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Prepared by :
          Rakshit V. Thumar
         M.Pharm Q.A. SEM-II

            Guided by:
   Ms. Urvisha V. Bangoriya
        Assistant professor
Quality Assurance Department
 S. J. Takkar Pharmacy college
              Rajkot
 SJTPC                           1
Contents
   History and Objectives
   Definitions
   Administration of the act and rules
   Provisions related to Import
   Provisions related to Manufacture
   Provisions related to Sale
   Labeling and Packaging
   Schedules to the act and rules
   Recent amendment act, 2008
   List of forms


           SJTPC                          2
History
 British misrule-Providing poor healthcare system to
 Indian citizens

 Observations made by-Drugs Enquiry
 Committee, Indian Medical Association

 Reports in- Indian Medical Gazette during 1920-30


 1940 – Drugs and Cosmetics Act
 1945 – Rules under the Act


Extended to whole of India……
                    SJTPC                          3
LIST OF AMENDING ACTS AND
  ADAPTATION ORDERS
1. The Drugs (Amendment) Act, 1955
2. The Drugs (Amendment) Act, 1960
3. The Drugs (Amendment) Act, 1962
4. The Drugs and Cosmetics (Amendment) Act, 1964
5. The Drugs and Cosmetics (Amendment) Act, 1972
6. The Drugs and Cosmetics (Amendment) Act, 1982
7. The Drugs and Cosmetics (Amendment) Act, 1995
8. The Drugs and cosmetics (Amendment) Act, 2008


           SJTPC                              4
Objectives
 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.
   To prevent substandard in drugs.
   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.

             SJTPC                                        5
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.


            SJTPC                                    6
Cosmetic :
      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.


           SJTPC                                   7
 Misbranded drugs :
  (a) if it is so coloured, 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.




          SJTPC                               8
 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.
            SJTPC                              9
 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



           SJTPC                                10
 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.

          SJTPC                                11
 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.


           SJTPC                               12
Administration of the act and rules
A) Advisory :
   1)Drugs Technical Advisory Board-DTAB
   2)Drugs Consultative Committee-D.C.C.
B) Analytical :
   1)Central Drugs Laboratory - CDL
   2)Drug Control Laboratory in states
   3)Government Analysts
C) Executives :
   1)Licensing authorities
   2)Controlling authorities
   3)Drug Inspectors
          SJTPC                            13
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
               SJTPC                                            14
 Nominated:
1) Two persons by the Central Government.
2) One person by the Central Government from
   the pharmaceutical industry
3) Two persons holding the appointment of
  Government Analyst under this Act,




        SJTPC                               15
 Elected:
1)one person, to be elected by the Executive Committee of
  the Pharmacy Council of India,

2)one person, to be elected by the Executive Committee of
  the Medical Council of India,

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;

           SJTPC                                        16
 Functions:
      To advise the Central Government and the
 State Governments on technical matters.
      To carry out the other functions assigned to it by
 this Act.




          SJTPC                                      17
Drugs Consultative Committee(DCC)
 It is also an advisory body constituted by central
 government.

 Constitution:
      Tworepresentatives        of   the     Central
 Government
    One   representative        of    each     State
 Government



            SJTPC                                 18
 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.
            SJTPC                                19
Central Drug Laboratory(CDL)
 Established in Calcutta, under the control of a director
    appointed by the Central Government.

Functions:
 Analysis or test of samples of drugs/cosmetics sent by
    the custom collectors or courts.
   Analytical Q.C. of the imported samples.
   Collection, storage and distribution of internal
    standards.
   Preparation of reference standards and their
    maintenance.
   Maintenance of microbial cultures.
   Any other duties entrusted by Central Government.
   Acting as an appellate authority in matter of disputes.

                  SJTPC                                       20
Drug control laboratories in state
In gujarat three laboratories established which
  collect, analysed and report the various sample of the drugs
  and food.
1) Baroda: Established in 1959.
2) Bhuj: Established in 1979.
3) Rajkot: Established in 1983
The laboratory has the following devision:-
 Pharmaceutical Chemistry Division
 Immunology Division
 Pharmacology Division
 Pharmacognocy Division
 Food Division
 Ayurvedic Division

                SJTPC                                        21
Function:
 Testing of drug sample
 Analysis of food sample
 Analysis of exicse sample




             SJTPC            22
Government analyst
 These officers are appointed by the central or state
  government and perform the duties.
Qualification of government analysist
1    Persons having qualification for appointment as
  government as govermental Analysis for allopathic
  drugs ;
2    having a degree in medicine, ayurved, sidha or
  unani system and not less than three year post
  graduate experience in the analysis of drugs in a
  laboratory under control of a government analyst.


