LAWS & REGULATION TO MAKE P'CEUTICAL COMPOUND & COSMATIC FOR HUMAN SAFETY.

1. DRUG & COSMATIC ACT 1940 AND RULE 1945
CHANDA MALVIYA
M. PHARMA
PHARMACOLOGY
VNS COLLEGE OF PHARMACY

2.  INTRODUCTION
 OBJECTIVES
 TERMINOLOGY
 SCHEDULE
 PROVISION OF ACT
 AMENDMENT
 SOME FORM

3. GOVERNMENT OF INDIA
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health)
THE DRUGS AND COSMETICS ACT 1940 & RULES 1945

4. INTRODUCTION
DRUG AND COSMATICS ACT 1940 & RULE 1945
 The Drug and Cosmetic Act, 1940 is an Act of the parliament of india which regulates the import,
manufacture and distribution of drugs in india.
 The Drug and Cosmetics Act, 1940 and Rules 1945 have been passed with objective of regulating the
import, manufacturing, distribution and sale of drug and cosmetics.
 The act regulates the manufacture and sale of drug and cosmetic through licensing so that these are
manufactured, distributed and sold only by the qualified person
 The act covers the drugs under allopathic, Ayurveda, homoeopathic and Unani system as well as drug
for veterinary use.

5. OBJECTIVES
 The D&C act was passed in 1940 [10 April 1940] with the main object to
 Import
 Manufacturing
 Distribution
 Sale of drug & cosmetics
 The act regulates the import of drug in india, so that no substandard or spurious drug will enter into our country.
 The act provide for the control over the sale and distribution of drugs by trained & qualified persons.
 To have control over the standard of drugs & cosmetics by taking samples & analysing them at approved laboratories.
 To prescribe the manner of labelling & packing of the various classes of drug & cosmetics.
 To have regular inspection of licensed premises by drug inspector.

6. TERMINOLOGY
 DRUG : 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.
 COSMATIC : Means 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.
 MISBRANDED DRUG :
[i] if it is coloured, coated, powdered or polished that damage is concealed or if it is made o appear of
better or greater therapeutic value than it really is or
[ii] if it is not labelled in the prescribe manner.

7. CONTI…
ADULTERED DRUG :
[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 insanitary conditions whereby it may have been contaminated
with filth or whereby it may have been rendered injurious to health; or
[iii] if its container is composed in whole or in part, of any poisonous or deleterious substance which may render
the contents injurious to health.
SPURIOUS DRUG :
[i] if it is imported under a name which belongs to another drug or
[ii] if it is an imitation of, or is a substitute for another drug or resembles another drug in a manner likely to
device or bears upon it or upon its label or container the name of another unless it is plainly and conspicuously
marked so as to reveal its true character and its lack of identity With such other drug.

8. SCHEDULE TO THE RULE
 Schedule A – proforma for application for the licences, issue and renewal of licences, for sending memoranda under the act.
 Schedule B – Rates of fee for test or analysis by the Central Drugs Laboratory por the Govt. Analyst.
 Schedule C – List of biological and other special products whose import, sale, distribution and manufacture are governed by
special provisions.
 Schedule C1 – List of other special products whose import, sale, distribution and manufacturing are governed by special
provision.
 Schedule D – List of drugs exempted from the provision of import of drugs.
 Schedule E1 – List of poisonous substances under the ayurvedic [including siddha] and unani system of medicine.
 Schedule F &F1 – provision applicable to the production, testing, storage, packing and labelling of biological and other special
products.
 Schedule F2 – Standard for surgical dressings.
 Schedule F3 – Standard for sterilized umbilical tapes.
 FF – Standard of ophthalmic preparations.
 Schedule G – List of substances that are required to be used only under medical supervision and which are to be labelled
accordingly.

9. CONTI…
 Schedule H – List of prescription drugs.
 Schedule J – Disease or ailments which a drug may not purport to prevent or cure.
 Schedule K – Drugs exempted from certain provisions relating to the manufacturing of the drug.
 Schedule M – GMP requirement of factory premises, plants and equipment.
 Schedule M1 – Requirement of factory premises etc. for manufacture of homoeopathic preparation.
 Schedule M2 – Requirement of factory premises for manufacture of cosmetics.
 Schedule N – List of minimum equipment for efficient running of a pharmacy.
 Schedule O – Standard for disinfectant fluids.
 Schedule P – Life periods of drugs.
 Schedule Q – List of coal tars colours permitted to be used in cosmetics.
 Schedule R – Standard for mechanical contraceptives.
 Schedule S – Standard for cosmetics.
 Schedule T – Requirement of factory premises and hygienic condition for ayurvedic [including siddha] and unani drugs.
 Schedule U – Particulars to be shown in manufacturing, raw material and analytical records of drugs.

10. CONTI…
 Schedule U1 – Particular to be shown in manufacturing, raw materials and analytical records of cosmetics.
 Schedule V – standard for patent or proprietary medicines.
 Schedule W – List of drugs which are to be marketed under generic names only.
 Schedule X – List of drugs whose import, mfg and sale, labelling and packaging are governed by special provision.
 Schedule Y – Requirement and guidelines clinical trials for import manufacture of new drugs.
PROVISION OF ACT
 IMPORT
 MANUFACTURING
 SALES
 LABELLING & PACKAGING

11. IMPORT OF DRUG
 Classes of drugs prohibited to import
 Import of drug under license
[i] Specified in schedule C /C1
[ii] Specified in schedule X
[iii] imported for test /analysis
[iv] imported for personal use
[v] Any new drug
 Drugs exempted from provision of import
 Offence and Penalites

12. MANUFACTURING
 Prohibition of manufacture
 Manufacture of other than in sche-C/C1
 Manufacture of those in sche-C/C1
 Manufacture of sche-X drugs
 Loan license
 Repackaging license
 Offence & Penlties

13. SALES
 Classes of drug prohibited to be sold
 Wholesale of biological sch-C/C1
 Wholesale of other than those specified in C/C1 and X
LABELING AND PACKAGING
 All the general and specific labelling and packaging specified to all classes of
drugs and cosmatic should be as per the provision made under the act.

14. D&C AMENDMENT ACT 2008
SALIENT FEATURES OF THE ACT
 Substantial enhancement in punishment.
 Life imprisonment for offeneders involved in mfg , sale and distribution of spurious and
adulterated drug likely to cause grievous hurt.
 Min punishment of 7 yrs which may extend to life imprisonment.
 Provision for compensation to affected person.

15. SOME FORMS
 Form 1 - Application for license, issue & renewal of license
 Form 2 - Certificate of test or analysis by the Central Drugs Laboratory
 Form 8 - Application for license to import biological and other special products specified in Schedules C and C-1
excluding those specified in Schedule X.
 Form 8-A - Application for license to import drugs specified in Schedule X to the Drugs and Cosmetics Rules
1945.
 Form 9 - Form of undertaking to accompany an application for an import license.
 Form 10 - License to import biological and other special products specified in Schedules C and C-1 excluding
those specified in Schedule X to the Drugs and Cosmetics Rules 1945
 Form 10-A - License to import drugs specified in Schedule X to the Drugs and Cosmetic Rules 1945

16. CONTI…
 Form 11 - License to import drugs for the purposes of examination, test or analysis.
 Form 12 - Application for license to import drugs for purpose of examination, test or analysis.
 Form 12-A - Application for the issue of a permit to import small quantities of drugs for personal use.
 Form 12-B - Permit for the import of small quantities of drugs for personal use.