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Regulatory aspects of Pharmaceuticals and Bulk
drug Manufacturing, Regulation of drugs and
               pharmaceuticals.

                 Under the guidance of
          Sri B. Thangabalan Sir, M. Pharm
                        (Ph.D)
                                                   By
                                 K. Sampath Kumar,
                                      Y11MPH18060,
                                        I/II M.Pharm,
                                       2nd Semester,
                             Pharmaceutical Analysis,
                           Sims college of Pharmacy.
1
Introduction:
Drugs play an important role in the health of both people and the
economy of a country.
Pharmaceutical drugs are available from a large number of sources.
People and Governments willing to spend money on drugs for many
reasons so, it must be safe, effective and good quality and used
appropriately.
This means, in turn, that development, production, importation,
exportation and subsequent distribution of drugs must be regulated
to ensure that they meet prescribed standards.
Therefore, effective drug regulation is required to ensure the safety,
efficacy and quality of drugs as well as accuracy and appropriateness
of the drug information available to the public
 2
Regulatory requirements
►In an ideal world, the need for analysis should be driven by the
desire to assure the quality of a drug product.

►However, in the real world the need for pharmaceutical drug
analysis is driven largely by regulatory requirements.

►A team consisting of R&D, QC, and QA unit members develops
these quality and compliance systems.

►It should be one of the highest priorities of top management and
QA units to develop and monitor these systems to comply with the
cGMP and GLP expectations.

►Compliance documents are needed, in addition to the regulatory
and research documents, to demonstrate the integrity of the data.

►Compliance documents refer to those reports required by GMP
and/or utilized during the course of inspection by a health
3
authority.
Key function of regulatory agencies

    Product registration (drug evaluation and authorization, and
    monitoring of drug efficacy and safety);
    Regulation     of   drug   manufacturing,       importation,   and
    distribution;
    Regulation & Control of drug promotion and information.
    Adverse drug reaction (ADR) monitoring.
    Licensing of premises, persons and practices.

    Goal of regulatory agency
    Main goal of drug regulation is to guarantee the safety, efficacy
    and quality of drugs available to public.

4
The drug regulation


                  Drug Laws

                  Drug Regulatory Agencies

                  Drug Regulatory Boards

                  Quality Control

                  Drug Information Centres etc.




5
Drug regulatory system in India

        Drugs and Health is in concurrent list of Indian Constitution It is
governed by both Centre and State Governments under the Drugs &
Cosmetics Act, 1940.


    MAIN BODIES


        Central Drug Standard Control Organization (CDSCO)
        Ministry Of Health & Family Welfare (MHFW)
        Indian Council Of Medical Research (ICMR)
        Indian Pharmaceutical Association (IPA)
        Drug Technical Advisory Board (DTAB)
        Central Drug Testing Laboratory (CDTL)
        Indian Pharmacopoeia Commission (IPC)
        National Pharmaceutical Pricing Authority (NPPA)
6
WELL DEFINED DRUG REGULATORY SYSTEM(Govt.
of India)


Ministry of health and family welfare


                    DTAB          DCGI




                     Enforcement & GMP audit Division
                     Quality Control Division – CDTL
                     Registration Division
                     New Drug Division
                     Pharmacovigilance

7
                     Trainings
Approval of Investigational New Drug (IND)



           IND Applicant       Approval




             CDSCO           Recommendation
                             to DCG (I)




          Examination        Detailed review
          by new drug            by IND
          division             committee




8
Central licensing


                                             Joint inspection
                        State licensing
     Manufacturer                            by state and
                            authority        central inspectors




      CLAA approval     License prepared      Examination of
       and grant of     by state licensing
         license
                                                 report
                             authority



9
CDSCO

     Central Drug Standard Control Organization


              Head quarters New Delhi
              North Zone Ghaziabad
              West Zone Mumbai
              South Zone Chennai
              East Zone Kolkata.
              Other zonal offices Ahmedabad and Hyderabad.
              Sub-Zonal Office 2
              Port offices/Airports 7
              Laboratories 6
10
CDSCO Drug Controller General (I)



