D and C Act 1940, Drugs and cosmetics act 1940, schedule N, Schedule M
PratibhaSonawane5
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Jul 04, 2024
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About This Presentation
D and C Act 1940, Drugs and cosmetics act 1940, schedule N, Schedule M
Slide Content
DRUGS AND COSMETIC ACT 1940
AND RULES THEREUNDER 1945
Prepared By: Mrs. Sonawane Pratibha Deepak
M.Pharm (Pharmacognosy)
Faculty, PES Modern College of Pharmacy for
Ladies,
Moshi ,Pune
AND RULES THEREUNDER 1945
Prepared By: Mrs. Sonawane Pratibha Deepak
M.Pharm (Pharmacognosy)
Faculty, PES Modern College of Pharmacy for
Ladies,
Moshi ,Pune
Objectives Of D and C Act
The Drug and Cosmetics act was passed in 1940 with main object
To regulate the import, manufacture, distribution, and sale of Drugs and
Cosmetics.
To regulates the manufacture by making the provisions, and rules, which
provides control over the manufacture of spurious or sub- standard drug in the
country.
To provides for the control over the sale & distribution of drugs by only trained
& qualified persons.
To provide for the control over the manufacture, sale and distribution of
Ayurvedic, Siddha, Unani and Homoepathic drugs
The Drug and Cosmetics act was passed in 1940 with main object
To regulate the import, manufacture, distribution, and sale of Drugs and
Cosmetics.
To regulates the manufacture by making the provisions, and rules, which
provides control over the manufacture of spurious or sub- standard drug in the
country.
To provides for the control over the sale & distribution of drugs by only trained
& qualified persons.
To provide for the control over the manufacture, sale and distribution of
Ayurvedic, Siddha, Unani and Homoepathic drugs
SCHEDULES TO THE RULES
Schedules Contents
A - List of forms used for making applications for issuing licenses, granting licenses,
sending memorandums.
B - Fees for test or analysis by the Central Drugs Laboratory or Government Analyst.
C - Biological and special products.
C (1) - Other special products (The import, manufacture and sale of schedules C and C (1)
drugs governed by special provisions).
D - Class of exempted drugs, which are exempted from a certain provision applicable to
import of drugs.
E - List of poisonous substances omitted(22-6-82).
E (1) - List of Ayurvedic, Siddha and Unani poisons substances.
Schedules Contents
A - List of forms used for making applications for issuing licenses, granting licenses,
sending memorandums.
B - Fees for test or analysis by the Central Drugs Laboratory or Government Analyst.
C - Biological and special products.
C (1) - Other special products (The import, manufacture and sale of schedules C and C (1)
drugs governed by special provisions).
D - Class of exempted drugs, which are exempted from a certain provision applicable to
import of drugs.
E - List of poisonous substances omitted(22-6-82).
E (1) - List of Ayurvedic, Siddha and Unani poisons substances.
S SCHEDULES TO THE RULES
F - Provisions applicable to blood Bank requirement and licensing to process Blood components.
F(I) - Provisions applicable to Vaccines, Antisera and Diagnostic antigens.
F(II) - Standards for Surgical Dressings.
F(III) - Standards for Umbilical Tapes.
FF - Standards for Ophthalmic preparation
G - List of substances required to be taken only under supervision of a registered Medical Practitioner.
The drugs to be labeled with words caution : It is dangerous to take this preparation except under
medical supervision.
H - Prescription drugs which are required to be sold by retail only on prescription of a Registered Medical
Practitioner.
I - Calculation of proportion of poisons in certain cases.
F - Provisions applicable to blood Bank requirement and licensing to process Blood components.
F(I) - Provisions applicable to Vaccines, Antisera and Diagnostic antigens.
F(II) - Standards for Surgical Dressings.
F(III) - Standards for Umbilical Tapes.
FF - Standards for Ophthalmic preparation
G - List of substances required to be taken only under supervision of a registered Medical Practitioner.
The drugs to be labeled with words caution : It is dangerous to take this preparation except under
medical supervision.
H - Prescription drugs which are required to be sold by retail only on prescription of a Registered Medical
Practitioner.
I - Calculation of proportion of poisons in certain cases.
SCHEDULES TO THE RULES
J - list of diseases and ailments which a drug may not claim to prevent or cure.
K - List of drugs exempted, from certain provision applicable to manufacture of drugs and sale of drugs.
L - List of drugs to be sold on prescription only.(Omitted)(22-6-82).
M - Good Manufacturing practices
M(I) - Requirement of factory premises, plant equipment etc. for manufactures of Homoeopathic drugs.
M(II) - Requirement of factory premises, plant equipments for the manufacture of cosmetics.
M(III - Requirement of factory premises for manufacture of Medical Devices.
N - List of minimum equipment for the efficient running of a Pharmacy.
O - Standards for disinfectant fluids.
J - list of diseases and ailments which a drug may not claim to prevent or cure.
K - List of drugs exempted, from certain provision applicable to manufacture of drugs and sale of drugs.
L - List of drugs to be sold on prescription only.(Omitted)(22-6-82).
M - Good Manufacturing practices
M(I) - Requirement of factory premises, plant equipment etc. for manufactures of Homoeopathic drugs.
M(II) - Requirement of factory premises, plant equipments for the manufacture of cosmetics.
M(III - Requirement of factory premises for manufacture of Medical Devices.
N - List of minimum equipment for the efficient running of a Pharmacy.
O - Standards for disinfectant fluids.
SCHEDULES TO THE RULES
P - List of life periods of drugs.
P(1) - Pack sizes of drugs.
Q - List of coalter colours permitted to be used in cosmetics and list of colors
permitted to be used in soaps.
R - Standards for condoms made up for rubber latex intended for single use.
R(I) - Standards for Medical devices.
S - Standards for cosmetics.
T - Requirements for factory premises and hygienic condition for Manufacture of
Ayurvedic (including siddha) and Unani drugs.
U - Particulars to be shown in manufacturing and analytical records of drugs
P - List of life periods of drugs.
P(1) - Pack sizes of drugs.
Q - List of coalter colours permitted to be used in cosmetics and list of colors
permitted to be used in soaps.
R - Standards for condoms made up for rubber latex intended for single use.
R(I) - Standards for Medical devices.
S - Standards for cosmetics.
T - Requirements for factory premises and hygienic condition for Manufacture of
Ayurvedic (including siddha) and Unani drugs.
U - Particulars to be shown in manufacturing and analytical records of drugs
.
SCHEDULES TO THE RULES
U(I) - Particulars to be shown in manufacturing records of cosmetics.
V - Standards for patent and proprietary medicines and for patent and
proprietary medicines containing vitamins.
W - List of drug which shall be marketed under generic name
X - List of habit forming, psychotropic and other such drugs.
Y - Requirement and guidelines on clinical trials, for import and
manufacture of new drugs.
SCHEDULES TO THE RULES
U(I) - Particulars to be shown in manufacturing records of cosmetics.
V - Standards for patent and proprietary medicines and for patent and
proprietary medicines containing vitamins.
W - List of drug which shall be marketed under generic name
X - List of habit forming, psychotropic and other such drugs.
Y - Requirement and guidelines on clinical trials, for import and
manufacture of new drugs.
1)
DRUGS
It includes,
I) all medicines for internal or external use of human beings or animals and all substances
Intended to be used for; or diagnosis, treatment, mitigation or prevention of any disease or
disorder in human beings or Animals, including preparation applied on human body for the
purpose of repelling insects like mosquitoes .
ii) such 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 the
human beings or Animals.
Iii) all substances intended for use as components of a drug including empty Gelatin capsules;
iv) such devices intended for internal or external use in diagnosis, treatment, Mitigation or
prevention of disease or disorders in human beings or animals.
DRUGS
It includes,
I) all medicines for internal or external use of human beings or animals and all substances
Intended to be used for; or diagnosis, treatment, mitigation or prevention of any disease or
disorder in human beings or Animals, including preparation applied on human body for the
purpose of repelling insects like mosquitoes .
ii) such 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 the
human beings or Animals.
Iii) all substances intended for use as components of a drug including empty Gelatin capsules;
iv) such devices intended for internal or external use in diagnosis, treatment, Mitigation or
prevention of disease or disorders in human beings or animals.
AYURVEDIC, SIDDHA OR UNANI DRUG:
It include all medicines intended for internal or external use
manufactured in accordance with the formulae described in the
authoritative books of Ayurvedic, Siddha or Unani systems for
prevention of disorder in human beings or animal and of medicine,
specified in first schedule.
It include all medicines intended for internal or external use
manufactured in accordance with the formulae described in the
authoritative books of Ayurvedic, Siddha or Unani systems for
prevention of disorder in human beings or animal and of medicine,
specified in first schedule.
MISBRANDED DRUGS:
If it is so colored, coated, powdered or polished that, damage is concealed or
if it is made to appear better or greater therapeutic value than it really is, or
If it is not labeled in the prescribed manner, or
If it’s label or container or anything accompanying the drugs bears any
statement, design or device which makes any false claim for the drug or
which is false or misleading in any particular.
If it is so colored, coated, powdered or polished that, damage is concealed or
if it is made to appear better or greater therapeutic value than it really is, or
If it is not labeled in the prescribed manner, or
If it’s label or container or anything accompanying the drugs 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:
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,
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, a color other than prescribed which may be used for the purpose of coloring
only; or
e) If it contains any harmful or toxic substances which may render it injurious to health or
f) If any substance mixed with it so as to render its quality or strength
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,
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, a color other than prescribed which may be used for the purpose of coloring
only; or
e) If it contains any harmful or toxic substances which may render it injurious to health or
f) If any substance mixed with it so as to render its quality or strength
SPURIOUS DRUG:
i) Imported under a name which belongs to another drug; or
ii) Which is an imitation of or is a substitute for another drug resembles to another
drug in a manner to bear upon its label or container the name of another drug
unless plainly or conspicuously marked so as to reveal its true character and its
lack of identity with such other drugs; or
iii) The label or container of which bears the name of an individual or company
purporting to be the manufacture of drug, which individual or company is
fictitious or does not exists; or
iv) which has been substituted wholly or in part by another drug or another
substances; or
v) Which purports to be the product of a manufacturer of whom it is not
truly a product.
i) Imported under a name which belongs to another drug; or
ii) Which is an imitation of or is a substitute for another drug resembles to another
drug in a manner to bear upon its label or container the name of another drug
unless plainly or conspicuously marked so as to reveal its true character and its
lack of identity with such other drugs; or
iii) The label or container of which bears the name of an individual or company
purporting to be the manufacture of drug, which individual or company is
fictitious or does not exists; or
iv) which has been substituted wholly or in part by another drug or another
substances; or
v) Which purports to be the product of a manufacturer of whom it is not
truly a product.
COSMETIC:
It means any article intended to be rubbed, poured,
sprinkled or sprayed or on introduced into or applied to
any part of the human body, for cleansing, beautifying,
promoting attractiveness or altering the appearance and
includes any article intended for use as a component of
cosmetic.
It means any article intended to be rubbed, poured,
sprinkled or sprayed or on introduced into or applied to
any part of the human body, for cleansing, beautifying,
promoting attractiveness or altering the appearance and
includes any article intended for use as a component of
cosmetic.
DRUG STORE:
Licensed premises for the sale of drugs, which do not require the services of a
qualified person.
CHEMIST AND DRUGGIST:
Licensed premises for the sale of the drugs which requires the services of a
qualified person but where the drugs are not compounded against prescription
PHARMACY:
Licensed premises for the sale of the drugs which requires the services of a
qualified person but where the drugs are compounded against prescription
Licensed premises for the sale of drugs, which do not require the services of a
qualified person.
