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By:
Dr.Lavanya.S.A
3rd Year PG Scholar
Under the guidance of:
Dr.M.S.Doddamani
Professor
Dept of RS & BK
TGAMC, Bellary
Dr.Shankara Gowda
Professor & HOD
Dept of RS & BK
TGAMC, Bellary
What is Law?
• Law is a system of rules and guidelines which are
enforced through social institutions to govern behaviour.
• Health is in concurrent list of Indian constitution and it is
governed by both central and state government.
• Legal enactments to regulate.
Objective
• The overall objective of a Drug Regulatory Authority (DRA) is to
ensure that medicinal products are of acceptable quality, safety
and efficacy, are manufactured and distributed in ways which
ensure their quality until they reach the patient/consumer, and
their commercial promotion is accurate.
Laws governing Ayurvedic Drugs are:
• Drug & Cosmetic Act-1940 & Rule -1945.
• Drug & Magic Remedies Act 1954.
• Prevention of Food Adulteration Act.
• Food standard and Safety Act -2006.
• Laws Pertaining to Narcotics.
• Factory & Pharmacy Act .
• Consumer protection Act 1986.
• Knowledge of GCP & Inspection manual prescribed by Dept. of
AYUSH, Govt. of India.
DRUG & COSMETIC RULES 1945
168 rules has been divided into parts from I – XIX
As per the different subjects pertaining to, Schedule
(organized plan for matters to be attended to, in this case it is
168 rules) with Annexure/Appendix (Something added at the
end, esp. an appendix or supplementary document for schedule)
from A to Y is mentioned.
16th Part – Manufacture for sale of Ayurvedic
Drugs
• 151 – Manufacture on more than one set of premises.
• 152 – Licensing Authorities.
• 153 – Application for license to manufacture Ayurvedic Drugs.
• 153 A – Loan license.
• 154 – Form of license to manufacture.
• 154 A – form of loan license to manufacture for sale of Ayurvedic
drugs.
• 155 – Certificate of Renewal.
• 155 A – Certificate of renewal of a loan license.
• 155 B – Certificate of award of GMP of Ayurvedic drugs.
• 156 – Duration of License.
• 156 A – Duration of Loan license.
• 157 – Conditions for the grant of renewal of a license in form 25-D.
• 158 – Conditions of license.
• 158 A – Condition of Loan License
• 159 – Cancellation and Suspension of Licenses.
• 160 – Identification of Raw materials.
16th Part A – Approval of Institutions for carrying
out tests on
• 160 A – Application for grant of approval for testing
Ayurvedic Drugs.
• 160 B – Form in which approval to be granted for
carrying out test on Ayurvedic Drugs on behalf of
licensees for manufacture of Ayurvedic drugs and
conditions for grant or renewal of such approval.
• 160 C – Duration of Approval.
• 160 D – Conditions of Approval .
• 160 E – Inspection before grant of approval.
• 160 F – Report of Inspection.
• 160 G – Procedure of approving Authority.
• 160 H – Application after Rejection.
• 160 I – Renewal.
• 160 J – Withdrawal and suspension of approvals.
17th Part – Labelling, packing and limit of Alcohol
in Ayurvedic Drugs
• 161 – Labelling, packing and limit of Alcohol.
• 161 A – Exemption in labelling and packing,
provisions for export of Ayurvedic drugs.
18th Part – Government Analysts and Inspectors
for Ayurvedic Drugs
• 162 – Duties of Inspectors specially authorised to inspect the
manufacture of Ayurvedic drugs.
• 162 A – Qualifications of the State Drug Licensing Authority
for Licensing of Ayurveda Drugs.
• 163 – Procedure for dispatch of sample to Govt Analyst and its
receipt by the Govt Analyst.
• 164 – Method of test or analysis to be employed in relation to
• 165 – Qualifications of Government Analyst.
• 166 – Duties of Government Analyst.
• 167 – Qualification of Inspector.
19th Part – Standards of Ayurvedic Drugs.
• 168 – Standards to be compiled within manufacture for sale or for
distribution of Ayurvedic drugs.
SCHEDULE - A:
• Form 1 – Memorandum to the Central drug Laboratory.
• Form 2- Certificate for test by the CDL.
• Form 3-7 & 8 – Application for license to import drugs
• Form 8 A - Application for license to import drugs specified in Schedule X .
• Form 9 – Form of undertaking to accompany an application for an import
license.
• Form 10 – License to import drugs excluding those specified in Schedule X.
• Form 11 – License to import drugs for the purposes of examination, test or
analysis.
• Form 11 A – License to import drugs by a Govt Hospital or Autonomous Medical
Institute for the treatment of Patients.
• Form 12 A – Application for the issue of a permit to import small quantities of
drugs for personal use.
• Form 13 A – Certificates of tests or analyst by Govt Analyst under Section 33H of
the D & C Act, 1940.
• Form 47 – Categories of Ayurvedic, Siddha & Unani drugs other than those
specified in the first Schedule of this Act for which testing will be carried out.
SCHEDULE E(1) [Rule 161 (2)]: List of Poisonous
drugs under Ayurvedic medicines.
Drugs of Vegetable origin Animal origin Mineral origin
Ahiphena Jayapala
Sarpa Visha
or
Snake poison
Gauripashana
Arka Karaveera Haratala
Bhallataka Langali Manahshila
Bhanga Parasika Yavani Parada
Danti Snuhi Rasa Karpura
Dhattura Vatsanabha Tuttha & Hingula
Gunja Vishamushti & Shringi
Visha
Girisindura &
Nagasindura
SCHEDULE - T (Rule 157): GMP for Ayurvedic Drugs
The GMP is prescribed as follows in Part 1 & part 2 to ensure that:
• Raw materials used in the manufacture of drugs are authentic, of
prescribed quality and are free from contamination.
• The manufacturing process is as been prescribed to maintain the
standards.
• Adequate quality control measures are adopted.
• The manufactured drug which is released for sla eis of acceptable
quality.
SCHEDULE – U :Rule 74, 74A, 74B, 78, 78A
• Particulars to be in records of Manufacturing, Raw
material, Analysis of Drugs.
SCHEDULE – V: Rule 124 B
• Standards for patent or Proprietary medicines.
SCHEDULE – X: Rule 23, 61, 75, 97, 105A
• List of drugs with special rules for import,
manufacturing, sale, packaging and label.
RECENT AMENDMENTS:
Notification:
The draft notification of the department of Ayush
on the use of permitted excipients i.e additives,
preservatives etc was published in Gazette of India
Extraordinary dated 9th July, 2008 for inviting
suggestions from stakeholders.