      Head           Zonal & sub      Port
                                                     Laboratory
     Quarter         Zonal office     Office




     New Drugs      GMP Audits       Import
     CLAA
                                               Testing of drug
                    Coordinates      Export    samples
     Imports
     DTAB/DCC
                    with states                Validation of
                                               Test Protocol




11
Functions undertaken by Central Government
Statutory function:

Laying down standards of drugs, cosmetics, diagnostics and devices.
Laying down regulatory measures, amendments to Acts and rules.
To regulate market authorization of new drugs.
To regulate clinical research in India
To approve licenses to manufacture certain categories of drugs as
Central License Approving Authority(CLAA) i.e. for Blood Banks, Large
Volume Parenterals and Vaccines & Sera.
To regulate the standards of imported drugs.
Work relating to the Drugs Technical Advisory Board ( DTAB ) and
Drugs Consultative Committee (DCC).
Testing of drugs by Central Drugs Labs.
12
NIHFW


National Institute of Health and Family Welfare

NIHFW is an Apex Technical Institute, funded by Ministry of
Health and Family Welfare, for promotion of health and family
welfare programmers in the country through education, training,
research, evaluation, consultancy and specialized services.


The NIHFW was established on March 9, 1977 by a merger of the
National Institute of Health Administration and Education (NIHAE)
with the National Institute of Family Planning (NIFP)


13
List of Governing Body Members of NIHFW

        • 18 members



                            1 Chairman
                             (ex-officio)


           1 Vice                           1 Member
         Chairman            NIHFW           Secretary
         (ex-officio)                       (ex-officio)


             9 Member
                                        6 Member
             (ex-officio)




14
ACTIVITIES AND RESPONSIBILITIES

     Measuring weight of children to assess the nutritional
     status.
     Assessment of diseases like level of anemia.
     Testing of food material like cooking salt for level iodine.
     To release fund on the advice of the Ministry.
     It is responsible for all governmental programs relating to
     family planning in India.




15
Structure and organization
     ICMR
                           Union Health Minister


                              Governing body


                            Scientific Advisory
                                  Board

     Scientific advisory                           Expert groups
          groups



     Scientific advisory                            Steering
         committee                                 Committee



16                             Task forces
ACTIVITIES AND RESPONSIBILITIES

     Extramural research is promoted by ICMR by establishing
     Centers for Advanced Research in different research areas.
     Open-ended research is conducted on the basis of applications
     for grants-in-aid received from scientists in non-ICMR Research
     Institutes, Medical colleges and Universities located in different
     parts of the country.
     Balancing of research efforts between different competing
     fields, especially when resources are severely limited, is a typical
     problem encountered in the management of medical research,
     particularly in developing countries

17
IPA
The Indian Pharmaceutical Association (IPA) has demanded to
amend the Drugs &Cosmetics Act and Rules 1945 to make only the
pharmacy graduates eligible to become expert staffs in the pharma
manufacturing units.
In the resolutions passed during the just concluded IPA
Convention, the IPA also urged the government to expedite action to
amend the Rules in such way that all regulatory positions in the
country must be an exclusive area for experienced and qualified
pharmacists.
Indian Pharmaceutical Association (IPA) is the premier professional
association of pharmacists in India.
The association has more than 10,000 members from various
parts of the country and it operates in India through 17 state
branches & more than 33 local branches.
The association represents various facts of pharmaceutical
profession and in managing several academic programmes.

18
DTAB

     DRUG TECHNICAL ADVISORY BOARD
     The Central Government constitute a Board (to be called the
     Drugs   Technical   Advisory   Board)     to   advise      the   Central
     Government and the State Governments on technical matters
     arising out of the administration of D&C, Act 1940
     The Board shall consist of the following members,
                          – 20 Members

                               10 ex-officio
                                Members

                     5
                                                    5 Elected
                 Nominated       DTAB               Members
                  Members
19
ACTIVITIES AND RESPONSIBILITIES

     It advices matter related to Drugs.
     The nominated and elected members of the Board shall hold
     office for three years, but shall be eligible for re-nomination and
     re-election.
     The Board may, subject to the previous approval of the Central
     Government, regulating its own procedure.