CHEMIST AND DRUGGIST:
Licensed premises for the sale of the drugs which requires the services of a
qualified person but where the drugs are not compounded against prescription
PHARMACY:
Licensed premises for the sale of the drugs which requires the services of a
qualified person but where the drugs are compounded against prescription
Drug Inspector:
i) In relation to Ayurvedic, Siddha or Unani drug, an person appointed by the
Central or State Government under section 33-G; &
ii) In relation to any other drug or cosmetic, a person appointed by the Central
or State Government under section 21
Government Analyst:
i) In relation to Ayurvedic, Siddha or Unani drug, a person appointed by
Central or State Government under section 33-F; &
ii) In relation to any other drug or cosmetic, a person appointed by the Central
or State Government under section 20
Drug Inspector and Government analyst
i) In relation to Ayurvedic, Siddha or Unani drug, an person appointed by the
Central or State Government under section 33-G; &
ii) In relation to any other drug or cosmetic, a person appointed by the Central
or State Government under section 21
Government Analyst:
i) In relation to Ayurvedic, Siddha or Unani drug, a person appointed by
Central or State Government under section 33-F; &
ii) In relation to any other drug or cosmetic, a person appointed by the Central
or State Government under section 20
Drug Inspector and Government analyst
DRUGS TECHNICAL ADVISORY BOARD ( D.T.A.B.)
➢ Under the provision (sec.5) of the Act, the central Government
appoints the Drugs Technical Advisory Board to advice the central
and the State Governments on technical matters arising out of
administration of this Act, and to carry out the other functions
assigned to it by this Act.
CONSTITUTION OF D.T.A.B :
The board consist of following members.
1) Ex-Officio-members.
2) Nominated members.
3) Elected members.
➢ Under the provision (sec.5) of the Act, the central Government
appoints the Drugs Technical Advisory Board to advice the central
and the State Governments on technical matters arising out of
administration of this Act, and to carry out the other functions
assigned to it by this Act.
CONSTITUTION OF D.T.A.B :
The board consist of following members.
1) Ex-Officio-members.
2) Nominated members.
3) Elected members.
Ex-Officio-members :
1.The Director-General of Health services, who is the chairman of the Board.
2.The Drug Controller of India.
3.The Director of the Central Drug Laboratory, Kolkatta.
4.The Director of the Central Research Institute, Kasauli.
5.The Director of the Indian Veterinary Research Institute, Izatnagar.
6.Director, Central Drug Research Institute, Lucknow.
7.The President, Pharmacy Council of India.
8.The President, Medical Council of India.
1.The Director-General of Health services, who is the chairman of the Board.
2.The Drug Controller of India.
3.The Director of the Central Drug Laboratory, Kolkatta.
4.The Director of the Central Research Institute, Kasauli.
5.The Director of the Indian Veterinary Research Institute, Izatnagar.
6.Director, Central Drug Research Institute, Lucknow.
7.The President, Pharmacy Council of India.
8.The President, Medical Council of India.
Nominated-members :
- members are nominated by Central Government.
9Two persons from Ex officio members who are incharge of the drugs control
in the States.
10One person from the pharmaceutical industry.
11Two Government Analysts.
- members are nominated by Central Government.
9Two persons from Ex officio members who are incharge of the drugs control
in the States.
10One person from the pharmaceutical industry.
11Two Government Analysts.
Elected-members :
12A teacher in pharmacy, pharmaceutical chemistry or Pharmacognosy or the staff of an
university or affiliated college elected by the Executive Committee of pharmacy
council of India.
13A teacher in medicine or therapeutics or the staff of an university or affiliated college
elected by the Executive Committee of the Medical Council of India.
14One pharmacologist, elected by the Governing body of the Indian Council of Medical
Research.
15One person elected by the Central Council of Indian Medical Association
16One person elected by Council of the Indian Pharmaceutical Association.
12A teacher in pharmacy, pharmaceutical chemistry or Pharmacognosy or the staff of an
university or affiliated college elected by the Executive Committee of pharmacy
council of India.
13A teacher in medicine or therapeutics or the staff of an university or affiliated college
elected by the Executive Committee of the Medical Council of India.
14One pharmacologist, elected by the Governing body of the Indian Council of Medical
Research.
15One person elected by the Central Council of Indian Medical Association
16One person elected by Council of the Indian Pharmaceutical Association.
DRUGS TECHNICAL ADVISORY BOARD (D.T.A.B)
➢nominated or elected members holds office for 3 years are eligible for
renomination and re-election
➢Central Government appoints a secretary of the board, and also provides
clerical and other staff.
➢The board may constitute sub-committees and may appoints persons to such
subcommittees who are not members of the board.
➢There is separate Ayurvedic and Unani Drugs Technical Advisory Board
constituted under the sec, 33-C of the Act.
➢nominated or elected members holds office for 3 years are eligible for
renomination and re-election
➢Central Government appoints a secretary of the board, and also provides
clerical and other staff.
➢The board may constitute sub-committees and may appoints persons to such
subcommittees who are not members of the board.
➢There is separate Ayurvedic and Unani Drugs Technical Advisory Board
constituted under the sec, 33-C of the Act.
DRUGS CONSULTATIVE COMMITTEE (DCC)
➢advisory committee constituted by Central Government to advise the Central and
State Governments and the Drugs Technical Advisory Board on any matter to
secure uniformity throughout India in the administration of this Act.
CONSTITUTION
1.Two representative of Central Government nominated by Central Government
and
2.One representative of each State Government nominated by the concerned
Government
separate “The Ayurvedic Siddha and Unani Drugs Consultative Committee”
➢advisory committee constituted by Central Government to advise the Central and
State Governments and the Drugs Technical Advisory Board on any matter to
secure uniformity throughout India in the administration of this Act.
CONSTITUTION
1.Two representative of Central Government nominated by Central Government
and
2.One representative of each State Government nominated by the concerned
Government
separate “The Ayurvedic Siddha and Unani Drugs Consultative Committee”
The Central Government established a Central Drug laboratory (Kolkata) under
the control of Director.
FUNCTIONS :
1.To analyze or test the samples of drugs or cosmetics sent it to by :
a) Customs collectors or any authorized officers
b) Court
2. To carry out such other duties given by the Central Government with the
permission of Central Government after consultation with the Drugs
Technical Advisory Board.
the control of Director.
FUNCTIONS :
1.To analyze or test the samples of drugs or cosmetics sent it to by :
a) Customs collectors or any authorized officers
b) Court
2. To carry out such other duties given by the Central Government with the
permission of Central Government after consultation with the Drugs
Technical Advisory Board.
3. In case of following drugs or classes of drugs, functions of CDL are carried
out at Central Research Institute Kasauli and are exercised by the Director of
that institute Sera, Vaccines, Toxins, Antigens, Antitoxins , Solution of serum
proteins for injection, Sterilized surgical ligature and suture .
4. The functions regarding Oral Polio Vaccine are exercised by the Deputy
Director and Head of the Polio Vaccine Testing laboratory of Central Research
Institute Kasauli.
out at Central Research Institute Kasauli and are exercised by the Director of
that institute Sera, Vaccines, Toxins, Antigens, Antitoxins , Solution of serum
proteins for injection, Sterilized surgical ligature and suture .
4. The functions regarding Oral Polio Vaccine are exercised by the Deputy
Director and Head of the Polio Vaccine Testing laboratory of Central Research
Institute Kasauli.
5. In case of the following drugs or classes of drugs, functions of CDL are
carried out at the Indian Veterinary Research Institute, Izatnagar or
Mukteshwar and are exercised by the Director of the Institutions.
Antisera, Vaccines, Toxoids and Diagnostic antigens for veterinary use.
6. In case of Condoms the functions of CDL are carried out at the Central
Indian Pharmacopoeia Laboratory, Ghaziabad, and are exercised by the
Director of the said laboratory.
carried out at the Indian Veterinary Research Institute, Izatnagar or
Mukteshwar and are exercised by the Director of the Institutions.
Antisera, Vaccines, Toxoids and Diagnostic antigens for veterinary use.
6. In case of Condoms the functions of CDL are carried out at the Central
Indian Pharmacopoeia Laboratory, Ghaziabad, and are exercised by the
Director of the said laboratory.
7. In case of VDRL ANTIGEN (Veneral Disease ) the functions of the CDL
carried out at the Laboratory of the Serologist and Chemical Examiner to the
Government of India, Calcutta, such functions are exercised by the Serologist
and Chemical Examiner of the said laboratory.
8. In respect of intrauterine devices and felope rings, the functions of laboratory
shall be exercised out at Department of Biochemical engineering, Indian
Institute of Technology, New Delhi and such functions shall be exercised by
head of the said department.
carried out at the Laboratory of the Serologist and Chemical Examiner to the
Government of India, Calcutta, such functions are exercised by the Serologist
and Chemical Examiner of the said laboratory.
8. In respect of intrauterine devices and felope rings, the functions of laboratory
shall be exercised out at Department of Biochemical engineering, Indian
Institute of Technology, New Delhi and such functions shall be exercised by
head of the said department.
Dispatch of samples for test or
analysis to CDL
➢Samples for test or analysis by courts are to be sent by registered post in a sealed packet,
marked with a distinguishing number with a memorandum in Form 1, accompanied with
prescribed fee to the director.
➢A specimen impression of the seal used to seal the packet and a copy memorandum (in
form 1) are to be sent separately by registered post
➢On receipt of the packet, authorized officer on behalf of the director opens the packet and
records the conditions of the seals on the packet.
➢After completion of test or analysis, the report is supplied in Form 2, together with full
protocols of the test applied.
➢Certificate regarding the reports is to be signed by Director or the authorized officer on his
behalf.
analysis to CDL
➢Samples for test or analysis by courts are to be sent by registered post in a sealed packet,
marked with a distinguishing number with a memorandum in Form 1, accompanied with
prescribed fee to the director.
➢A specimen impression of the seal used to seal the packet and a copy memorandum (in
form 1) are to be sent separately by registered post
➢On receipt of the packet, authorized officer on behalf of the director opens the packet and
records the conditions of the seals on the packet.
➢After completion of test or analysis, the report is supplied in Form 2, together with full
protocols of the test applied.
➢Certificate regarding the reports is to be signed by Director or the authorized officer on his
behalf.
DRUG INSPECTOR QUALIFICATIONS :
➢Drug Inspector:
i) In relation to Ayurvedic, Siddha or Unani drug, an person appointed by
the Central or State Government under section 33-G; &
ii) In relation to any other drug or cosmetic, a person appointed by the
Central or State Government under section 21
➢A graduate in pharmacy or pharmaceuticals Science or Medicine with
specialization in Clinical Pharmacology or Microbiology from recognized
University.
➢Drug Inspector:
i) In relation to Ayurvedic, Siddha or Unani drug, an person appointed by
the Central or State Government under section 33-G; &
ii) In relation to any other drug or cosmetic, a person appointed by the
Central or State Government under section 21
➢A graduate in pharmacy or pharmaceuticals Science or Medicine with
specialization in Clinical Pharmacology or Microbiology from recognized
University.
P Provided that for the purpose of Inspection, of manufacture of
substances specified in Schedule C, a person appointed as a
Drug Inspector should have;
(i)Not less than 18 months experience in the manufacture of at least one of the substances
specified in schedule C; or
(ii)Not less than 18 months experience in testing of at least one of the substances specified in
a schedule C in a approved laboratory ;or
(iii)Not less than 3 years experience in the inspection of firms manufacturing any of the
substances specified in Schedule C during the course of their service as the Drugs
Inspector.
