D pharmacy Second year

1. D & C Act 1940, Rule
there under 1945
Mr G.A.Shete

2.  Objective :
 To regulate import, manufacture , sale & distribution of drug &cosmetics.
 The Act regulates the import of drug into India so that no substandard or spurious
drug will find its way in India.
 The Act regulates the manufacture of by making provisions & rules which provide
control over manufacture of substandard or spurious drug.
 The act also provide control over the sale & distribution of drugs by only trained &
qualified persons.
 Schedules to the Act
 First Schedule: List of Ayurvedic, Siddha & Unani Books.
 Second Schedule: Standards to be compiled with by imported drugs & by drugs
manufactured for sale, sold, stocked or exhibited for sale or distribution.

3.  Contents:
 Schedule A: Contains various forms and formats of letters for applications of
licensing etc.
 Schedule B: Contains fees structure for government-run labs.
 Schedule C: Contains various biological products and their regulation. Examples:
Serums, Adrenaline Vitamins etc.[ Vaccines ]
 Schedule D: List of drugs exempted from the provision of import of drugs
 Schedule F: This contains regulations and standards for running a blood bank.
 Schedule F-I: This contains regulations and standards for vaccines
 Schedule F-II: This contains regulations and standards for surgical dressing.
 Schedule F-III: This contains regulations and standards for umbilical tapes.

4.  Schedule F-F: This contains regulations and standards for ophthalmic ointments and
solutions.
 Schedule K: Contains various substances and drugs and their corresponding
regulation
 Schedule M: Contains various regulations for manufacturing, premises, waste
disposal and equipment.
 Schedule N: Contains various regulations and requirements for a pharmacy
 Schedule O: Contains various regulations and requirements for disinfectant fluids.
 Schedule P: Contains regulations regarding life period and storage of various drugs.
 Schedule P-I: Contains regulations regarding retail package size of various drugs.
 Schedule Q: Contains a list of permitted dyes and pigments in soap and cosmetics.
 Schedule R: Contains various regulations and requirements for condoms and other
mechanical contraceptives.

5.  Schedule S: Lists various cosmetics and toiletries, and directs the manufacturers of
cosmetics to conform to the latest Bureau of Indian Standards requirements.
 Schedule T: Contains various regulations and requirements for manufacture of
Ayurvedic, Siddha and Unani products.
 Schedule U: Contains various regulations and requirements for record keeping.
 Schedule V: Contains standards for drug patents.
 Schedule Y: Contains requirement and guidelines for clinical trials.

6.  Misbranded drugs.—For the purposes of this Chapter a drug shall be deemed to be
misbranded—
 (a) if it is so coloured, coated, powdered or polished that damage is concealed or if it
is made to appear of better or greater therapeutic value than it really is; or
 (b) if it is not labelled in the prescribed manner; or
 (c) if its label or container or anything accompanying the drug bears any statement,
design or device which makes any false claim for the drug or which is false or
misleading in any particular.]
 Adulterated drugs.— For the purposes of this Chapter, a drug shall be deemed to be
adulterated.—
 (a) if it consists, in whole or in part, of any filthy, putrid or decomposed substance; or
 (b) if it has been prepared, packed or stored under insanitary conditions whereby it
may have been contaminated with filth or whereby it may have been rendered
injurious to health; or

7.  (c) if its container is composed in whole or in part, of any poisonous or deleterious
substance which may render the contents injurious to health; or
 (d) if it bears or contains, for purposes of colouring only, a colour other than one
which is prescribed; or
 (e) if it contains any harmful or toxic substance which may render it injurious to
health; or
 (f) if any substance has been mixed therewith so as to reduce its quality or strength.
 Spurious drugs.— For the purposes of this Chapter, a drug shall be deemed to be
spurious—
 (a) if it is imported under a name which belongs to another drug; or
 (b) if it is an imitation of, or a substitute for, another drug or resembles another drug in
a manner likely to deceive or bears upon it or upon its label or container the name of
another drug unless it is plainly and conspicuously marked so as to reveal its true
character and its lack of identity with such other drug; or

8.  (c) if the label or the container bears the name of an individual or company purporting
to be the manufacturer of the drug, which individual or company is fictitious or does
not exist; or
 (d) if it has been substituted wholly or in part by another drug or substance; or
 (e) if it purports to be the product of a manufacturer of whom it is not truly a product.
 Misbranded cosmetics.—For the purposes of this chapter, a cosmetic shall be deemed
to be misbranded—
 (a) if it contains a colour which is not prescribed; or
 (b) if it is not labelled in a prescribed manner; or
 (c) if the label or container or anything accompanying the cosmetic bears any
statement which is false or misleading in any particular.
 9D. Spurious cosmetics.—For the purposes of this Chapter, a drug shall be deemed to
be spurious,—
 (a) if it is imported under the name which belongs to another cosmetic; or

9.  b) if it is an imitation of, or is a substitute for, another cosmetic or resembles another
cosmetic in a manner likely to deceive or bears upon it or upon its label or container
the name of another cosmetic, unless it is plainly or conspicuously marked so as to
reveal its true character and its lack of identity with such other cosmetic; or
 (c) if the label or the container bears the name of an individual or company purporting
to be the manufacturer of the cosmetic, which individual or company is fictitious or
does not exist; or
 (d) if it purports to be the product of a manufacturer of whom it is not truly a product.]