20
CDTL


     CENTRAL DRUG TESTING LABORATORY

     The central drug laboratory, Kolkata is national statutory
     laboratory of the government of India for quality control of drug
     and cosmetic and established under the D&C act ,1940.
     Oldest    quality   control   laboratory   of   the   drug   control
     authorities in India.
     Function under the director general of Health Services in the
     Ministry of Health and Family Welfare.




21
FUNCTIONS UNDER TAKEN

► Statutory Function :

To Act as an Appellate authority.
To function as Government Analyst for such states who do not have
their own testing facilities.
Analytical quality control of majority of the imported drugs.
Analytical quality control of drug formulations manufactured
within the country on behalf of the Central & State Drug standard
control organization

►Other Functions:

Procurement, establishment, maintenance, Storage and distribution
of I.P & International Reference standards.
Preparation and standardization of I.P. reference standards against
USP, BP primary standards.
To undertake analytical research in standardization and
methodology development of drug.
22
IPC
           Indian Pharmacopoeia Commission


                         General body
                         (19 Members)



             CIPL lab        IPC         Governing body
                                         (10members)


                  IPC              Scientific body
               secretariat         23 experts




23
ACTIVITIES AND RESPONSIBILITIES

     Development of comprehensive monographs.
     Accord priority to monographs of drugs included in the
     national Essential Drug List and their dosage forms.
     Preparation of monograph for products that have normally
     been in the market for not less than 2 years.
     Collaborate with pharmacopoeias like the BP, USP, JP and
     International Pharmacopoeia with a view to harmonizing with
     global standards.




24
NPPA
       National Pharmaceutical Pricing Authority
• For the purpose of implementing provisions of DPCO, powers of
the Government have been vested in the National Pharmaceutical
Pricing Authority (NPPA).
• Drugs have been declared as essential and accordingly put under
the Essential Commodities Act.
• Only 74 out of 500 commonly used bulk drugs are kept under
statutory price control.
• However, the prices of other drugs can be regulated, if warranted
in public interest.
• The NPPA was established on 29th August 1997 as an
independent body of experts following the Cabinet Committee’s
decision in September 1994 while reviewing the Drug Policy.
25
NPPA


     The Authority, inter alia, has been entrusted with the task of

     fixation/revision of prices of pharmaceutical products (bulk

     drugs and formulations),

     enforcement of provisions of the Drugs (Prices Control) Order

     monitoring the prices of controlled and decontrolled drugs in

     the country.




26
Features

     Ceiling and Non Ceiling Prices of drugs and medicines in the

     controlled category regulated .

     Ceiling Price is the single maximum selling price fixed that is

     applicable throughout the country in the case of each bulk drug,

     which is under price control.

     Non-Ceiling Price fixed by NPPA are specific to a particular

     pack size of scheduled formulation of a particular company.



27
GMP

            Good Manufacturing Pratices


     GMP guidelines are not prescriptive instructions on how to
     manufacture products.
     They are a series of general principles that must be observed
     during manufacturing.
     When a company is setting up its quality program and
     manufacturing process, there may be many ways it can fulfill
     GMP requirements.
     It is the company's responsibility to determine the most effective
     and efficient quality process.
28
REQUIREMENTS



 To ensure that their products are safe, pure, and effective.
To minimize or eliminate contamination, mix up and errors.
Issues including recordkeeping, personnel
qualifications, sanitation, cleanliness, equipment verification, process
validation, and complaint Handling.
GMP is also sometimes referred to as "cGMP”.
Failure of firms to comply with GMP regulations can result in very
serious consequences including recall, fines, and even
imprisonment.



29
WHO GUIDELINES (World Health Organization):

Who is an agency of United Nations. It is a specialised agency and its
primary responsibility includes international health matters so that
the goal, health for all, can be achieved.
The WHO GMP and the certification scheme was accepted by WHA
(world health assembly) in solution no WHA 28.65, as the revised
version in 1975.
With    appearance       of   ISO   (International Organization   For
Standardization) the WHO GMP needed next revision. The revised text
contains 3 parts.