Provided further that for the first 4 years from the date on which chapter IV of the
Act takes effect in the States, persons whose qualifications, training and experience
are considered adequate may be appointed as Inspectors and their appointments
continued even after 4 years, if the State Government is satisfied.
substances specified in Schedule C, a person appointed as a
Drug Inspector should have;
(i)Not less than 18 months experience in the manufacture of at least one of the substances
specified in schedule C; or
(ii)Not less than 18 months experience in testing of at least one of the substances specified in
a schedule C in a approved laboratory ;or
(iii)Not less than 3 years experience in the inspection of firms manufacturing any of the
substances specified in Schedule C during the course of their service as the Drugs
Inspector.
Provided further that for the first 4 years from the date on which chapter IV of the
Act takes effect in the States, persons whose qualifications, training and experience
are considered adequate may be appointed as Inspectors and their appointments
continued even after 4 years, if the State Government is satisfied.
POWERS OF DRUG INSPECTOR
Within the local limits for which the Inspector is appointed, he may :
(i)Inspect :
(a) premises - drug or cosmetic is being manufactured
the means - employed for standardizing and testing the drug or
cosmetic.
(b) premises - any drug or cosmetic is being sold or
stocked or exhibited or offered for sale, or distributed.
(ii)Take samples of any drug or Cosmetic :
(a) being manufactured or being sold or is stocked or offered
for sale or being distributed .
(b) From any person who is conveying, delivering or preparing to deliver
any drug or cosmetic to a purchaser or a consignee.
Within the local limits for which the Inspector is appointed, he may :
(i)Inspect :
(a) premises - drug or cosmetic is being manufactured
the means - employed for standardizing and testing the drug or
cosmetic.
(b) premises - any drug or cosmetic is being sold or
stocked or exhibited or offered for sale, or distributed.
(ii)Take samples of any drug or Cosmetic :
(a) being manufactured or being sold or is stocked or offered
for sale or being distributed .
(b) From any person who is conveying, delivering or preparing to deliver
any drug or cosmetic to a purchaser or a consignee.
(iii) Search any person - in connection with the offence at all reasonable times.
(iv) Enter and search - any place or premises in which he believe that an offence is
being committed or has been committed , at all reasonable times
(v) Stop and search - any vehicle which he has reason to believe, used for carrying
any drug or cosmetic in respect of which offence has been or has being
committed.
POWERS OF DRUG INSPECTOR
(iv) Enter and search - any place or premises in which he believe that an offence is
being committed or has been committed , at all reasonable times
(v) Stop and search - any vehicle which he has reason to believe, used for carrying
any drug or cosmetic in respect of which offence has been or has being
committed.
POWERS OF DRUG INSPECTOR
(vi) Give order in writing -
to the person in possession of drug or cosmetic in respect of which offence has been
committed or is being committed,
not to be dispose stock of such drug or cosmetic for a specific period not
exceeding twenty days or unless the defect may be removed,
may seize the stock of such drug or cosmetic or any substance or article used
to carry drug.
(vii) Examine any record, register, document or any other material object found while
exercising above powers and seize if he has reason to believe that is an evidence of
the commission of an offence under the Act.
(viii) Exercise any other powers - for carrying out the purpose of this act
POWERS OF DRUG INSPECTOR
to the person in possession of drug or cosmetic in respect of which offence has been
committed or is being committed,
not to be dispose stock of such drug or cosmetic for a specific period not
exceeding twenty days or unless the defect may be removed,
may seize the stock of such drug or cosmetic or any substance or article used
to carry drug.
(vii) Examine any record, register, document or any other material object found while
exercising above powers and seize if he has reason to believe that is an evidence of
the commission of an offence under the Act.
(viii) Exercise any other powers - for carrying out the purpose of this act
POWERS OF DRUG INSPECTOR
Duties of Drug Inspector :
The duties of Drug Inspector are conveniently grouped as follows;
I. Duties in relationship to the sale of drugs and cosmetics.
II. Duties in relationship to the manufacture of drugs and cosmetics.
I.Duties in relationship to the sale of drugs and cosmetics.
a)To inspect at least twice a year all establishment licensed for sale of drugs in the area
assigned to him and to check whether the conditions of the licenses are observed or
not.
b) If he thinks necessary, to obtain and send the samples of imported drugs and
cosmetics for test or analysis, which are being sold, or stocked in contravention of the
provision of the Act.
The duties of Drug Inspector are conveniently grouped as follows;
I. Duties in relationship to the sale of drugs and cosmetics.
II. Duties in relationship to the manufacture of drugs and cosmetics.
I.Duties in relationship to the sale of drugs and cosmetics.
a)To inspect at least twice a year all establishment licensed for sale of drugs in the area
assigned to him and to check whether the conditions of the licenses are observed or
not.
b) If he thinks necessary, to obtain and send the samples of imported drugs and
cosmetics for test or analysis, which are being sold, or stocked in contravention of the
provision of the Act.
Duties of Drug Inspector :
c)To investigate any complaint in writing made to him.
d)To institute prosecutions in case of breach of the Act and Rules.
e)To maintain the records relating to all inspections and actions taken by him and to
submit copies of such records to the controlling authority.
f)To make inquires and inspections regarding the sale of drugs in contravention of the
act.
g)To detain the imported packages, if he suspects to contain drugs, the import of which
is prohibited.
c)To investigate any complaint in writing made to him.
d)To institute prosecutions in case of breach of the Act and Rules.
e)To maintain the records relating to all inspections and actions taken by him and to
submit copies of such records to the controlling authority.
f)To make inquires and inspections regarding the sale of drugs in contravention of the
act.
g)To detain the imported packages, if he suspects to contain drugs, the import of which
is prohibited.
Duties of Drug Inspector :
II. Duties in relationship to the manufacture of Drugs and Cosmetics.
Subject to the instruction by the controlling authority it shall be the duty of Drug
Inspector –
a)To inspect at least twice a year, all premises licensed for manufacture of drugs
within the area allotted to him and to satisfy whether the conditions of the licence
and the provisions of the Act and Rules thereunder are being observed or not.
II. Duties in relationship to the manufacture of Drugs and Cosmetics.
Subject to the instruction by the controlling authority it shall be the duty of Drug
Inspector –
a)To inspect at least twice a year, all premises licensed for manufacture of drugs
within the area allotted to him and to satisfy whether the conditions of the licence
and the provisions of the Act and Rules thereunder are being observed or not.
b) To inspect premises licensed for manufacture of drugs, specified in Schedule C and
c(1) and
➢ to observe plant and process of manufacture, means employed,
➢Means of standardization and testing of drugs,
➢Method and places of storage conditions,
➢qualification of technical staff employed,
➢details of location, construction, administration which may affect potency or purity
of the product.
c(1) and
➢ to observe plant and process of manufacture, means employed,
➢Means of standardization and testing of drugs,
➢Method and places of storage conditions,
➢qualification of technical staff employed,
➢details of location, construction, administration which may affect potency or purity
of the product.
c)To send, a detailed report of inspection to the controlling authority after each
inspection indicating conditions of licence and provisions of the Act and the
Rules which are being observed
d)To take samples of drugs manufactured on the premises and send them for test
or analysis.
e)To check all records and registers required to be maintained under the Rules.
f)To institute prosecutions in respect of the breaches of the Act and Rules
thereunder.
inspection indicating conditions of licence and provisions of the Act and the
Rules which are being observed
d)To take samples of drugs manufactured on the premises and send them for test
or analysis.
e)To check all records and registers required to be maintained under the Rules.
f)To institute prosecutions in respect of the breaches of the Act and Rules
thereunder.
PROCEDURE OF INSPECTIONS
(A)For taking samples of drugs for analysis and their dispatch to the Government
Analyst :
i.Intimate the purpose to a person from whom, he takes samples, in writing in a
prescribed form (Form-17).
ii.fair price of the sample be tendered and acknowledgement thereof be obtained. If
price is refused, person be issued with a receipt in prescribed form (Form-16-A).
iii.in the presence of concerned person divide the sample in four parts Each portion
is effectively sealed and marked suitably. The concerned person is allowed to put
his own seal and mark.
If sample is taken from manufacturing premises, it should be divided in only
three parts.
(A)For taking samples of drugs for analysis and their dispatch to the Government
Analyst :
i.Intimate the purpose to a person from whom, he takes samples, in writing in a
prescribed form (Form-17).
ii.fair price of the sample be tendered and acknowledgement thereof be obtained. If
price is refused, person be issued with a receipt in prescribed form (Form-16-A).
iii.in the presence of concerned person divide the sample in four parts Each portion
is effectively sealed and marked suitably. The concerned person is allowed to put
his own seal and mark.
If sample is taken from manufacturing premises, it should be divided in only
three parts.
PROCEDURE OF INSPECTIONS
Further if drug is packed in small volume containers or gets damaged or
deteriorates on exposure, three or four container to be taken as the case may be and
sealed and marked.
(a) Restore one portion/container with the person from whom
sample is taken.
(b) Send one portion/container to the Government analyst for test or
analysis.
(c) Reserve one portion/container for production before the court if
proceedings are instituted in case of such samples.
(d) Send remaining portion to a warrantor, if any, (whose name
address and other particulars have been disclosed).
Further if drug is packed in small volume containers or gets damaged or
deteriorates on exposure, three or four container to be taken as the case may be and
sealed and marked.
(a) Restore one portion/container with the person from whom
sample is taken.
(b) Send one portion/container to the Government analyst for test or
analysis.
(c) Reserve one portion/container for production before the court if
proceedings are instituted in case of such samples.
(d) Send remaining portion to a warrantor, if any, (whose name
address and other particulars have been disclosed).
PROCEDURE OF INSPECTIONS
(B) For Seizures of Stocks :
❖Whenever Inspector suspects that any drug or cosmetic contravences any of the
provision of the Act, he may seize any stock of such drugs or records, registers,
documents etc.
❖Which are believed to be evidence of the commission of an offence and he should
inform to a judicial magistrate as soon as possible and take his order for the
custody of the same.
❖If the alleged contravention be such that, defect may be remedied by the possessor
and if Inspector is being satisfied, he can revoke his order and may return the
material to possessor.
(B) For Seizures of Stocks :
❖Whenever Inspector suspects that any drug or cosmetic contravences any of the
provision of the Act, he may seize any stock of such drugs or records, registers,
documents etc.
❖Which are believed to be evidence of the commission of an offence and he should
inform to a judicial magistrate as soon as possible and take his order for the
custody of the same.
❖If the alleged contravention be such that, defect may be remedied by the possessor
and if Inspector is being satisfied, he can revoke his order and may return the
material to possessor.
PENALTY FOR OBSTRUCTING INSPECTIOR :
❖If any person willfully obstructs an Inspector in the exercise of the
powers conferred upon him or refuses to produce any record, register or any other
document when required, he shall be punishable with imprisonment upto 3 years
or with fine or with both.
❖If any person willfully obstructs an Inspector in the exercise of the
powers conferred upon him or refuses to produce any record, register or any other
document when required, he shall be punishable with imprisonment upto 3 years
or with fine or with both.
GOVERNMENT ANALYSTS
➢ State Government by notifying in the official Gazette, Appoint Government
analyst under sub-section (1) Of section 20, of the Act, for the analysis and
testing of sample of drugs and cosmetics in Drug Control Laboratories.
➢ Central Government may also appoint Government Analyst for specified
categories of the drugs or cosmetics under sub-section (2) of section 20 of the
Act.
