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THE DRUGS AND COSMETICS ACT, 1940

Title : THE DRUGS AND COSMETICS ACT, 1940

Year : 1940



(1) Where an offence under this Act has been committed by a company, every person who at the time the offence was committed, was in charge of, and was responsible to the company for the conduct of the business of the company, as well as the company 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 sub-section shall render any such person liable to any punishment provided in this Act if he proves that the offence was committed without his knowledge or that he exercised all due diligence to prevent the commission of such offence.

(2) Notwithstanding anything contained in sub-section (1), where an offence under this Act has been committed by a company and it is proved that the offence has been committed with the consent or connivance of, or is attributable to any neglect on the part of, any director, manager, secretary or other officer of the company, such director, manager, secretary or other officer shall also be deemed to be guilty of that offence and shall be liable to be proceeded against and punished accordingly.

Explanation.-For the purposes of this section-

(a) "Company" means a body corporate, and includes a firm or other association of individuals; and

(b) "Director" in relation to a firm means a partner in the firm.

34A -1* Offences by Government departments

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 without its or his knowledge or that such authority or person exercised all due diligence to prevent the commission of such offence.

34AA -2* Penalty for vexatious search or seizure

Any Inspector exercising powers under this Act or the rules made there under, who,-

(a) Without reasonable ground of suspicion searches any place, vehicle, vessel or other conveyance; or

(b) Vexatiously and unnecessarily searches any person; or

(c) Vexatiously and unnecessarily seizes any drug or cosmetic, or any substance or article, or any record, register, document or other material object; or

(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.]

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1. Inserted by Act 13 of 1964, section 28 (w.e.f. 15-9-1964).

2. Inserted by Act 68 of 1982, section 36 (w.e.f. 1-2-1983).

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(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.

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1. Substituted by Act 68 of 1982, section 37, for certain words (w.e.f. 1-2-1983).

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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.

36A -4* Certain offences to be tried summarily

Notwithstanding anything contained in the Code of Criminal Procedure, 1973, 5*[all offences (except the offences triable by the Special Court under section 36AB or Court of Session) under this Act], punishable with imprisonment for a term not exceeding three years, other than an offence under clause (b) of sub-section (1) of section 33-I, shall be tried in a summary way by a Judicial Magistrate of the first class specially empowered in this behalf by the State Government or by a Metropolitan Magistrate and the provisions of sections 262 to 265 (both inclusive) of the said Code shall, as far as may be, apply to such trial:

Provided that, in the case of any conviction in a summary trial under this section, it shall be lawful for the Magistrate to pass a sentence of imprisonment for a term not exceeding one year:

Provided further that when at the commencement of, or in the course of, a summary trial under this section it appears to the Magistrate that the nature of the case is such that a sentence of imprisonment for a term exceeding one year may have to be passed or that it is, for any other reason, undesirable to try the case summarily, the Magistrate shall, after hearing the parties, record an order to that effect and thereafter recall any witness who has been examined and proceed to hear or rehear the case in the manner provided by the said Code.]

36AB - Special Courts

6*[(1) The Central Government, or the State Government, in consultation with the Chief Justice of the High Court, shall, for trial of offences relating to adulterated drugs or spurious drugs and punishable under clauses (a) and (b) of section 13, subsection (5) of section 22, clauses (a) and (c) of section 27, section 28, section 28A, section 28B and clause (b) of sub-section (1) of section 30 and other offences relating to adulterated drugs or spurious drugs, by notification, designate one or more Courts of Session as a Special Court or Special Courts for such area or areas or for such case or class or group of cases as may be specified in the notification.

Explanation.-In this sub-section, "High Court" means the High Court of the State in which a Court of Session designated as Special Court was functioning immediately before such designation.

(2) While trying an offence under this Act, a Special Court shall also try an offence, other than an offence referred to in sub-section (1), with which the accused may, under the Code of Criminal Procedure, 1973(2 of 1974), be charged at the same trial.]

36AC - Offences to be cognizable and non-bailable in certain cases

6*[(1) Notwithstanding anything contained in the Code of Criminal Procedure, 1973(2 of 1974) -

(a) Every offence, relating to adulterated or spurious drug and punishable under clauses (a) and (c) of sub-section (1) of section 13, clause (a) of subsection (2) of section 13, sub-section (3) of section 22, clauses (a) and (c) of section 27, section 28, section 28A, section 28B and sub-sections (1) and (2) of section 30 and other offences relating to adulterated drugs or spurious drugs, shall be cognizable.