Part I: out lines the general concepts of quality assurance and salient
components of GMP’s.
Part II: outlines on actions to be taken by production & quality control
personnel separately for implementing general principles of quality
assurance.
Part III: supporting and supplementary guidelines.


30
The revised text of GMP appears as annex.

 ANNEX I: Quality Management in the Drug Industry
 – Philosophy & Essential Elements

                  Quality Assurance
                  Good Manufacturing Practice
                  Quality Control
                  Sanitation & Hygiene
                  Validation
                  Complaints
                  Product recalls
                  Contract Production & Analysis
                  Self inspection and quality audits
                  Personnel
                  Premises
                  Material
                  Documentation

31
ANNEX II:
 Good Practices – Production & Quality Control

               Good Practices in Production
               Good Practices in Quality Control

 ANNEX III:
 Supporting and Supplementary Guidelines

           Sterile pharmaceutical Products
           Good Manufacturing Practice for Active
           Pharmaceutical Ingredients




32
WHO GMP Certification
      Originally established in 1969 and revised in 1975.
Main objectives were :

           To inspect drug manufacturing facilities
           To assess compliance of GMP

This would facilitate implementation of the scheme.

WHO GMP ensures the following:

              Avoidance of Cross- Contamination
              Prevention of Mix-ups
              Provide Traceability
              Accountability of actions
              Responsibility
              Product Performance Guarantee


33
FDA

 DEFINITION
        The U.S. Food and drug administration is an agency of the
 United States Department of Health and Human services and is
 responsible for the safety regulation of most type of foods

                  dietary supplements
                  Drug
                  Vaccines
                  Biological medical products
                  blood products
                  medical devices
                  radiation – emitting devices
                  veterinary products and
                  Cosmetics

 The agency of the U.S. Department of Health and Human Services.
 Established in 1927.
34
How does ICH work?

ICH    operates    through    the   ICH    Steering   Committee     with
administrative     support    from   the   ICH   Secretariat   and   ICH
Coordinators.
The Steering Committee meets at least twice a year . During these
meetings, new topics will be considered for adoption, reports are
received on the progress of existing topics, and maintenance and
implementation of the guidelines are discussed.
The topics identified for harmonization by the Steering Committee
are selected from Safety, Quality, Efficacy, and Multidisciplinary
matters.



35
Your Responsibilities Under The Law
1. Before searching any person, explain him that he has a right to be
  searched before a gazetted officer or a magistrate. If he so
  requires, take him to a gazetted officer or a magistrate before whom
  he can be searched. (Section 50.) without giving him a chance to
  part with the drug, controlled substance, etc. you can search him
  under Section 100 of the Cr. P. C. (Section 50(5) and 50 (6)).
2. Take down any information given by any person in writing before
  authorizing a search (Section 41). If the search is under Section
  42, also send a copy of the information taken in writing or the
  grounds of belief for search within 72 hours to your immediate
  superior officer.
3. Inform the arrested person, as soon as may be, the grounds of his
 36
  arrest (Section 52 (1)).
4. If a person is arrested or an article has been seized under a
     warrant issued by a magistrate, forward the person/seized article
     to that magistrate (Section 52 (2)).
5. If the person has been arrested or the article has been seized
     otherwise than under a warrant , forward it to the nearest police
     station or any other officer empowered under section 53 (Section
     52 (3)).
6. If the person has been arrested or the article has been seized
     otherwise than under a warrant , forward it to the nearest police
     station or any other officer empowered under section 53 (Section
     52 (3)).
7. Whenever      you arrest any person, make a full report to your

37
     superior within 48 hours ( Section 57)
IMMUNITIES IN DRUG CASES
1. Officers Officers acting in discharge of their duties in good faith
   under the Act are immune from suits, prosecution and other
   legal proceedings ( Section 69).
2. Addicts Addicts charged with consumption of drugs (section 27)
   or with offences involving small quantities will be immune from
   prosecution if they volunteer for de addiction. This immunity
   may be withdrawn if the addict does not undergo complete
   treatment (Section 64 A ).
3. Offenders Central or state governments can tender immunity to
   an offender in order to obtain his evidence in the case. This
   immunity is granted by the government and not by the court
   (Section 64).
4. Minors All offences committed under any law by persons under
   the age of 18 will be covered by the Juvenile Persons (Care and
   protection) Act. This Act seeks to reform such juveniles rather
   than punish them under the respective Acts. It prevails over any
   other Act in respect of persons below the age of 18.

