Drugs and cosmetics act 1940 and rules 1945

1

Drugs and Cosmetics Act 1940and Rules 1945

Department of PharmacyDr. B. R. Ambedkar University, Agra -282002

Prepared by: ANOOP [email protected] B.Pharm

2

CONTENT

1. History2. List Of Amending Acts And Adaptation Order3. Objectives4. Part I &II5. Definitions6. Administration Of The Act And Rules7. Salient features of the Drugs and Cosmetics (Amendment) Act, 20088. Provision of the act for import, sale, manufacturing & labeling &

packaging 9. Questions

3

HISTORY

4

POSITIN TILL 1930 : India was largely dependent on import of modern medicines until after first word war.

In August 1930 the government of India appointed a drug Enquiry Committee under the chairmanship of colonel R.N. Chopra, to go in to the question of adulterated & substandard drugs sold in country & to recommend step by which this menace could be control.

The Drug Enquiry Committee submitted its report in 1931,the government of India could not give effect to its recommendation till 1937.

After passing of the government of India Act,1935, drug became provincial subject & therefore center could pass law in respect of only imports.

The drug import Bill was prepared & placed for consideration before the assembly in 1939. This was not acceptable to the public & provinces for uniform & comprehensive legislation. This led to the introduction of the Indian Drug Bill in the Central Legislature. It was passed & received assent of Governor General in Council & became Drug Act in 1940

5

LIST OF AMENDING ACTS AND ADAPTATION ORDER

1. The Repealing and Amending Act, 1949 (40 of 1949).

2. The Adaptation of Laws Order, 1950.

3. The Part B States (Laws) Act, 1951 (3 of 1951)

4. The Drugs (Amendment) Act, 1955 (11 of 1955)



7. The Drugs and Cosmetics (Amendment) Act, 1964 (13 of 1964)

8. The Drugs and Cosmetics (Amendment) Act, 1972 (19 of 1972).




12. The Drugs and cosmetics (Amendment) Act, 2008

6

OBJECTIVESTo prevent substandard in drugs, presumably for treatment. maintaining high standards of medical

To regulate the import, manufacture, distribution and sale of drugs & cosmetics through licensing.

Manufacture, distribution and sale of drugs and cosmetics by qualified persons only.

Act has nothing to do with the Excise duty

To regulate the manufacture and sale of Ayurvedic, Siddha and Unani drugs.

To establish Drugs Technical Advisory Board(DTAB) and Drugs Consultative Committees(DCC) for Allopathic and allied drugs and cosmetics.

7

Part I Drug & cosmetic act,1940

CHAPTER I : INTRODUCTORY

CHAPTER II : THE DRUGS TECHNICAL ADVISORY BOARD, THE CENTRAL DRUG LABORATORY, THE

DRUGS CONSULTATIVE COMMITTEE

CHAPTER III : IMPORT OF DRUGS AND COSMETICS

CHAPTER IV : MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS AND

COSMETICS

CHAPTER IV-A : PROVISIONS RELATING TO AYURVEDIC,

SIDDHA AND UNANI DRUGS

CHAPTER V: MISCELLANEOUS

8

Part 2: Drug & Cosmetic Rules,1945

PART I : PRELIMINARY

PART II : THE CENTRAL DRUGS LABORATORY

PART III (Rules 9 to 20)

PART IV : IMPORT [AND REGISTERATION]

PART V: GOVERNMENT ANALYSTS, INSPECTORS, LICENCING AUTHORITIES AND CONTROLLING AUTHORITIES

PART VI : SALE OF DRUGS OTHER THAN HOMOEOPATHIC MEDICINES

PART VI-A : SALE OF HOMEOPATHIC MEDICINES

PART VII : MANUFACTURE FOR SALE OR FOR DISTRIBUTION OF DRUGS OTHER THAN HOMOEOPATIC MEDICINES

9

PART VIII : MANUFACTURE FOR EXAMINATION, TEST OR ANALYSIS

PART IX : LABELLING AND PACKING OF DRUGS OTHER THAN HOMOEOPATHIC MEDICINES

PART X : SPECIAL PROVISIONS RELATING TO BIOLOGICAL ANDOTHER SPECIAL PRODUCTS

PART XA : IMPORT OF MANUFACTURE OF NEW DRUG FOR CLINICAL TRIALS OR MARKETING

PART XB : REQUIREMENTS FOR THE COLLECTION, STORAGE,PROCESSING AND DISTRIBUTION OF WHOLE HUMAN BLOOD, HUMAN BLOOD COMPONENTS BY BLOOD BANKS AND MANUFACTURE OF BLOOD PRODUCTS

10

PART XI : EXEMPTIONS

PART XII : STANDARDS

PART XIII : IMPORT OF COSMETICS

PART XIV : MANUFACTURE OF COSMETIC FOR SALE OR FOR DISTRIBUTION

PART XV : LABELLING, PACKING AND STANDARDS OF COSMETICS

PART XV : MANUFACTURE FORSALE OF AYURVEDIC (INCLUDING SIDDHA) OR UNANI DRUGS

11

PART XVII : LABELLING, PACKING AND LIMIT OF ALCOHOL IN] AYURVEDIC (INCLUDING SIDDHA) OR UNANI DRUGS

PART XVIII-GOVERNMENT ANALYSIS AND INSPECTORS FOR AYURVEDIC (INCLUDING SIDDHA) OR UNANI DRUGS

PART XIX : STANDARDS OF AYURVEDIC, SIDDHA AND UNANI DRUGS

12

DEFINITIONS

13

“COSMETIC” means any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applicated 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.

http://en.wikipedia.org/wiki/File:Cosmetics.JPG

14

DRUG

(I) 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;

(II) Such substances (other than food) intended to affect the structure or any function of human body or intended to be used for the destruction of (vermin) or insects which cause disease in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette

(III) All substances intended for use as components of a drug including empty gelatin capsules; and

15

IV) Such devices intended 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 Board

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 labeled in the prescribed manner; or

(c) if its label or container or anything accompanying the drug bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular.