(b) No person accused, of an offence punishable under clauses (a) and (c) of sub-section (1) of section 13, clause (a) of sub-section (2) of section 13, subsection (3) of section 22, clauses (a) and (c) of section 27, section 28, section 28A, section 28B and sub-sections (1) and (2) of section 30 and other offences relating to adulterated drugs or spurious drugs, shall be released on bail or on his own bond unless-

(i) The Public Prosecutor has been given an opportunity to oppose the application for such release; and

(ii) Where the Public Prosecutor opposes the application, the court is satisfied that there are reasonable grounds for believing that he is not guilty of such offence and that he is not likely to commit any offence while on bail:

Provided that a person, who, is under the age of sixteen years, or is a woman or is sick or infirm, may be released on bail, if the Special Court so directs

(2) The limitation on granting of bail specified in clause (b) of sub-section (1) is in addition to the limitations under the Code of Criminal Procedure, 1973(2 of 1974) or any other law for the time being in force on granting of bail.

(3) Nothing contained in this section shall be deemed to affect the special powers of the High Court regarding bail under section 439 of the Code of Criminal Procedure, 1973(2 of 1974) and the High Court may exercise such powers including the power under clause (b) of sub-section (1) of that section as if the reference to "Magistrate" in that section includes also a reference to a "Special Court" designated under section 36AB.]

36AD - Application of Code of Criminal Procedure, 1973 to proceedings before special Court

6*[(1) Save as otherwise provided in this Act, the provisions of the Code of Criminal Procedure, 1973(2 of 1974) (including the provisions as to bails or bonds), shall apply to the proceedings before a Special Court and for the purposes of the said provisions, the Special Court shall be deemed to be a Court of Session and the person conducting the prosecution before the Special Court, shall be deemed to be a Public Prosecutor:

Provided
that the Central Government or the State Government may also appoint, for any case or class or group of cases, a Special Public Prosecutor.

(2) A person shall not be qualified to be appointed as a Public Prosecutor or a Special Public Prosecutor under this section unless he has been in practice as an advocate for not less than seven years, under the Union or a State, requiring special knowledge of law.

(3) Every person appointed as a Public Prosecutor or a Special Public Prosecutor under this section shall be deemed to be a Public Prosecutor within the meaning of clause (u) of section 2 of the Code of Criminal Procedure, 1973(2 of 1974) and the provisions of that Code shall have effect accordingly.]

36AE - Appeal and revision

6*[The High Court may exercise, so far as may be applicable, all the powers conferred by Chapter XXIX or Chapter XXX of the Code of Criminal Procedure, 1973(2 of 1974), on a High Court, as if a Special Court within the local limits of the jurisdiction of the High Court were a Court of Session trying cases within the local limits of the jurisdiction of the High Court.]

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1. The words "section 32 of" omitted by Act 13 of 1964 section 29 (w.e.f. 15-9-1964).

2. Substituted by Act 68 of 1982, section 38, for "the Code of Criminal Procedure, 1898 (5 of 1898)"' (w.e.f. 1-2-1983).

3. Substituted by Act 68 of 1982, section 38, for "any Presidency Magistrate or any Magistrate of the first class" (w.e.f. 1-2-1983).

4. Inserted by Act 68 of 1982 section 39 (w.e.f. 1-2-1983).

5. Substituted by the drug and cosmetics (amendment) act 2008 dated 05.12.2008 for the words "all offences under this Act".

6. Inserted by the drug and cosmetics (amendment) act 2008.

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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 under 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, 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.

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1. Inserted by Act 13 of 1964, section 30 (w. e. f. 15-9-1964).

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1*[THE FIRST SCHEDULE
[See section 3(a)]

2*[A.-AYURVEDIC AND SIDDHA SYSTEMS]

S.No.    Name of books

Ayurveda

1.    Arogya Kalpadruma

2.    Arka Prakasha

3.    Arya Bhishak

4.    Ashtanga Hridaya

5.    Ashtanga Samgraha

6.    Ayurveda Kalpadruma

7.    Ayurveda Prakasha

8.    Ayurveda Samgraha

9.    Bhaishajya Ratnavali

10.   Bharat Bhaishajya Ratnakara

11.   Bhava Prakasha

12.   Brihat Nighantu Ratnakara

13.   Charaka Samhita

14.   Chakra Datta

15.   Gada Nigraha

16.   Kupi Pakva Rasayana

17.   Nighantu Ratnakara

18.   Rasa Chandanshu

19.   Rasa Raja Sundara

20.   Rasaratna Samuchaya

21.   Rasatantra Sara Siddha Prayoga Samgraha
 
11*[21 A Rastantra Sar Va Siddha Prayog Samgraha Part II (Edition 2006).]