10.  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
 (2) No person who has any financial interest in the import, manufacture or sale of
drugs or cosmetics shall be appointed to be a Government Analyst under sub-section
(1) or sub-section (2) of this section.
 Qualifications of Government Analyst. ____ 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
3[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

11.  (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, 4[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 3[University established in India by law or has an
equivalent qualification recognized and notified by the Central Government for such
purpose] or possesses the Associate ship 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 4[or has completed training on testing of drugs,
including items stated in Schedule C, in Central Drugs Laboratory]:

12.  Provided that-
 4[(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.

13.  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.
 Duties of Government Analysts.−(1) The Government Analyst shall cause to be
analyzed or tested such samples or drugs 1[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.

14.  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 State Government, as the case may be.
 (2) No person who has any financial interest 1[in the import, manufacture or sale of
drugs or cosmetics] shall be appointed to be an Inspector under this section.
 Powers of Inspectors.—(1) Subject to the provisions of section 23 and of any rules
made by the Central Government in this behalf, an Inspector may, within the local limits
of the area for which he is appointed,—
 (a) inspect,—
 (i) any premises wherein any drug or cosmetic is being manufactured and the means
employed for standardising and testing the drug or cosmetic;
 (ii) any premises wherein any drug or cosmetic is being sold, or stocked or exhibited or
offered for sale, or distributed;
 (b) take samples of any drug or cosmetic,—

15.  (i) which is being manufactured or being sold or is stocked or exhibited or offered for
sale, or is being distributed;
 (ii) from any person who is in the course of conveying, delivering or preparing to
deliver such drug or cosmetic to a purchaser or a consignee;
 (c) at all reasonable times, with such assistance, if any, as he considers necessary,--
 (i) search any person, who, he has reason to believe, has secreted about his person, any
drug or cosmetic in respect of which an offence under this Chapter has been, or is
being, committed; or
 (ii) enter and search any place in which he has reason to believe that an offence under
this Chapter has been, or is being, committed; or
 (iii) stop and search any vehicle, vessel or other conveyance which, he has reason to
believe, is being used for carrying any drug or cosmetic in respect of which an offence
under this Chapter has been, or is being, committed, and order in writing the person in
possession of the drug or cosmetic in respect of which the offence has been, or is
being, committed, not to dispose of any stock of such drug or cosmetic for a

16.  specified period not exceeding twenty days, or, unless the alleged offence is such that
the defect may be removed by the possessor of the drug or cosmetic, seize the stock of
such drug or cosmetic and any substance or article by means of which the offence has
been, or is being, committed or which may be employed for the commission of such
offence;
 examine any record, register, document or any other material object found with any
person, or in any place, vehicle, vessel or other conveyance referred to in clause (c)],
and seize the same if he has reason to believe that it may furnish evidence of the
commission of an offence punishable under this Act or the rules made thereunder;
 require any person to produce any record, register, or other document relating to the
manufacture for sale or for distribution, stocking, exhibition for sale, offer for sale or
distribution of any drug or cosmetic in respect of which he has reason to believe that
an offence under this Chapter has been, or is being, committed;
 exercise such other powers as may be necessary for carrying out the purposes of this
Chapter or any rules made thereunder.

17.  Qualifications of Inspectors. —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 specialization in Clinical Pharmacology or Microbiology from a
University established in India by law:
 Provided that only
 (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 authorized to inspect the manufacture of the
substances mentioned in Schedule C hose Inspectors: ⎯

18.  Duties of Inspectors of Premises Licensed for Sale
 Subject to instructions of Controlling Authority, it shall be the duty of an Inspector
authorized to inspect premises licensed for the sale of drugs.
 (i) to inspect, not less than once a year, all establishment for sale. to satisfy himself that
conditions of licenses are being observed.
 (ii) to procure and send the drug for test or analysis if he has reason to suspect that drug
is sold or stocked in contravention with provisions of the Act or Rules.
 (iii) to investigate complaint in writing.
 (iv) to maintain a record of inspections. to make necessary enquiries.
 (v) to institute prosecutions in respect of breaches of the Act and Rules.
 (viii) when authorized by the State Government, to detain imported packages which he
has reason to believe contain drugs, the import of which is prohibited.

19.  Duties of Inspectors to Inspect Manufacture of Drugs or Cosmetics
 Subject to instructions of Controlling Authority, the following duties are performed:
 (i) to inspect, not less than once a year, all premises licenced for manufacture of drugs
or cosmetics
 (ii) to satisfy himself that conditions of licence are fulfi lIed.
 (iii) to inspect plant, process of manufacture and standardization, storage, technical
qualifications and other details for Schedules C and C (1) drugs.
 (iv) to send detailed inspection report to Controlling Authority.
 (v) to take samples for test or analysis in accordance with Rules.