16

Adulterated 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; or

(d) if it bears or contains, for purposes of colouring only, a colour other than one which is prescribed; or

(e) if it contains any harmful or toxic substance which may render it injurious to health; or

(f) if any substance has been mixed therewith so as to reduce its quality or strength.

17

Spurious drugs :

(a) if it is imported under a name which belongs to another drug; or

(b) if it is an imitation of, or a substitute for, another drug or resembles another drug in a manner likely to deceive or bears upon it or upon its label or container the name of another drug unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug; or

(c) if it has been substituted wholly or in part by another drug or substance; or

(d) if it purports to be the product of a manufacturer of whom it is not truly a product.

18

Manufacture :

In relation to any drug or cosmetic, it includes any process or part of a process for

making, altering, ornamenting, finishing, packing, 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 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.

19

Government Analysts.

(1) The State Government may, by notification in the Official Gazette, appoint such persons as it thinks fit, having the prescribed qualifications, to be Government Analysts for such areas in the state and in respect of such drugs or [classes of drug or such cosmetics or classes of cosmetics] as may specified in the notification.

(2) The Central Government may also, by notification in the Official Gazette, appoint such persons as it thinks fit, having the prescribed qualifications, to be Government Analysts in respect of such drugs or [classes of drugs or such cosmetics or classes of cosmetics] as may be specified in the notification

(3) Notwithstanding anything contained in sub-section (1) or sub-section (2), neither the Central Government nor a State Government shall appoint as a Government Analyst any official not serving under it without the previous consent of the Government under which he is serving.

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

20

Inspectors.

(1) The Central Government or a State Government may, by notification in the Official Gazette, appoint such person as it thinks fit, having the prescribed qualification, to be Inspectors for such areas as may be assigned to them by the Central Government or State Government, as the case may be.

(2) The powers which may be exercised by an Inspector and the duties which may be performed by him, the drugs or [classes of drugs or cosmetics or classes of cosmetics] in relation to which and the conditions, limitations or restrictions subject to which, such powers and duties may be exercised or performed shall be such as may be prescribed.

(3) No person who has any financial interest [in the import, manufacture or sale of drugs or cosmetics] shall be appointed to be an Inspector under this section.

(4) Every Inspector shall be deemed to be public servant within the meaning of section 21 of the Indian Penal Code (45 of 1860), and shall be officially subordinate to such authority [having the prescribed qualification] as the Government appointing him may specify in this behalf.

21

STANDARDS OF QUALITY

(a) in relation to a drug, that the drug complies with the standard set out in[the Second Schedule], and

(b) in relation to a cosmetic, that the cosmetic compiles with such standard as may be prescribed.

22

Schedules to the Act

First schedule – Names of books under Ayurvedic and Siddha systems

Second schedule – Standard to be complied with by imported drugs and by drugs manufactured for sale, sold, stocked or exhibited for sale or distribution

23

Schedules to the rulesType Content

“A” Performa For Forms( Application, Issue, Renewal, Etc.)

“B” Rates Of Fee For Test Or Analysis By CDL Or Govt. Analysts

“C” List Of Biological And Special Products (Injectable) Applicable To Special Provisions.

“C1” List Of Biological And Special Products (Non parentral) Applicable To Special Provisions.

“D” List Of Drugs That Are Exempted From Provisions Of Import

“E1” List Of Poisonous Substances Under The Ayurvedic , Siddha And Unani Systems

“F” Provisions Applicable To Blood Bank

24

Type Content

“F1” Special Provision Applicable To Biological And Special Products, Eg. Bacterial And Viral Vaccines, Sera From Living Animals, Bacterial Origin Diagnostic Agents

“F2” Standards For Surgical Dressings

“F3” Standards For Umbilical Tapes

“Ff” Standards For Ophthalmic Preparations

“G” List Of Substances Required To Be Used Under Medical Supervision And Labelled Accordingly

“H” List Of Substances (Prescription) That Should Be Sold By Retail Only On Prescriptions Of R.M.P.

25

Type Content

“J” List Of Diseases And Ailments That Drug Should Not Claim To Cure

“K” List Of Drugs That Are Exempted From Certain Provisions Regarding Manufacture

“M” Requirements Of Manufacturing Premises, GMP Requirements Of Factory Premises, Plants And Equipments

“M1” Requirements Of Factory Premises For Manufacture Of Homeopathic Medicines

“M2” Requirements Of Factory Premises For Manufacture Of Cosmetics

“M3” Requirements Of Factory Premises For Manufacture Of Medical Devices

“N” List Of Equipment To Run A Pharmacy

“O” Standards For Disinfectant Fluids

26

Type Content

“P” Life Period(expiry) Of Drugs

“Q” Coal Tar Colors Permitted To Be Used In Cosmetics

“R” Standards For Mechanical Contraceptives

“R1” Standards For Medical Devices

“S” Standards For Cosmetics

“T” Requirements (GMP) Of Factory Premises For Ayurvedic, Siddha, Unani Drugs

“U” Manufacturing And Analytical Records Of Drugs

“U1” Manufacturing And Analytical Records Of Cosmetics

“V” Standards For Patent Or Proprietary Medicines

“W” List Of Drugs Marketed Under Generic Names- Omitted

“X” List Of Narcotic Drugs And Psychotropic Substances

“Y” Requirement And Guidelines On Clinical Trials For Import And Manufacture Of New Drugs

27

Administration of the act and rulesA) Advisory :

1)Drugs Technical Advisory Board-DTAB2)Drugs Consultative Committee-D.C.C.