38
References


1. DRUG REGULATORY AFFAIRS by sachin itkar, Dr.S.wyavahare
2. www.fda.gov/cder/guidance/index.htm
3. www.fda.gov/cber/cberftp.html.




39
40
41
End of 2nd semester


     Thank you all for your cooperation and
     appreciation. All the best for the exams &
     your future


                           Ur’s
                    K. Sampath Kumar


42

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Regulatory aspects

  • 1. Regulatory aspects of Pharmaceuticals and Bulk drug Manufacturing, Regulation of drugs and pharmaceuticals. Under the guidance of Sri B. Thangabalan Sir, M. Pharm (Ph.D) By K. Sampath Kumar, Y11MPH18060, I/II M.Pharm, 2nd Semester, Pharmaceutical Analysis, Sims college of Pharmacy. 1
  • 2. Introduction: Drugs play an important role in the health of both people and the economy of a country. Pharmaceutical drugs are available from a large number of sources. People and Governments willing to spend money on drugs for many reasons so, it must be safe, effective and good quality and used appropriately. This means, in turn, that development, production, importation, exportation and subsequent distribution of drugs must be regulated to ensure that they meet prescribed standards. Therefore, effective drug regulation is required to ensure the safety, efficacy and quality of drugs as well as accuracy and appropriateness of the drug information available to the public 2
  • 3. Regulatory requirements ►In an ideal world, the need for analysis should be driven by the desire to assure the quality of a drug product. ►However, in the real world the need for pharmaceutical drug analysis is driven largely by regulatory requirements. ►A team consisting of R&D, QC, and QA unit members develops these quality and compliance systems. ►It should be one of the highest priorities of top management and QA units to develop and monitor these systems to comply with the cGMP and GLP expectations. ►Compliance documents are needed, in addition to the regulatory and research documents, to demonstrate the integrity of the data. ►Compliance documents refer to those reports required by GMP and/or utilized during the course of inspection by a health 3 authority.
  • 4. Key function of regulatory agencies Product registration (drug evaluation and authorization, and monitoring of drug efficacy and safety); Regulation of drug manufacturing, importation, and distribution; Regulation & Control of drug promotion and information. Adverse drug reaction (ADR) monitoring. Licensing of premises, persons and practices. Goal of regulatory agency Main goal of drug regulation is to guarantee the safety, efficacy and quality of drugs available to public. 4
  • 5. The drug regulation Drug Laws Drug Regulatory Agencies Drug Regulatory Boards Quality Control Drug Information Centres etc. 5
  • 6. Drug regulatory system in India Drugs and Health is in concurrent list of Indian Constitution It is governed by both Centre and State Governments under the Drugs & Cosmetics Act, 1940. MAIN BODIES Central Drug Standard Control Organization (CDSCO) Ministry Of Health & Family Welfare (MHFW) Indian Council Of Medical Research (ICMR) Indian Pharmaceutical Association (IPA) Drug Technical Advisory Board (DTAB) Central Drug Testing Laboratory (CDTL) Indian Pharmacopoeia Commission (IPC) National Pharmaceutical Pricing Authority (NPPA) 6
  • 7. WELL DEFINED DRUG REGULATORY SYSTEM(Govt. of India) Ministry of health and family welfare DTAB DCGI  Enforcement & GMP audit Division  Quality Control Division – CDTL  Registration Division  New Drug Division  Pharmacovigilance 7  Trainings
  • 8. Approval of Investigational New Drug (IND) IND Applicant Approval CDSCO Recommendation to DCG (I) Examination Detailed review by new drug by IND division committee 8
  • 9. Central licensing Joint inspection State licensing Manufacturer by state and authority central inspectors CLAA approval License prepared Examination of and grant of by state licensing license report authority 9
  • 10. CDSCO Central Drug Standard Control Organization Head quarters New Delhi North Zone Ghaziabad West Zone Mumbai South Zone Chennai East Zone Kolkata. Other zonal offices Ahmedabad and Hyderabad. Sub-Zonal Office 2 Port offices/Airports 7 Laboratories 6 10
  • 11. CDSCO Drug Controller General (I) Head Zonal & sub Port Laboratory Quarter Zonal office Office New Drugs GMP Audits Import CLAA Testing of drug Coordinates Export samples Imports DTAB/DCC with states Validation of Test Protocol 11