               SJTPC                                     23
Duties:
 1) The Government Analyst shall cause to be
  analysed or tested such samples or drugs
  and cosmetics as may be sent to him by
  Inspectors.
 2)A Government Analyst shall from time to
  time forward reports to the Government
  giving the result of analytical work and
  research with a view to their publication.

           SJTPC                            24
Licencing authority
Qualification:
(i) Graduate in Pharmacy on Pharmaceutical
  Chemistry or in Medicine with specialization in
  clinical pharmacology or microbiology from a
  University established in India by law; and
(ii)Experience in the manufacture or testing of drugs
  a minimum period of five years, Provided that the
  requirements as to the academic qualification shall
  not apply to those inspectors .


            SJTPC                                  25
Duties:
(1) to inspect all establishments licensed
  for the sale of drugs within the area
  assigned to him;
(2) to satisfy himself that the conditions
  of the licences are being observed;
(3) to procure and send for test or
  analysis, if necessary, imported
  packages.
(4) to investigate any complaint.
           SJTPC                             26
(5) to maintain a record of all inspections made and
  action taken by him in the performance of his
  duties,
(6) to make such enquiries and inspections as may be
  necessary to detect the sale of drugs in
  contravention to the Act;




             SJTPC                                 27
Controlling authority
Qualification:
 graduate in Pharmacy or Pharmaceutical Chemistry
  or in Medicine with specialization in clinical
  Pharmacology or microbiology from a University
  established in India by law and
 experience in the manufacture or testing of drugs or
  enforcement of the provisions of the Act for a
  minimum period of five years:



              SJTPC                                      28
Drug Inspector
Qualification
1    Persons having qualification for appointment as
  government as govermental Analysis for allopathic
  drugs ; or
2     having a degree in ayurved, sidha or unani system
  and not less than three year post graduate experience
  in the analysis of drugs in a laboratory under control of
  (a) a government analyst, or (b) a chemical
  examinar, or (c) head of an institution specially
  approved for this purpose.


               SJTPC                                      29
Power:
a) Inspect, --
(i) any premises where in any drug or cosmetic is
  being manufactured.
(ii) any premises where in any drug or cosmetic is
  being sold, or stocked or exhibited or offered for
  sale, or distributed ;
(b) Take samples of any drug or cosmetic,--
(i) which is being manufactured or being sold or is
  stocked or exhibited or offered for sale, or is being
  distributed;
(ii) from any person who is in the course of
  conveying, delivering or preparing to deliver such
  drug or cosmetic to a purchaser or a consignee.

              SJTPC                                       30
Provision
                  of Act


         Manufacturi                  Labeling
Import                       Sales
            ng                           &
                                     Packaging




         SJTPC                                   31
IMPORT




SJTPC            32
IMPORT of drugs
 Classes of drugs prohibited to import
 Import 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
 Drugs exempted from provisions of import
 Offences and Penalties



            SJTPC                            33
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.
                SJTPC                                      34
Import of the biological
    drugs(C/C1)
Conditions to be fulfillled:
 Licensee must have adequate facility for the storage.

 Licensee must maintain a record of the sale.

 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.
                SJTPC                                       35
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 even 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.
          SJTPC                                   36
Drugs Imported for
  examination, test or analysis
 Conditions to be fulfilled:
 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.
            SJTPC                                   37
Drugs imported for personal use
Conditions to be fulfilled:
 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.

 Drugs must be declared to the custom
  collectors if so directed.
        SJTPC                             38
Import of drugs without license
 Substances not used for medicinal pupose
 Drugs in Sch-C1 required for manufacturing and not for
  medicinal use.
 Substances which are both drugs and foods such as:
      Condensed/Powdered Milk
      Malt
      Lactose
      Farex/Cereal
      Oats
 Predigested foods
 Ginger, Pepper, Cumin, Cinnamon


           SJTPC                                       39
Penalties related to Import
          OFFENCES                         PENALTIES


Import      of    spurious  OR a) 3 years imprisonment and
adulterated drug OR drug which    5000 Rs.     fine on first
involves risk to human beings or  conviction
animals OR drug not having b) 5 years imprisonment OR
therapeutic values                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
          SJTPC                                                40
Cosmetics 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