Gazette notification issued under the D&C Rule 1945
1. 755(E)- 23-10-2008
Considering the growing demand for ASU drugs, on
the recommendation of Ayurvedic, Siddha and Unani Drug
Technical Advisory Board, the amendment to Rule 169 for
permitting excipients, preservatives, antioxidants,
flavouring agents etc in ASU medicines was carried out.
The final notification has been issued in this regard
on 23rd October, 2008.
2. 893 (E) -24-12-2008
Rule 170 has been amended regarding issuance of
guidelines for evaluation of ASU Drugs and other traditional
medicines of India.
The purpose of issue of these guidelines is to
develop methodologies for record and valuation, improve
quality, valuable research for providing appropriate
evaluation methods to facilitate the development of
regulation and registration.
Conclusion: Standardization & Quality control of
ISM & H Drugs:
• Laying down the pharmacopoeial standards for ASU
medicine both for single and compound drugs is an
essential item of work.
• 4 different pharmacopoeia committees are working for
preparing official formularies to evolve uniform
standards in preparation of drugs of ASU & H and to
prescribe working standards for single and compound
formulations.
• Pharmacopoeial Laboratory for Indian Medicine (PLIM):
Established in the year 1970 as standard setting cum drug
testing Laboratory for Indian Medicine at the National Level. The
worked out standards, in the form of monographs are published
by the Ministry of Health & Family Welfare for ASU
Pharmacopoeia of India.
• Drug Control Cell (ISM):
Notification for recognition of Private Drug Testing Lab for
ASU Drugs.
• Workshops on GMP:
GMP Workshops have been organised for sensitizing
state ISM & H Drug Licensing Authorities, Drug Inspector and
ISM manufacturers in 6 different place & Rs.25,000 for each
workshop is given.
• Report on TKDL.
• Indian Medicines Pharmaceutical Corporation Limited:
The objective of the company is to manufacture the
classical quality Ayurvedic & Unani drugs for use in Central Govt
Hospitals.
Poisonous substances: [Schedule –E1]
Revised August 2010
Amendments:
• The seeds of two herbal sources ( Ahiphena and bhanga) have not been
considered as poisonous.
• Snuhi has been omitted from the list.
• Two minerals i.e: sindura & Girisindura have been omitted from the list.
• Only the seeds of Gunja and Jayapala are considered as poisonous.
• Vatsanabha and Shringi have been grouped under one.
• Chemical composition of Haratala & Manahshila are specified clearly.
• Botanical identity of Parasika yavani has been changed from Hyocyamus
inibar linn to hyocyamus niger linn.
DRUG & MAGIC REMEDIES ACT 1954:
• Drug & Magic remedies ( Objectionable Advertisements ) Act,
1954.
• It is an Act to control the advertisement of drugs in certain
cases and to prohibit the advertisement for certain purposes
of remedies alleged to possess magic qualities. The Act
extends to the whole of India except, State of Jammu and
Kashmir. It was notified on 30th April, 1954 and amended in
1963.
• Advertisements means:
- Circular
- Label
-Wrapper
- Other document
-Announcement – oral or by light sound or smoke
Advertisements Prohibited:
• Leading to the use of a drug for :
- Miscarriage.
- Prevention of conception in Women.
- Maintenance/ Improvement of Sexual Pleasure.
- Correction menstrual disorders
• Diseases and ailments which a drug may not purport
to prevent or cure or make claims to prevent or cure:
Appendicitis Arteriosclerosis Blindness
Blood poisoning Bright’s disease Cancer
Cataract Deafness Diabetes
Disorders of brain Nervous debility Disorders of theoptical
Disorders of uterus Disorders of
menstrual flow
Disorders of nervous
system
Disorders of Prostatic
gland
Dropsy Epilepsy
Sexual impotence Female diseases Fevers
Fits Obesity Impotency
Hydrocele Hysteria Infantile paralysis
Insanity Leprosy Leucoderma
Lockjaw Locomotor ataxia Lupus
NARCOTIC DRUGS & PSYCHOTROPIC
SUBSTANCES ACT
• The term narcotic originally referred medically to any
psychoactive compound with sleep-inducing
properties.
• Psychotropic Substances are Pharmaco-therapeutic
agent that possesses action to alter mood,
behaviour, cognitive processes, or mental stress.
The statutory control over narcotic drugs was
being exercised under The Opium Act, 1857, The
Opium Act, 1878 and The Dangerous Drugs Act,
1930. The provisions of these enactments were
found to be inadequate because of the passage of
time and developments in the field of illicit drug
traffic and drug abuse "at national and international
level. To consolidate and to amend the existing laws
relating to narcotic drugs a comprehensive legislation
was considered to be necessary.
Accordingly the Narcotic Drugs and Psychotropic
Substances Bill, 1985 was introduced in the Lok-Sabha on 23rd
August, 1985. It was passed by both the Houses of Parliament
and it was assented by the President on 16 September 1985. It
came into force PSYCHOTROPIC SUBSTANCES ACT, 1985
(shortened to NDPS Act). Under the NDPS Act, it is illegal for a
person to produce/manufacture/ cultivate, possess, sell, purchase,
transport, store, and/or consume any narcotic drug or
psychotropic substance
• The Act has been amended twice - in 1988 and 2001. The Act
extends to the whole of India The Act describes itself as "An
Act to consolidate and amend the law relating to narcotic
drugs, to make stringent provisions for the control and
regulation of operations relating to narcotic drugs and
psychotropic substances, to provide for the forfeiture of
property derived from, or used in, illicit traffic in narcotic
drugs and psychotropic substances, to implement the
provisions of the International Convention on Narcotic Drugs
and Psychotropic Substances and for matters connected
therewith."
Narcotic Drugs and Psychotropic Substances
Act, 1985 (NDPS Act ) .
This Act prohibits:
• - Cultivation of opium poppy, cannabis and coca plants
• -Production, manufacture, possession, sale, purchase,
transport, warehousing, use, consumption, import,
export or transshipment of any narcotic drug or
psychotropic substance.
• except for medical and scientific purposes and as per the
rules or orders and conditions of license issued.
• NDPS Act empowers central government to frame rules
for certain purposes and state governments to frame
rules for certain others. Thus, there are NDPS Rules, 1985
of the central government and state NDPS Rules of
different states. Violation of any rule of either the state
or central NDPS Rules attracts punishment under the
NDPS Act.
Prevention of Food Adulteration Act 1954:
• Food is an essential commodity required for the survival
of all living organisms. Such an important commodity has
to be properly protected by law in order to ensure its
availability to consumers in hygienic conditions.
• The prevention of adulteration in foods and their
products is the responsibility of the Govt and ethical duty
of the society.
• This Act is aimed at preventing import, manufacture,
sale or distribution of adulterated and misbranded
food and also to prevent all types of food
Adulterations. It is extended to whole of India. In
many states, it is Food and Drug Administration
looking after the implementation of the provisions of
this Act.