B) Analytical :1)Central Drugs Laboratory - CDL2)Drug Control Laboratory in states3)Government Analysts

C) Executives :1)Licensing authorities2)Controlling authorities3)Drug Inspectors

D) Schedule NE) Schedule MF) Schedule Y

28

Drugs Technical Advisory Board(DTAB)Ex-Officio:

(i) Director General of Health Services (Chairman)(ii) Drugs Controller, India

(iii)Director of the Central Drugs Laboratory, Calcutta(iv) Director of the Central Research Institute, Kasauli

(v)Director of Indian Veterinary Research Institute, Izatnagar(vi) President of Medical Council of India

(vii) President of the Pharmacy Council of India(viii)Director of Central Drug Research Institute, Lucknow

29

Nominated:

1. Two persons by the Central Government from among persons who are in charge of drugs control in the States

2. One person by the Central Government from the pharmaceutical industry

3. Two persons holding the appointment of Government Analyst under this Act, to be nominated by the Central Government

30

Elected:

1. One person, to be elected by the Executive Committee of the Pharmacy Council of India, from among teachers in pharmacy or pharmaceutical chemistry or pharmacognosy on the staff of an Indian university or a college affiliated thereto;

2. One person, to be elected by the Executive Committee of the Medical Council of India, from among teachers in medicine or therapeutics on the staff of an Indian university or a college affiliated thereto;

3. One pharmacologist to be elected by the Governing Body of the Indian Council of Medical Research;

4. One person to be elected by the Central Council of the Indian Medical Association;

5. One person to be elected by the Council of the Indian Pharmaceutical Association;

31

Functions:

I. To advise the Central Government and the State Governments on technical matters arising out of the administration of this Act.

II.Modification & Amendments in the Act with consultation of Board.

III.To carry out the other functions assigned to it by this Act.

(The nominated and elected members of the Board shall hold office for three years, but shall be eligible for re-nomination and re-election)

32

Drugs Consultative Committee(DCC)

• It is also an advisory body constituted by central government.

Constitution:Two representatives of the Central Government One representative of each State Government

33

Drugs Consultative Committee(DCC)

Functions: To advise the Central Government, the State Governments and

the Drugs Technical Advisory Board on any other matter tending to secure uniformity throughout India in the administration of this Act.

The Drugs Consultative Committee shall meet when required Has power to regulate its own procedure.

34

Central Drug Laboratory(CDL) Established in Calcutta, under the control of a director appointed by the Central Government.

Functions:1. Analysis or test of samples of drugs/cosmetics sent by the custom collectors or courts.2. Analytical Q.C. of the imported samples.

3. Collection, storage and distribution of internal standards.4. Preparation of reference standards and their maintenance.

5. Maintenance of microbial cultures.6. Any other duties entrusted by Central Government.

7. Acting as an appellate authority in matter of DISPUTES.8. Training of drug analysis.

9. To advise the central drug control administration in respect of quality & toxicity.10. To work out analytical specification of Monographs for IP & Homeopathic P.copoeia.

11. Analysis of cosmetics Central drug testing Lab.(CDLT), CHENNAI, MUMBAI,GUWAHATI

35

N.B.:• Biological & microbiological Test/Analysis are not carried out by C.D.L, sent to

Directore of central Research Institute-Kasauli.• Biological for Veterinary use sent to the Director, Indian Veterinary Research

Institute, Izatnagar• Test on condoms are carried out at the central Indian Pharmacopoeial laboratory,

Ghaziabad

PROCEDURE1. All samples of drugs/cosmetics sent to C.D.L. for analysis by court under

registered post & sealed with copy of memorandum.

2. A copy of memorandum & specimen of impression of seal on packet sent separately by registration post.

3. On receipt of the packet, director/officer should record the conditions of seal on packet

4. On completion of test/analysis the director required to supply a report of the analysis.

36

Government analyst

• State government appoint persons as government analysts for the purpose of analysis/testing of samples of drugs & cosmetics.

• The central government may also appoint such person as a government analysts.

• Government analyst should have NO direct or indirect interest in Import, Manufacture OR Sale of drugs & cosmetics.

37

QUALIFICATIONA) For the analysis/testing of other than Biological(c/c1)

1.A graduate in Medicine OR Science OR Pharmacy OR Pharmaceutical chemistry & with at least 5 year post graduate experience in testing OR has completed two years training on testing of drugs, including in Sch.C in CDL.

2.A postgraduate degree in Medicine OR Science OR Pharmacy OR Pharmaceutical chemistry & with at least 3 year experience in testing OR has completed two years training on testing of drugs, including in Sch.C in CDL.

3.Holding associateship Diploma of the Instiution of Chemists with Analysis of drugs & Pharmaceuticals with at least 3 year experience in testing.OR has completed two years training on testing of drugs, including in Sch.C in CDL.

38

B) For the analysis/testing of Biological( Sch c/c1)

USED FOR HUMAN BEINGS

1. A graduate in Medicine OR Science OR Pharmacy OR Pharmaceutical chemistry. And trained either in physiology or bacteriology, Serology, pathology, pharmacology or Microbiology& with at least 5 year experience in testing of biological products & have at least 6 months training in Approvaled Laboratory.