           SJTPC                               41
MANUFACTURE




SJTPC          42
Manufacture
 Prohibition of manufacture
 Manufacture of other than in Sch-C/C1
 Manufacture of those in Sch-C/C1
 Manufacture of Sch-X drugs
 Loan license
 Repackaging license
 Offences & Penalties




          SJTPC                           43
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
          SJTPC                            44
Manuf. of drugs other than in Sch-
C/C1
 Conditions:
  Premises should comply with schedule ‘M’
  Adequate      facility for testing, separate from
     manufacturing
    Adequate storage facility
    Records maintained for at least 2 years from date of
     Exp.
    Should provide sample to authority
    Furnish data of stability
    Maintain the inspection book
    Maintain reference samples from each batch

             SJTPC                                    45
Manuf. of drugs those in Schedule-
C/C1(Biological)
Conditions:
 Drugs must be issued in previously sterilized sealed
    glass or suitable container
   Containers should comply with Sch-F
   Some classes tested for aerobic & anaerobic micro-
    organism.eg. Sera ,Insulin, Pituitary hormones.
   Serum tested for abnormal toxicity
   Parentral in doses of 10 ml or more should be tested for
    freedom from Pyrogens
   Separate lab. for culture & manipulation of spore
    bearing Pathogens
   Test for sterility should be carried out.

             SJTPC                                       46
Manufacture Of Sch-X drugs
Conditions:
 Accounts of all transactions regarding manuf. should
    be maintained in serially.(Preserved for 5 years)
   Have to sent invoice of sale to licensing authority every
    3 months
   Store drugs in direct custody of responsible person.
   Preparation must be labeled with XRx
   Marketed in packings not exceeding
      100 unit dose –Tablets/Capsules
      300 ml- Oral liquid
      5 ml - Injection


                 SJTPC                                          47
Loan License
 Definition:
      A 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
 licenses.

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

          SJTPC                               48
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
 Schdule-C/C1 and X.




         SJTPC                                   49
Penalties related to
          Manufacture
           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
Manuf. of drugs in contravention of a) Imprisonment up to 3 months &
the provisions                         Rs.500 fine
                                    b) Imprisonment up to 6 months
                                       & Rs.1000 fine on subsequent
                                       conviction

                SJTPC                                                  50
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


            SJTPC                                   51
SALE



SJTPC          52
Sale of Drugs
 Classes of drugs prohibited to be sold
 Wholesale of biological (C/C1)
 Wholesale of other than those specified in C/C1
 and X




         SJTPC                                 53
Class of drug prohibited to sale
 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, Armed force.
   Physician’s samples

               SJTPC                                    54
Wholesale of biological (C/C1)
 Adequate premises, with greater than 10 M2
  area, with proper storage facility
 Drugs sold only to retailer having license
 Premises should be in charge of competent
  person who is Reg. Pharmacist.
 Records of purchase & sale
 Records preserved for 3 years from date of sale
 License should displayed on premises



          SJTPC                                     55
whole sale from other than
   specified in c/c1 and x
 All the conditions as discussed in for biological.
 Compounding is made by or under the direct and
  personal supervision of a qualified person.




              SJTPC                                    56
Labeling & Packaging
All the general and specific
 labeling     and       packaging
 specified to all classes of drugs
 and cosmetics should be as per
 the provisions made under the
 act.

     SJTPC                      57
For allopathy
 Label




          SJTPC             58
For ayurvedic, siddha, unani
homoepathy and cosmetics
LABEL




        SJTPC                  59
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




          SJTPC                                      60
Schedules to the rules
TYPE                                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 (nonparenteral)
        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
                SJTPC                                                61
Schedules to the rules
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.
                  SJTPC                                                 62
Schedules to the rules
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
                  SJTPC                                                      63
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

                SJTPC                                            64
Schedules to the rules
TYPE                              CONTENT


“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

               SJTPC                                            65
Drugs and Cosmetics (Amendment)
Act, 2008
Salient features of the Act:-

 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
          SJTPC                                   66
Different types of forms
 Forms.




             SJTPC                    67
QUESTIONS
 Describe the functions of Central Drug Laboratory.
 Sale of drugs according to Drugs and Cosmetic Act.
 Describe the administration of Drug and cosmetics act
 Manufacture of drugs according to Drugs and
 Cosmetics Act.