Permitted Antioxidants in Food:
Tocopherol, Ascorbic acid, lecithin.
• Permitted colours in food:
Chlorophyll, caramel, beta-caratene, annatto, coal-tar
dyes, saffron and curcumin. The colour content should be more
than 0.2mg per kg of food material.
• Preservatives permitted in Food:
Class I – Common salt, Sugar, Dextrose, Glucose, Syrup,
Vinegar, Honey and edible vegetable oil.
Class II – Benzoic acid and salts, Sulphorous acids and
salts, nitrates, methyl diacetate, potassium and calcium salts of
lactic acid. No nitrate or nitrite preservative to be added to
infant food.
Food standards and Safety Act - 2006
• Food "means any substance, whether processed, partially
processed or unprocessed, which is intended for human
consumption and includes primary food, Genetically
modified or engineered food or food containing such
ingredients, infant food, packaged drinking water,
alcoholic drink, chewing gum, and any substance,
including water used into the food during its
manufacture, preparation or treatment but does not
include any animal feed, live animals unless they are
prepared or processed for placing on the market for
human consumption, plants , prior to harvesting, drugs
and medicinal products , cosmetics, narcotic or
psychotropic substances. (acc to the Act)
• The legislation that dealt with food safety in India was the Prevention of Food
Adulteration Act, 1954 (hereinafter referred to as "PFA").
• The PFA had been in place for over five decades and there was a need for
change due to varied reasons which include the changing requirements of our
food industry.
• The Act also aims to establish a single reference point for all matters relating
to food safety and standards, by moving from multi- level, multi-
departmental control to a single line of command.
• To this effect, the Act establishes an independent statutory Authority – the
Food Safety and Standards Authority of India with head office at Delhi. Food
Safety and Standards Authority of India (FSSAI) and the State Food Safety
Authorities shall enforce various provisions of the Act.
• The Food Safety & Standards Act was enacted by Government of
India on 24th August, 2006
• For implementation/ enforcement , the Food Safety & Standards
Authority of India (FSSAI) was constituted on 5.09.2008.
Mandate :
• Laying down science based standards for articles of food and to
regulate their manufacture, storage, distribution, sale and import, to
ensure availability of safe and wholesome food for human
consumption and for matters connected therewith or incidental
thereto.
Duties & Functions of FSSAI:
• Framing rules, regulations, standards and guidelines in
relation to articles of food.
• Procedure and the enforcement of quality control on any
article of imported into India.
• Guidelines for accreditation of certification bodies
engaged in certification of Food safety management
system for food business.
• Guidelines for accreditation of laboratories and their
notification.
• Providing scientific advice and technical support to the
central Govt and state Govt in matters of framing the
policy and rule sin areas which have a direct or indirect
bearing of food safety and nutrition.
Salient features of the Act:
 Emphasis on gradual shift from regulatory regime to self
compliance through food safety management system.
 Enforcement of the Act by the (i) Central Licensing Authority,
(ii) State Licensing Authority in each state/ UT through the
State Food Safety Commissioners, Designated Officers &
Food Safety Officers for Licensing, inspection & sampling etc.
(iii) Registering Authority - Panchayati Raj/Municipal bodies
 No License for Petty/small food business operators - Only
registration is mandatory
 A single License for one or more articles of food and also
for different establishments/ premises in the same area
 Regulation of food imported in the country
 Harmonisation of domestic standards with international
food standards.
 Covering health foods, food supplements,
nutraceuticals.
 New justice dispensation system for fast track disposal
of cases of contravention and compensation in case of
injury or death of consumer.
 Graded penalty depending upon the gravity of offences
for selling food not of the nature/ substance or quality,
substandard food, misbranded food including misleading
advertisement
 Liability of food safety officers ( Section 39 of FSSA) where
vexatiously and without reasonable ground seizure of food
or adulterant is found with penalty up to Rs. One Lakh.
 A single reference point for all matters relating to food
safety & standards , by moving from multi-level, multi-
departmental control to a single line of command
FACTORY AND PHARMACY ACT
Factory Act:
 In India the first Factories Act was passed in 1881.
 This Act was basically designed to protect children and to
provide few measures for health and safety of the
workers.
 This law was applicable to only those factories, which
employed 100 or more workers. In 1891 another
factories Act was passed which extended to the factories
employing 50 or more workers.
CONTENTS
Chapter I – Preliminary Chapter VI –Working hours of
adults
Chapter II – The Inspecting
Staff
Chapter VII –Employment of
young persons
Chapter III – Health Chapter VIII -Annual leave
with wages
Chapter IV – Safety Chapter IX – Special
provisions.
Chapter IV A-Provisions
relating to hazardous
substances
Chapter X –Penalties and
procedure
Chapter V – Welfare Chapter XI - Supplemental
Object and Scope:
 This act extends to whole of India.
 The main object of this act is to ensure adequate safety
measures and to promote the health & welfare of
workers employed in factories.
 The act also make provisions regarding employment of
women & young person (including children &
adolescents), annual leave with wages etc.
Applicable:
 It covers all the manufacturing process and
establishments falling under the definition of
‘factory’ as defines under the sec. 2(m).
 Unless otherwise provide it is also applicable to
establishments of central/ state govt. (Sec. 116)
Administration:
The state govt. carry out administration of the act
through:
1. Inspecting Staff (sec. 8)
2. Certifying Surgeons (sec. 10)
3. Welfare Officers (sec. 49)
4. Safety Officers (sec. 40-B)
PHARMACY ACT:
 Act No 8 of 1948
 Enactment Date : 4th March, 1948
 ACT YEAR_NO: 194808
 The Act has been extended to Goa, Daman and Diu
by Regulation 11 of 1963, s. 3 and schedule.
 The whole of the Union territory of Lakshadweep by
Regulation 8 of 1965, s. 3 and Sch. (w.e.f. 1-10-1967)
and Dadra and Nagar Haveli by 'Regulation 6 of 1963.
 To the States of Maharashtra Gujarat, Mysore and
Rajasthan, the Act applies as adapted and modified by
S.O. 2814, dated 14-8-1964, Gazette of India,
Extraordinary, Pt. II, Sec. 3(ii), p. 717 (w.e.f. 1-9-1969)
comes into force in Pondicherry with modification by
Regulation 7 of 1963, s. 3
 It extends to the whole of India except the State of
Jammu and Kashmir.
 Contents are explained in 5 chapters.
CONTENT
 History of Pharmacy Act.
 Objectives
 Definitions
 The Pharmacy Council Of India and it’s functions-
 Design of the educational pattern
 Approval of Institutions/withdrawal of approvals
 Maintenance of Central Register of Pharmacists
 State Pharmacy Council and it’s functions
 Maintenance of registers
 Entry and removal of names
 Removal of name from registers
 Printing of Registers
 Inspection by State Council
 Offences and Penalties
Definitions-
 “Pharmacy Act” – An act to regulate the profession
of pharmacy.
