JURISPRUDENCE Unit-1 Bachlor of Pharmacy
JURISPRUDENCE Unit-1 Bachlor of Pharmacy
JURISPRUDENCE Unit-1 Bachlor of Pharmacy
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BP505T-UNIT-I 10Hours
Drugs and Cosmetics Act, 1940 and its rules 1945:
Objectives, Definitions, Legal definitions of schedules to the Act and Rules
Import of drugs – Classes of drugs and cosmetics prohibited from import, Import under license
or permit. Offences and penalties.
Manufacture of drugs – Prohibition of manufacture and sale of certain drugs, Conditions for
grant of license and conditions of license for manufacture of drugs, Manufacture of drugs for
test, examination and analysis, manufacture of new drug, loan license and repacking license.
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Introduction
Drug is an essential commodity and is required to be regulated in terms of its import,
manufacture, sale and distribution. The Central Government and State Government are charged
with the responsibility of providing the drugs of desired quality to the needy patients and in order
to ensure this primary obligation of the Government, the network is required to be developed to
root out adulterated, misbranded and spurious drugs from the society.
Objectives
1. For preventing substandard in drugs, probably for treatment and preserving high medical
standards.
2. For controlling the import, manufacture, distribution, and sale of drugs and cosmetics by
licensing.
3. For ensuring that manufacture, distribution, and sale of drugs and cosmetics is done by
qualified persons only.
4. For controlling the manufacture, and sale of Ayurvedic, Siddha, and Unani drugs.
5. Establishment of Drugs Technical Advisory Board (DTAB) and Drugs Consultive
Committees (DCC) for Allopathic and Allied drugs and Cosmetics [1].
Important Definitions
1. Drug
It Includes:
(i) All medicines for internal or external use of human beings or animals and substances used for
or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human
beings or animals including, preparations applied on human body for the purpose of repelling
insects like mosquitoes.
(ii) The substances other than food which may affect the structure or any function of the human
body or used for the destruction of insects or vermin which cause disease in human beings or
animals as specified from time to time by the Central Government by notification in the Official
Gazette.
(iii) The substances used as components of a drug including, empty gelatin capsules.
(iv) The devices used for internal or external use in the diagnosis, treatment, mitigation or
prevention of disease or disorder in human beings or animals, as may be specified from time to
time by the Central Government by notification in the Official Gazette after consultation with the
Drugs Technical Advisory Board (DTAB).
2. Cosmetic
It means any article intended to be sprayed, poured, rubbed or sprinkled on, or introduced into,
or applied to the human body or its any part for cleansing, beautifying, promoting attractiveness
or altering the appearance. It also includes any articles intended for use as a component of
cosmetic.
3. Ayurvedic, Siddha or Unani Drugs
These include all medicines used for internal or external purposes or used in the diagnosis,
treatment, mitigation or prevention of disease or disorder in human beings or animals and
manufactured exclusively in accordance with the formulae described in the authoritative books
of Ayurvedic, Siddha and Unani Tibby Systems of Medicines specified in the First Schedule to
the Drugs and Cosmetics Act, 1940.
4. Gudakhu
It is a tobacco product used for rubbing against human teeth. It contains tobacco powder, lime
and molasses along with red mineral matter. It is a cosmetic within the provisions of the Act.
5. Patent or Proprietary Medicine
It means:
(i) In relation to Ayurvedic, Siddha or Unani System of Medicine, all formulations containing
only such ingredients mentioned in the formulae described in the authoritative books of
Ayurvedic, Siddha or Unani System of Medicine specified in First Schedule to the Act but does
not include the medicine .administered by parenteral route.
(ii) In relation to any other system of medicine including, allopathic, a drug presented in a form
ready for internal or external administration of human beings or animals and which is not
included for the time being in the editions of Indian Pharmacopoeia or any other Pharmacopoeia.
6. Misbranded Drug
A drug is considered as a misbranded drug:
(i) if it is not labeled in the prescribed manner,
or
(ii) if it is so coloured, coated, powdered or polished that damage is concealed or it is made to
appear of better or greater therapeutic value than it really is,
or
(iii) if the label or container or anything accompanying the drug bears any statement, design or
device which makes any false claim for the drug or gives misleading information.
7. Adulterated Drug
A drug is considered to be adulterated:
(i) if it consists in whole or in part of any filthy, putrid, or decomposed substance,
or
(ii) if it has been prepared, packed or stored under poor sanitary conditions whereby, it may have
been contaminated with filth and rendered injurious to health,
or
(iii) if container of the drug is composed in whole or in part of any poisonous substance which
may render the contents injurious to health,
or
(iv) if it contains a colour other than one which is prescribed,
or
(v) if the drug contains any harmful or toxic substance which may render it injurious to health,
or
(vi) if the drug is admixed with any substance so as to reduce its quality or strength.
8. Manufacture in relation to Drug or Cosmetic
Any process fully or partly used for making, altering, ornamenting, finishing packing, labeling,
breaking up or otherwise treating or adopting any drug/cosmetic with a view to its sale or
distribution but, does not include the compounding or dispensing of any drug or the packing of
any drug or cosmetic in the ordinary course of retail business.
9. Spurious Drug
A drug is deemed to be a spurious drug:
(i) if it is imported under a name which belongs to another drug,
or
(ii) if it is an imitation of or a substitute for another drug or if it resembles another drug in a
manner likely to deceive or bears upon it or its label or container the name of another drug,
or
(iii) if it has been substituted wholely or in part by another drug substance,
or
(iv) if it claims to be the product of a manufacturer or company of whom it is not truly a product.
10. Misbranded Cosmetic
A cosmetic shall be deemed to be misbranded:
(i) if it contains a colour which is not prescribed,
or
(ii) if it is not labelled in prescribed manner, or
(iii) if the label or container or anything accompanying the cosmetic bears any statement which
is false or misleading.