2. A postgraduate degree in Medicine OR Science OR Pharmacy OR Pharmaceutical chemistry or assosiateship Diploma of the Institution of Chemists with Analysis of drugs & Pharmaceuticals.

3.And trained either in physiology or bacteriology, Serology, pathology, pharmacology or Microbiology& with at least 3 year experience in testing of biological products & have at least 6 months training in Approvaled Laboratory has completed two years training on testing of drugs, including in Sch.C in CDL.

39

C) For the analysis/testing of Biological for veterinary use

1. A graduate in veterinary Science OR General Science OR medicine OR Pharmacy.

And atleast 5 year experience of testing.2. A postgraduate in veterinary Science OR General Science OR medicine

OR Pharmacy OR Pharmaceutical Chemistry. And atleast 3 year experience of testing.

DUTIES

2. To analyze & test sample of drugs & cosmetics sent by inspector or other persons & furnish reports.

3. To engage in any research work & forward the report to the government with a view to publication.

40

PROCEDURE

1. On receipt of samples the analyst should record the condition or the seal & compare it with the impression of the seal received separatly.

2. After completion of the analysis, a report in triplicate with full details

should be supplied.

41

EXECUTIVESi) LICENSING AUTHORITIES

FOR IMPORT: the central government appoints licensing authorities to issue licences for the import of drugs.

FOR MANUFACTURE & SALE: the state governments appoint licensing authorities for respective territories to issues licence for the respective & sale of drugs & for the manufacture & sale of drugs & for manufacture of cosmetic.

The licensing authorities are designated differently in different states. As Drug controller Director Drug control Administration Officer in charge, Drug control Commissioner- FDCA

42

ii) CONTROLLING AUTHORITIES All inspectors appointed shall be under the control of a

controlling authority.

QUALIFICATION• A graduate in Medicine OR Pharmacy OR Pharmaceutical

chemistry (Clinical Pharmacology) OR Microbiology.

And at least 5 year experience in the manufacture or testing of drugs or enforcement of the Act.

43

DRUG INSPECTORS

State government appoint persons as drug inspectors to inspect premises licensed for manufacture of drugs & cosmetics & sale of drugs.

The central government may also appoint such persons. Drug inspectors should have no any financial interest in the import,

manufacture or sale of drugs and cosmetics.

All drug inspectors are public servant within the meaning of Indian Penal Code.

Inspectors are required to keep all information's confidential & not to disclose

44

QUALIFICATION

A) TO INSPECT PREMISES MANUFACYURE OTHER THAN BIOLOGICAL & PREMISES

ANUFACTURE BIOLOGICAL (C/G)

1. A degree in Pharmacy2. Science or3. Medicine (Clinical P.cology OR Microbiology)

Any qualification of above and-

A) Not less than 18 Months experience in manufacturing OR testing of the substances specified in

Sch.C OR

B) Not less than 3 Years experience in the inspection of firm manufacturing any of the the

substsnces specified in Sch.C

45

B) TO INSPECT PREMISES MANUFACYURE BIOLOGICAL (VETERINARY)

1. A graduate in veterinary Science OR General Science OR medicine OR Pharmacy. And 18 months experience in the manufacture OR testing of veterinary biological.

2. A graduate in veterinary Science OR General Science OR medicine OR Pharmacy OR Pharmaceutical Chemistry. And at least 3 year experience in the inspection of Firm Manufacturing

veterinary biological.

DUTIES: classified under 2 headsi) Inspection of premises, licensed for the sale of drugs.ii) Inspection of premises licensed for the manufacture of drugs &

cosmetics

46

Inspection of sale premises,

1.To inspect not less than once a year all shops within the area assigned to him

2.He checks whether the conditions of licences are being fulfilled or not.3.To obtain & send sale samples for analysis.

4.To investigate any complaints5.To institute prosecution6.To maintain recored of all inspection.

7.To detain packages of imported drugs.8.To enter & search where an offence is belived to be commited.9.To exercise other duties as may be necessary

47

Inspection Of Manufacturing Premises

1. To inspect not less than once a year all shops within the area assigned to

him. If manufacturer manufacturing biological drugs (C/C1), inspect plant,

process, standardizing & testeing of drgs & method of storage & technical

qualification of the staff.

2. To take sample & send for analysis

3. To check all record & registers.

4. To institute legal proceeding in case of breach of the Act.

5. To send detailed report of each inspection.

48

POWERS1.Inspect any premises where drugs OR cosmetics being manufactured or

sold or if biological product check plant, process & testing

2.Take samples of drugs OR cosmetics which are being manufactured or sold.

3.Enter and search any premises in which an offence is believed to be committed.

4.Examine & seize any records, registers & documents5.Search any person, who he has reason to believe has secreted about any

drug or cosmetic in respect of which an offence is being committed.

6.Stop & search any vehicle,vessel or other conveyance used for carring any drug or cosmaticin respect of which an offence being committed.

