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  Indian Laws and Regulations Related to Health
Drugs and Cosmetics Act, 1940 - Penalty for subsequent offences

Introduction

Definitions

The Central Drugs Laboratory

The Drugs Consultative Committee

Prohibition of import of certain drugs or cosmetics

Standards of quality

Prohibition of manufacture and sale or certain drugs and cosmetics

Inspectors

Penalty for subsequent offences

Confiscation

Chapter not to apply to [Ayurvedic, Siddha or Unani] drugs

Power to give directions

Offences by Government Departments

First Schedule

Second Schedule

26. Purchaser of drug or cosmetic enabled to obtain test or analysis. – Any person [(Note: Ins. by Act 71 of 1986, sec.2 (w.e.f. 15-9-1987)) 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 [(Note: Ins. by Act 21 of 1962, sec.15 (w.e.f. 27-7-1964)) or cosmetic] [(Note: Subs. by Act 71 of 1986, sec.2) purchased by him or it] and to receive a report of such test or analysis signed by the Government Analyst.

[(Note: Added by Act 71 of 1986, sec.2) Explanation. – For the purposes of this section and section 32, "recognised consumer association" means a voluntary consumer association registered under the Companies Act, 1956 or any other law for the time being in force.]

26A. Powers of Central Government to prohibit manufacture, etc., of drug and cosmetic 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 or purported to be 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 manufacture, sale or distribution of such drug or cosmetic.]

COMMENT

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.

27. Penalty for manufacture, sale,of drugs in contravention of this Chapter. – Whoever, himself or by any other person on his behalf, manufacturers for sale or for distribution, or sells, or stocks or exhibits or offers for sale or distributes,-

(a) any drug deemed to be adulterated under section 17A or spurious under section 17B or which when used by any person for or in the diagnosis, treatment, mitigation, or prevention of any disease or disorder is likely to cause his death or is likely to cause such harm on his body as would amount to grievous hurt within the meaning of section 320 of the Indian Penal Code solely on account of such drug being adulterated or spurious or not of standard quality, as the case may be, shall be punishable with imprisonment for a term which shall not be less than five years but which may extend to a term of life and with fine which shall not be less than ten thousand rupees ;

(b) any drug —

(i) deemed to be adulterated under section 17A, but not being a drug referred to in clause (a), or

(ii) without a valid licence as required under clause © of section 18, 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 five thousand rupees :

Provided that the Court may, for any adequate and special reasons to be recorded in the judgment, impose a sentence of imprisonment for a term of less than one year and of fine of less than five thousand rupees :

(c) any drug deemed to be spurious under section 17B, but not being a drug referred to in clause (a) shall be punishable with imprisonment for a term which shall not be less than three years but which may extend to five years and with fine which shall not be less than five thousand rupees :

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 three years but not less than one year,

(d) any drug, other than a drug referred to in clause (a) or clause (b) or clause (c), in contravention of any other provision of this Chapter or any rule made there under, shall be punishable with imprisonment for a term which shall not be less than one year but which may extend to two years and with fine :

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.

COMMENT

"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.

27A. Penalty for manufacture, sale, etc., of cosmetics in contravention of this Chapter. – Whoever himself or by any other person on his behalf manufacturers for sale or for distribution, or sells, or stocks or exhibits or offers for sale –

(i) Any cosmetic deemed to be spurious under section 17C shall be punishable with imprisonment for a term, which may extend to three years and with fine ;

(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.

28. Penalty for non-disclosure of the name of the manufacturer,.— Whoever contravenes the provisions of section 18A [or section 24] 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.

28A. Penalty for not keeping documents., and for non-disclosure of information. — Whoever without reasonable cause or excuse, contravenes the provision of section 18B 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 both.

29. Penalty for use of Government Analyst’s report for advertising. – 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 [(Note: Ins. by Act 21 of 1962, sec.15 (w.e.f. 27-7-1964)) or cosmetic], shall be punishable with fine which may extend to five hundred rupees.

30. Penalty for subsequent offences. – [(1) (Note: Subs. by Act 68 of 1982, sec.25, for sub-section (1) (w.e.f. 1-2-1983)) Whoever having been convicted of an offence, --

(a) Under clause (b) of section 27 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 extend to six years and with fine which shall not be less than ten thousand rupees :

Provided that the Court may, for any adequate and special reasons to be mentioned in the judgement, impose a sentence of imprisonment for a term of less than two years and of fine of less than ten thousand rupees :

(b) Under clause (c) of section 27, 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 extend to four years or with fine which shall not be less than five thousand rupees, or with both.]

(c) Under clause (d) of section 27, 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 extend to four years or with fine which shall not be less than five thousand rupees, or with both.]

[(1A) (Note: Ins. by Act 21 of 1962, sec.20 (w.e.f. 27-7-1964)) Whoever, having been convicted of an offence under section 27A is again convicted under that section, shall be punishable with imprisonment for a term which may extend to two years, or with fine which may extend to [(Note: Subs. by Act 68 of 1982, sec.25, for "one thousand rupees" (w.e.f. 1-2-1983)) two thousand rupees], or with both.]

(2) Whoever, having been convicted of an offence under (Note: The words and figures "section 28 or" omitted by Act 13 of 1964, sec.20 (w.e.f. 15-9-1964)) section 29 is again convicted of an offence under the same section, shall be punishable with imprisonment which may extend to [(Note: Subs. by Act 13 of 1964, sec.20, for "two years") ten years], or with fine, or with both.]

COMMENT

The first and the second or the subsequent offences must all relate to the branches of the provisions of this Act; Kamal Singh v. State , 1957 All LJ 9.

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Posted by:  san15, India  Posted on: 12/18/2012
Please confirm whether the drug is in JP and not in IP , is it mandatory to claim JP?
Posted by:  mtcgases, India  Posted on: 9/22/2012
there are people who are using a single liquid oxygen tank for both medical and industrial oxygen, and theboth grades liquid oxygen is being transported in the same transport tank, both the grades of oxygen are filled from the same filling manifold, even the liquid oxygen is being imported from bhutan and sold in india, Is it legal as per indian Drug Act.
Posted by:  Shwetaracha06,  Posted on: 9/19/2012
Hi, Mohanjeeva We would like to have your contact details..(Regarding tooth powder)Plz rply or you can mail me mail id : rachashweta06@gmail.com
Posted by:  Mohanjeeva, India  Posted on: 8/29/2012
Sir
We are 100% Merchandise Exporter for the past 10years .We are having a sample Ash tooth powder and we want the detailed test report for the following items in terms of percentage :
1) Ash
2) Potash Alum
3) Menthol
4) Thaimol
5) Amaranth Dye
6) Propylene Glycol
7) Industrial Sweetener (Sacrin)
Kindly advise us to whom we have to proceed for the above particulars .
Awaiting your early reply .
Rgds
Posted by:  indianguy, India  Posted on: 8/22/2012
sir, where can i get the information of schedule T for manufacturing of an ayurvedic drugs.
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