11. Spurious Cosmetic
A cosmetic shall be deemed to be spurious:
(i) if it is imported under a name which belongs to another cosmetic,
or
(ii) if it is an imitation of or a substitute for another cosmetic; resembles another cosmetic in a
manner likely to deceive; or bears upon it or upon its label or container the name of another
cosmetic,
or
(iii) if the label or container bears the name of an individual or a company purporting to be the
manufacturer of the cosmetic which individual or company is fictitious or does not exist,
or
(iv) if it purports to be the product of a manufacturer of whom it is not truly a product.
Schedules to the Act and Rules [2]
There are two Schedules to the Act and 35 Schedules to the Rules.
The Schedules to the Act
1. First Schedule: It comprises the list of books of references for Ayurvedic, Siddha and Unani
medicines. There are 57 books of Ayurveda, 30 books of Siddha and 13 of Unani Tibb systems
listed in the Schedule which are used for different formulations in accordance with the provisions
of the Act.
2. Second Schedule: It comprises of the standards to be complied with for imported drugs,
manufacture of drugs, their sale, stocking and storage etc.
The Schedules to the Rules
Schedule A: Different Forms for application to procure licence, renewal of licence, and for all
other activities.
Schedule B: Rates of fees charged for analysis by COL or State Drugs Laboratories.
Schedule C: List of biological and other special products governed by special provisions
Schedule C (I): List of other special products governed by special provisions
Schedule D: Class of drugs: extent and conditions of exemption
Schedule D (I): Undertaking of the manufacturer or his authorized agent required to be
submitted along with application form for obtaining a registration certificate.
Schedule D (II): Undertaking of the manufacturer or his authorized agent required to be
submitted along with application form for registration of a bulk drug or its formulation or its
import into India
Schedule E (I): List of poisonous substance under Ayurvedic , Siddha and Unani medicines
Schedule F: Requirement for operation of blood bank and / or preparation of blood components
Schedule F(I): Provisions for bacterial vaccines, viral vaccines, antisera, diagnostic antigens,
etc.
Schedule F (II): Standards for surgical dressings
Schedule F (III): Standards for Umbilical tapes
Schedule FF: Standards for ophthalmic preparations
Schedule G: Drugs required to be taken under medical supervision.
Schedule H: List of prescription drugs
Schedule J: List of diseases or ailments which a drug may not purport to prevent or cure.
Schedule K: Drugs exempted from certain provisions related to manufacturer.
Schedule M: GMP (Good Manufacturing Practices) comprising requirements of factory
premises, plant and equipment
Schedule M-l: Homoeopathic preparations requirements of factory premises, plants and
equipments
Schedules M-(II): Cosmetics - requirements of factory premises for manufacture
Schedules M-(III): Requirements of factory premises for manufacture of medical devices
Schedule N: List of minimum equipment of running a pharmacy
Schedule O: Standards for disinfectant fluids
Schedule P: Life period of drugs
Schedule P-l: Pack sizes of drugs
Schedule Q: List of colours, dyes and pigments permitted in cosmetics and soaps, list of colours
permitted in soaps
Schedule R: Standards for condoms of rubber latex and other mechanical contraceptives
Schedule R-I: Standards for medical devices
Schedules S: Standards for Cosmetics
Schedules T: GMP (Good Manufacturing Practices) for manufacture of Ayurvedic, Siddha and
Unani medicines, G.M.P., machinery, equipment minimum manufacturing premises, etc.
Schedules U: Particulars required to be shown in manufacturing records; raw material and
analytical records
Schedules U (1): Particulars required to be shown in manufacturing records.
Schedules V: Standards for patent or proprietary medicines
Schedules X: Psychotropic substances
Schedules Y: Requirements and guidelines on clinical trials for import and manufacture of new
drug
Import of drugs and cosmetics [3]
The import of drugs and cosmetics is regulated by the provisions of this Act.
Classes of drugs and cosmetics prohibited from import
The following categories of drugs and cosmetics are prohibited from import:
1. Drugs or cosmetics which are not of standard qualities.
2. Drugs or cosmetics which are misbranded, spurious and adulterated.
3. Drugs or cosmetics for import of which licence is required.
4. Any patent or proprietary medicine without true formula or list of active ingredients and
their quantities.
5. Any drug or formulation which claims to prevent or cure diseases mentioned schedule J.
6. Any drug or cosmetic for which manufacture, sale or distribution is prohibited in country
of its origin.
7. Any drug which is not packed or not labeled in conformity with the Rules of the Act.
8. Any cosmetic containing an ingredient which may render it unsafe or harmful.
9. Any drug or cosmetic the import of which is prohibited by Act.
Exemptions
The drugs exempted from provisions regulating the import of drugs are shown in Table 1.
Table 1: Drugs exempted from provisions regulating the import
Offences penalties
First Conviction Subsequent Conviction
1. An offence of any Imprisonment upto three years Imprisonment upto 5 years or
adulterated (section 9-A) or and a fine upto five thousand a fine upto ten thousand
spurious drug (section 9-B) or rupees. rupees or both.
cosmetic (section 9-0) being
imported into the country in
violation of provisions of the
Act
2. Import of drugs or Imprisonment upto 6 months Imprisonment upto 12 months
cosmetics other than those or a fine upto 500 rupees or or a fine upto 1000 rupees or
referred above the import of both. both.
which is forbidden.
3. Any drug or cosmetic Imprisonment upto three years Imprisonment upto 5 years or
imported in contravention or a fine upto five thousand a fine upto ten thousand
with provisions of any rupees or both. rupees or both.
notification issued under
Section 10-A