20.  Import of Drugs and Cosmetics
 Prohibition of Import of Certain Drugs and Cosmetics
 The following categories of drugs and cosmetics are prohibited from import:
 (i) Drugs or cosmetics which are not of standard qualities.
 (ii) Drugs or cosmetics which are misbranded, spurious and adulterated.
 (iii) Drugs or cosmetics for import of which licence is required.
 (iv) Any patent or proprietary medicine without true formula or list of active ingredients
and their quantities.
 (v) Any drug or formulation which claims to prevent or cure diseases mentioned
schedule J.
 (vi) Any drug or cosmetic for which manufacture, sale or distribution is prohibited in
country of it origin.
 (vii) Any drug which is not packed or not labeled in conformity with the Rules of the
Act.

21.  (viii) Any cosmetic containing an ingredient which may render it unsafe or harmful.
 (ix) Any drug or cosmetic the import of which is prohibited by Act.

22.  The Drugs Technical Advisory Board.—(1) The Central Government shall, as soon
as may be, constitute a Board (to be called the Drugs Technical Advisory Board) to
advise the Central Government and the State Governments on technical matters
arising out of the administration of this Act and to carry out the other functions
assigned to it by this Act.
 the Director General of Health Services, ex officio, who shall be Chairman;
 the Drugs Controller, India, ex officio;
 the Director of the Central Drugs Laboratory, Calcutta, ex officio;
 the Director of the Central Research Institute, Kasauli, ex officio;
 the Director of Indian Veterinary Research Institute, Izatnagar, ex officio;
 the President of Medical Council of India, ex officio;
 the President of the Pharmacy Council of India, ex officio;
 the Director of Central Drug Research Institute, Lucknow, ex officio;

23.  two persons to be nominated by the Central Government from among persons who are
in charge of drugs control in the States;
 one person, to be elected by the Executive Committee of the Pharmacy Council of
India, from among teachers in pharmacy or pharmaceutical chemistry or
pharmacognosy on the staff of an Indian university or a college affiliated thereto;
 one person, to be elected by the Executive Committee of the Medical Council of India,
from among teachers in medicine or therapeutics on the staff of an Indian university or
a college affiliated thereto;
 one person to be nominated by the Central Government from the pharmaceutical
industry;
 one pharmacologist to be elected by the Governing Body of the Indian Council of
Medical Research;
 one person to be elected by the Central Council of the Indian Medical Association;
 one person to be elected by the Council of the Indian Pharmaceutical Association;

24.  two persons holding the appointment of Government Analyst under this Act, to be
nominated by the Central Government.
 The nominated and elected members of the Board shall hold office for three years, but
shall be eligible for re-nomination and re-election:
 The Drugs Consultative Committee.—(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 other 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.

25.  The Central Drugs Laboratory.
 the functions of the Central Drugs Laboratory;
 to analyse or test such samples of drugs as may be sent to it under sub-section (2) of
section 11, or under sub-section (4) of section 25 of the Act;
 to carry out such other duties as may be entrusted to it by the Central Government or,
with the permission of the Central Government, by a State Government after
consultation with the Drugs Technical Advisory Board.
 The functions of the Laboratory in respect of the following drugs or classes of drugs
shall be carried out at the Central Research Institute, Kasauli, and the functions of the
Director in respect of the said drugs or classes of drugs shall be exercised by the
Director of the said Institute :___
(1) Sera.
(2) Solution of serum proteins intended for injection.
(3) Vaccines.

26. (4) Toxins.
 (5) Antigens.
 (6) Anti-toxins.
 (7) Sterilized surgical ligature and sterilized surgical suture.
 (8) Bacteriophages:
 The functions of the Laboratory in respect of the following drugs or classes of drugs
shall be carried out at the Indian Veterinary Research Institute, Izatnagar and the
functions of the Director in respect of the said drugs or classes of drugs shall be
exercised by the Director of either of the said institutes.
 (1) Anti-sera for veterinary use.
 (2) Vaccines for veterinary use.
 (3) Toxoids for veterinary use.
 (4) Diagnostic Antigens for veterinary use.

27.  The functions of the laboratory in respect of condoms shall be carried out at the
Central Indian Pharmacopoeia Laboratory, Ghaziabad, and the functions of the
Director in respect of the said condoms shall be exercised by the Director of the said
Laboratory.
 The functions of the Laboratory in respect of the following drug shall be carried out
at the Laboratory of the Serologist and Chemical Examiner to the Government of
India, Calcutta and the functions of the Director in respect of the said drug shall be
performed by the Serologist and Chemical Examiner of the said Laboratory :__
 VDRL Antigen.
 The function of the Laboratory in respect of Intra-Utrine Devices and Falope Rings
shall be carried out at the Central Drugs Testing Laboratory, Thane, Maharashtra and
the functions of the Director in respect of the said devices shall be exercised by the
Director of the said Laboratory