              SJTPC                                    68
References
 www.cdsco.nic.in
 “Pharmaceutical Jurisprudence”, Jani GK, Atul
  prakashan; Fifth edition(2005-06); 28.
 “Forensic Pharmacy”, Kokate CK and Gokhle
  SB, Pharma Book Syndicate; 152
 “Laboratories” http://www.gujhealth.gov.in/fdc-
  laboratory.htm



             SJTPC                                  69
SJTPC   70

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Drugs & cosmetics act 1940

  • 1. Prepared by : Rakshit V. Thumar M.Pharm Q.A. SEM-II Guided by: Ms. Urvisha V. Bangoriya Assistant professor Quality Assurance Department S. J. Takkar Pharmacy college Rajkot SJTPC 1
  • 2. Contents  History and Objectives  Definitions  Administration of the act and rules  Provisions related to Import  Provisions related to Manufacture  Provisions related to Sale  Labeling and Packaging  Schedules to the act and rules  Recent amendment act, 2008  List of forms SJTPC 2
  • 3. History  British misrule-Providing poor healthcare system to Indian citizens  Observations made by-Drugs Enquiry Committee, Indian Medical Association  Reports in- Indian Medical Gazette during 1920-30  1940 – Drugs and Cosmetics Act  1945 – Rules under the Act Extended to whole of India…… SJTPC 3
  • 4. LIST OF AMENDING ACTS AND ADAPTATION ORDERS 1. The Drugs (Amendment) Act, 1955 2. The Drugs (Amendment) Act, 1960 3. The Drugs (Amendment) Act, 1962 4. The Drugs and Cosmetics (Amendment) Act, 1964 5. The Drugs and Cosmetics (Amendment) Act, 1972 6. The Drugs and Cosmetics (Amendment) Act, 1982 7. The Drugs and Cosmetics (Amendment) Act, 1995 8. The Drugs and cosmetics (Amendment) Act, 2008 SJTPC 4
  • 5. Objectives  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.  To prevent substandard in drugs.  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. SJTPC 5
  • 6. 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. SJTPC 6
  • 7. Cosmetic : 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. SJTPC 7
  • 8.  Misbranded drugs : (a) if it is so coloured, 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. SJTPC 8
  • 9.  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. SJTPC 9
  • 10.  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 SJTPC 10
  • 11.  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. SJTPC 11
  • 12.  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. SJTPC 12
  • 13. Administration of the act and rules A) Advisory : 1)Drugs Technical Advisory Board-DTAB 2)Drugs Consultative Committee-D.C.C. B) Analytical : 1)Central Drugs Laboratory - CDL 2)Drug Control Laboratory in states 3)Government Analysts C) Executives : 1)Licensing authorities 2)Controlling authorities 3)Drug Inspectors SJTPC 13
  • 14. 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 SJTPC 14
  • 15.  Nominated: 1) Two persons by the Central Government. 2) One person by the Central Government from the pharmaceutical industry 3) Two persons holding the appointment of Government Analyst under this Act, SJTPC 15
  • 16.  Elected: 1)one person, to be elected by the Executive Committee of the Pharmacy Council of India, 2)one person, to be elected by the Executive Committee of the Medical Council of India, 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; SJTPC 16
  • 17.  Functions: To advise the Central Government and the State Governments on technical matters. To carry out the other functions assigned to it by this Act. SJTPC 17
  • 18. Drugs Consultative Committee(DCC)  It is also an advisory body constituted by central government.  Constitution: Tworepresentatives of the Central Government One representative of each State Government SJTPC 18
  • 19.  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. SJTPC 19
  • 20. Central Drug Laboratory(CDL)  Established in Calcutta, under the control of a director appointed by the Central Government. Functions:  Analysis or test of samples of drugs/cosmetics sent by the custom collectors or courts.  Analytical Q.C. of the imported samples.  Collection, storage and distribution of internal standards.  Preparation of reference standards and their maintenance.  Maintenance of microbial cultures.  Any other duties entrusted by Central Government.  Acting as an appellate authority in matter of disputes. SJTPC 20
  • 21. Drug control laboratories in state In gujarat three laboratories established which collect, analysed and report the various sample of the drugs and food. 1) Baroda: Established in 1959. 2) Bhuj: Established in 1979. 3) Rajkot: Established in 1983 The laboratory has the following devision:-  Pharmaceutical Chemistry Division  Immunology Division  Pharmacology Division  Pharmacognocy Division  Food Division  Ayurvedic Division SJTPC 21
  • 22. Function:  Testing of drug sample  Analysis of food sample  Analysis of exicse sample SJTPC 22