➢ State Government by notifying in the official Gazette, Appoint Government
analyst under sub-section (1) Of section 20, of the Act, for the analysis and
testing of sample of drugs and cosmetics in Drug Control Laboratories.
➢ Central Government may also appoint Government Analyst for specified
categories of the drugs or cosmetics under sub-section (2) of section 20 of the
Act.
GOVERNMENT ANALYSTS
Continued…..
➢ A person to be appointed as a Government Analyst should have no financial
interest in the import, manufacture or sale of the drug or cosmetics.
➢ Government Analyst for Ayurvedic, Siddha & Unani drugs is appointed by
State and Central Government under section 33-F, of the Act.
Continued…..
➢ A person to be appointed as a Government Analyst should have no financial
interest in the import, manufacture or sale of the drug or cosmetics.
➢ Government Analyst for Ayurvedic, Siddha & Unani drugs is appointed by
State and Central Government under section 33-F, of the Act.
GOVERNMENT ANALYSTS
Qualifications :
A person appointed as a Government Analyst should possess the following
qualifications.
1)A graduate in medicine or science or pharmacy or pharmaceutical
chemistry of a recognised University, with not less than 5 years
post-graduate experience in the testing of drugs ; or
1)A post graduate degree in medicine or science or pharmacy or
pharmaceutical chemistry of a recognised University with not less than 3
years experience ; or
Qualifications :
A person appointed as a Government Analyst should possess the following
qualifications.
1)A graduate in medicine or science or pharmacy or pharmaceutical
chemistry of a recognised University, with not less than 5 years
post-graduate experience in the testing of drugs ; or
1)A post graduate degree in medicine or science or pharmacy or
pharmaceutical chemistry of a recognised University with not less than 3
years experience ; or
GOVERNMENT ANALYSTS
Qualifications :
3)Associateship Diploma of the Institution of Chemists (India) with
‘Analysis of Drugs and Pharmaceuticals’ as one of the subjects with
not less than 3 years experience in the testing of drugs in a laboratory
under the control of :
a) A Government Analyst ; or
b) Head of an Institution or testing laboratory approved for the purpose
by the appointing authority.
Qualifications :
3)Associateship Diploma of the Institution of Chemists (India) with
‘Analysis of Drugs and Pharmaceuticals’ as one of the subjects with
not less than 3 years experience in the testing of drugs in a laboratory
under the control of :
a) A Government Analyst ; or
b) Head of an Institution or testing laboratory approved for the purpose
by the appointing authority.
GOVERNMENT ANALYSTS
Provided that :
a)For the purpose of testing or analysis of drugs specified in Schedule C, a
person to be appointed should produce evidence of satisfactory training in
Physiology, Bacteriology or Serology or Pathology or Pharmacology or
Microbiology and should have the said experience.
b) For a period of 4 years from the day on which the chapter IV of the Act
(Manufacture, Sale and Distribution of Drugs and Cosmetics) take effect in
the states, persons whose training and experience are considered adequate
and competence may be appointed as Government Analysts and such persons
may be continued in service after 4 years also.
Provided that :
a)For the purpose of testing or analysis of drugs specified in Schedule C, a
person to be appointed should produce evidence of satisfactory training in
Physiology, Bacteriology or Serology or Pathology or Pharmacology or
Microbiology and should have the said experience.
b) For a period of 4 years from the day on which the chapter IV of the Act
(Manufacture, Sale and Distribution of Drugs and Cosmetics) take effect in
the states, persons whose training and experience are considered adequate
and competence may be appointed as Government Analysts and such persons
may be continued in service after 4 years also.
GOVERNMENT ANALYSTS
Provided that :
c)A person to be appointed as a Government Analyst should not be engaged
directly or indirectly in trade or business connected with the manufacture of
drugs.
d)For the purpose of examination of the veterinary biological products, the
person appointed as Government Analyst should be graduate in Veterinary
Science or General Science or Medicine or Pharmacy. With not less than 5
years experience in the standardization of biological products or a person
having post graduate degree in above faculties with not less than 3 years said
experience.
Provided that :
c)A person to be appointed as a Government Analyst should not be engaged
directly or indirectly in trade or business connected with the manufacture of
drugs.
d)For the purpose of examination of the veterinary biological products, the
person appointed as Government Analyst should be graduate in Veterinary
Science or General Science or Medicine or Pharmacy. With not less than 5
years experience in the standardization of biological products or a person
having post graduate degree in above faculties with not less than 3 years said
experience.
GOVERNMENT ANALYSTS
Provided that :
e)The Person already appointed as Government Analysts
may continue to remain in service if the appointing authority so desires,
eventhough he does not fulfill the said qualifications.
Duties of Government Analyst :
i.To analyse or test the samples of drugs and cosmetics sent to him by Drug
Inspectors or other persons and to furnish the reports of the results of such
analysis or test .
ii.To forward to the Government, the reports of analytical & research work, with
a view to their publication at the discretion of the Government.
Provided that :
e)The Person already appointed as Government Analysts
may continue to remain in service if the appointing authority so desires,
eventhough he does not fulfill the said qualifications.
Duties of Government Analyst :
i.To analyse or test the samples of drugs and cosmetics sent to him by Drug
Inspectors or other persons and to furnish the reports of the results of such
analysis or test .
ii.To forward to the Government, the reports of analytical & research work, with
a view to their publication at the discretion of the Government.
GOVERNMENT ANALYSTS
Procedure on receipt of samples :
❖ On receipt of a package of a sample from Drug Inspector, the Government
analyst compares the seals on the package with the specimen impression of the
seal received separately and notes the conditions of seals on the package.
❖ On completion of test or analysis, he supplies to the Inspector a report of
analysis in triplicate in Form 13, together with full protocols of the tests applied.
❖If purchaser wants to analyse or test drug or cosmetic, he has to make an
application for test or analysis in Form 14-A accompanied with prescribed fees
and the report of test or analysis of such drug or cosmetic is to be supplied in
Form 14-B, by Government Analyst.
Procedure on receipt of samples :
❖ On receipt of a package of a sample from Drug Inspector, the Government
analyst compares the seals on the package with the specimen impression of the
seal received separately and notes the conditions of seals on the package.
❖ On completion of test or analysis, he supplies to the Inspector a report of
analysis in triplicate in Form 13, together with full protocols of the tests applied.
❖If purchaser wants to analyse or test drug or cosmetic, he has to make an
application for test or analysis in Form 14-A accompanied with prescribed fees
and the report of test or analysis of such drug or cosmetic is to be supplied in
Form 14-B, by Government Analyst.
LICENCING AUTHORITY
Central government appoints an authority called ‘Licencing Authority’ to
issue licence for import of drugs
Each state government appoints licencing authority to issue licence for
manufacturing, distribution and sale of drugs and cosmetics for a
specified area
Central government appoints an authority called ‘Licencing Authority’ to
issue licence for import of drugs
Each state government appoints licencing authority to issue licence for
manufacturing, distribution and sale of drugs and cosmetics for a
specified area
FUNCTIONS OF LICENCING AOTHORITY
They issue licence for import of drugs.
They issue licence for manufacturing, distribution and sale of drugs and
cosmetics.
They can issue or refuse licence depending upon whether applicant satisfies
the condition prescribed or not.
The licencing authority is empowered to cancel or suspend the license
issued by them, if authority fails to observe any condition of licence after
giving reasonable opportunity to explain their cases.
They issue licence for import of drugs.
They issue licence for manufacturing, distribution and sale of drugs and
cosmetics.
They can issue or refuse licence depending upon whether applicant satisfies
the condition prescribed or not.
The licencing authority is empowered to cancel or suspend the license
issued by them, if authority fails to observe any condition of licence after
giving reasonable opportunity to explain their cases.
PROVISIONS RELATING TO SALE
OF DRUGS
D&C Act provides sale of drug only on issue of licence.
State government appoint Licencing authority for a specified area to issue
licence for sale, stock or exhibit for sale or distribute drugs.
Applicant has to make an application in a prescribed form for grant of
licence.
Granted licence should be renewed within six months of its expiry.
OF DRUGS
D&C Act provides sale of drug only on issue of licence.
State government appoint Licencing authority for a specified area to issue
licence for sale, stock or exhibit for sale or distribute drugs.
Applicant has to make an application in a prescribed form for grant of
licence.
Granted licence should be renewed within six months of its expiry.
APPLICATION FOR GRANT OR RENEWAL OF
LICENCE FOR SALE OF DRUGS
SR.NO
.
CATEGORY OF DRUGS FORM NO.
1 Drugs other than specified in schedule X19
2 Restricted licence 19A
3 Wholesale/ Distribute drugs from a motor
vehicle
19AA
4 Schedule X drugs 19C
LICENCE FOR SALE OF DRUGS
SR.NO
.
CATEGORY OF DRUGS FORM NO.
1 Drugs other than specified in schedule X19
2 Restricted licence 19A
3 Wholesale/ Distribute drugs from a motor
vehicle
19AA
4 Schedule X drugs 19C
FORMS OF LICENCE
Sr NoLicence Issued RetailRestrictedWholesaleWholesale or
distribution from
motor vehicle
1 Forms for drugs
other than C,C(1)
and X
20 20-A 20-B 20-BB
2 Forms for drugs
specified in
schdule C, C(1).
21 21-A 21-B 21-BB
3 Forms for drugs
Specified in
schedule X
20-F - 20-G -
Sr NoLicence Issued RetailRestrictedWholesaleWholesale or
distribution from
motor vehicle
1 Forms for drugs
other than C,C(1)
and X
20 20-A 20-B 20-BB
2 Forms for drugs
specified in
schdule C, C(1).
21 21-A 21-B 21-BB
3 Forms for drugs
Specified in
schedule X
20-F - 20-G -
Prohibition of manufacture and sale of certain drugs
and cosmetics
No person shall manufacture or sell or stock or exhibit for sale or distribute
(i)Any drug which is not of a standard quality or is misbranded, adulterated or spurious.
(ii)Any patent proprietary medicine which label does not display true formulae.(in) Any
misbranded, spurious or sub-standard cosmetic.
(iii)Any drug which by means of any statement, design or device claims to cure or mitigate any
disease specified in schedule J.
(iv) Any cosmetic containing any ingredient which may render unsafe or harmful for use.
(v) Any drug in contravention to any provisions of the Act and rules there under.
(vi) Any drugs not intended for sale.
(vii) Any drug or cosmetic, imported or manufactured in contravention to any of the provisions of
the Act and rules made there under.
(viii)Any drug in contravention of the conditions of license.
(ix)Any drug intended for free distribution to the members of the medical profession.
and cosmetics
No person shall manufacture or sell or stock or exhibit for sale or distribute
(i)Any drug which is not of a standard quality or is misbranded, adulterated or spurious.
(ii)Any patent proprietary medicine which label does not display true formulae.(in) Any
misbranded, spurious or sub-standard cosmetic.
(iii)Any drug which by means of any statement, design or device claims to cure or mitigate any
disease specified in schedule J.
(iv) Any cosmetic containing any ingredient which may render unsafe or harmful for use.
(v) Any drug in contravention to any provisions of the Act and rules there under.
(vi) Any drugs not intended for sale.
(vii) Any drug or cosmetic, imported or manufactured in contravention to any of the provisions of
the Act and rules made there under.
(viii)Any drug in contravention of the conditions of license.
(ix)Any drug intended for free distribution to the members of the medical profession.
Prohibition of import of certain cosmetics :
The import of following classes of cosmetics is prohibited.
(i)Cosmetics which are not of standard quality.
(ii) Misbranded cosmetic.
(iii)Cosmetics containing Hexachlorophene.
(iv)Cosmetics containing coal tar colour other than the one prescribed.
