4. âPharmaceutical Jurisprudenceâ
Pharmaceutical: - relating to medicinal drugs, or their
preparation, use, or sale or a compound manufactured for use as a
medicinal drug.
Jurisprudence: - the theory or philosophy of law or a legal system
5. History
īTill 1930:- after the first world war, India was dependent on import of modern
medicines.
īIn 1930 (August): govt. of India appointed a drug enquiry committee under the
supervision of R. N. Chopra
īThis committee submitted the reports in 1931 but the govt. of India did not
attention till 1937.
īIn 1940: Drug & Cosmetics Act
īIn 1945: Drug & Cosmetics Rules
īIt extends to whole India
6. LIST OF AMENDING ACTS AND
ADAPTATION ORDERS
īThe Drugs (Amendment) Act, 1955
īThe Drugs (Amendment) Act, 1960
īThe Drugs (Amendment) Act, 1962
īThe Drugs and Cosmetics (Amendment) Act, 1964
īThe Drugs and Cosmetics (Amendment) Act, 1972
ī The Drugs and Cosmetics (Amendment) Act, 1982
īThe Drugs and Cosmetics (Amendment) Act, 1995
ī The Drugs and cosmetics (Amendment) Act, 2008
7. Objectives
īTo regulate the import, manufacture, distribution and sale of drugs &
cosmetics through licensing.
īTo prevent substandard in drugs, maintaining high standards of
medical.
īManufacture, distribution and sale of drugs and cosmetics by qualified
persons only.
īTo regulate the manufacture and sale of Ayurvedic, Siddha and Unani
drugs.
īTo establish Drugs Technical Advisory Board(DTAB) and Drugs
Consultative Committees(DCC) for Allopathic and allied drugs and
cosmetics.
8. Definitions
Drugs:- All medicines for internal or external use of human beings or animals and all
substances intended to be 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.
īSuch 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 insects which cause disease in
human beings or animals, as may be specified from time to time by the Central Govt. by
notification in the Official Gazette;
īAll substances intended for use as components of a drug including gelatin capsule
īSuch devices intended for internal & external use in the diagnosis, treatment or prevention
of diseases, as may be specified from time to time by the Central Govt by the notification
in the Official Gazette, after consultation with Board.
Cosmetics:- Any article intended to be rubbed, poured, sprinkled or sprayed on, or
introduced into, or otherwise applied to, the human body or any part thereof for cleansing,
beautifying, promoting attractiveness, or altering the appearance, and includes any article
intended for use as a component of cosmetic.
9. Misbranded drugs:- (a) if it is so colored, coated, powdered or polished that damage is
concealed or if it is made to appear of better or greater therapeutic value than it really is; or
(b) if it is not labelled in the prescribed manner.
(c)If its label or container or anything accompanying the drug bears any statement, designs
or device which makes any false claim for the drug or which is false or misleading in any
particular way.
Adulterated(less pure or lower quality) drug:- (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.
(d)If it contains any harmful or toxic substances which may render it injurious to
health
(e)If any substance has been mixed therewith so as to reduce its quality.
Spurious (false) drug:- (a) if it is imported under a name which belongs to another drug;
or
10. (b) if it is an imitation of, or a substitute for, another drug or resembles another drug in a
manner likely to deceive or bears upon it or upon its label or container the name of another
drug
(c)If it purports to be the product of a manufacturer of whom it is not truly a product.
Manufacture:- In relation to any drug or cosmetic, it includes any process or part of a
process for making, altering, ornamenting, finishing, pac king, labelling, breaking up or
otherwise treating or adopting any drug or 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.
Patent or proprietary (ownership) medicine:- A drug which is a remedy or
prescription presented in a form ready for internal or external administration of
human beings or animals and which is not included in the edition of the Indian
Pharmacopoeia for the time being or any other Pharmacopoeia authorized in this
behalf by the Central Government.
11. Inspector:-
īthe Central or State Govt may, by notification in the Official Gazette, appoint such
person as it thinks fit, having the prescribed qualification.
īThe powers which may be exercised by an inspector and the duties which may be
performed by him.