 “Registered Pharmacist”- A person whose name is
for the time being entered in the register of the state
in which he or she is for the time being residing or
carrying on his profession or business of pharmacy
objective
 To regulate the pharmacy education in the country for the purpose of
registration as a pharmacist under the pharmacy act.
 To restore the Pharmacy profession in its due place in the health services.
 Raising the status of the profession of Pharmacy in India.
 To regulate the practice of Pharmacy in India.
 To provide uniform education and training through out India.
 To maintain control over persons entering the profession of pharmacy.
 To Protect the Public Health
– Medical Use of Drugs
– Drug Abuse
THE PHARMACY COUNCIL OF INDIA-
The first pharmacy council of India(P.C.I) constituted by
central government in 1949. It is reconstituted every 5
years.
A) Constitution office Bearers : It consists of three
different types of members-
1. Elected member
2. Nominated member
3. EX-Officio Member
OFFENCES PENALTIES
1. Falsely claiming to be a
registered pharmacist.
1.(a) Fine up to Rs. 500.00 on
first conviction.
(b) Fine up to Rs. 1000.00
and/or 6 months
imprisonment of any
subsequent conviction.
2. Dispensed by unregistered
persons.
Exception:
Medical practitioners.
2. 6 months imprisonment OR
Fine up to Rs. 1000.00 OR Both.
3.Failure to surrender certificate
of registration.
3. Fine up to Rs. 50.00
4.Obstructing State pharmacy
council Inspectors.
4. 6 months imprisonment OR
Fine up to Rs. 1000.00 OR Both.
CONSUMER PROTECTION ACT:
• Enacted by the Parliament in the year 1986
Objectives:
• To provide for better protection of interest of consumers.
• To make provisions for the establishment of Consumer
Councils and other authorities for the settlement of
consumer disputes.
• Consumer is one who
– Buys any goods for a consideration and includes a
hire-purchaser;
– Any user of such goods for consideration but
excludes one, who obtains for re-sale or for
commercial purposes;
– Hires a service for consideration and includes a
beneficiary of such service, if availed of with the
approval of the hirer.
CONTENTS:
• Chapter II – Preliminary
- Short title, extent, commencement & application.
- Definitions.
- Act not in derogation of any other law.
• Chapter II –Consumer protection councils
- The Central Consumer Protection Council.
- Procedure for meetings of the Central Council.
- Objects of The Central Council.
- The state Consumer Protection Councils.
- Objects of the state council
- The District Consumer Protection Council.
• Chapter III – Consumer disputes redressal agencies
- Establishment of consumer disputes redressal agencies.
- Composition of the District Forum
- Jurisdiction of the District forum
- Manner in which complaint shall be made
- Procedure on admission of complaint
- Finding of the District forum
- Appeal
- Composition of the state Commission
- Jurisdiction of the state commission
- Transfer of cases
- Circuit benches
• Procedure applicable to State Commissions
• Appeals
• Hearing of Appeal
• Composition of the National Commission
• Jurisdiction of the National Commission
• Power of and procedure applicable to the National Commission
• Power to set aside ex parte orders
• Transfer of cases
• Circuit Benches
• Vacancy in the Office of the President
• Appeal
• Finality of orders
• Limitation period
• Administrative Control
• Enforcement of orders of the District Forum, the State
Commission or the National Commission
• Dismissal of frivolous or vexatious complaints
• Penalties
• Appeal against order passed under section 27
• Chapter IV – Miscellaneous
- Protection of action taken in good faith.
- Service of notice etc.
- Power to remove difficulties.
- Vacancies or defects in appointment not to invalidate orders.
- Power to make rules.
- Power of the National Commission to make regulations.
- Rules and regulations to be laid before each house of
parliament.
GCP-Good Clinical Practice
• GCP compliance provides public assurance that the
rights, safety and well-being of human subjects
involved in research are protected .
• Good Clinical Practice is the compilation of accepted
ethical and scientific standards governing clinical
research that ensure the integrity of data obtained
and the protection of human research subjects.
Goals of GCP:
• To protect the rights, safety and welfare of humans
participating in research 􀁺
• To assure the quality, reliability and integrity of data
collected
• To provide standards and guidelines for the conduct
of clinical research
GCP Components:
• Food and Drug Administration (FDA) regulations and
guidance documents
• International Conference on Harmonization (ICH)
guidelines
• State and local laws
• Medical Standard of Care
• Medical Ethics
GCP guidelines for ASU Medicines:
• The Department of AYUSH has issued good clinical practice
(GCP) guideline in March 2013 for clinical trial in Ayurveda,
Siddha and Unani (ASU) medicines which will facilitate the
researcher and institutions in adopting a standard way of
good practice while conducting the ASU clinical trials.
• The GCP is a set of guidelines which encompasses the design,
conduct, termination, audit, analysis, reporting and
documentation of the studies involving human subjects.
• These guidelines are formulated based on CDSCO
Document on GCP Guidelines (2001) for Clinical Trials
on Pharmaceutical Products.
• The guidelines seek to establish two cardinal
principles: protection of the rights of human subjects
and authenticity of ASU medicine clinical trial data
generated.
Principles of GCP
• Confidentiality of records that could identify subjects
should be protected.
• Investigational products should be manufactured,
handled and stored in accordance with applicable GCP.
• Systems and procedures that ensure the quality of every
aspect of the trial should be implemented, which is
generally the responsibility of the sponsor.
Disclaimer:
This manual has been prepared on the basis of provisions in
the D & C Rules,1945 for inspectors and drug testing institutions aimed
at providing orientation and training about the procedure to be
followed for approving laboratories engaged in testing of ASU drugs.
The contributors and reviewers have taken due care to ensure
correctness of the contents before publication and cannot be held
responsible for any omission or inadvertent errors, nor can they
warrant that all aspects of the subject have been covered. The manual
is a guiding tool and does not have any connotation of legal binding.
• This Inspection manual covering various aspects about the
qualifications, duties and responsibilities of Inspectors will be a
much needed helpful guide for orientation of ASU Inspectors for
proper discharge of their duties under D&C Act and Rules
thereunder.
• The inspection manual of Drug testing laboratory is especially
explained in detail for development of insight of the Inspectors
regarding interpretation and implementation of the Rules.
• Role of State licensing Authority in facilitating such inspection is
explained keeping in view essential points to be focused while
forwarding the application for joint inspection to the Central
Government.
• It also includes the list of recommended equipment
required for carrying out analysis of ASU drugs and raw
materials. The manual also touches upon various essential
books that may be required for testing of ASU drugs.