22.    Rasa Tarangini

23.    Rasa Yoga Sagara

24.    Rasa Yoga Ratnakara

25.    Rasa Yoga Samgraha

26.    Rasendra Sara Samgraha

27.    Rasa Pradipika

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 Chintamani

36.    Vaidyaka Shabda Sindu

37.    Vaidyaka Chikitsa Sara

38.    Vaidya Jiwan

39.    Basava Rajeeyam

40.    Yoga Ratnakara

41.    Yoga Tarangini

42.    Yoga Chintamani

43.    Kashyapasamhita

44.    Bhelasamhita

45.    Vishwanathachikitsa

46.    Vrindachikitsa

47.    Ayurvedachintamani

48.    Abhinavachintamani

49.    Ayurveda-ratnakar

50.    Yogaratnasangraha

51.    Rasamrita

52.    Dravyagunanighantu

53.    Rasamanijari

54.    Bangasena

3*[54A.12*[Ayurvedic Formulary of India and its Parts]

54B.     Aurveda Sara Sangraha]

5*[54C. Ayurvedic Pharmacopoeia of India]

11*[54D. Ayurvedic Pharmacopoeia of India and its Parts.]Siddha

55.    Siddha Vaidya Thirattu

56.    Therayar Maha Karisal

57.    Brahma Muni Karukkadai (300)

58.    Bhogar (700)

59.    Pulippani (500)

60.    Agasthiyar 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)

68.    Veeramamuni Nasa Kandam

69.    Agasthiyar (600)

70.    Agasthiyar Kanma Soothiram

71.    Siddhar's Chillarai Kovai

72.    Yogi Vatha Kaviyam

73.    Therayar Tharu

74.    Agasthiyar Vaidya Kaviyam (1500)

75.    Bala Vagadam

76.    Chimittu Rathna (Rathna) Churukkam

77.    Nagamuni (200)

78.    Agasthiyar Chillarai Kovai

79.    Chikicha Rathna Deepam

80.    Agasthiyar Nayana Vidhi

81.    Yugi Karisal (151)

82.    Agasthiyar Vallathi (600)

83.    Therayar Thaila Varkam

6*[84.Siddha Formulary of Unani Medicine (Part I)]

11*[85.Siddha Pharmacopoeia of India and its Parts.]

7*[B.-UNANI TIBB SYSTEM]

S.No.   Name of book

1.    Karabadin Qadri

2.    Karabadin Kabir

3.    Karabadin Azam

4.    Ilaj-ul-Amraz

5.    Al Karabadin

6.    Biaz Kabir Vol. II

7.    Karabadin Jadid

8.    Kitalf-ul-Taklis

9.    Sanat-ul-Taklis

10.  Mifta-ul-Khazain

11.  Madan-ul-Aksir

12.  Makhzan-ul-Murabbat

8*[13.National Formulary of Unani Medicine9[* * *]]

10*[14. Unani Pharmacopoeia of India]

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1. Substituted by Act 13 of 1964, section 31, for the Schedule. First Schedule came into force (w.e.f. 1-2-1969) and the Second Schedule came into force (w.e.f. 15-9-1964).

2. Substituted by Act 68 of 1982, section 41, for the heading "A.-AYURVED1C (INCLUDING SIDDHA) SYSTEM" (w.e.f. 1-2-1983).

3. Inserted by G.S.R. 735 (E), dated 28th August, 1987.

4. Omitted by G.S.R. 423 (E), dated 11th June, 2002 (w.e.f. 11-6-2002).

5. Inserted by G.S.R. 423 (E), dated 11th June, 2002 (w.e.f. 11-6-2002).

6. Added by G.S.R. 735 (E), dated 28th August, 1987.

7. Substituted by Act 68 of 1982, section 41, for the heading "B.-UNANI (TIBB) SYSTEM" (w.e.f 1-2-1983).

8. Added by G.S.R. 735 (E), dated 28th August, 1987.

9. The brackets, word and figures "(Part I)" omitted by G.S.R. 72 (E), dated 31st January, 2003.

10. Inserted by G.S.R. 72 (E), dated 31st January, 2003.

11. Inserted by G.S.R. 337(E) dated 15.04.2010.

12. Substituted by G.S.R. 337(E) dated 15.04.2010 previous text was : -
"Aurvedic Formulary of India4[* * *]"
 
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THE SECOND SCHEDULE

(See sections 8 and 16)

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

S.No
  Class of drugStandard to be complied
1.Patent or proprietary medicines1*[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.
2.

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 Serminstitut, 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.
4A
 2* Homoeopathic Medicines:-

(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 label of the container and such other standards as may be prescribed by the Central Government.

5.

3* Other drugs:-

(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 in force 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.
Standards of identity, purity and strength specified for drugs in the edition of such official Pharmacopoeia of any other country for the time being in force 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 such official Pharmacopoeia for the time being in force, but are specified in the edition immediately preceding the standards of identity, purity and strength shall be those occurring in such immediately preceding edition of such official Pharmacopoeia and such other standards as may be prescribed.

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1. Inserted by S.O. 887, dated 19th March, 1966.

2. Substituted by Notification No. G.S.R. 820, dated 6th June, 1978.

3. Substituted by Notification No. G.S.R. 883, dated 18th August, 1973.

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Last updated on October, 2016

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