īNo person who has any financial interest (in import, manufacture or sale of
products) shall be appointed to be an inspector under this section
īEvery inspector shall be deemed to be the public servant within the meaning of
section 21 of the Indian Panel Code and shall be officially subordinate to such
authority as the Govt appointed him may specify in this behalf.
12. Import of drugs
īClasses of drugs prohibited to import
īImport of drug under license
1)Specified in Schedule-C/C1
2)Specified in Schedule-X
3)Imported for Test/Analysis
4)Imported for personal use
5)Any new drugs
īDrugs exempted from provisions of import
īOffences and Penalties
13. Import of the biological
drugs(C/C1)
Conditions to be fulfilled:-
īLicensee must have adequate facility for the storage.
īLicensee must maintain a record of the sale.
īLicensee must allow an inspector to inspect premises and to check the
records.
īLicensee must furnish the sample to the authority.
īLicensee must not sell drugs from which sample iswithdrawn and he
is advised not to sale, and recall the batch from the market.
14. Import of the Schedule-X drugs
(Narcotic & Psychotropic drugs)
Conditions to be fulfilled:-
īLicensee must have adequate storage facility.
īApplicant must be reputable in the occupation, trade or business
ī The license granted even before should not be suspended or
cancelled.
īThe licensee has not been convicted any offence under the Drugs and
Cosmetics Act or Narcotic and Psychotropic Substances Act.
15. Drugs Imported for
examination, test or analysis
īLicense is necessary under form-11
īMust use imported drugs only for said purpose and at the place
specified in the license.
īMust keep the record with respect to quantities, name of the
manufacturer and date of import.
īMust allow an inspector to inspect the premises and check the records.
16. Drugs imported for personal use
īUp to 100 average doses may be imported without any permit,
provided it is part of passengerâs luggage.
īMore than 100 doses imported with license. Apply on form no.-12-
A,12-B.
īDrugs must be bonafide personal use.
ī Drugs must be declared to the custom collectors if so directed.
17. Import of drugs without license
īSubstances not used for medicinal pupose
īDrugs in Sch-C1 required for manufacturing and not for medicinal
use.
īSubstances which are both drugs and foods such as:-
âĸ Condensed/Powdered Milk
âĸ Malt
âĸ Lactose
âĸ Oats
īPre-digested foods
īGinger, Pepper, Cumin, Cinnamon
18. Offences:-
ī Import of spurious OR adulterated drug OR drug which involves risk
to human beings or animals OR drug not having therapeutic values
Penalties:- a) 3 years imprisonment and 5000 Rs. fine on first
conviction
b) 5 years imprisonment OR 1000 Rs. fine OR both for subsequent
conviction
Offences:-Contravention of the provision
Penalties:- a) 6 months imprisonment OR 500 Rs. fine OR both for first
conviction
b) 1 year imprisonment OR 1000 Rs. fine
19. Schedule
Objective:- To make available Standard Quality drug/ cosmetic to consumer.
Schedule to the Act
First schedule â Names of books under Ayurvedic and Siddha systems
Second schedule â Standard to be complied with by imported drugs and by drugs manufactured for
sale, sold, stocked or exhibited for sale or distribution
Name of few books under 1st Schedule:-
Ayurveda:-
īAyurvedic Formulary Of India (Part I)
īArogya Kalpadruma
īCharak Samhita
īAyurveda Samgraha
īBhaishajya Ratnavali
Siddha:-
īSiddha Formulary Of India (Part I)
īBhogar
21. Schedule to the Rules
īSchedule A:- Proforma for application for the licenses, issue and renewal of licences,
for sending memoranda under the act.
īSchedule B:- Rates of fees for test or analysis by the Central Drug Laboratory or the
Government Analyst.
īSchedule C:- List of Biological and special products (Inject able) applicable to
special provisions. Examples are sera, vaccines, antigens, insulin, sterilized surgical
ligature and suture, sterile disposable device for single use, antibiotics in injectable form
etc.