(v)Cosmetics containing prescribed colours which contain more than 2 p.p.m. of arsenic or 20
p.p.m. of lead or 100 p.p.m. of heavy metals other than lead.
(vi)Cosmetics intended for use on the eye-brow or the eyelash, or around the eye containing any
Coal Tar Dye Colour, Coal Tar base or Coal Tar Dye intermediate.
(vii)Cosmetics containing mercury compounds.
(viii)Cosmetics containing any ingredient which may render them unsafe or harmful for use.
(ix)Cosmetics coloured with arsenic or lead compounds. However, small quantities of cosmetics,
the import of which is otherwise prohibited, maybe imported for personal use if,
(i) They form part of a passenger's baggage and for the bonafide use of the passenger,and
(ii) They are declared to the customs authorises on being directed to do so
The import of following classes of cosmetics is prohibited.
(i)Cosmetics which are not of standard quality.
(ii) Misbranded cosmetic.
(iii)Cosmetics containing Hexachlorophene.
(iv)Cosmetics containing coal tar colour other than the one prescribed.
(v)Cosmetics containing prescribed colours which contain more than 2 p.p.m. of arsenic or 20
p.p.m. of lead or 100 p.p.m. of heavy metals other than lead.
(vi)Cosmetics intended for use on the eye-brow or the eyelash, or around the eye containing any
Coal Tar Dye Colour, Coal Tar base or Coal Tar Dye intermediate.
(vii)Cosmetics containing mercury compounds.
(viii)Cosmetics containing any ingredient which may render them unsafe or harmful for use.
(ix)Cosmetics coloured with arsenic or lead compounds. However, small quantities of cosmetics,
the import of which is otherwise prohibited, maybe imported for personal use if,
(i) They form part of a passenger's baggage and for the bonafide use of the passenger,and
(ii) They are declared to the customs authorises on being directed to do so
Classes of drugs prohibited to import
Misbranded drugs
Drugs of substandard quality
Drugs claiming to cure diseases specified in Sch-J
Adulterated drugs
Spurious drugs Drugs whose manufacture, sale/distribution are
prohibited in original country, except for the purpose of test,
examination and analysis.
Patent /Proprietary medicines whose true formula is not disclosed.
Misbranded drugs
Drugs of substandard quality
Drugs claiming to cure diseases specified in Sch-J
Adulterated drugs
Spurious drugs Drugs whose manufacture, sale/distribution are
prohibited in original country, except for the purpose of test,
examination and analysis.
Patent /Proprietary medicines whose true formula is not disclosed.
OFFENCES AND PENALTIES
Any adulterated or spurious drug
when used by any person, is likely to
cause his death or cause grievous hurt
under sec. 320 of the I.P.C.
punishable with imprisonment for a
term not less than five years but
which may extend to life
imprisonment and with fine not less
than Rs.10,000/-
1.Any one who himself or by any other person on his behalf, manufactures for sale
or for distribution or sells or stocks or exhibits for sale or offers for sale or
distributes.
Any adulterated or spurious drug
when used by any person, is likely to
cause his death or cause grievous hurt
under sec. 320 of the I.P.C.
punishable with imprisonment for a
term not less than five years but
which may extend to life
imprisonment and with fine not less
than Rs.10,000/-
1.Any one who himself or by any other person on his behalf, manufactures for sale
or for distribution or sells or stocks or exhibits for sale or offers for sale or
distributes.
drug deemed to be adulterated
but which is not likely to cause
death or grievous hurt or any
drug without valid license
imprisonment not less than one
year but which may extend to
three years and fine not less than
5,000 on first conviction and
imprisonment not less than two
years but which may extent to six
years and with fine not less than
Rs. 10,000/- on any subsequent
conviction. (for any special and
adequate reasons, court may
reduce the imprisonment and
fine)
OFFENCES AND PENALTIES
but which is not likely to cause
death or grievous hurt or any
drug without valid license
imprisonment not less than one
year but which may extend to
three years and fine not less than
5,000 on first conviction and
imprisonment not less than two
years but which may extent to six
years and with fine not less than
Rs. 10,000/- on any subsequent
conviction. (for any special and
adequate reasons, court may
reduce the imprisonment and
fine)
OFFENCES AND PENALTIES
Any drug deemed to be spurious
but which is not likely to cause
death or any grievous hurt
imprisonment not less than three
years but which may extend to
five years and with fine not less
than Rs. 5000/- provided that for
any adequate and special reason
court may impose imprisonment
less than three year, on first
conviction and with fine not less
than Rs. 10,000/- on any
subsequent conviction.
OFFENCES AND PENALTIES
but which is not likely to cause
death or any grievous hurt
imprisonment not less than three
years but which may extend to
five years and with fine not less
than Rs. 5000/- provided that for
any adequate and special reason
court may impose imprisonment
less than three year, on first
conviction and with fine not less
than Rs. 10,000/- on any
subsequent conviction.
OFFENCES AND PENALTIES
drug in contravention of other
provision of this chapter
imprisonment not less than one
year but which may extend to
two years and with fine. Provided
that for any adequate and special
reasons court may impose
imprisonment less than one year.
For any subsequent conviction of
an offence, be punishable with
imprisonment not less than one
years but which may extend to
four years or with fine not less
than Rs. 5000/-
OFFENCES AND PENALTIES
provision of this chapter
imprisonment not less than one
year but which may extend to
two years and with fine. Provided
that for any adequate and special
reasons court may impose
imprisonment less than one year.
For any subsequent conviction of
an offence, be punishable with
imprisonment not less than one
years but which may extend to
four years or with fine not less
than Rs. 5000/-
OFFENCES AND PENALTIES
spurious cosmetics be punishable with imprisonment
up to 3 years and fine
OFFENCES AND PENALTIES
up to 3 years and fine
OFFENCES AND PENALTIES
cosmetics in contravention of the
provisions of the act and rules
there under
punishable with imprisonment up
to one year or with fine up to Rs.
1,000 or with both, on first
conviction and with
imprisonment up to two years
and with fine up to two thousand
rupees or with both on any
subsequent conviction.
OFFENCES AND PENALTIES
provisions of the act and rules
there under
punishable with imprisonment up
to one year or with fine up to Rs.
1,000 or with both, on first
conviction and with
imprisonment up to two years
and with fine up to two thousand
rupees or with both on any
subsequent conviction.
OFFENCES AND PENALTIES
Any one who does not disclose,
the name of the manufacturer or
his agent from whom he acquired
the drug, if required by the
inspector,
imprisonment for a term which
may extend to Rs. 1,000/- or with
both.
2) Penalty for non – disclosure of the name of the manufacturer
OFFENCES AND PENALTIES
the name of the manufacturer or
his agent from whom he acquired
the drug, if required by the
inspector,
imprisonment for a term which
may extend to Rs. 1,000/- or with
both.
2) Penalty for non – disclosure of the name of the manufacturer
OFFENCES AND PENALTIES
Whoever without reasonable
cause or excuse does not
maintain records, registers and
documents as prescribed (Sec. 18
b), does not furnish information
to the authorized officers under
drugs and cosmetics Act,
punishable with imprisonment up
to 1 year or with fine up to Rs.
1,000/- or with both.
3) Penalty for non – keeping document etc. and for non- disclosure of
information:
OFFENCES AND PENALTIES
cause or excuse does not
maintain records, registers and
documents as prescribed (Sec. 18
b), does not furnish information
to the authorized officers under
drugs and cosmetics Act,
punishable with imprisonment up
to 1 year or with fine up to Rs.
1,000/- or with both.
3) Penalty for non – keeping document etc. and for non- disclosure of
information:
OFFENCES AND PENALTIES
Whoever himself or by any other
person manufacture, sells or
distributes any drug or cosmetics,
whose manufacture, sale etc. is
prohibited in the public interest
by notification in the official
gazette,
punishable with imprisonment up
to three years and fine up to
Rs.5,000/-.
OFFENCES AND PENALTIES
4) Penalty for manufacture etc. of drugs or cosmetics, whose manufacture,
sale etc. is prohibited in the public interest:
person manufacture, sells or
distributes any drug or cosmetics,
whose manufacture, sale etc. is
prohibited in the public interest
by notification in the official
gazette,
punishable with imprisonment up
to three years and fine up to
Rs.5,000/-.
OFFENCES AND PENALTIES
4) Penalty for manufacture etc. of drugs or cosmetics, whose manufacture,
sale etc. is prohibited in the public interest:
Who ever uses any repot of a test
or analysis made by CDL or
government analyst or extract
from such report for the purpose
of advertising any drug or
cosmetics
punishable with fine up to
Rs.500/- on first conviction and
with imprisonment up to ten
years or with fine or with both on
any subsequent conviction.
5. Penalty for use of government analysis report for advertising:
OFFENCES AND PENALTIES
or analysis made by CDL or
government analyst or extract
from such report for the purpose
of advertising any drug or
cosmetics
punishable with fine up to
Rs.500/- on first conviction and
with imprisonment up to ten
years or with fine or with both on
any subsequent conviction.
5. Penalty for use of government analysis report for advertising:
OFFENCES AND PENALTIES
GENERAL REQUIREMENT OF LABELLING
1.Name of the drug : following preparation should be labeled with proper names
I) preparations containing any new drug as a single active ingredient.
Ii) preparations containing any drug specified in schedule w as the single active
Ingredient.
2.Statement of net content: in terms of weight , volume, number of units of
contents
3.The content of active ingredients expressed in terms of:
❖ For oral liquids: content per single dose as per 5 ml or multiple thereof.
❖ For liquid parenterals : content per mililitre or percentage by volumes or
content per dose.
❖ For drugs in solid form for parenteral use units or weight per gram or
milligram.
❖ For tablets, capsules, pills etc: content per tablet/ capsule/pill, etc.
❖ For other preparations: contents in terms of percentage by weight or volume as
Unit per gram or per milliliter.
1.Name of the drug : following preparation should be labeled with proper names
I) preparations containing any new drug as a single active ingredient.
Ii) preparations containing any drug specified in schedule w as the single active
Ingredient.
2.Statement of net content: in terms of weight , volume, number of units of
contents
3.The content of active ingredients expressed in terms of:
❖ For oral liquids: content per single dose as per 5 ml or multiple thereof.
❖ For liquid parenterals : content per mililitre or percentage by volumes or
content per dose.
❖ For drugs in solid form for parenteral use units or weight per gram or
milligram.
❖ For tablets, capsules, pills etc: content per tablet/ capsule/pill, etc.
❖ For other preparations: contents in terms of percentage by weight or volume as
Unit per gram or per milliliter.
4.The name and address of the manufacturer
5.Distinctive batch number
6.Mnufacturing license number
7.Date of manufacture
8.Date of expiry of potency
9.Labelling of mechanical contraceptive
➢ Date of manufacturing
➢ Date up to which it retain its properties
➢ Storage condition for preserving contraceptive properties
10. Samples to the medical practitioner-physicians sample –not to be
Sold
11. Preparation containing more than 3 percent by volume of alcohol quantity
Expressed in average percentage by volume in the finished product
5.Distinctive batch number
6.Mnufacturing license number
7.Date of manufacture
8.Date of expiry of potency
9.Labelling of mechanical contraceptive
➢ Date of manufacturing
➢ Date up to which it retain its properties
➢ Storage condition for preserving contraceptive properties
10. Samples to the medical practitioner-physicians sample –not to be
Sold
11. Preparation containing more than 3 percent by volume of alcohol quantity
Expressed in average percentage by volume in the finished product
12.Categories of drugs:
➢ conspicuous red vertical line of at least 1mm width on the left side
running through the body of label for:
Narcotic analgesics, hypnotics, sedatives, tranquillizers, corticosteroids,
hormones, hypoglycemic, antimicrobials, antiepileptic, anti- depressants,
anticoagulants, anti-cancer drugs and the drugs under schedule ‘G’ , ‘H’
and ‘X’.
