-numbered as section 33P by Act 13 of 1964, sec. 27 (w.e.f. 15-9-1964).
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 without its or his knowledge or that such authority or person exercised all due diligence to prevent the commission of such offence.
A Chemist in a bottling company is an officer of the company; Municipal Corporation of Delhi v.G.S. Gujaral, 1972 FAC 621 (del).
1. Ins. by Act 13 of 1964, sec. 28 (w.e.f. 15-9-1964).
(d) Commits, as such Inspector, any other act, to the injury of any person without having reason to believe that such act is required for the execution of his duty shall be punishable with fine which may extend to one thousand rupees.
1. Ins. by Act 68 of 1982, sec. 36 (w.e.f. 1-2-1983).
(1) If any person is convicted of an offence under this Act, 1[the Court before which the conviction takes place shall, on application made to it by the Inspector, cause] the offender’s name, place of residence, the offence of which he has been convicted and the penalty which has been inflicted upon him, to be published at the expense of such person in such newspapers or in such other manner as the Court may direct.
(2) The expenses of such publication shall be deemed to form part of the costs relating to the conviction and shall be recoverable in the same manner as those costs are recoverable.
1. Subs. by Act 68 of 1982, sec. 37, for certain words (w.e.f. 1-2-1983).
Notwithstanding anything contained in 1[***] 2[the Code of Criminal Procedure, 1973 (2 of 1974)], it shall be lawful for 3[any Metropolitan Magistrate or any Judicial Magistrate of the first class] to pass any sentence authorized by this Act in excess of his powers under 1[***] the said Code.
1. The words “section 32 of” omitted by Act 13 of 1964, sec. 29 (w.e.f. 15-9-1964).
2. Subs. by Act 68 of 1982, sec. 38, for “the Code of Criminal Procedure,1898 (5 of 1898)” (w.e.f. 1-2-1983).
3. Subs. by Act 68 of 1982, sec. 38, for “any Presidency Magistrate or any Magistrate of the first class” (w.e.f. 1-2-1983).
1. Ins. by Act 68 of 1982, sec. 39 (w.e.f. 1-2-1983).
No suit, prosecution or other legal proceeding shall lie against any person for anything which is in good faith done or intended to be done under this Act.
Every rule made this Act shall be laid as soon as 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 sessions, 2[and if, before the expiry of the session immediately following the session 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.
1. Ins. by Act 13 of 1964, sec. 30 (w.e.f. 15-9-1964).
2. Subs. by Act 68 of 1982, sec. 40, for certain words (w.e.f. 1-2-1983).
1. Added by G.S.R. 735 (E), dated 28th August, 1987.
2. Subs. by Act 68 of 1982, sec. 41, for the heading “B.—UNANI (TIBB) SYSTEM” (w.e.f. 1-2-1983).
3. Added by G.S.R. 735 (E), dated 28th August, 1987.
4. The brackets, word and figure “(Part I)” omitted by G.S.R. 780 (E), dated 25th November, 2004.
STANDARDS TO BE COMPLIED WITH BY IMPORTED DRUGS AND BY DRUGS MANUFACTURED FOR SALE, SOLD, STOCKED OR EXHIBITED FOR SALE FOR DISTRIBUTED.
1. Patent or proprietary medicines [(Note: Ins. by Notification No. S.O. 887, dated 19th March, 1966, Gazette of India, Pt. II, Sec.3(ii), p.819) other than Homoeopathic medicines]. The formula or list of ingredients displayed in the prescribed manner on the label or container and such other standards as may be prescribed.
22. Substances commonly known as vaccines, sera, toxine, toxoids, antitoxins, and antigens and biological products of such nature. The standards maintained at the International Laboratory for Biological Standards, Stantans Seruminstitut, Copenhagen, and such further standards of strength, quality and purity as may be prescribed.
3. Vitamins, hormones and analogous products. 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.
4. Substances (other than food) intended to affect the structure or any function of the human body or intended to be used for the destruction of vermin or insects which cause disease in human beings or animals. Such standards as may be prescribed.
(a) Drugs included in the Homoeopathic Pharmacopoeia of India. Standards of identity, purity and strength specified in the edition of the Homoeopathic Pharmacopoeia of India for the time being and such other standards as may be prescribed.
(b) Drugs not included in the Homoeopathic Pharmacopoeia of India but which are included in the Homoeopathic Pharmacopoeia of United States of America or the United Kingdom or the German Homoeopathic Pharmacopoeia. Standards of identity, purity and strength prescribed for the drugs in the edition of such Pharmacopoeia for the time being in which they are given and such other standards as may be prescribed.
(c) Drugs not included in the Homoeopathic Pharmacopoeia of India or the United States of America, or the United Kingdom or the German Homoeopathic Pharmacopoeia. The formula or list of ingredients displayed in the prescribed manner on the lable of the container and such other standards as may be prescribed by the Central Government].
(a) Drugs included in the Indian Pharmacopoeia.
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 prescribed.In case the standards of identity, purity and strength for drugs are not specified in the edition of the Indian Pharmacopoeia for the time being in force but are specified in the edition of the Indian Pharmacopoeia immediately preceding, the standards of identity, purity and strength shall be those occurring in such immediately preceding edition of the Indian Pharmacopoeia and such other standards as may be prescribed.
(b) Drugs not included in the Indian Pharmacopoeia but which are included in the official Pharmacopoeia of any other country.
1. Ins. by S.O. 887, dated 19th March, 1966.
2. Subs. by G.S.R. 299 (E), dated 23rd April, 1984.
3. Omitted by G.S.R. 299 (E), dated 23rd April, 1984.
4. Subs. by G.S.R. 820, dated 6th June, 1978.
5. Subs. by G.S.R. 883, dated 18th August, 1973.

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