• This Inspection Manual is not a substitute of the Drugs &
Cosmetics Act 1940 and Rules thereunder but this manual
is expected to help State Licensing Authorities to augment
the regulatory capacities of Inspectors and in developing
Master Trainers as well.
Dr.Lavanya-  Laws pertaining to Ayurvedic drugs

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Dr.Lavanya- Laws pertaining to Ayurvedic drugs

  • 1. By: Dr.Lavanya.S.A 3rd Year PG Scholar Under the guidance of: Dr.M.S.Doddamani Professor Dept of RS & BK TGAMC, Bellary Dr.Shankara Gowda Professor & HOD Dept of RS & BK TGAMC, Bellary
  • 2. What is Law? • Law is a system of rules and guidelines which are enforced through social institutions to govern behaviour. • Health is in concurrent list of Indian constitution and it is governed by both central and state government. • Legal enactments to regulate.
  • 3. Objective • The overall objective of a Drug Regulatory Authority (DRA) is to ensure that medicinal products are of acceptable quality, safety and efficacy, are manufactured and distributed in ways which ensure their quality until they reach the patient/consumer, and their commercial promotion is accurate.
  • 4. Laws governing Ayurvedic Drugs are: • Drug & Cosmetic Act-1940 & Rule -1945. • Drug & Magic Remedies Act 1954. • Prevention of Food Adulteration Act. • Food standard and Safety Act -2006. • Laws Pertaining to Narcotics. • Factory & Pharmacy Act . • Consumer protection Act 1986. • Knowledge of GCP & Inspection manual prescribed by Dept. of AYUSH, Govt. of India.
  • 5. DRUG & COSMETIC RULES 1945 168 rules has been divided into parts from I – XIX As per the different subjects pertaining to, Schedule (organized plan for matters to be attended to, in this case it is 168 rules) with Annexure/Appendix (Something added at the end, esp. an appendix or supplementary document for schedule) from A to Y is mentioned.
  • 6. 16th Part – Manufacture for sale of Ayurvedic Drugs • 151 – Manufacture on more than one set of premises. • 152 – Licensing Authorities. • 153 – Application for license to manufacture Ayurvedic Drugs. • 153 A – Loan license. • 154 – Form of license to manufacture. • 154 A – form of loan license to manufacture for sale of Ayurvedic drugs. • 155 – Certificate of Renewal. • 155 A – Certificate of renewal of a loan license.
  • 7. • 155 B – Certificate of award of GMP of Ayurvedic drugs. • 156 – Duration of License. • 156 A – Duration of Loan license. • 157 – Conditions for the grant of renewal of a license in form 25-D. • 158 – Conditions of license. • 158 A – Condition of Loan License • 159 – Cancellation and Suspension of Licenses. • 160 – Identification of Raw materials.
  • 8. 16th Part A – Approval of Institutions for carrying out tests on • 160 A – Application for grant of approval for testing Ayurvedic Drugs. • 160 B – Form in which approval to be granted for carrying out test on Ayurvedic Drugs on behalf of licensees for manufacture of Ayurvedic drugs and conditions for grant or renewal of such approval. • 160 C – Duration of Approval.
  • 9. • 160 D – Conditions of Approval . • 160 E – Inspection before grant of approval. • 160 F – Report of Inspection. • 160 G – Procedure of approving Authority. • 160 H – Application after Rejection. • 160 I – Renewal. • 160 J – Withdrawal and suspension of approvals.
  • 10. 17th Part – Labelling, packing and limit of Alcohol in Ayurvedic Drugs • 161 – Labelling, packing and limit of Alcohol. • 161 A – Exemption in labelling and packing, provisions for export of Ayurvedic drugs.
  • 11. 18th Part – Government Analysts and Inspectors for Ayurvedic Drugs • 162 – Duties of Inspectors specially authorised to inspect the manufacture of Ayurvedic drugs. • 162 A – Qualifications of the State Drug Licensing Authority for Licensing of Ayurveda Drugs. • 163 – Procedure for dispatch of sample to Govt Analyst and its receipt by the Govt Analyst. • 164 – Method of test or analysis to be employed in relation to
  • 12. • 165 – Qualifications of Government Analyst. • 166 – Duties of Government Analyst. • 167 – Qualification of Inspector.
  • 13. 19th Part – Standards of Ayurvedic Drugs. • 168 – Standards to be compiled within manufacture for sale or for distribution of Ayurvedic drugs. SCHEDULE - A: • Form 1 – Memorandum to the Central drug Laboratory. • Form 2- Certificate for test by the CDL. • Form 3-7 & 8 – Application for license to import drugs • Form 8 A - Application for license to import drugs specified in Schedule X . • Form 9 – Form of undertaking to accompany an application for an import license.
  • 14. • Form 10 – License to import drugs excluding those specified in Schedule X. • Form 11 – License to import drugs for the purposes of examination, test or analysis. • Form 11 A – License to import drugs by a Govt Hospital or Autonomous Medical Institute for the treatment of Patients. • Form 12 A – Application for the issue of a permit to import small quantities of drugs for personal use. • Form 13 A – Certificates of tests or analyst by Govt Analyst under Section 33H of the D & C Act, 1940. • Form 47 – Categories of Ayurvedic, Siddha & Unani drugs other than those specified in the first Schedule of this Act for which testing will be carried out.
  • 15. SCHEDULE E(1) [Rule 161 (2)]: List of Poisonous drugs under Ayurvedic medicines. Drugs of Vegetable origin Animal origin Mineral origin Ahiphena Jayapala Sarpa Visha or Snake poison Gauripashana Arka Karaveera Haratala Bhallataka Langali Manahshila Bhanga Parasika Yavani Parada Danti Snuhi Rasa Karpura Dhattura Vatsanabha Tuttha & Hingula Gunja Vishamushti & Shringi Visha Girisindura & Nagasindura
  • 16. SCHEDULE - T (Rule 157): GMP for Ayurvedic Drugs The GMP is prescribed as follows in Part 1 & part 2 to ensure that: • Raw materials used in the manufacture of drugs are authentic, of prescribed quality and are free from contamination. • The manufacturing process is as been prescribed to maintain the standards. • Adequate quality control measures are adopted. • The manufactured drug which is released for sla eis of acceptable quality.
  • 17. SCHEDULE – U :Rule 74, 74A, 74B, 78, 78A • Particulars to be in records of Manufacturing, Raw material, Analysis of Drugs. SCHEDULE – V: Rule 124 B • Standards for patent or Proprietary medicines. SCHEDULE – X: Rule 23, 61, 75, 97, 105A • List of drugs with special rules for import, manufacturing, sale, packaging and label.
  • 18. RECENT AMENDMENTS: Notification: The draft notification of the department of Ayush on the use of permitted excipients i.e additives, preservatives etc was published in Gazette of India Extraordinary dated 9th July, 2008 for inviting suggestions from stakeholders.