These provisions shall not apply to the preparations for animal treatment
and external use, ophthalmic preparations, ear drops, sterile sutures and
surgical dressings and parenterals.
➢ conspicuous red vertical line of at least 1mm width on the left side
running through the body of label for:
Narcotic analgesics, hypnotics, sedatives, tranquillizers, corticosteroids,
hormones, hypoglycemic, antimicrobials, antiepileptic, anti- depressants,
anticoagulants, anti-cancer drugs and the drugs under schedule ‘G’ , ‘H’
and ‘X’.
These provisions shall not apply to the preparations for animal treatment
and external use, ophthalmic preparations, ear drops, sterile sutures and
surgical dressings and parenterals.
Medicines for internal use:
Besides the particulars mentioned in clause (a), following additional particulars
shall appear on the label or container or medicines.
Schedule G- the word caution – it is dangerous to take this preparation except
under medical supervision should be conspicuously printed and underlined.
Schedule H:
I) symbol Rx conspicuously displayed on the left top Corner of the label.
Ii) the word schedule H drug warning: to be sold by retail on the
prescription of a registered medical practitioner only:
Besides the particulars mentioned in clause (a), following additional particulars
shall appear on the label or container or medicines.
Schedule G- the word caution – it is dangerous to take this preparation except
under medical supervision should be conspicuously printed and underlined.
Schedule H:
I) symbol Rx conspicuously displayed on the left top Corner of the label.
Ii) the word schedule H drug warning: to be sold by retail on the
prescription of a registered medical practitioner only:
c) schedule H and comes within purview of the dangerous drugs Act 1930:
(now, Narcotic and psychotropic substance Act, 1985):
i) Symbol NRx conspicuously displayed on the left top corner of the
label in red ink.
ii) Schedule H drug warning : to be sold by retail on the prescription
of a registered medical practitioner only.
d) schedule X
i) Symbol XRx in red conspicuously displayed on the left top corner
of the label.
ii) The world schedule X drug warning: to be sold by retail on the
prescription of a registered medical practitioner only
(now, Narcotic and psychotropic substance Act, 1985):
i) Symbol NRx conspicuously displayed on the left top corner of the
label in red ink.
ii) Schedule H drug warning : to be sold by retail on the prescription
of a registered medical practitioner only.
d) schedule X
i) Symbol XRx in red conspicuously displayed on the left top corner
of the label.
ii) The world schedule X drug warning: to be sold by retail on the
prescription of a registered medical practitioner only
2. Lotion, liniment, liquid antiseptic or other liquid medicine for external
application – the worlds in capital ‘for external use only’.
3. Medicines for treatment of human ailments containing Industrial methylated
spirit shall indicate the fact on label And labeled with worlds : ‘for external
use only’.
4. Specified in schedule X in bulk form symbol xrx in red on the left top corner.
5. Patent and proprietary medicines containing vitamins : the Word indicating
whether for,
For therapeutic use’
For prophylactic use’
a)For pediatric use (as the may be schedule V)
b)Age of the child/infant for whose use it is meant
application – the worlds in capital ‘for external use only’.
3. Medicines for treatment of human ailments containing Industrial methylated
spirit shall indicate the fact on label And labeled with worlds : ‘for external
use only’.
4. Specified in schedule X in bulk form symbol xrx in red on the left top corner.
5. Patent and proprietary medicines containing vitamins : the Word indicating
whether for,
For therapeutic use’
For prophylactic use’
a)For pediatric use (as the may be schedule V)
b)Age of the child/infant for whose use it is meant
6. Non-sterile surgical ligature and sutures.
The words in a conspicuous manner and in indelible red ink,
‘non-sterile surgical ligature (suture), not to be used for
operations upon the human body unless efficiently sterilized.
7. Patent and proprietary medicine:
a) Name and address of the manufacturer
b)True formula or list of ingredients printed in indelible ink on outer label
of every package
8. Pharmacopoeial and other official drugs: name or synonym as
specified in the pharmacopoeia followed by the abbreviations
Recognized, ‘I.P., B.P., B.P.C. Etc. Out in such pharmacopoeia.
The words in a conspicuous manner and in indelible red ink,
‘non-sterile surgical ligature (suture), not to be used for
operations upon the human body unless efficiently sterilized.
7. Patent and proprietary medicine:
a) Name and address of the manufacturer
b)True formula or list of ingredients printed in indelible ink on outer label
of every package
8. Pharmacopoeial and other official drugs: name or synonym as
specified in the pharmacopoeia followed by the abbreviations
Recognized, ‘I.P., B.P., B.P.C. Etc. Out in such pharmacopoeia.
9. Ophthalmic preparations: (schedule FF)
A. Ophthalmic solutions and suspensions :
❖ additional particular shall be shown on the label of container:
❖ The statement use the solution within one month after opening the container.
❖ Name and concentration of the preservative used.
❖ Words ‘not for injection’.
❖ Special instructions regarding storage, wherever applicable.
Warning:
❖ If irritation persists or increases, discontinue the use and consult physician.
❖ Do not touch the dropper tip or the other dispensing tip to any surface since this may
Contaminate solution.
A. Ophthalmic solutions and suspensions :
❖ additional particular shall be shown on the label of container:
❖ The statement use the solution within one month after opening the container.
❖ Name and concentration of the preservative used.
❖ Words ‘not for injection’.
❖ Special instructions regarding storage, wherever applicable.
Warning:
❖ If irritation persists or increases, discontinue the use and consult physician.
❖ Do not touch the dropper tip or the other dispensing tip to any surface since this may
Contaminate solution.
B . Ophthalmic ointment :
special instructions regarding storage, wherever applicable “Warning”: if
irritation persists or increases, discontinue the use and consult physician.
11. Medicine treatment of animals.
The words ‘not for human use. For animal treatment only’.
Symbol depicting the head of a domestic animal.
12.Disinfectants : (schedule O)
▪Name of the product and name and address of the manufacturer.
▪Grade, of manufacture and R.W. Coefficient of the product.
▪Date of manufacture and date before which it should be used.
▪Quantity.
▪Method of use.
13. Coloured medicines : common name of the colour used shall be displayed on
the label.
special instructions regarding storage, wherever applicable “Warning”: if
irritation persists or increases, discontinue the use and consult physician.
11. Medicine treatment of animals.
The words ‘not for human use. For animal treatment only’.
Symbol depicting the head of a domestic animal.
12.Disinfectants : (schedule O)
▪Name of the product and name and address of the manufacturer.
▪Grade, of manufacture and R.W. Coefficient of the product.
▪Date of manufacture and date before which it should be used.
▪Quantity.
▪Method of use.
13. Coloured medicines : common name of the colour used shall be displayed on
the label.
(Hair dyes containing paraphenylene diamine or other coal tar dyes or coal tar
intermediates should be labeled with the following words (On outer and the inner
labels ).
➢ ‘’Caution: This product contains ingredients which may cause skin irritation in
certain cases & so a preliminary test according to the accompanying directions
should first be made.
➢ The product should not be used for dyeing the eye-lashes or eye-brows; as such
use may cause blindness’’.
In addition, the following instructions in English & other local language should
appear on each package of Hair dyes.
➢‘‘This preparation may cause serious inflammation of the skin in some cases & so a
preliminary test should always be carried out to determine whether or not special
sensitivity exists
Labeling Provisions of Hair dyes
intermediates should be labeled with the following words (On outer and the inner
labels ).
➢ ‘’Caution: This product contains ingredients which may cause skin irritation in
certain cases & so a preliminary test according to the accompanying directions
should first be made.
➢ The product should not be used for dyeing the eye-lashes or eye-brows; as such
use may cause blindness’’.
In addition, the following instructions in English & other local language should
appear on each package of Hair dyes.
➢‘‘This preparation may cause serious inflammation of the skin in some cases & so a
preliminary test should always be carried out to determine whether or not special
sensitivity exists
Labeling Provisions of Hair dyes
➢ To make the test, cleanse a small area of skin behind the ear or upon the
inner surface of the forearm, using either soap & water or alcohol.
➢ Apply a small quantity of the hair dye as prepared for use to the area &
allow it to dry.
➢ After twenty four hours, wash the area gently with soap & water.
If no irritation or inflammation is apparent, it may be assumed that no
hypersensitivity to the dye exists.
➢The test should, however, be carried out before each & every application.
➢ This preparation should on no account be used for dyeing eyebrows or eye-
lashes as severe inflammation of the eye or even blindness may result
Labeling Provisions of Hair dyes
inner surface of the forearm, using either soap & water or alcohol.
➢ Apply a small quantity of the hair dye as prepared for use to the area &
allow it to dry.
➢ After twenty four hours, wash the area gently with soap & water.
If no irritation or inflammation is apparent, it may be assumed that no
hypersensitivity to the dye exists.
➢The test should, however, be carried out before each & every application.
➢ This preparation should on no account be used for dyeing eyebrows or eye-
lashes as severe inflammation of the eye or even blindness may result
Labeling Provisions of Hair dyes
The label on the container shall display:
(i)The name of vaccine (Proper name)
(ii)The batch number or lot number
(iii)The total number of doses in the container or contents in milliliters.
(iv)Potency
(v)Expiry date
In addition to above information, the label on the package shall show:
(i) Proper name
(ii) Contents in Milliliters or doses
(iii) Batch number
(iv) The name and address manufacturer
(v) Manufacturing license No
(vi) The date of manufacture & date of expiry
(vii) Storage conditions
Vaccines Labelling Provisions of Vaccines
(i)The name of vaccine (Proper name)
(ii)The batch number or lot number
(iii)The total number of doses in the container or contents in milliliters.
(iv)Potency
(v)Expiry date
In addition to above information, the label on the package shall show:
(i) Proper name
(ii) Contents in Milliliters or doses
(iii) Batch number
(iv) The name and address manufacturer
(v) Manufacturing license No
(vi) The date of manufacture & date of expiry
(vii) Storage conditions
Vaccines Labelling Provisions of Vaccines
(i) Loan licence:
It means a licence which a licensing authority may issue to an applicant
who does not have his own arrangements for manufacture but who
intends to avail himself of the manufacturing facilities owned by another
licensee/ manufacturer.
(i)Application for the grant or renewal of loan licences to manufacture for
sale or for distribution of drugs other than those specified in Schedule C,
Schedule C (1) & Sch. X shall be made up to ten items for each category
of drugs shall be made in Form 24-A accompanied by a licence fee of
rupees 6000/- & an inspection fee of rupees 1500/- to the licensing
authority.
(ii)The Licensing Authority shall, before the grant of a loan licence,
satisfy himself that the manufacturing unit has adequate equipment, staff,
capacity for manufacture, & facilities for testing, to undertake the
manufacture on the behalf of the applicant for a loan licence
It means a licence which a licensing authority may issue to an applicant
who does not have his own arrangements for manufacture but who
intends to avail himself of the manufacturing facilities owned by another
licensee/ manufacturer.
(i)Application for the grant or renewal of loan licences to manufacture for
sale or for distribution of drugs other than those specified in Schedule C,
Schedule C (1) & Sch. X shall be made up to ten items for each category
of drugs shall be made in Form 24-A accompanied by a licence fee of
rupees 6000/- & an inspection fee of rupees 1500/- to the licensing
authority.
