Download - Regulatory aspects
Regulatory aspects of Pharmaceuticals and Bulk drug Manufacturing, Regulation of drugs and
pharmaceuticals.
By K. Sampath Kumar,
Y11MPH18060,I/II M.Pharm,
2nd Semester,Pharmaceutical Analysis,
Sims college of Pharmacy.
Under the guidance of
Sri B. Thangabalan Sir, M. Pharm
(Ph.D)
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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
Introduction:
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►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
authority.
Regulatory requirements
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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.
Key function of regulatory agencies
Goal of regulatory agency
Main goal of drug regulation is to guarantee the safety, efficacy
and quality of drugs available to public.
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Drug Laws
Drug Regulatory Agencies
Drug Regulatory Boards
Quality Control
Drug Information Centres etc.
The drug regulation
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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
Enforcement & GMP audit Division
Quality Control Division – CDTL
Registration Division
New Drug Division
Pharmacovigilance
Trainings
DCGIDTAB
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Approval of Investigational New Drug (IND)
IND Applicant
CDSCO
Examination
by new drug
division
Recommendation
to DCG (I)
Approval
Detailed review
by IND
committee
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ManufacturerState licensing
authority
Joint inspection
by state and
central inspectors
Examination of
report
License prepared
by state licensing
authority
CLAA approval
and grant of
license
Central licensing
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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
CDSCO
Central Drug Standard Control Organization
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CDSCO Drug Controller General (I)
Head
QuarterZonal & sub
Zonal office
Port
OfficeLaboratory
New Drugs
CLAA
Imports
DTAB/DCC
GMP Audits
Coordinates
with states
Import
ExportTesting of drug
samples
Validation of
Test Protocol
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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.
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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)
NIHFW
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• 18 members
List of Governing Body Members of NIHFW
NIHFW
1 Chairman
(ex-officio)
1 Vice
Chairman
(ex-officio)
1 Member
Secretary
(ex-officio)
9 Member
(ex-officio)6 Member
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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.
ACTIVITIES AND RESPONSIBILITIES
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Structure and organization
Union Health Minister
Governing body
Scientific Advisory
Board
Task forces
Scientific advisory
groups
Scientific advisory
committee
Expert groups
Steering
Committee
ICMR
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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
ACTIVITIES AND RESPONSIBILITIES
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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.
IPA
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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
DTAB
DTAB5
Nominated
Members
5 Elected
Members
10 ex-officio
Members
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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.
ACTIVITIES AND RESPONSIBILITIES
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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.
CDTL
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► 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.
FUNCTIONS UNDER TAKEN
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Indian Pharmacopoeia Commission
IPC
General body
(19 Members)
CIPL lab Governing body
(10members)
IPC
secretariat
Scientific body
23 experts
IPC
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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.
ACTIVITIES AND RESPONSIBILITIES
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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.
NPPA
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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.
NPPA
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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.
Features
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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.
GMP
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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.
REQUIREMENTS
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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.
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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
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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
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WHO GMP CertificationOriginally 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
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DEFINITIONThe 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.
FDA
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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.
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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
arrest (Section 52 (1)).
Your Responsibilities Under The Law
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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
superior within 48 hours ( Section 57)37
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.
IMMUNITIES IN DRUG CASES
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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.
References
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