  • 19. Gazette notification issued under the D&C Rule 1945 1. 755(E)- 23-10-2008 Considering the growing demand for ASU drugs, on the recommendation of Ayurvedic, Siddha and Unani Drug Technical Advisory Board, the amendment to Rule 169 for permitting excipients, preservatives, antioxidants, flavouring agents etc in ASU medicines was carried out. The final notification has been issued in this regard on 23rd October, 2008.
  • 20. 2. 893 (E) -24-12-2008 Rule 170 has been amended regarding issuance of guidelines for evaluation of ASU Drugs and other traditional medicines of India. The purpose of issue of these guidelines is to develop methodologies for record and valuation, improve quality, valuable research for providing appropriate evaluation methods to facilitate the development of regulation and registration.
  • 21. Conclusion: Standardization & Quality control of ISM & H Drugs: • Laying down the pharmacopoeial standards for ASU medicine both for single and compound drugs is an essential item of work. • 4 different pharmacopoeia committees are working for preparing official formularies to evolve uniform standards in preparation of drugs of ASU & H and to prescribe working standards for single and compound formulations.
  • 22. • Pharmacopoeial Laboratory for Indian Medicine (PLIM): Established in the year 1970 as standard setting cum drug testing Laboratory for Indian Medicine at the National Level. The worked out standards, in the form of monographs are published by the Ministry of Health & Family Welfare for ASU Pharmacopoeia of India. • Drug Control Cell (ISM): Notification for recognition of Private Drug Testing Lab for ASU Drugs.
  • 23. • Workshops on GMP: GMP Workshops have been organised for sensitizing state ISM & H Drug Licensing Authorities, Drug Inspector and ISM manufacturers in 6 different place & Rs.25,000 for each workshop is given. • Report on TKDL. • Indian Medicines Pharmaceutical Corporation Limited: The objective of the company is to manufacture the classical quality Ayurvedic & Unani drugs for use in Central Govt Hospitals.
  • 24. Poisonous substances: [Schedule –E1] Revised August 2010 Amendments: • The seeds of two herbal sources ( Ahiphena and bhanga) have not been considered as poisonous. • Snuhi has been omitted from the list. • Two minerals i.e: sindura & Girisindura have been omitted from the list. • Only the seeds of Gunja and Jayapala are considered as poisonous. • Vatsanabha and Shringi have been grouped under one. • Chemical composition of Haratala & Manahshila are specified clearly. • Botanical identity of Parasika yavani has been changed from Hyocyamus inibar linn to hyocyamus niger linn.
  • 25. DRUG & MAGIC REMEDIES ACT 1954: • Drug & Magic remedies ( Objectionable Advertisements ) Act, 1954. • It is an Act to control the advertisement of drugs in certain cases and to prohibit the advertisement for certain purposes of remedies alleged to possess magic qualities. The Act extends to the whole of India except, State of Jammu and Kashmir. It was notified on 30th April, 1954 and amended in 1963.
  • 26. • Advertisements means: - Circular - Label -Wrapper - Other document -Announcement – oral or by light sound or smoke Advertisements Prohibited: • Leading to the use of a drug for : - Miscarriage. - Prevention of conception in Women. - Maintenance/ Improvement of Sexual Pleasure. - Correction menstrual disorders
  • 27. • Diseases and ailments which a drug may not purport to prevent or cure or make claims to prevent or cure: Appendicitis Arteriosclerosis Blindness Blood poisoning Bright’s disease Cancer Cataract Deafness Diabetes Disorders of brain Nervous debility Disorders of theoptical Disorders of uterus Disorders of menstrual flow Disorders of nervous system Disorders of Prostatic gland Dropsy Epilepsy Sexual impotence Female diseases Fevers Fits Obesity Impotency Hydrocele Hysteria Infantile paralysis Insanity Leprosy Leucoderma Lockjaw Locomotor ataxia Lupus
  • 28. NARCOTIC DRUGS & PSYCHOTROPIC SUBSTANCES ACT • The term narcotic originally referred medically to any psychoactive compound with sleep-inducing properties. • Psychotropic Substances are Pharmaco-therapeutic agent that possesses action to alter mood, behaviour, cognitive processes, or mental stress.
  • 29. The statutory control over narcotic drugs was being exercised under The Opium Act, 1857, The Opium Act, 1878 and The Dangerous Drugs Act, 1930. The provisions of these enactments were found to be inadequate because of the passage of time and developments in the field of illicit drug traffic and drug abuse "at national and international level. To consolidate and to amend the existing laws relating to narcotic drugs a comprehensive legislation was considered to be necessary.
  • 30. Accordingly the Narcotic Drugs and Psychotropic Substances Bill, 1985 was introduced in the Lok-Sabha on 23rd August, 1985. It was passed by both the Houses of Parliament and it was assented by the President on 16 September 1985. It came into force PSYCHOTROPIC SUBSTANCES ACT, 1985 (shortened to NDPS Act). Under the NDPS Act, it is illegal for a person to produce/manufacture/ cultivate, possess, sell, purchase, transport, store, and/or consume any narcotic drug or psychotropic substance
  • 31. • The Act has been amended twice - in 1988 and 2001. The Act extends to the whole of India The Act describes itself as "An Act to consolidate and amend the law relating to narcotic drugs, to make stringent provisions for the control and regulation of operations relating to narcotic drugs and psychotropic substances, to provide for the forfeiture of property derived from, or used in, illicit traffic in narcotic drugs and psychotropic substances, to implement the provisions of the International Convention on Narcotic Drugs and Psychotropic Substances and for matters connected therewith."
  • 32. Narcotic Drugs and Psychotropic Substances Act, 1985 (NDPS Act ) . This Act prohibits: • - Cultivation of opium poppy, cannabis and coca plants • -Production, manufacture, possession, sale, purchase, transport, warehousing, use, consumption, import, export or transshipment of any narcotic drug or psychotropic substance. • except for medical and scientific purposes and as per the rules or orders and conditions of license issued.
  • 33. • NDPS Act empowers central government to frame rules for certain purposes and state governments to frame rules for certain others. Thus, there are NDPS Rules, 1985 of the central government and state NDPS Rules of different states. Violation of any rule of either the state or central NDPS Rules attracts punishment under the NDPS Act.
  • 34. Prevention of Food Adulteration Act 1954: • Food is an essential commodity required for the survival of all living organisms. Such an important commodity has to be properly protected by law in order to ensure its availability to consumers in hygienic conditions. • The prevention of adulteration in foods and their products is the responsibility of the Govt and ethical duty of the society.