īSchedule C(1):- List of Biological and special products (non parentral) applicable to
special provisions. Examples are Drugs belonging to Digitalis and its preparation, Ergot
and its preparation containing drugs,Vitamins and its preparation, Vaccines, In-vitro
devices for HIV,HCV etc.
īSchedule D:- Exemption of drugs from provision of import
22. Drugs come under Schedule D are:
1) Substances not intended for medical use
2) Substances which are used both as articles of food as well as drugs: -- All condensed or
powdered milk. -- Farex, oats, latex and all other similar cereal preparations excepting those for
parenteral use. -- Virol, bovril, chicken essence and all other similar predigested food. -- Ginger,
Pepper, Cumin, Cinnamon and all other similar spices and condiments.
3) Drugs and cosmetics imported for manufacture and export by units situated in âSpecial
Economic Zoneâ as notified by the Govt. of India from time to time.
Schedule âD (I)â:- Information required to be submitted by the manufacturer or his authorised
agent with the application form for a registration certificate.
īThe format shall be properly filled in and the detailed information, secret in nature,
ī may be furnished on a Computer Floppy.
Schedule âD (II)â:- Information required to be submitted by the manufacturer or his
authorized agent with the Application Form for the registration of a bulk
drug/formulation/special product for its import into India.
īThe format shall be properly filled in and the detailed information, secret in nature,
23. Schedule âEâ (1):- List of poisonous substances under the Ayurvedic , Siddha and Unani
systems.
Schedule âFâ:- provisions applicable to the blood bank
(i) Space, equipment and supplies required for a blood bank.
(ii) Minimum requirement for grant of license to procure blood components from whole
human blood.
Schedule âFâ (1):- Provision applicable to the production of bacterial and viral vaccines.
īProvision applicable to the production of all sera from living animals.
īProvision applicable to the production and standardization of the diagnostic agents.
Schedule âF (II)â:- Standards for Surgical Dressings
īSurgical dressings include bandage cloth, absorbent gauze, rolled bandage, etc.
Schedule âF(III)â:- Standards for Sterilized Umbilical tapes
Schedule âFFâ:- Standards for ophthalmic preparations
Schedule âGâ:- List of substances required to be used under medical supervision and
labelled accordingly
24. Schedule âHâ:- List of substances (prescription) that should be sold by retail only on
prescriptions of R.M.P.
Schedule âJâ:- Diseases and ailments which a drug may not purport to prevent or cure or
make claims to prevent or cure.
īDiseases under this schedule are:- AIDS, Angina Pectoris, Diabetes, Cancer, Blindness,
Deafness, Fairness of skin, Improvement in height of children/adults
Schedule âKâ:- The drugs specified in Schedule K shall be exempted from the provisions of
Chapter IV of the Act and the Rules made there under to the extent and subject to the
conditions specified in that Schedule.
Schedule âMâ:- Requirements of manufacturing premises, GMP requirements of factory
premises, plants and equipments.
Schedule âM1â:- Requirements of factory premises for manufacture of Homeopathic
medicines
Schedule âM2â:- Requirements of factory premises for manufacture of cosmetics
Schedule âM3â:- Requirements of factory premises for manufacture of medical devices
Schedule âNâ:- List of minimum equipment for the efficient running of a pharmacy
Schedule âOâ:- Standard for disinfectant fluids.
25. Schedule âPâ:- Life period (expiry) of drugs
Schedule âP-1â:- Packing of drugs
Schedule âQâ:- Part 1:-List of dyes, colours and pigments permitted in cosmetics and
soaps.
Part II:- List of colours permitted in soaps.
Schedule âRâ:- Standards for mechanical contraceptives.
Schedule âR-1â:- Standards for Medical Devices
Schedule âSâ:- Standards for cosmetics in finished form
Schedule âTâ:- Requirements (GMP) of factory premises for Ayurvedic, Siddha, Unani
drugs
Schedule âUâ:- Manufacturing, raw materials and analytical records of drugs.
Schedule âU(1)â:- Manufacturing, raw materials and analytical records of cosmetics
Schedule âVâ:- Standards for patent or proprietary medicines.