7.Exercise such other power as may be necessary

49

PROCEDURE

1. Whenever inspector take sample of drugs, he should inform the purpose in writing in the prescribed form.(No.17)

2. He shall tender the fair price in cash or credit.

3. If price is not accepted he should tender a receipt in prescribed form No.16

4. Divide the sample in four part if sample is taken from sales premises. in three part if sample is taken from manufacturing premises. If small container or likely to deteriorate, the inspector may take 3 or 4 such containers

5. Each part/container sealed & marked.6. Allow the person to add his mark or seal to such part/containers.7. Once part/container of the sample sent to the Govt. analyst, second is reserved for the court, third is

sent to warrantor & fourth returned to person from whom sample is taken

8. Sample sent to Govt. Analyst by registration post or personally

9. Affter the report of analysis has been received from Gvt. Analyst. Drug inspector will decide any further action.

50

Salient features of the Drugs and Cosmetics (Amendment) Act, 2008

Substantial enhancement in punishment

Life imprisonment for offenders involved in manufacture, sale and distribution of spurious and adulterated drug likely to cause grievous hurt

Minimum punishment of seven years which may extend to life imprisonment

Provision for compensation to affected person

51

Corresponding enhancement in punishment for repeated offenders

Cognizance can be taken on the complaint of any gazette officer authorized by Central or State Government

Cases to be tried by Sessions Court

Designation of special courts for trial of offences in respect of adulterated and spurious drugs

52

All offences relating to adulterated and spurious drugs made cognizable and non bailable

Restrictions on bail – Bail cannot be granted unless public prosecutor is heard

Certain offences made compoundable

Provisions of Act

Import Manufacturing Sales Labeling & Packaging

IMPORT

IMPORT OF DRUGS

A. Classes of drugs prohibited to import

B. Import of drug under license1)Specified in Schedule-C/C1

2)Specified in Schedule-X3)Imported for Test/Analysis4)Imported for personal use5)Import Of Homeopathic & Cosmetics Drugs

C. Drugs exempted from provisions of importD. Custom FrontiersE. Offences and Penalties

A. 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.

Drugs not labeled / packed in prescribed manner.

Drugs of biological products (C/C1) after the date of expiry

Drugs not claiming therapeutic values.

Drugs which is risky to human beings or animals.

Patent/Proprietary medicines whose true formula is not disclosed.

Any new drug except with express permission of Lic.authority.

B. Import of drug under license/permit

1. License is required

2. License is obtaining on application to the proper licensing authority (Customs collection/drug Controller of India)

3. License is valid up to 31st December.

4. License should inform to the licensing authority, if any changes.

1) Import of the biological drugs(C/C1)

Conditions to be fulfilled :

Licensee must have adequate facility for the storage.

Licensee must maintain a record of the sale, showing the particulars of the names of drugs and of the persons to whom they have been sold.

Licensee must allow an inspector to inspect premises and to check the records.

Licensee must furnish the sample to the authority.

Licensee must not sell drugs from which sample is withdrawn and he is advised not to sale, and recall the batch from the market.

Licensee must comply with undertaking given in Form No. 9

2) Import of the Schedule-X drugs (Narcotic & Psychotropic drugs)

Conditions to be fulfilled:

Licensee must have adequate storage facility.

Applicant must be reputable in the occupation, trade or business.

The license granted ever before should not be suspended or cancelled.

The licensee has not been convicted any offence under the Drugs and Cosmetics Act or Narcotic and Psychotropic Substances Act.

3) Drugs Imported for examination, test or analysis


License is necessary under form-11

Must use imported drugs only for said purpose and at the place specified in the license.

Must keep the record with respect to quantities, name of the manufacturer and date of import.

Must allow an inspector to inspect the premises and check the records.

4) Drugs imported for personal use


Up to 100 average doses may be imported without any permit, provided it is part of passenger’s luggage.

More than 100 doses imported with license. Apply on form no.-12-A,12-B

Drugs must be bonafide personal use.

The quantity should be reasonable & covered by R.P.M. prescription.

Drugs must be declared to the custom collectors if so directed.

5) IMPORT OF HOMEOPATHIC & COSMETICS DRUGS In general Homeopathic cosmetics drugs imported into India without any

license. New Homeopathic medicines can be imported with licenseCosmetics prohibited to import:

Misbranded cosmetics, Spurious cosmetics Cosmetic containing harmful ingredients Cosmetics not of standard quality

which contains more than-2 ppm Arsenic, 20 ppm lead, 100 ppm heavy metals

Cosmetics meant for eye and containing coal tar dyes Cosmetics colored with lead OR arsenic compounds

Cosmetics containing Hexachlorophene OR Mercury Risky to user

C. Import of drugs without license

• Substances not used for medicinal purpose

• Drugs in Sch-C1 required for manufacturing and not for medicinal use.

• Substances which are both drugs and foods such as:Condensed/Powdered MilkMaltLactoseFarex /CerealOats

• Predigested foods – Virol, Bovril, Chickens essence• Ginger, Pepper, Cumin, Cinnamon• Drugs transit through India to foreign country.

D. CUSTOM FRONTIERSROUTES PLACESBY Road/Rail

Ferozepore Cantt, Amritsar Rly Station, (Pakistan) ranaghat, Mohiassan, Bongaon (Bangladesh), Raxaul(Nepal)

BY sea Madras, Bombay, Calcutta, Cochin, VishakhapatnamBY Air Madras, Bombay, Calcutta, Delhi, Ahmadabad, Hyderabad

OFFENCE PENALTIES

Import of spurious OR adulterated drug OR drug which involves risk to human beings or animals OR drug not having therapeutic values

a) 3 years imprisonment and 5000 Rs. fine on first conviction

b) 5 years imprisonment OR 1000 Rs. fine OR both for subsequent conviction

Contravention of the provision a) 6 months imprisonment OR 500 Rs. fine OR both for first conviction

b) 1 year imprisonment OR 1000 Rs. fine for subsequent offence

E. OFFENCES & PENALTIES

MANUFACTURE

ManufactureA. Prohibition of manufacture

B. Manufacture of other than in Sch-C/C1

C. Manufacture of those in Sch-C/C1

D. Manufacture of Sch-X drugs

E. Loan license

F. Repackaging license

G. Offences & Penalties

A. Prohibition of manufacture

• Drug not of standard quality or misbranded, adulterated or spurious.