  • 12. Functions undertaken by Central Government Statutory function: Laying down standards of drugs, cosmetics, diagnostics and devices. Laying down regulatory measures, amendments to Acts and rules. To regulate market authorization of new drugs. To regulate clinical research in India To approve licenses to manufacture certain categories of drugs as Central License Approving Authority(CLAA) i.e. for Blood Banks, Large Volume Parenterals and Vaccines & Sera. To regulate the standards of imported drugs. Work relating to the Drugs Technical Advisory Board ( DTAB ) and Drugs Consultative Committee (DCC). Testing of drugs by Central Drugs Labs. 12
  • 13. NIHFW National Institute of Health and Family Welfare NIHFW is an Apex Technical Institute, funded by Ministry of Health and Family Welfare, for promotion of health and family welfare programmers in the country through education, training, research, evaluation, consultancy and specialized services. The NIHFW was established on March 9, 1977 by a merger of the National Institute of Health Administration and Education (NIHAE) with the National Institute of Family Planning (NIFP) 13
  • 14. List of Governing Body Members of NIHFW • 18 members 1 Chairman (ex-officio) 1 Vice 1 Member Chairman NIHFW Secretary (ex-officio) (ex-officio) 9 Member 6 Member (ex-officio) 14
  • 15. ACTIVITIES AND RESPONSIBILITIES Measuring weight of children to assess the nutritional status. Assessment of diseases like level of anemia. Testing of food material like cooking salt for level iodine. To release fund on the advice of the Ministry. It is responsible for all governmental programs relating to family planning in India. 15
  • 16. Structure and organization ICMR Union Health Minister Governing body Scientific Advisory Board Scientific advisory Expert groups groups Scientific advisory Steering committee Committee 16 Task forces
  • 17. ACTIVITIES AND RESPONSIBILITIES Extramural research is promoted by ICMR by establishing Centers for Advanced Research in different research areas. Open-ended research is conducted on the basis of applications for grants-in-aid received from scientists in non-ICMR Research Institutes, Medical colleges and Universities located in different parts of the country. Balancing of research efforts between different competing fields, especially when resources are severely limited, is a typical problem encountered in the management of medical research, particularly in developing countries 17
  • 18. IPA The Indian Pharmaceutical Association (IPA) has demanded to amend the Drugs &Cosmetics Act and Rules 1945 to make only the pharmacy graduates eligible to become expert staffs in the pharma manufacturing units. In the resolutions passed during the just concluded IPA Convention, the IPA also urged the government to expedite action to amend the Rules in such way that all regulatory positions in the country must be an exclusive area for experienced and qualified pharmacists. Indian Pharmaceutical Association (IPA) is the premier professional association of pharmacists in India. The association has more than 10,000 members from various parts of the country and it operates in India through 17 state branches & more than 33 local branches. The association represents various facts of pharmaceutical profession and in managing several academic programmes. 18
  • 19. DTAB DRUG TECHNICAL ADVISORY BOARD The Central Government constitute a Board (to be called the Drugs Technical Advisory Board) to advise the Central Government and the State Governments on technical matters arising out of the administration of D&C, Act 1940 The Board shall consist of the following members, – 20 Members 10 ex-officio Members 5 5 Elected Nominated DTAB Members Members 19
  • 20. ACTIVITIES AND RESPONSIBILITIES It advices matter related to Drugs. The nominated and elected members of the Board shall hold office for three years, but shall be eligible for re-nomination and re-election. The Board may, subject to the previous approval of the Central Government, regulating its own procedure. 20
  • 21. CDTL CENTRAL DRUG TESTING LABORATORY The central drug laboratory, Kolkata is national statutory laboratory of the government of India for quality control of drug and cosmetic and established under the D&C act ,1940. Oldest quality control laboratory of the drug control authorities in India. Function under the director general of Health Services in the Ministry of Health and Family Welfare. 21