(ii)The Licensing Authority shall, before the grant of a loan licence,
satisfy himself that the manufacturing unit has adequate equipment, staff,
capacity for manufacture, & facilities for testing, to undertake the
manufacture on the behalf of the applicant for a loan licence
(iii)Application for manufacture of more than ten items for each category
of drug on a loan licence shall be accompanied by an addition fee of
rupees 300/- per additional item specified in Schedule M.& M-III
(iv)If the Licensing Authority is satisfied that a loan licence is defaced,
damaged or lostor otherwise rendered useless he may, on payment of a
1000/- Rs issue a duplicate licence.
(v)An original licence or a renewed licence in Form 25 valid for a period
of five years on which it is granted or renewed.
of drug on a loan licence shall be accompanied by an addition fee of
rupees 300/- per additional item specified in Schedule M.& M-III
(iv)If the Licensing Authority is satisfied that a loan licence is defaced,
damaged or lostor otherwise rendered useless he may, on payment of a
1000/- Rs issue a duplicate licence.
(v)An original licence or a renewed licence in Form 25 valid for a period
of five years on which it is granted or renewed.
Restricted licences :
(i) Restricted licences shall be issued subject to the discretion of the
Licensing Authority, to dealers or persons in respect of drugs whose sale
does not require the supervision of a qualified person.
(ii) Licences to itinerant vendors shall be issued only in exceptional
circumstances for bonafide traveling agents of firms dealing in drugs or
for a vendor who purchases drugs from a licensed dealer for distribution in
rural areas where other channels of distribution of drugs are not available.
(iii)For restricted licence, applicant has to make an application in Form-
19A and the licence issued for drugs other than those specified in schedule
C,C(1),and X in Form 20A and for drugs specified in schedule C, C(1) in
Form 21-A The restricted licence in Form 21-A may also issued to a
travelling agent of a firm for drugs specified in Schedule C.
(i) Restricted licences shall be issued subject to the discretion of the
Licensing Authority, to dealers or persons in respect of drugs whose sale
does not require the supervision of a qualified person.
(ii) Licences to itinerant vendors shall be issued only in exceptional
circumstances for bonafide traveling agents of firms dealing in drugs or
for a vendor who purchases drugs from a licensed dealer for distribution in
rural areas where other channels of distribution of drugs are not available.
(iii)For restricted licence, applicant has to make an application in Form-
19A and the licence issued for drugs other than those specified in schedule
C,C(1),and X in Form 20A and for drugs specified in schedule C, C(1) in
Form 21-A The restricted licence in Form 21-A may also issued to a
travelling agent of a firm for drugs specified in Schedule C.
(iv)Such licence is not needed for venders for the specific purpose of
distribution to medical practioner or dealers.
(v)Such licence in not needed to traveling agents of licensed
manufacturers, agents of such manufacturers and importers of drugs
engaged in free distribution of samples of medicine among members of
the medical profession, hospitals, dispensaries and the medical or research
institutions
distribution to medical practioner or dealers.
(v)Such licence in not needed to traveling agents of licensed
manufacturers, agents of such manufacturers and importers of drugs
engaged in free distribution of samples of medicine among members of
the medical profession, hospitals, dispensaries and the medical or research
institutions
(iv)Such licence is not needed for venders for the specific purpose of
distribution to medical practioner or dealers.
(v)Such licence in not needed to traveling agents of licensed
manufacturers, agents of such manufacturers and importers of drugs
engaged in free distribution of samples of medicine among members of
the medical profession, hospitals, dispensaries and the medical or research
institutions
distribution to medical practioner or dealers.
(v)Such licence in not needed to traveling agents of licensed
manufacturers, agents of such manufacturers and importers of drugs
engaged in free distribution of samples of medicine among members of
the medical profession, hospitals, dispensaries and the medical or research
institutions
Conditions of license for sale of schedule H and schedule X drug under D and C,
1940.
sale of drugs specified in schedule H and schedule X:
1)substances specified in schedule H and schedule X should not be sold by retail and
sold only in accordance with the prescription of RMP. In case of substances specified
in schedule X, the prescription should be duplicate, one copy of which is retained by
licensee and preserved for at least for two years.
2)drugs from schedule H and schedule X, supplied to registered medical practitioner,
hospitals, dispensaries and nursing homes, shall be supplied only against signed
written order and such order should be preserved for at least for two years.
3)A prescription of RMP against which drugs from schedule H or schedule X,
supplied should: i)be in writing and signed by the person giving it, with his usual
signature and be dated. Ii)specify the name and address of the patient or name and
address or owner of the animal if drug is for veterinary use.
Iii)indicate the total amount of drugs supplied and doses to be taken.
1940.
sale of drugs specified in schedule H and schedule X:
1)substances specified in schedule H and schedule X should not be sold by retail and
sold only in accordance with the prescription of RMP. In case of substances specified
in schedule X, the prescription should be duplicate, one copy of which is retained by
licensee and preserved for at least for two years.
2)drugs from schedule H and schedule X, supplied to registered medical practitioner,
hospitals, dispensaries and nursing homes, shall be supplied only against signed
written order and such order should be preserved for at least for two years.
3)A prescription of RMP against which drugs from schedule H or schedule X,
supplied should: i)be in writing and signed by the person giving it, with his usual
signature and be dated. Ii)specify the name and address of the patient or name and
address or owner of the animal if drug is for veterinary use.
Iii)indicate the total amount of drugs supplied and doses to be taken.
How do Schedule ‘X’ drugs are supplied on retail counter?
Sale of schedule X drugs:-
1.Schedule X drugs shall be supplied only on a prescription of a RMP and such
prescription should be in duplicate, one copy of which is retained by licensee
and preserved for at least 2 years. Unless otherwise stated in the prescription by
the prescriber, such drugs must not be dispensed more than once.
2. The supply of drugs specified in schedule X shall be recorded at the time of
supply in a bound and serially page numbered register, specially maintained for
the purpose and separate pages shall be allotted for each drug and the following
particulars shall be entered in the register.
i) Date of supply and opening and closing stocks of drug on that day and relevant
bill numbers.
ii) Name of drug, its manufacturer’s name and Batch number or lot number.
iii) Name and address of the purchaser/patient.
iv) Date of prescription and name and address of RMP
v) Signature of the registered pharmacist under whose supervision supply is made.
vi) Specify the name and address of the patient or name and address or the owner of
the animal if drug is for veterinary use.
Sale of schedule X drugs:-
1.Schedule X drugs shall be supplied only on a prescription of a RMP and such
prescription should be in duplicate, one copy of which is retained by licensee
and preserved for at least 2 years. Unless otherwise stated in the prescription by
the prescriber, such drugs must not be dispensed more than once.
2. The supply of drugs specified in schedule X shall be recorded at the time of
supply in a bound and serially page numbered register, specially maintained for
the purpose and separate pages shall be allotted for each drug and the following
particulars shall be entered in the register.
i) Date of supply and opening and closing stocks of drug on that day and relevant
bill numbers.
ii) Name of drug, its manufacturer’s name and Batch number or lot number.
iii) Name and address of the purchaser/patient.
iv) Date of prescription and name and address of RMP
v) Signature of the registered pharmacist under whose supervision supply is made.
vi) Specify the name and address of the patient or name and address or the owner of
the animal if drug is for veterinary use.
Schedule N:
1)Entrance - The front of a pharmacy shall bear an inscription “Pharmacy”.
2) Premises –
The premises of a pharmacy shall be separated from rooms for private use.
The premises shall be well built, dry, well lit and ventilated and of sufficient
dimensions to allow the goods in stock especially medicaments and poisons to be
kept in a clearly visible and appropriate manner.
The area of the section to be used as dispensing department shall be not less than 6
square meters for one pharmacist working therein with additional 2 square meters
for each additional pharmacist. The height of the premises shall be at least 2.5
meters.
The floor of the pharmacy shall be smooth and washable.
The walls shall be plastered or tiled or oil painted so as to maintain smooth,
durable and washable surface devoid of holes, cracks and crevices.
A pharmacy shall be provided with ample supply of good quality water.
The dispensing department shall be separated by a barrier to prevent the admission
of the public.
1)Entrance - The front of a pharmacy shall bear an inscription “Pharmacy”.
2) Premises –
The premises of a pharmacy shall be separated from rooms for private use.
The premises shall be well built, dry, well lit and ventilated and of sufficient
dimensions to allow the goods in stock especially medicaments and poisons to be
kept in a clearly visible and appropriate manner.
The area of the section to be used as dispensing department shall be not less than 6
square meters for one pharmacist working therein with additional 2 square meters
for each additional pharmacist. The height of the premises shall be at least 2.5
meters.
The floor of the pharmacy shall be smooth and washable.
The walls shall be plastered or tiled or oil painted so as to maintain smooth,
durable and washable surface devoid of holes, cracks and crevices.
A pharmacy shall be provided with ample supply of good quality water.
The dispensing department shall be separated by a barrier to prevent the admission
of the public.
➢3) Furniture and apparatus –
A pharmacy shall contain furniture of required size & suitable apparatus.
Drugs, chemicals, and medicaments shall be kept in a room appropriate to
their properties and in such special containers as will prevent any
deterioration of the contents or of contents of containers kept near them.
Drawers, glasses and other containers used for keeping medicaments shall be
of suitable size and capable of being closed tightly to prevent the entry of
dust.
Every container shall bear a label of appropriate size, easily readable with
names of medicaments as given in the Pharmacopoeias.
A pharmacy shall be provided with a dispensing bench having impervious &
washable top.
.
A pharmacy shall contain furniture of required size & suitable apparatus.
Drugs, chemicals, and medicaments shall be kept in a room appropriate to
their properties and in such special containers as will prevent any
deterioration of the contents or of contents of containers kept near them.
Drawers, glasses and other containers used for keeping medicaments shall be
of suitable size and capable of being closed tightly to prevent the entry of
dust.
Every container shall bear a label of appropriate size, easily readable with
names of medicaments as given in the Pharmacopoeias.
A pharmacy shall be provided with a dispensing bench having impervious &
washable top.
.
A pharmacy shall be provided with a cupboard with lock and key for
the storage of poisons and shall be clearly marked with the work
‘POISON’ in red letters on a white background.
Containers of all concentrated solution shall bear special label or
marked with the words “To be diluted”.
A Pharmacy shall be provided with the following minimum apparatus
and books necessary for making of official preparations and
prescriptions-
the storage of poisons and shall be clearly marked with the work
‘POISON’ in red letters on a white background.
Containers of all concentrated solution shall bear special label or
marked with the words “To be diluted”.
A Pharmacy shall be provided with the following minimum apparatus
and books necessary for making of official preparations and
prescriptions-
Apparatus-
Balance, dispensing, sensitivity 30 mg. , sensitivity 1 gm. 500 ml Balance,
counter, capacity 3 Kgm, sensitivity 1 gm.
Beakers, lipped, assorted sizes, Bottles, prescription, ungraduated assorted sizes
Cork, extractor, Evaporating dishes, porcelain, Filter paper, Funnels, glass,
Litmus paper, blue and red, Measure glasses cylindrical 10 ml, 25 ml, 100 ml
and 500 ml
Mortars and pestles, glass, Ointment pots, Ointment slab, porcelain, Pipettes,
graduated, 2 ml, 5 ml and 10 ml
Mortars and pestles, glass, Ointment pots, Ointment slab, porcelain, Pipettes,
graduated, 2 ml, 5 ml and 10 ml
Rubber stamps and pad, Scissors, Spatulas, rubber or vulcanite, Spatulas,
stainless steel.