  • 35. • This Act is aimed at preventing import, manufacture, sale or distribution of adulterated and misbranded food and also to prevent all types of food Adulterations. It is extended to whole of India. In many states, it is Food and Drug Administration looking after the implementation of the provisions of this Act. Permitted Antioxidants in Food: Tocopherol, Ascorbic acid, lecithin.
  • 36. • Permitted colours in food: Chlorophyll, caramel, beta-caratene, annatto, coal-tar dyes, saffron and curcumin. The colour content should be more than 0.2mg per kg of food material. • Preservatives permitted in Food: Class I – Common salt, Sugar, Dextrose, Glucose, Syrup, Vinegar, Honey and edible vegetable oil. Class II – Benzoic acid and salts, Sulphorous acids and salts, nitrates, methyl diacetate, potassium and calcium salts of lactic acid. No nitrate or nitrite preservative to be added to infant food.
  • 37. Food standards and Safety Act - 2006 • Food "means any substance, whether processed, partially processed or unprocessed, which is intended for human consumption and includes primary food, Genetically modified or engineered food or food containing such ingredients, infant food, packaged drinking water, alcoholic drink, chewing gum, and any substance, including water used into the food during its manufacture, preparation or treatment but does not include any animal feed, live animals unless they are prepared or processed for placing on the market for human consumption, plants , prior to harvesting, drugs and medicinal products , cosmetics, narcotic or psychotropic substances. (acc to the Act)
  • 38. • The legislation that dealt with food safety in India was the Prevention of Food Adulteration Act, 1954 (hereinafter referred to as "PFA"). • The PFA had been in place for over five decades and there was a need for change due to varied reasons which include the changing requirements of our food industry. • The Act also aims to establish a single reference point for all matters relating to food safety and standards, by moving from multi- level, multi- departmental control to a single line of command. • To this effect, the Act establishes an independent statutory Authority – the Food Safety and Standards Authority of India with head office at Delhi. Food Safety and Standards Authority of India (FSSAI) and the State Food Safety Authorities shall enforce various provisions of the Act.
  • 39. • The Food Safety & Standards Act was enacted by Government of India on 24th August, 2006 • For implementation/ enforcement , the Food Safety & Standards Authority of India (FSSAI) was constituted on 5.09.2008. Mandate : • Laying down science based standards for articles of food and to regulate their manufacture, storage, distribution, sale and import, to ensure availability of safe and wholesome food for human consumption and for matters connected therewith or incidental thereto.
  • 40. Duties & Functions of FSSAI: • Framing rules, regulations, standards and guidelines in relation to articles of food. • Procedure and the enforcement of quality control on any article of imported into India. • Guidelines for accreditation of certification bodies engaged in certification of Food safety management system for food business. • Guidelines for accreditation of laboratories and their notification. • Providing scientific advice and technical support to the central Govt and state Govt in matters of framing the policy and rule sin areas which have a direct or indirect bearing of food safety and nutrition.
  • 41. Salient features of the Act:  Emphasis on gradual shift from regulatory regime to self compliance through food safety management system.  Enforcement of the Act by the (i) Central Licensing Authority, (ii) State Licensing Authority in each state/ UT through the State Food Safety Commissioners, Designated Officers & Food Safety Officers for Licensing, inspection & sampling etc. (iii) Registering Authority - Panchayati Raj/Municipal bodies  No License for Petty/small food business operators - Only registration is mandatory
  • 42.  A single License for one or more articles of food and also for different establishments/ premises in the same area  Regulation of food imported in the country  Harmonisation of domestic standards with international food standards.  Covering health foods, food supplements, nutraceuticals.  New justice dispensation system for fast track disposal of cases of contravention and compensation in case of injury or death of consumer.
  • 43.  Graded penalty depending upon the gravity of offences for selling food not of the nature/ substance or quality, substandard food, misbranded food including misleading advertisement  Liability of food safety officers ( Section 39 of FSSA) where vexatiously and without reasonable ground seizure of food or adulterant is found with penalty up to Rs. One Lakh.  A single reference point for all matters relating to food safety & standards , by moving from multi-level, multi- departmental control to a single line of command
  • 44. FACTORY AND PHARMACY ACT Factory Act:  In India the first Factories Act was passed in 1881.  This Act was basically designed to protect children and to provide few measures for health and safety of the workers.  This law was applicable to only those factories, which employed 100 or more workers. In 1891 another factories Act was passed which extended to the factories employing 50 or more workers.
  • 45. CONTENTS Chapter I – Preliminary Chapter VI –Working hours of adults Chapter II – The Inspecting Staff Chapter VII –Employment of young persons Chapter III – Health Chapter VIII -Annual leave with wages Chapter IV – Safety Chapter IX – Special provisions. Chapter IV A-Provisions relating to hazardous substances Chapter X –Penalties and procedure Chapter V – Welfare Chapter XI - Supplemental
  • 46. Object and Scope:  This act extends to whole of India.  The main object of this act is to ensure adequate safety measures and to promote the health & welfare of workers employed in factories.  The act also make provisions regarding employment of women & young person (including children & adolescents), annual leave with wages etc.
  • 47. Applicable:  It covers all the manufacturing process and establishments falling under the definition of ‘factory’ as defines under the sec. 2(m).  Unless otherwise provide it is also applicable to establishments of central/ state govt. (Sec. 116)
  • 48. Administration: The state govt. carry out administration of the act through: 1. Inspecting Staff (sec. 8) 2. Certifying Surgeons (sec. 10) 3. Welfare Officers (sec. 49) 4. Safety Officers (sec. 40-B)
  • 49. PHARMACY ACT:  Act No 8 of 1948  Enactment Date : 4th March, 1948  ACT YEAR_NO: 194808  The Act has been extended to Goa, Daman and Diu by Regulation 11 of 1963, s. 3 and schedule.  The whole of the Union territory of Lakshadweep by Regulation 8 of 1965, s. 3 and Sch. (w.e.f. 1-10-1967) and Dadra and Nagar Haveli by 'Regulation 6 of 1963.
  • 50.  To the States of Maharashtra Gujarat, Mysore and Rajasthan, the Act applies as adapted and modified by S.O. 2814, dated 14-8-1964, Gazette of India, Extraordinary, Pt. II, Sec. 3(ii), p. 717 (w.e.f. 1-9-1969) comes into force in Pondicherry with modification by Regulation 7 of 1963, s. 3  It extends to the whole of India except the State of Jammu and Kashmir.  Contents are explained in 5 chapters.