  • 22. FUNCTIONS UNDER TAKEN ► Statutory Function : To Act as an Appellate authority. To function as Government Analyst for such states who do not have their own testing facilities. Analytical quality control of majority of the imported drugs. Analytical quality control of drug formulations manufactured within the country on behalf of the Central & State Drug standard control organization ►Other Functions: Procurement, establishment, maintenance, Storage and distribution of I.P & International Reference standards. Preparation and standardization of I.P. reference standards against USP, BP primary standards. To undertake analytical research in standardization and methodology development of drug. 22
  • 23. IPC Indian Pharmacopoeia Commission General body (19 Members) CIPL lab IPC Governing body (10members) IPC Scientific body secretariat 23 experts 23
  • 24. ACTIVITIES AND RESPONSIBILITIES Development of comprehensive monographs. Accord priority to monographs of drugs included in the national Essential Drug List and their dosage forms. Preparation of monograph for products that have normally been in the market for not less than 2 years. Collaborate with pharmacopoeias like the BP, USP, JP and International Pharmacopoeia with a view to harmonizing with global standards. 24
  • 25. NPPA National Pharmaceutical Pricing Authority • For the purpose of implementing provisions of DPCO, powers of the Government have been vested in the National Pharmaceutical Pricing Authority (NPPA). • Drugs have been declared as essential and accordingly put under the Essential Commodities Act. • Only 74 out of 500 commonly used bulk drugs are kept under statutory price control. • However, the prices of other drugs can be regulated, if warranted in public interest. • The NPPA was established on 29th August 1997 as an independent body of experts following the Cabinet Committee’s decision in September 1994 while reviewing the Drug Policy. 25
  • 26. NPPA The Authority, inter alia, has been entrusted with the task of fixation/revision of prices of pharmaceutical products (bulk drugs and formulations), enforcement of provisions of the Drugs (Prices Control) Order monitoring the prices of controlled and decontrolled drugs in the country. 26
  • 27. Features Ceiling and Non Ceiling Prices of drugs and medicines in the controlled category regulated . Ceiling Price is the single maximum selling price fixed that is applicable throughout the country in the case of each bulk drug, which is under price control. Non-Ceiling Price fixed by NPPA are specific to a particular pack size of scheduled formulation of a particular company. 27
  • 28. GMP Good Manufacturing Pratices GMP guidelines are not prescriptive instructions on how to manufacture products. They are a series of general principles that must be observed during manufacturing. When a company is setting up its quality program and manufacturing process, there may be many ways it can fulfill GMP requirements. It is the company's responsibility to determine the most effective and efficient quality process. 28
  • 29. REQUIREMENTS  To ensure that their products are safe, pure, and effective. To minimize or eliminate contamination, mix up and errors. Issues including recordkeeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint Handling. GMP is also sometimes referred to as "cGMP”. Failure of firms to comply with GMP regulations can result in very serious consequences including recall, fines, and even imprisonment. 29
  • 30. WHO GUIDELINES (World Health Organization): Who is an agency of United Nations. It is a specialised agency and its primary responsibility includes international health matters so that the goal, health for all, can be achieved. The WHO GMP and the certification scheme was accepted by WHA (world health assembly) in solution no WHA 28.65, as the revised version in 1975. With appearance of ISO (International Organization For Standardization) the WHO GMP needed next revision. The revised text contains 3 parts. Part I: out lines the general concepts of quality assurance and salient components of GMP’s. Part II: outlines on actions to be taken by production & quality control personnel separately for implementing general principles of quality assurance. Part III: supporting and supplementary guidelines. 30
  • 31. The revised text of GMP appears as annex. ANNEX I: Quality Management in the Drug Industry – Philosophy & Essential Elements Quality Assurance Good Manufacturing Practice Quality Control Sanitation & Hygiene Validation Complaints Product recalls Contract Production & Analysis Self inspection and quality audits Personnel Premises Material Documentation 31
