Chapter V Chapter V

(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.

(1) An application for an import licence for small quantities of a new drug, as defined in Rule 122-E for the purpose of treatment of patients suffering from life threatening diseases, or diseases causing serious permanent disability, or such diseases requiring therapies for unmet medical needs, shall be made in Form 12-AA, by a Medical Officer of the Government Hospital or Autonomous Medical Institution, which shall be certified by the Medical Superintendent of the Government Hospital or Head of the Autonomous Medical Institution, as the case may be. (2) The licensing authority may require such further particulars to be supplied, as he may consider necessary. (3) Every application in Form 12-AA shall be accompanied by a fee of Rs. 100 for a single drug and an additional fee of Rs. 50 for each additional drug. (4) The fees shall be paid through a challan in the Bank of Baroda, Kasturba Gandhi Marg, New Delhi-110001 or any other branch or branches of Bank of Baroda, or any other Bank, as notified, from time to time, by the Central Government, to be credited under the Head of Account 0210- Medical and Public Health, 04- Public Health, 104- Fees and Fine.

Any Inspector exercising powers under this Act or the rules made thereunder, 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.

(1) If any person is convicted of an offence under this Act, 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 cost relating to the conviction and shall be recoverable in the same manner as those costs are recoverable.

Notwithstanding anything contained in the Code of Criminal Procedure, 1973 (2 of 1974) it shall be lawful for any Metropolitan Magistrate or any Judicial Magistrate of the first class to pass any sentence authorised by this Act in excess of his powers under the said Code.

Notwithstanding anything contained in the Code of Criminal Procedure, 1973 (2 of 1974), all offences 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.

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 from 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.

Data relating to the environmental risk assessment for r-DNA products.

(1) If the Director of the laboratory appointed for the purpose by the Central Government or any other officer empowered by him on this behalf, subject to the approval of the Central Government, reports to the Customs Collector that the samples of any drug in a consignment are not of standard quality, or that the drug contravenes in any other respect the provisions of Chapter III of the Act or the Rules thereunder and that the contravention is such that it cannot be remedied by the importer, the Customs Collector shall communicate the report forthwith to the importer who shall, within two months of his receiving the communication either export all the drugs of that description in the consignment, to the country in which they were manufactured or forfeit them to the Central Government which shall cause them to be destroyed : Provided that the importer may within fifteen days of receipt of the report make a representation against the report to the Customs Collector, and the Customs Collector shall forward the representation with a further sample to the licensing authority, who after obtaining, if necessary, the report of the Director of the Central Drugs Laboratory, shall pass orders thereon which shall be final. (2) If the Director of the laboratory appointed for the purpose by the Central Government or any other officer empowered by him on this behalf, subject to the approval of the Central Government reports to the Customs Collector that the samples of any drug contravene in any respect the provisions of Chapter III of the Act or the Rules thereunder and that the contravention is such that it can be remedied by the importer, the Customs Collector shall communicate the report forthwith to the importer and permit him to import the drug on his giving an undertaking in writing not to dispose of the drug without the permission of the officer authorised in this behalf by the Central Government.

The drugs specified in Schedule D shall be exempt from the provisions of Chapter III of the Act and of the Rules made thereunder to the extent, and subject to the conditions specified in that Schedule.