  • 23. Government analyst  These officers are appointed by the central or state government and perform the duties. Qualification of government analysist 1 Persons having qualification for appointment as government as govermental Analysis for allopathic drugs ; 2 having a degree in medicine, ayurved, sidha or unani system and not less than three year post graduate experience in the analysis of drugs in a laboratory under control of a government analyst. SJTPC 23
  • 24. Duties:  1) The Government Analyst shall cause to be analysed or tested such samples or drugs and cosmetics as may be sent to him by Inspectors.  2)A Government Analyst shall from time to time forward reports to the Government giving the result of analytical work and research with a view to their publication. SJTPC 24
  • 25. Licencing authority Qualification: (i) Graduate in Pharmacy on Pharmaceutical Chemistry or in Medicine with specialization in clinical pharmacology or microbiology from a University established in India by law; and (ii)Experience in the manufacture or testing of drugs a minimum period of five years, Provided that the requirements as to the academic qualification shall not apply to those inspectors . SJTPC 25
  • 26. Duties: (1) to inspect all establishments licensed for the sale of drugs within the area assigned to him; (2) to satisfy himself that the conditions of the licences are being observed; (3) to procure and send for test or analysis, if necessary, imported packages. (4) to investigate any complaint. SJTPC 26
  • 27. (5) to maintain a record of all inspections made and action taken by him in the performance of his duties, (6) to make such enquiries and inspections as may be necessary to detect the sale of drugs in contravention to the Act; SJTPC 27
  • 28. Controlling authority Qualification:  graduate in Pharmacy or Pharmaceutical Chemistry or in Medicine with specialization in clinical Pharmacology or microbiology from a University established in India by law and  experience in the manufacture or testing of drugs or enforcement of the provisions of the Act for a minimum period of five years: SJTPC 28
  • 29. Drug Inspector Qualification 1 Persons having qualification for appointment as government as govermental Analysis for allopathic drugs ; or 2 having a degree in ayurved, sidha or unani system and not less than three year post graduate experience in the analysis of drugs in a laboratory under control of (a) a government analyst, or (b) a chemical examinar, or (c) head of an institution specially approved for this purpose. SJTPC 29
  • 30. Power: a) Inspect, -- (i) any premises where in any drug or cosmetic is being manufactured. (ii) any premises where in any drug or cosmetic is being sold, or stocked or exhibited or offered for sale, or distributed ; (b) Take samples of any drug or cosmetic,-- (i) which is being manufactured or being sold or is stocked or exhibited or offered for sale, or is being distributed; (ii) from any person who is in the course of conveying, delivering or preparing to deliver such drug or cosmetic to a purchaser or a consignee. SJTPC 30
  • 31. Provision of Act Manufacturi Labeling Import Sales ng & Packaging SJTPC 31
  • 33. IMPORT of drugs  Classes of drugs prohibited to import  Import 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  Drugs exempted from provisions of import  Offences and Penalties SJTPC 33
  • 34. 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. SJTPC 34
  • 35. Import of the biological drugs(C/C1) Conditions to be fulfillled:  Licensee must have adequate facility for the storage.  Licensee must maintain a record of the sale.  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. SJTPC 35
  • 36. 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 even 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. SJTPC 36
  • 37. Drugs Imported for examination, test or analysis Conditions to be fulfilled:  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. SJTPC 37
  • 38. Drugs imported for personal use Conditions to be fulfilled:  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.  Drugs must be declared to the custom collectors if so directed. SJTPC 38
  • 39. Import of drugs without license  Substances not used for medicinal pupose  Drugs in Sch-C1 required for manufacturing and not for medicinal use.  Substances which are both drugs and foods such as: Condensed/Powdered Milk Malt Lactose Farex/Cereal Oats  Predigested foods  Ginger, Pepper, Cumin, Cinnamon SJTPC 39
  • 40. Penalties related to Import OFFENCES PENALTIES Import of spurious OR a) 3 years imprisonment and adulterated drug OR drug which 5000 Rs. fine on first involves risk to human beings or conviction animals OR drug not having b) 5 years imprisonment OR therapeutic values 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 SJTPC 40