• Patent or Proprietary medicine

• Drugs in Sch-J

• Risky to human beings or animals

• Drugs without therapeutic value

• Preparation containing cyclamates

B. Manuf. of drugs other than in Sch-C/C1

PRCEDURE:

A Licence is obtained from licensing authority (Food & Drugs Control Administration) on application in prescribed form (No-24) with prescribed fees (Rs. 6000, 1500)

If the conditions fulfilled ,then licence is issued in a prescribed Form (No. 25)

There are two types of condition for all manufacturing licence. Condition which are to be satisfied before a licence is granted & conditions which are to be complied with after a licence is granted

Conditions:1.Premises should comply with schedule ‘M’2.The manufacture shall be conducted under the active supervision /

direction of competent technical staff. 3.Adequate facility for testing, separate from manufacturing4.Adequate storage facility5.Any change in premises, plant or staff, it reported to authority6.Records maintained for at least 2 years from date of Exp.7.Licensee Should provide sample to authority

8.On demand Furnish data of stability9.Maintain the inspection book

10.Maintain reference samples from each batch11.Accounts of production recorded & maintained for 5 years or 1 year after

Expiry.

C. Manuf. of drugs those in Schedule-C/C1(Biological)

PRCEDURE:• A License is obtained from licensing authority (Food & Drugs Control Administration) on application in prescribed form (No-27) with prescribed fees (Rs. 6000, 1500)• If the conditions fulfilled ,then license is issued in a prescribed Form (No. 28)

Conditions:1. Drugs must be issued in previously sterilized sealed glass or suitable container

2. Containers should comply with requirement of Sch-F3. Drugs must comply with standards of Sch-F

4. Some classes tested for aerobic & anaerobic micro-organism.eg. Sera ,Insulin, Pituitary hormones.

5. Serum tested for freedom from abnormal toxicity6. Multi dose container for liquids should contain preservatives of spore bearing

pathogens.

7. Parenteral in doses of 10 ml or more should be tested for freedom from Pyrogens

8. Separate lab. for culture & manipulation of spore bearing Pathogens9. Test for sterility should be carried out.

D. Manufacture Of Sch-X drugs

PRCEDURE:• A License is obtained from licensing authority (Food & Drugs Control Administration) on application in prescribed form (No-27 B) with prescribed fees (Rs. 6000, 1500)• If the conditions fulfilled ,then license is issued in a prescribed Form (No. 28 B)

Conditions:1) Accounts of all transactions regarding manuf. should be maintained in serially

bound & paged register.(Preserved for 5 years) A) Accounts Of Drugs Used In Manufacture:

1. Date Of Issue2. Name Of Drug3. Opening Balance4. Anticipated Yield – Actual Yield5. Wastage6. Qualification

B) Accounts Of Production7. Date Of Manufacture8. Name Of Drug9. Batch No.10. Anticipated Yield – Actual Yield11. Wastage12. Qualification13.Quantity Of Raw Material

2. Have to sent copies of invoice of sale to licensing authority every 3 months

3. Store drugs in direct custody of responsible person.

4. Preparation must be labeled with XRx

5. Marketed in packing's not exceeding 100 unit dose –Tablets/Capsules 300 ml- Oral liquid 5 ml - Injection

E. Loan licenseDefinition:

A person(applicant) who does not have his own arrangements(factory) for manufacture but who wish to avail the manufacturing facilities owned by another licensee. Such licenses are called Loan licenses.

Loan licenses are issued for:1) Drugs other than specified in C/C1 & X.2) Drugs specified in Schedule-C/C1

PRCEDURE:• A License is obtained from licensing authority (Food & Drugs Control Administration) on application in prescribed form (No-24-A, 27-A) with prescribed fees (Rs. 6000, 1500)• If the conditions fulfilled ,then license is issued in a prescribed Form (No.25-A, 28-A)

Conditions:1. Application must be supported by parent firm.2. Drugs inspector inspect the premises of parent firm & assess the spare capacity.

3. Loan licensee is required to test each batch of raw material & finished products.4. Record of testing should be maintained for 5 years, or 2 years in case of expiry

dated drugs.

5. If the licence of the parent firm is cancelled/suspended the loan licensee will also be deemed to be suspended or cancelled.

6. Patent or proprietary medicines should contains the constituents in therapeutic/prophylactic quantities.

7. Patent medicines should be safe for use in the context of vehicles & additives.8. The ingredients & their quantities must have therapeutic justification.

9. The production must be supervised by competent person of loan licence

F. Repackaging license

• Definition:Process of breaking up any drug from a bulk container into small packages and labeling with a view to their sale and distribution.

Repackaging of drugs is granted of drugs other than Schedule-C/C1 and X.

PRCEDURE:•A License is obtained from licensing authority (Food & Drugs Control

Administration) on application in prescribed form (No-24-B,) with prescribed fees (Rs. 500, 200)•If the conditions fulfilled ,then license is issued in a prescribed Form

(No.25-B,)

Conditions:

1.Adequate space & equipments should be provided.2.Repacking must be supervised by competent person.3.Adequate arrangement for analysis of raw materials & repacked drugs.

4.Maintain records of analysis for at least 3 years from date of manufacture, 3 months for expiry dated drugs.

5.Adequate space for storage of drugs.6.Licensee should allow an inspector to inspect premises, records & take

sample of drugs.

7.Licensee should be displayed on the premises.8.Factory premises must comply with the condition prescribed in Sch.-M9.If any change in competent staff immediately informs to authority.