Spirit lamp, Glass stirring rods, Thermometer, 0oC to 200oC, Tripod stand
,Watch glasses, Water bath, Pill Machine, Pill Boxes, Suppository mould.
Balance, dispensing, sensitivity 30 mg. , sensitivity 1 gm. 500 ml Balance,
counter, capacity 3 Kgm, sensitivity 1 gm.
Beakers, lipped, assorted sizes, Bottles, prescription, ungraduated assorted sizes
Cork, extractor, Evaporating dishes, porcelain, Filter paper, Funnels, glass,
Litmus paper, blue and red, Measure glasses cylindrical 10 ml, 25 ml, 100 ml
and 500 ml
Mortars and pestles, glass, Ointment pots, Ointment slab, porcelain, Pipettes,
graduated, 2 ml, 5 ml and 10 ml
Mortars and pestles, glass, Ointment pots, Ointment slab, porcelain, Pipettes,
graduated, 2 ml, 5 ml and 10 ml
Rubber stamps and pad, Scissors, Spatulas, rubber or vulcanite, Spatulas,
stainless steel.
Spirit lamp, Glass stirring rods, Thermometer, 0oC to 200oC, Tripod stand
,Watch glasses, Water bath, Pill Machine, Pill Boxes, Suppository mould.
Books:
i) The Indian Pharmacopoeia (current Edition)
ii) National Formulary of Indian (Current Edition)
iii) The drugs and Cosmetics Act, 1940
iv) The Drugs and Cosmetics Rules, 1945
v) The Pharmacy Act, 1948
vi) Narcotic Drugs and Psychotropic Substances Act,1985
vii) The Dangerous Drugs Act, 1930
i) The Indian Pharmacopoeia (current Edition)
ii) National Formulary of Indian (Current Edition)
iii) The drugs and Cosmetics Act, 1940
iv) The Drugs and Cosmetics Rules, 1945
v) The Pharmacy Act, 1948
vi) Narcotic Drugs and Psychotropic Substances Act,1985
vii) The Dangerous Drugs Act, 1930
Schedule C:List of "Biological and Special Products", whose
import,sale,distribution and manufacture are governed by special
provisions e.g.-
➢Sera
➢Parenteral Serum Proteins Solution
➢Parenteral Vaccines
➢Toxins
➢Antigens
➢Antitoxins
➢Neo-arsphenamine and analogous substances used for the specific treatment
ofinfective diseases.
➢ Insulin
➢ Pitutary (Posterior Lobe) Extract
➢ Adrenaline and Solutions of Salts of Adrenaline
➢Antibiotics and their parenteral preparations.
➢Other parenteral preparations and sterile products
➢Sterile surgical suture and ligature
➢Bacteriophages
➢ Ophthalmic preparations
➢ Sterile Disposable Devices for single use only
import,sale,distribution and manufacture are governed by special
provisions e.g.-
➢Sera
➢Parenteral Serum Proteins Solution
➢Parenteral Vaccines
➢Toxins
➢Antigens
➢Antitoxins
➢Neo-arsphenamine and analogous substances used for the specific treatment
ofinfective diseases.
➢ Insulin
➢ Pitutary (Posterior Lobe) Extract
➢ Adrenaline and Solutions of Salts of Adrenaline
➢Antibiotics and their parenteral preparations.
➢Other parenteral preparations and sterile products
➢Sterile surgical suture and ligature
➢Bacteriophages
➢ Ophthalmic preparations
➢ Sterile Disposable Devices for single use only
Schedule C(1):List of "Other Special Products", whose
import, sale, distribution and manufacture are
governed by special provisions.
➢Digitalis group drugs and their non-parenteral preparations
➢Ergot and it's non-parenteral preparations.
➢Adrenaline and it's non-parenteral preparations.
➢Fish liver oil and it's preparations.Vitamins and non-parenteral
preparations of any vitamins.
➢ Liver extract and it's non-parenteral preparations.
➢ Hormones and their non-parenteral preparations
➢ Non-parenteral vaccines.
➢Various Antibiotics and non-parenteral preparations of Antibiotics.
➢ In-vitro Blood Grouping Sera.
➢ In-vitro Diagnostic Devices for HIV, HbsAg and HCV.
import, sale, distribution and manufacture are
governed by special provisions.
➢Digitalis group drugs and their non-parenteral preparations
➢Ergot and it's non-parenteral preparations.
➢Adrenaline and it's non-parenteral preparations.
➢Fish liver oil and it's preparations.Vitamins and non-parenteral
preparations of any vitamins.
➢ Liver extract and it's non-parenteral preparations.
➢ Hormones and their non-parenteral preparations
➢ Non-parenteral vaccines.
➢Various Antibiotics and non-parenteral preparations of Antibiotics.
➢ In-vitro Blood Grouping Sera.
➢ In-vitro Diagnostic Devices for HIV, HbsAg and HCV.
Schedule G Prescription Drugs:
1. Aminopterin
2.Chlorthiazide
3.Glibenclamide
4. Insulin
5. Phenformin
6. Chlorcyclazine
7. Diphenhydramine
8. Promethazine, etc.
9. Carbutamide
10.Chlorpropamide
11. Hydantoin
12. Metformin
13. Tolbutamide
14. Chlorpheneramine
15. Pheneramine
1. Aminopterin
2.Chlorthiazide
3.Glibenclamide
4. Insulin
5. Phenformin
6. Chlorcyclazine
7. Diphenhydramine
8. Promethazine, etc.
9. Carbutamide
10.Chlorpropamide
11. Hydantoin
12. Metformin
13. Tolbutamide
14. Chlorpheneramine
15. Pheneramine
Schedule H - Prescription Drugs:Presently 521 drugs
are categorised under Schedule-H.
Albendazole, Hepatitis. B vaccine, Analgin, Ibuprofen, Androgenic
anabolic, oestrogenicand projestational substances, Antibiotics,
Atenolol, Atorvastatin, Baclofen,.Barbituric Acid, Insulin human,
Indomethacin, Interferon, Levodopa, Lithium corbonate,
Lorazepam Chlorpromazine, Cimetidine ,Ciprofloxacin
hydrochloride,Clarithromycin ,Clindamycin ,Clobazam,
Clofibrate1, Clonazepam, Clotrimazole ,Dapsone,Diclofenac
sodium, Dopamine hydrochloride, Epinephrine, Ergot alkalolds ,
Estradiol succinate ,Flurazepam ,Heparin, Mebendazole,
Metronidazole, Narcotic drugs ,Nitroglycerin , Norfloxacin
,Ofloxacin, Phenobarbital, Phenyl butazine, Prednisolone stearoyl
glycolate, Quinidine sulphate ,Ranitidine , Salbutamol sulphate,
Telmisartan ,Tinidazole, Vasopressin, Betamethasone,
Dexamethasone
are categorised under Schedule-H.
Albendazole, Hepatitis. B vaccine, Analgin, Ibuprofen, Androgenic
anabolic, oestrogenicand projestational substances, Antibiotics,
Atenolol, Atorvastatin, Baclofen,.Barbituric Acid, Insulin human,
Indomethacin, Interferon, Levodopa, Lithium corbonate,
Lorazepam Chlorpromazine, Cimetidine ,Ciprofloxacin
hydrochloride,Clarithromycin ,Clindamycin ,Clobazam,
Clofibrate1, Clonazepam, Clotrimazole ,Dapsone,Diclofenac
sodium, Dopamine hydrochloride, Epinephrine, Ergot alkalolds ,
Estradiol succinate ,Flurazepam ,Heparin, Mebendazole,
Metronidazole, Narcotic drugs ,Nitroglycerin , Norfloxacin
,Ofloxacin, Phenobarbital, Phenyl butazine, Prednisolone stearoyl
glycolate, Quinidine sulphate ,Ranitidine , Salbutamol sulphate,
Telmisartan ,Tinidazole, Vasopressin, Betamethasone,
Dexamethasone
Schedule H1 - Prescription Drugs: Presently 47 drugs are
categorised under ScheduleH1, few of them are given below:
1.Alprazolam
2.Codeine
3.Ethambutol hydrochloride
4.Gemifloxacin
5.Nitrazepam
6.Rifampicin
7.Balofloxacin
8.Dizepam
9.Isoniazid
10.Levofloxacin
11.Oxytocin
12.Sparfloxacin
categorised under ScheduleH1, few of them are given below:
1.Alprazolam
2.Codeine
3.Ethambutol hydrochloride
4.Gemifloxacin
5.Nitrazepam
6.Rifampicin
7.Balofloxacin
8.Dizepam
9.Isoniazid
10.Levofloxacin
11.Oxytocin
12.Sparfloxacin
Schedule-K:Certain classes of drugs are exempted from some provisions relating
to manufacture, sale and distribution of drugs. Schedule- prescribes:
(a) Classes of drugs
(b) Extent of exemption and
(c) Conditions of exemption
Subject to specified conditions, following classes of drugs are exempted from all
related provisions:
1. Drugs not for medicinal use:
2. Drugs supplied by a Registered Medical Practitioner to his own patients.
3. Specified substances, which are used both as articles of food as well as drug
Hair fixers containing gum mucilage
4. Radio pharmaceuticals
5. Drugs supplied by the specified health workers under the health or family
welfare programmed of Central or State Government
6. Homeopathic medicines supplied by a Registered Homeopathic Medical Practitioner
to his own patients.
7. Whole Human Blood, collected and transfused by specified centres of Armed Forces
of Medical Services
8. Custom made devices.
to manufacture, sale and distribution of drugs. Schedule- prescribes:
(a) Classes of drugs
(b) Extent of exemption and
(c) Conditions of exemption
Subject to specified conditions, following classes of drugs are exempted from all
related provisions:
1. Drugs not for medicinal use:
2. Drugs supplied by a Registered Medical Practitioner to his own patients.
3. Specified substances, which are used both as articles of food as well as drug
Hair fixers containing gum mucilage
4. Radio pharmaceuticals
5. Drugs supplied by the specified health workers under the health or family
welfare programmed of Central or State Government
6. Homeopathic medicines supplied by a Registered Homeopathic Medical Practitioner
to his own patients.
7. Whole Human Blood, collected and transfused by specified centres of Armed Forces
of Medical Services
8. Custom made devices.
Ammendments
The Drugs (Amendment) Act, 1960 (35 of 1960)
The Drugs (Amendment) Act, 1962 (21 of 1962)
The Drugs and Cosmetics (Amendment) Act, 1964 (13 of 1964)
The Drugs and Cosmetics (Amendment) Act, 1972 (19 of 1972)
The Drugs and Cosmetics (Amendment) Act, 1982 (68 of 1982)
The Drugs and Cosmetics (Amendment) Act, 1986
The Drugs and Cosmetics (Amendment) Act, 1995 (71 of 1995)
The Drugs and Cosmetics (Amendment) Act, 2008 (26 of 2008)
[8]
Recent amendments - The Drugs and Cosmetics (Amendment) Act,
2017
The Drugs (Amendment) Act, 1960 (35 of 1960)
The Drugs (Amendment) Act, 1962 (21 of 1962)
The Drugs and Cosmetics (Amendment) Act, 1964 (13 of 1964)
The Drugs and Cosmetics (Amendment) Act, 1972 (19 of 1972)
The Drugs and Cosmetics (Amendment) Act, 1982 (68 of 1982)
The Drugs and Cosmetics (Amendment) Act, 1986
The Drugs and Cosmetics (Amendment) Act, 1995 (71 of 1995)
The Drugs and Cosmetics (Amendment) Act, 2008 (26 of 2008)
[8]
Recent amendments - The Drugs and Cosmetics (Amendment) Act,
2017
THANK YOU
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