  • 41. Cosmetics 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 SJTPC 41
  • 43. Manufacture  Prohibition of manufacture  Manufacture of other than in Sch-C/C1  Manufacture of those in Sch-C/C1  Manufacture of Sch-X drugs  Loan license  Repackaging license  Offences & Penalties SJTPC 43
  • 44. 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 SJTPC 44
  • 45. Manuf. of drugs other than in Sch- C/C1 Conditions:  Premises should comply with schedule ‘M’  Adequate facility for testing, separate from manufacturing  Adequate storage facility  Records maintained for at least 2 years from date of Exp.  Should provide sample to authority  Furnish data of stability  Maintain the inspection book  Maintain reference samples from each batch SJTPC 45
  • 46. Manuf. of drugs those in Schedule- C/C1(Biological) Conditions:  Drugs must be issued in previously sterilized sealed glass or suitable container  Containers should comply with Sch-F  Some classes tested for aerobic & anaerobic micro- organism.eg. Sera ,Insulin, Pituitary hormones.  Serum tested for abnormal toxicity  Parentral in doses of 10 ml or more should be tested for freedom from Pyrogens  Separate lab. for culture & manipulation of spore bearing Pathogens  Test for sterility should be carried out. SJTPC 46
  • 47. Manufacture Of Sch-X drugs Conditions:  Accounts of all transactions regarding manuf. should be maintained in serially.(Preserved for 5 years)  Have to sent invoice of sale to licensing authority every 3 months  Store drugs in direct custody of responsible person.  Preparation must be labeled with XRx  Marketed in packings not exceeding  100 unit dose –Tablets/Capsules  300 ml- Oral liquid  5 ml - Injection SJTPC 47
  • 48. Loan License  Definition: A 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 licenses. Loan licenses are issued for: 1) Drugs other than specified in C/C1 & X. 2) Drugs specified in Schedule-C/C1 SJTPC 48
  • 49. 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 Schdule-C/C1 and X. SJTPC 49
  • 50. Penalties related to Manufacture 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 Manuf. of drugs in contravention of a) Imprisonment up to 3 months & the provisions Rs.500 fine b) Imprisonment up to 6 months & Rs.1000 fine on subsequent conviction SJTPC 50
  • 51. 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 SJTPC 51
  • 53. Sale of Drugs  Classes of drugs prohibited to be sold  Wholesale of biological (C/C1)  Wholesale of other than those specified in C/C1 and X SJTPC 53
  • 54. Class of drug prohibited to sale  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, Armed force.  Physician’s samples SJTPC 54
  • 55. Wholesale of biological (C/C1)  Adequate premises, with greater than 10 M2 area, with proper storage facility  Drugs sold only to retailer having license  Premises should be in charge of competent person who is Reg. Pharmacist.  Records of purchase & sale  Records preserved for 3 years from date of sale  License should displayed on premises SJTPC 55
  • 56. whole sale from other than specified in c/c1 and x  All the conditions as discussed in for biological.  Compounding is made by or under the direct and personal supervision of a qualified person. SJTPC 56
  • 57. Labeling & Packaging All the general and specific labeling and packaging specified to all classes of drugs and cosmetics should be as per the provisions made under the act. SJTPC 57
  • 59. For ayurvedic, siddha, unani homoepathy and cosmetics LABEL SJTPC 59
  • 60. 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 SJTPC 60
  • 61. Schedules to the rules TYPE 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 (nonparenteral) 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 SJTPC 61
  • 62. Schedules to the rules 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. SJTPC 62
  • 63. Schedules to the rules 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 SJTPC 63
  • 64. 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 SJTPC 64
  • 65. Schedules to the rules TYPE CONTENT “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 SJTPC 65
  • 66. Drugs and Cosmetics (Amendment) Act, 2008 Salient features of the Act:-  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 SJTPC 66
  • 67. Different types of forms  Forms. SJTPC 67
  • 68. QUESTIONS  Describe the functions of Central Drug Laboratory.  Sale of drugs according to Drugs and Cosmetic Act.  Describe the administration of Drug and cosmetics act  Manufacture of drugs according to Drugs and Cosmetics Act. SJTPC 68
  • 69. References  www.cdsco.nic.in  “Pharmaceutical Jurisprudence”, Jani GK, Atul prakashan; Fifth edition(2005-06); 28.  “Forensic Pharmacy”, Kokate CK and Gokhle SB, Pharma Book Syndicate; 152  “Laboratories” http://www.gujhealth.gov.in/fdc- laboratory.htm SJTPC 69
  • 70. SJTPC 70

Editor's Notes

  1. F exp