Schedule âWâ:- List of drugs marketed under generic names
Schedule âXâ:- List of narcotic drugs and psychotropic substances
Schedule âYâ:- Requirement and guidelines on clinical trials for import and manufacture of
new drugs
26. Manufacture of drugs
īProhibition of manufacture
īManufacture of other than in Sch-C/C1
ī Manufacture of those in Sch-C/C1
ī Manufacture of Sch-X drugs
īLoan license
īRepackaging license
ī Offences & Penalties
27. Prohibition of manufacture
īDrug not of standard quality or misbranded, adulterated or spurious.
īPatent or Proprietary medicine.
īDrugs in Schedule-J
īRisky to human beings or animals
īDrugs without therapeutic value
Manufacture of drugs other than in Schedule-C/C1
Conditions:-
īPremises should comply with schedule âMâ
īAdequate facility for testing, separate from manufacturing
īAdequate storage facility
īRecords maintained for at least 2 years from date of Exp.
īShould provide sample to authority
īFurnish data of stability
īMaintain the inspection book
īMaintain reference samples from each batch
28. Manufacture of drugs those in Schedule-
C/C1(Biological)
Conditions:-
ī Drugs must be issued in previously sterilized sealed glass or suitable container
ī Containers should comply with Schedule-F
ī Some classes tested for aerobic & anaerobic microorganism. eg. Sera,Insulin, Pituitary
hormones.
īSerum tested for abnormal toxicity
īParenteral in doses of 10 ml or more should be tested for freedom from Pyrogens
īSeparate laboratory for culture & manipulation of spore bearing Pathogens
īTest for sterility should be carried out.
29. Manufacture Of Schedule-X drugs
Conditions:-
īAccounts of all transactions regarding manuf. Should be maintained in
serially.(Preserved for 5 years)
īHave to sent invoice of sale to licensing authority every 3 months
īStore drugs in direct custody of responsible person.
īPreparation must be labeled with XRx
īMarketed in packings not exceeding
ī§ 100 unit dose âTablets/Capsules
ī§ 300 ml- Oral liquid
ī§ 5 ml - Injection
30. Loan License
Definition:-
īA person(applicant) who does not have his own arrangements(factory) for manufacture
but who wish to manufacturing facilities owned by another licensee. Such licenses are
called Loan license.
Loan licenses are issued for:-
1) Drugs other than specified in C/C1 & X.
2) Drugs specified in Schedule-C/C1.
Repackaging license
Definition:-
īProcess of breaking up any drug from a bulk container into small packages and labeling
with a view to their sale and distribution.
īRepackaging of drugs is granted of drugs other than Schedule-C/C1 and X.
31. Offences & Penalties
Offences Penalties
Manufacture of any spurious drugs a) 1-3 years imprisonment and
Rs.5000 fine
b) 2-6 years imprisonment &
Rs.10000 fine on subsequent
conviction
Manufacture of adulterated drugs a) 1 year imprisonment & Rs.2000
fine
b) 2 years imprisonment &
Rs.2000 fine for subsequent
conviction
Manufacture of drugs in contravention of
the provisions
a) Imprisonment up to 3 months &
Rs.500 fine
b) Imprisonment up to 6 months
& Rs.1000 fine on subsequent
conviction
32. Sales of drugs
īClasses of drugs prohibited to be sold
īWholesale of biological (C/C1)
īWholesale of other than those specified in C/C1 and X
Classes of drugs prohibited to be sold
īMisbranded, spurious, adulterated and drugs not of standard quality
īPatent/Proprietary drugs with undisclosed formula
īSchedule-J drugs
īExpired drugs.
īDrugs used for consumption by government
īschemes such as, Armed force.
ī Physicianâs samples
33. Wholesale of biological (C/C1)
īAdequate premises, with greater than 10 M square area, with proper storage facility
īDrugs sold only to retailer having license
īPremises should be in charge of competent person who is Registered Pharmacist.
īRecords of purchase & sale
īRecords preserved for 3 years from date of sale
īLicense should displayed on premises.
Wholesale of other than those specified in C/C1 and X
īAll the conditions as discussed in for biological.
ī Compounding is made by or under the direct and personal supervision of a qualified
person.