A person appointed as a Government Analyst under the Act shall be a person who— (a) is a graduate in medicine or science or pharmacy or Pharmaceutical Chemistry of a University established in India by law or has an equivalent qualification recognized and notified by the Central Government for such purpose and has had not less than five years’ post-graduate experience in the testing of drugs in a laboratory under control of (i) a Government Analyst appointed under the Act, or (ii) the head of an Institution or testing laboratory approved for the purpose by the appointing authority, or has completed two years’ training on testing of drugs, including items stated in Schedule C, in Central Drugs Laboratory, or (b) possesses a post-graduate degree in medicine or science or pharmacy or Pharmaceutical chemistry of a University established in India by law or has an equivalent qualification recognized and notified by the Central Government for such purpose or possesses the Associateship Diploma of the Institution of Chemists (India) obtained by passing the said examination with ‘Analysis of Drugs and Pharmaceuticals’ as one of the subjects and has had after obtaining the said post-graduate degree or diploma not less than three years’ experience in the testing of drugs in a laboratory under the control of (i) a Government Analyst appointed under the Act, or (ii) the head of an Institution or testing laboratory approved for the purpose by the appointing authority or has completed training on testing of drugs, including items stated in Schedule C, in Central Drugs Laboratory: Provided that- (i) for purpose of examination of items in Schedule C,- (ia) the persons appointed under clause (a) or (b) and having degree in Medicine, Physiology, Pharmacology, Microbiology, Pharmacy should have experience or training in testing of said items in an institution or laboratory approved by the appointing authority for a period of not less than six months; (ib) the person appointed under clause(a) or (b) but not having degree in the above subjects should have experience or training in testing of said Schedule C drugs for a period of not less than three years in an institution or laboratory approved by the appointing authority or have completed two years training on testing of drugs including items stated in Schedule C in Central Drugs Laboratory; (ii) for a period of four years from the date on which Chapter IV of the Act takes effect in the States, persons whose training and experience are regarded by the appointing authority as affording, subject to such further training, if any, as may be considered necessary, a reasonable guarantee of adequate knowledge and competence, may be appointed as Government Analysts. The persons so appointed may, if the appointing authority so desires, continue in service after the expiry of the said period of four years; (iii) no person who is engaged directly or indirectly in any trade or business connected with the manufacture of drugs shall be appointed as a Government Analyst for any area : Provided further that for the purpose of examination of Anti-sera, Toxoid and Vaccines and Diagnostic Antigens for Veterinary use, the person appointed shall be a person who is a graduate in Veterinary Science, or general science, or medicine or pharmacy and has had not less than five years’ experience in the standardization of biological products or person holding a post-graduate degree in Veterinary Science, or general science, or medicine or pharmacy or pharmaceutical chemistry with an experience of not less than three years in the standardization of biological products : Provided also that persons, already appointed as Government Analysts may continue to remain in service, if the appointing authority so desires, notwithstanding the fact that they do not fulfil the qualifications as laid down in clause (a), clause (b) or the preceding proviso.

(1) The Government Analyst shall cause to be analysed or tested such samples or drugs and cosmetics as may be sent to him by Inspectors or other persons under the provisions of Chapter IV of the Act and shall furnish reports of the results of test or analysis in accordance with these Rules. (2) A Government Analyst shall from time to time forward to the Government reports giving the result of analytical work and research with a view to their publication at the discretion of Government.

On receipt of a package from an Inspector containing a sample for test or analysis, the Government Analyst shall compare the seals on the packet or on portion of sample or container with the specimen impression received separately and shall note the condition of the seals on the packet or on portion of sample or container. After the test or analysis has been completed, he shall forthwith supply to the Inspector a report in triplicate in Form 13 of the result of the test or analysis, together with full protocols of the tests or analysis applied: Explanation.—It shall be deemed to be full and sufficient compliance with the requirement of the rule in respect of the supply of “protocols of the tests or analysis applied”, if— (1) for pharmacopoeial drug, where the tests or methods of analysis prescribed in the official pharmacopoeia are followed, references to the specific tests or analysis in the pharmacopoeias are given in the report; (2) for patent or proprietary medicines for which the tests and methods prescribed in any of the official pharmacopoeias are applicable and are followed, references to the specific tests or analysis in the pharmacopoeias are given in the report; (3) for patent or proprietary medicines containing pharmacopoeial drugs for which the official tests or analysis or methods of assays are modified and applied, a description of the actual tests or, as the case may be, analysis or methods of assays so applied is given in the report; (4) for patent or proprietary medicines for which no pharmacopoeial tests or methods of analysis are available or can be applied but for which tests or methods of analysis given in standard books or journals are followed, a description of such tests or methods of analysis applied together with the reference to the relevant books or journals from which the tests or methods of analysis have been adopted, is given in the report; (5) for those drugs for which methods of test are not available and have been evolved by the Government Analyst, a description of tests applied is given in the report.

An application from a purchaser for test or analysis of a drug under section 26 of the Act shall be made in Form 14 A and the report of test or analysis of the drug made on such application shall be supplied to the applicant in Form 14-B.

The fees to be paid by a person submitting to the Government Analyst under section 26 of the Act for test or analysis of a drug purchased by him shall be those specified in Schedule B.

A person who is appointed an Inspector under the Act shall be a person who has a degree in Pharmacy or Pharmaceutical Sciences or Medicine with specialisation in Clinical Pharmacology or Microbiology from a University established in India by law: Provided that only those Inspectors: — (i) Who have not less than 18 months’ experience in the manufacture of at least one of the substances specified in Schedule C, or (ii) Who have not less than 18 months’ experience in testing of at least one of the substances in Schedule C in a Laboratory approved for this purpose by the licensing authority, or (iii) Who have gained experiences of not less than three years in the inspection of firms manufacturing any of the substances specified in Schedule C during the tenure of their services as Drugs Inspectors; shall be authorised to inspect the manufacture of the substances mentioned in Schedule C: Provided further that the requirement as to the academic qualification shall not apply to persons appointed as Inspectors on or before the 18th day of October, 1993.