  • 32. ANNEX II: Good Practices – Production & Quality Control Good Practices in Production Good Practices in Quality Control ANNEX III: Supporting and Supplementary Guidelines Sterile pharmaceutical Products Good Manufacturing Practice for Active Pharmaceutical Ingredients 32
  • 33. WHO GMP Certification Originally established in 1969 and revised in 1975. Main objectives were :  To inspect drug manufacturing facilities  To assess compliance of GMP This would facilitate implementation of the scheme. WHO GMP ensures the following: Avoidance of Cross- Contamination Prevention of Mix-ups Provide Traceability Accountability of actions Responsibility Product Performance Guarantee 33
  • 34. FDA DEFINITION The U.S. Food and drug administration is an agency of the United States Department of Health and Human services and is responsible for the safety regulation of most type of foods dietary supplements Drug Vaccines Biological medical products blood products medical devices radiation – emitting devices veterinary products and Cosmetics The agency of the U.S. Department of Health and Human Services. Established in 1927. 34
  • 35. How does ICH work? ICH operates through the ICH Steering Committee with administrative support from the ICH Secretariat and ICH Coordinators. The Steering Committee meets at least twice a year . During these meetings, new topics will be considered for adoption, reports are received on the progress of existing topics, and maintenance and implementation of the guidelines are discussed. The topics identified for harmonization by the Steering Committee are selected from Safety, Quality, Efficacy, and Multidisciplinary matters. 35
  • 36. Your Responsibilities Under The Law 1. Before searching any person, explain him that he has a right to be searched before a gazetted officer or a magistrate. If he so requires, take him to a gazetted officer or a magistrate before whom he can be searched. (Section 50.) without giving him a chance to part with the drug, controlled substance, etc. you can search him under Section 100 of the Cr. P. C. (Section 50(5) and 50 (6)). 2. Take down any information given by any person in writing before authorizing a search (Section 41). If the search is under Section 42, also send a copy of the information taken in writing or the grounds of belief for search within 72 hours to your immediate superior officer. 3. Inform the arrested person, as soon as may be, the grounds of his 36 arrest (Section 52 (1)).
  • 37. 4. If a person is arrested or an article has been seized under a warrant issued by a magistrate, forward the person/seized article to that magistrate (Section 52 (2)). 5. If the person has been arrested or the article has been seized otherwise than under a warrant , forward it to the nearest police station or any other officer empowered under section 53 (Section 52 (3)). 6. If the person has been arrested or the article has been seized otherwise than under a warrant , forward it to the nearest police station or any other officer empowered under section 53 (Section 52 (3)). 7. Whenever you arrest any person, make a full report to your 37 superior within 48 hours ( Section 57)
  • 38. IMMUNITIES IN DRUG CASES 1. Officers Officers acting in discharge of their duties in good faith under the Act are immune from suits, prosecution and other legal proceedings ( Section 69). 2. Addicts Addicts charged with consumption of drugs (section 27) or with offences involving small quantities will be immune from prosecution if they volunteer for de addiction. This immunity may be withdrawn if the addict does not undergo complete treatment (Section 64 A ). 3. Offenders Central or state governments can tender immunity to an offender in order to obtain his evidence in the case. This immunity is granted by the government and not by the court (Section 64). 4. Minors All offences committed under any law by persons under the age of 18 will be covered by the Juvenile Persons (Care and protection) Act. This Act seeks to reform such juveniles rather than punish them under the respective Acts. It prevails over any other Act in respect of persons below the age of 18. 38
  • 39. References 1. DRUG REGULATORY AFFAIRS by sachin itkar, Dr.S.wyavahare 2. www.fda.gov/cder/guidance/index.htm 3. www.fda.gov/cber/cberftp.html. 39
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  • 42. End of 2nd semester Thank you all for your cooperation and appreciation. All the best for the exams & your future Ur’s K. Sampath Kumar 42