G. Penalties related to Manufacture

OFFENCES PENALTIESManufacture of any spurious drugs OR adulterated drugs – cause Death

a) imprisonment not less than 5 Year which may be extend to life imprisonment and not less than 10,000Rs. fine

b) 2-6 years imprisonment & Rs.10000 fine on subsequent conviction

Manufacture of adulterated drugs- not cause death

a) 1-3 years imprisonment and Rs.5000 fine

b) 2-6 years imprisonment & Rs.10000 fine on subsequent conviction

Manuf. of drugs in contravention of the provisions

a) Imprisonment from 1-2 years with time

OFFENCES PENALTIESPerson who do not keep record OR disclose information,

Imprisonment up to 1 year & Rs.1000 fine

Manufacturer who gives a false warranty, that drugs do not contravene any provision of the Act

Imprisonment up to 1 year & Rs.500 fine or both

Manufacture of cosmetics

Prohibited for the following classes of drug:• Misbranded or spurious cosmetics and of substandard quality• Cosmetics containing hexachlorophene or mercury compounds• Cosmetics containing color which contain more than-

- 2 ppm of arsenic, 20 ppm of lead, 100 ppm of heavy metals

• Eye preparations containing coal-tar color• List of cosmetics Skin Powders, Skin Powder For Infants, Tooth Powder, Tooth Paste, Skin

Creams, Hair Oils, Shampoo-soap-based, Shampoo-synthetic Detergent Based, Hair Cream

OFFENCES PENALTIESManufacture of spurious cosmetics

3 years imprisonment & fine.

Contravention of the provision 1 year imprisonment & Rs. 2000 fine

SALE

Sale of Drugs

1.Classes of drugs prohibited to be sold

2.Wholesale of biological (C/C1) drugs

3.Wholesale of other than those specified in C/C1 and X

4.Wholesale of Sch-X drugs

5.Retail sale1. General licences2. Restricted licences

6. Offences & Penalties

1. Classes of drugs prohibited to be sold

• Misbranded, spurious, adulterated and drugs not of standard quality

• Patent/Proprietary drugs with undisclosed formula

• Sch-J drugs• Expired drugs.

• Drugs used for consumption by government schemes such as E.S.I.S., Armed force.

• Physician’s samples• Drugs Manufactured/Imported In Contravention Of The Provisions

Of The Act.

2. Wholesale of biological (C/C1)PRCEDURE:• A License is obtained from licensing authority (Food & Drugs Control Administration) on application in prescribed form (No-19-C) with prescribed fees (Rs.1500)

• If the conditions fulfilled ,then license is issued in a prescribed Form (No. 21- B)

CONDITIONS:

1. Adequate premises, which should not be less than 10M2 Equipped with the facilities for the proper storage of the drugs.

2. Licensee should take precautions while storage

3. The drug should be sold only to those persons who are licensed to retail them.

4. Premises should be in the charge of the competent person –who is register pharmacist OR who has passed the matriculation examination with four years experience in dealing with drug.

EXEMPTION:It does not apply to the sale of drugs to-

Hospital institute Medical institute Educational institute Research institute Government authorities

5. For any additional category to sell, licensee should obtain the permission.6. Record of the purchases and sales should be maintained under following headings:

7. Date of purchases and sales8. Names/addresses of firms from whom purchased and persons to whom sold.9. Names, quantities and batch no. of drugs10.Names of the manufacturers.

11.Records should be preserved for 3 years from the date of sale.12.Licence should be displayed on premises

3. Wholesale of other than those specified in C/C1 and X

PRCEDURE:• A License is obtained from licensing authority (Food & Drugs Control Administration) on application in prescribed form (No-19) with prescribed fees (Rs.1500)

• If the conditions fulfilled ,then license is issued in a prescribed Form (No. 20- B)

CONDITION: all the conditions (no.1-7) as discussed above in part(c).

8. The licensee should comply with the provision of the drugs and cosmetics act-1940 and rules there under.

9. The compounding is made by or under the direct and personal supervision of a qualified person.

4. Wholesale of Sch.- X

PRCEDURE:• A License is obtained from licensing authority (Food & Drugs Control Administration) on application in prescribed form (No-19-C) with prescribed fees (Rs.500)

• If the conditions fulfilled ,then license is issued in a prescribed Form (No. 20)

CONDITION: all the conditions (no.1-7) as discussed above in part(c) and 8-9 of part (d) are also applicable to sch-X

10. The licensee should forward to the licensing authority copies of the invoices of sale made to the retail dealers.

5. Retail saleTwo licences are issued

1. General licences2. Restricted licences

General licences are granted to persons who have premises for the business & who engaged the services of qualify persons to supervise the sale & do compounding & dispensing.

Issue for following category:• Other than those specified in sch.-c/c1 & x• For drugs specified in sch.-c/c1• For sch.-x drugs

CONDITIONS

1. The licensee must have adequate premises 10 M2 equipped with facility for storage.

2. Requirement prescribed to run pharmacy as per sch.N

3. All register & records should be prevented for 2 years.4. Licensee must allow an inspector to inspect the premises register & records.

5. If any changes in qualified staff report to the licensing authority.6. Precaution should be taken for the storage of sch.c/c1 drug.

7. The licence should be displayed at prominent place.8. Maintain the inspection book.

9. Drug should be sold only to license holder.10. Drug should be purchased from license manufacturer.

11. Do not stock & sell expired dated drug.12. No drug intended for physician sample central govt. health scheme.

13. Veterinary product stored separately & labeled with “NOT FOR HUMAN USE”.

14. If drug dispensed after compounding it shall be recorded in prescription register.

Restricted licence granted to those dealers who do not engaged the services of the qualified person & only deal with such classes of drugs whose sells can be effected without qualified person & vendors who don’t have fixed premise.