  • 51. CONTENT  History of Pharmacy Act.  Objectives  Definitions  The Pharmacy Council Of India and it’s functions-  Design of the educational pattern  Approval of Institutions/withdrawal of approvals  Maintenance of Central Register of Pharmacists  State Pharmacy Council and it’s functions  Maintenance of registers  Entry and removal of names  Removal of name from registers  Printing of Registers  Inspection by State Council  Offences and Penalties
  • 52. Definitions-  “Pharmacy Act” – An act to regulate the profession of pharmacy.  “Registered Pharmacist”- A person whose name is for the time being entered in the register of the state in which he or she is for the time being residing or carrying on his profession or business of pharmacy
  • 53. objective  To regulate the pharmacy education in the country for the purpose of registration as a pharmacist under the pharmacy act.  To restore the Pharmacy profession in its due place in the health services.  Raising the status of the profession of Pharmacy in India.  To regulate the practice of Pharmacy in India.  To provide uniform education and training through out India.  To maintain control over persons entering the profession of pharmacy.  To Protect the Public Health – Medical Use of Drugs – Drug Abuse
  • 54. THE PHARMACY COUNCIL OF INDIA- The first pharmacy council of India(P.C.I) constituted by central government in 1949. It is reconstituted every 5 years. A) Constitution office Bearers : It consists of three different types of members- 1. Elected member 2. Nominated member 3. EX-Officio Member
  • 55. OFFENCES PENALTIES 1. Falsely claiming to be a registered pharmacist. 1.(a) Fine up to Rs. 500.00 on first conviction. (b) Fine up to Rs. 1000.00 and/or 6 months imprisonment of any subsequent conviction. 2. Dispensed by unregistered persons. Exception: Medical practitioners. 2. 6 months imprisonment OR Fine up to Rs. 1000.00 OR Both. 3.Failure to surrender certificate of registration. 3. Fine up to Rs. 50.00 4.Obstructing State pharmacy council Inspectors. 4. 6 months imprisonment OR Fine up to Rs. 1000.00 OR Both.
  • 56. CONSUMER PROTECTION ACT: • Enacted by the Parliament in the year 1986 Objectives: • To provide for better protection of interest of consumers. • To make provisions for the establishment of Consumer Councils and other authorities for the settlement of consumer disputes.
  • 57. • Consumer is one who – Buys any goods for a consideration and includes a hire-purchaser; – Any user of such goods for consideration but excludes one, who obtains for re-sale or for commercial purposes; – Hires a service for consideration and includes a beneficiary of such service, if availed of with the approval of the hirer.
  • 58. CONTENTS: • Chapter II – Preliminary - Short title, extent, commencement & application. - Definitions. - Act not in derogation of any other law. • Chapter II –Consumer protection councils - The Central Consumer Protection Council. - Procedure for meetings of the Central Council. - Objects of The Central Council. - The state Consumer Protection Councils. - Objects of the state council - The District Consumer Protection Council.
  • 59. • Chapter III – Consumer disputes redressal agencies - Establishment of consumer disputes redressal agencies. - Composition of the District Forum - Jurisdiction of the District forum - Manner in which complaint shall be made - Procedure on admission of complaint - Finding of the District forum - Appeal - Composition of the state Commission - Jurisdiction of the state commission - Transfer of cases - Circuit benches
  • 60. • Procedure applicable to State Commissions • Appeals • Hearing of Appeal • Composition of the National Commission • Jurisdiction of the National Commission • Power of and procedure applicable to the National Commission • Power to set aside ex parte orders • Transfer of cases • Circuit Benches • Vacancy in the Office of the President
  • 61. • Appeal • Finality of orders • Limitation period • Administrative Control • Enforcement of orders of the District Forum, the State Commission or the National Commission • Dismissal of frivolous or vexatious complaints • Penalties • Appeal against order passed under section 27
  • 62. • Chapter IV – Miscellaneous - Protection of action taken in good faith. - Service of notice etc. - Power to remove difficulties. - Vacancies or defects in appointment not to invalidate orders. - Power to make rules. - Power of the National Commission to make regulations. - Rules and regulations to be laid before each house of parliament.
  • 63. GCP-Good Clinical Practice • GCP compliance provides public assurance that the rights, safety and well-being of human subjects involved in research are protected . • Good Clinical Practice is the compilation of accepted ethical and scientific standards governing clinical research that ensure the integrity of data obtained and the protection of human research subjects.
  • 64. Goals of GCP: • To protect the rights, safety and welfare of humans participating in research 􀁺 • To assure the quality, reliability and integrity of data collected • To provide standards and guidelines for the conduct of clinical research
  • 65. GCP Components: • Food and Drug Administration (FDA) regulations and guidance documents • International Conference on Harmonization (ICH) guidelines • State and local laws • Medical Standard of Care • Medical Ethics
  • 66. GCP guidelines for ASU Medicines: • The Department of AYUSH has issued good clinical practice (GCP) guideline in March 2013 for clinical trial in Ayurveda, Siddha and Unani (ASU) medicines which will facilitate the researcher and institutions in adopting a standard way of good practice while conducting the ASU clinical trials. • The GCP is a set of guidelines which encompasses the design, conduct, termination, audit, analysis, reporting and documentation of the studies involving human subjects.
  • 67. • These guidelines are formulated based on CDSCO Document on GCP Guidelines (2001) for Clinical Trials on Pharmaceutical Products. • The guidelines seek to establish two cardinal principles: protection of the rights of human subjects and authenticity of ASU medicine clinical trial data generated.
  • 68. Principles of GCP • Confidentiality of records that could identify subjects should be protected. • Investigational products should be manufactured, handled and stored in accordance with applicable GCP. • Systems and procedures that ensure the quality of every aspect of the trial should be implemented, which is generally the responsibility of the sponsor.
  • 69.
  • 70. Disclaimer: This manual has been prepared on the basis of provisions in the D & C Rules,1945 for inspectors and drug testing institutions aimed at providing orientation and training about the procedure to be followed for approving laboratories engaged in testing of ASU drugs. The contributors and reviewers have taken due care to ensure correctness of the contents before publication and cannot be held responsible for any omission or inadvertent errors, nor can they warrant that all aspects of the subject have been covered. The manual is a guiding tool and does not have any connotation of legal binding.
  • 71. • This Inspection manual covering various aspects about the qualifications, duties and responsibilities of Inspectors will be a much needed helpful guide for orientation of ASU Inspectors for proper discharge of their duties under D&C Act and Rules thereunder. • The inspection manual of Drug testing laboratory is especially explained in detail for development of insight of the Inspectors regarding interpretation and implementation of the Rules. • Role of State licensing Authority in facilitating such inspection is explained keeping in view essential points to be focused while forwarding the application for joint inspection to the Central Government.
  • 72. • It also includes the list of recommended equipment required for carrying out analysis of ASU drugs and raw materials. The manual also touches upon various essential books that may be required for testing of ASU drugs. • This Inspection Manual is not a substitute of the Drugs & Cosmetics Act 1940 and Rules thereunder but this manual is expected to help State Licensing Authorities to augment the regulatory capacities of Inspectors and in developing Master Trainers as well.