(1) All Inspectors appointed by the Central Government shall be under the control of an officer appointed in this behalf by the Central Government. (2) All Inspectors appointed by the State Government shall be under the control of an officer appointed in this behalf by the State Government. (3) For the purposes of these rules an officer appointed by the Central Government under sub-rule (1), or as the case may be, an officer appointed by the State Government under sub-rule (2), shall be a controlling authority.

2[54C Ayurvedic Pharmacopoeia of India.]

Siddha

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)

70 Agasthiyar Kanma Soothiram 71 18 Siddar’s Chillarai Kovai 72 Yog 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

1[84 Siddha Formulary of India (Part I)]

2[B.—UNANI TIBB SYSTEM]

Serial No. Name of book

6 Biaz Kabir Vol. II 7 Karabadin Jadid 8 Kitab-ul-Taklis 9 Sanat-ul-Taklis 10 Mifta-ul-Khazain 11 Madan-ul-Aksir 12 Makhzan-ul-murabhat

1[13 National Formulary of Unani Medicine (Part I)]

¹ Ins. by Notifn. No. G.S.R. 735 (E), dated the 28th August, 1987.

² Ins. by Notifn. No. G.S.R. 423 (E), dated the 11th June, 2002.

³ Ins. by Notifn. No. G.S.R. 735 (E), dated the 28th August, 1987.

⁴ Subs. by Act 68 of 1982, s. 41 (w.e.f. 1-2-1983).

_________________________________________________________________________________________________________________________

Drugs and Cosmetics Act, 1940

THE SECOND SCHEDULE

(See sections 8 and 16)

S

TANDARDS TO BE COMPLIED WITH BY IMPORTED DRUGS AND BY DRUGS MANUFACTURED FOR SALE, SOLD,

STOCKED OR EXHIBITED FOR SALE OR DISTRIBUTED

Class of drug

Standard to be complied with 1 2 1. Patent or proprietary medicines

1[other than

Homoeopathic medicines]

2.

2[Substances commonly known as vaccines, sera toxins, toxoids, antitoxins and antigens and biological products of like nature, for human use or for veterinary use.

3* * *

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.

1[4-A. Homoeopathic Medicines.

The formula of list of ingredients displayed in the prescribed manner on the label of the container and such other standards as may be prescribed.

The standards maintained at the International Laboratory for Biological Standards, Stantans Serum Institute, Copenhagen and at the Central Veterinary Laboratory, Weybridge Surrey, U.K., and such other laboratories recognized by the World Health Organization from time to time, and such further standards of strength, quality and purity, as may be prescribed.]

• • * Such standards as may be prescribed.

1. (1) The Standards specified from time to time in the Homoeopathic Pharmacopoeia of the United States

of America or the United Kingdom or Germany for

the medicines included therein.

1. (2) For the Homoeopathic medicines not included in the Homoeopathic Pharmacopoeia of the United States of America or the United Kingdom or Germany, the standards approved by the Central Government and displayed in the prescribed manner on the label of the container.] _________________________________________________________________________________________________

¹ Ins. by Notifn. No. S.O. 887, dated the 19th March 1966, Gazette of India , Pt. II, Sec. 3 (ii), p. 819.

² Subs. by Notifn. No. G.S.R. 299(E), dated the 23rd April 1984.

3. Entry 3 omitted by Notifn. No. G.S.R. 299(E), dated the 23rd April, 1984.

Drugs and Cosmetics Act, 1940

1[5. Other drugs:

1. (a) Drugs included in the Indian Pharmacopoeia
2. (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 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.

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 of such official

Pharmacopoeia and such other standards as may be

prescribed.] Class of drug Standard to be complied with

1 2

¹ Subs. by Notifn. No. G.S.R. 885, dated the 4

_____________________________________________________________________________________________ th August, 1973, Gazette of India, Pt. II, s. 3(i), p. 1643.

DEPARTMENT OF HEALTH NOTFICATION

New Delhi, the 21st December 1945

No. F. 28-10/45-H (1). _ In exercise of the powers conferred by

1[sections 6(2), 12, 33 and 33N] of the Drugs and Cosmetics Act, 1940 (XXIII of 1940), the Central Government is pleased to make the following Rules: __ RULES