Condition

1. The licence can deal only in such drugs which can be sold without supervision of a qualified person.

2. If licence is vendor he should buy drugs only from fixed dealer which is specified in his licence.

3. Licensee has to take adequate precautions for preserving the properties of the drugs.

4. The licence should be prominently displayed in the premise. In case of vendor it should remain on his person.

5. The drugs should be sold in their original containers.

6. Drugs should be purchased only from a duly licensed dealer or manufacturer.

OFFENCES &PENALTIES OFFENCES PENALTIES FOR

FIRST CONVICTIONPENALTIES FOR

SUBSEQUENT CONVICTION

Anyone who sells any adulterated or spurious drugs or drugs which likely to cause death.

5 Years to life time Imprisonment & Rs.10,000 fine

Imprisonment up to10 years or Rs.20,000 fine or both

Seles of any adulterated or spurious drugs or drugs which is not likely to cause death.

1 -3 Years Imprisonment & Rs.5000 fine

2-6 Years Imprisonment & Rs.10,000 fine

Sales of any drugs in contravention of pro-vision of the Act

1 -2 Years Imprisonment & fine

2-6 Years Imprisonment & Rs.5000 fine

If records are not kept & information not disclosed

3 Years Imprisonment or Rs.1000 fine or both

3-6 Years Imprisonment or Rs.1000 fine or both

Disposal of the expired drugs

• Instead of returning the expired drugs to the manufacturers, such drugs should be destroyed at the premises of the licensee in the whose possession the drugs have expired.

• Expired drugs are to be destroyed at the premises of the within 3 months from the expiry date.

Disposal of the drugs if licence is cancelled

1. If the licensee wishes to dispose of the drugs in his possession in the premises in respect of which the licence has been cancelled, he should apply in writing to the Lic. Authority giving following particulars :

A. Name & address of person to whom the drugs are proposed to be sold

B. Name of the drugs together with their quantities, Batch No., the name, addresses of the manufactures & date of expiry.

2. The Lic. Authority, after examination of the particulars furnished, & after inspection by an inspector, grant the necessary permission for the disposal.

Labeling & Packaging

Labeling & Packaging

1. Labeling general

2. Labeling special

The following are the general requirements of labelling of drugs:1. Name of drugs with trade name e.g. 2. Name or synonym specified in the official pharmacopoeias, official

compendia or formularies (I.P., B.P., U.S.P., N.F.)3. Net contents – weight, volume or number of units. E.g. 10 tablets4. Quantities of active ingredients expressed either.

• Amount per single dose for liquid• Amount per milliliter for parenteral• Amount per unit (Tablet, capsule)• Percentage by weight or volume• Unit per gram or per milliliter E.g.

PARACETAMOL I.P. TABLETS METACIN – TABLETS

PARACETAMOL IP 500 mg.EXCIPIENTs Q.S.

5. Name & address of manufacturer & LIC. No

6. A distinctive batch number, lot number e.g.

7. Date of manufacture & date of expiry e.g.

8. Precautionary information9.

10. General information • Shake well before use (Suspension, Emulsion, lotion)• For external use only ( if external preparation)• Not to be sold ( if physician sample)• For animal use only ( for veterinary products)

THEMIS PHARMACEUTICALSVAPI, GUJARAT. Mfg. LIC. No. G-2104

Batch no. 5/50, lot No. 6

Mfg. dt 5/2/94 Expiry dt. 4/2/99

STORE IN DARK STORE IN COOLPLACE

Labelling specialClass of

drugsNature of medicines Specific particulars appeared on label

Schedule C/C1

In original form 1) Proper name in addition to patent name2) Potency in units3) Name & address of manufacturer4) Licence No. under which manufacturer5) Date of manufacture6) Date of expiry7) Precaution for preparation

Schedule G

Made up ready for internal use

It is dangerous to take the preparation except under medicinal supervision.

Schedule G

External use No caution required

Class of drugs Nature of medicines Specific particulars appeared on label

Schedule H Internal useNot narcotic & psychotropic substances

1) Rx symbol on left top corner of the label

2) Schedule H drugs.3) WARNING: to be sold by retail on

the prescription of a R.M.P. onlyInternal usenarcotic & psychotropic substances

1) N.Rx symbol on left top corner of the label

2) Schedule H drugs.3) WARNING: to be sold by retail on

the prescription of a R.M.P. onlyExternal use External use only

Schedule X Internal use 1) N.Rx in red ink symbol on left top corner of the label

2) Schedule X drugs.3) WARNING: to be sold by retail on

the prescription of a R.M.P. onlyExternal use External use only

Class of drugs Nature of medicines

Specific particulars appeared on label

Patent and proprietary containing vitamin

----- “ For Therapeutic Use “ OR “For Prophylactic Use “ OR : For Pediatric use”

Non sterile surgical ligature suture

------- ‘non sterile”Operation unless sterilised

Mechanical contraceptives ------- 1) As per Schedule- R2) Date of manufacture3) storage condition

QUESTION

1. Drugs & Cosmetic Acts (16)2. Schedule M (8)3. Gove. Analyst & inspector (8)4. Short note: Import of drugs and cosmetics. 085. Write on sale of drug according to Drug and Cosmetic

Act. 086. Sale of drugs according to drugs and cosmetic Act. 087. Describe the functions of Central Drug Laboratory. 08

Thank you

Drugs and cosmetics act 1940 and rules 1945

Health & Medicine