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8/8/2019 At Present the Following Acts and Rules Made
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The Drugs and Cosmetics Act, 1940 The Pharmacy Act, 1948
The Drugs and Magic Remedies (Objectionable
Advertisement) Act, 1954
The Narcotic Drugs and Psychotropic SubstancesAct, 1985
The Medicinal and Toilet Preparations (Excise
Duties) Act, 1956
The Drugs (Prices Control) Order 1995 (under theEssential Commodities Act)
Important Drug Laws
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SOMEOTHER LAWS
The Industries (Development
and Regulation) Act, 1951
The Trade and MerchandiseMarks Act, 1958
The Indian Patent and Design
Act, 1970 Factories Act
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How they impact on pharmaceutical industry ?
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1. The Drugs and Cosmetics Act 1940.
The object of the Act is to regulate the import,
manufacture, distribution and sale of drugs.
Under the provisions of this Act, the Central
Government appoints the Drugs Technical Advisory
Board to advise the Central Government and the
State Governments on technical matters arising out
of the administration of this Act. The board can
constitute subcommittees for the consideration of
a particular matter.
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2. The Pharmacy Act 1948
The Pharmacy Act was passed in 1948 and was amended in 1959,1976 and 1984.
The aim of this law is to regulate the profession of Pharmacy in India.
Under the provisions of this act the Central Government constitutes a
Central Pharmacy Council of India consisting of following members:
Six members from the Teachers of pharmacy.
Six members from practicing pharmacists or Pharmaceutical
Chemists holding degree of diploma.
One member elected by the Medical Council of India.
The Director-General of Health Services.
The Director of the Central Drugs Laboratory.
The Chief Chemist, Central Revenues.
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One member to represent each state elected by members of State
Councils who shall be a registered pharmacist.
One member to represent each State Government who shall beeither registered medical practitioner or a registered pharmacist.
The President and Vice-President of the Central Council of
Pharmacy are elected by the members of the Council among
themselves, hold office for five years and are eligible for re-election.
The conducting of courses of study for pharmacists, and the
examinations in Pharmacy in the states are subject to the
approval of the Central Council. Besides the Council has the
responsibility to supervise the Education of Pharmacy in theStates. Where it is found that the course of study is not in
conformity with the Education Regulations, the Council may
withdraw approval accorded to the course or the examination.
The Central Council can approve qualifications granted by an
outside authority for qualifying for registration under this Act
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The Act makes it incumbent upon the State Governments to
constitute State Pharmacy Councils with the following members:
a) Six members elected from amongst themselves by registered
Pharmacists of the state.
b) Five members of whom at least two shall be persons possessing a
prescribed degree or diploma in Pharmacy or Pharmaceutical
Chemistry or members of the Pharmaceutical profession
nominated by the State Government.
c) One member elected by the State Medical Council.
d) The Chief Medical Officer of the State.
e) The State Drug Controller.
f) The Government Analyst.
State Pharmacy Councils
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The State Government has under the provisions
of the Pharmacy Act to get a register of the State
Pharmacists prepared and it is the StatePharmacy Council which has to maintain the
register. The register shall contain the name and
residential address of Pharmacist, the date of his
first admission to the register, qualifications forregistration, his professional address, the name of
his employer and prescribed particulars
Registration of Pharmacists
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3. The Drugs and Magic Remedies (Objectionable Advertisements) Act 1954
This Act is meant to control the Advertisements regarding drugs; it prohibits the
advertising of remedies alleged to possess magic qualities and to provide for mattersconnected there with.
The Drugs and Magic Remedies Act prohibits a person from taking part in publication
of any advertisement referring to any drug which suggests use of the drug for:
a) the procurement of miscarriage in women or prevention of conception in
women; andb) the maintenance or improvement of the capacity of the human being for
sexual pleasure;
c) the correction of menstrual disorders in women;
d) the diagnosis, cure, mitigation, treatment or prevention of any venereal
disease. It is prohibited to directly or indirectly give a false impressionregarding the true character of a drug or make false claim for it or to convey
any false or misleading information in any material particular about it. No
person shall import into or export from India any document containing
advertisement of this nature
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Whoever contravenes the provisions of this Act shall, on conviction, be
punishable with imprisonment which may extend to six months, with or without
fine. In case of subsequent convictions the imprisonment can be extended to
one year. The document, article or thing which contains the offendingadvertisement can be seized and confiscated.
If the person contravening any of the provisions of the Act is a company, every
person who at the time the offence was committed was in charge of the
business of the company shall be deemed guilty.
The prohibition under this Act does not apply to: a) any signboard or notice
displayed by a registered medical practitioner including the treatment for any of
the disease, b) any treaties or book dealing with any of the matters from a
bonafide scientific standpoint, c) any advertisement related to any drug sent
confidentially to any registered medical practitioners or to chemists fordistribution among registered medical practitioners or to a hospital or laboratory,
and d) Government advertisements
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4. The Narcotic Drugs and Psychotropic Substances Act, 1985
This is an Act to consolidate and amend the
law relating to Narcotic Drugs, to makestringent provisions for the control and
regulation of operations relating to Narcotic
Drugs and Psychotropic Substances and for
matters connected therewith.
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SCHEDULE Y WHAT IT COVERS AND ITS AFFECT ONPHARMACEUTICAL INDUSTRY IN INDIA
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What is SCHEDULE Y?
Requirements and guidelines for permission
to import and / or manufacture of new
drugs for sale or to undertake clinical trials
Refer to rules 122A, 122B, 122D, 122DA,
122DAA and 122E
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PART XA of D & C RULES 1945
122-A Application for permission to import new
drug
122-B Application for approval to manufacturenew drug
122-C Deleted
122-D Permission to import or manufacture FDC
122-DA Permission to conduct clinical trials for
New Drug / Investigational New Drug
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122-DAA
CLINICAL TRIAL
Clinical trial means a systematic study of new
drug(s) in human subject(s) to generate data fordiscovering and / or verifying the clinical,
pharmacological (including pharmacodynamic
and pharmacokinetic) and /or adverse effects
with the objective of determining safety and / orefficacy of the new drug.
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122-E.
NEW DRUG
- Not been used in the country under labeling
conditions- Approved but now proposed to be marketed
with modified or new claims indications,
dosage, dosage form , route of administration
- FDC, individually approved, to be combined for
the first time in a fixed ratio or if ratio is
changed
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New chemical entity or a product having
therapeutic indication but which has
never been earlier tested on human
beings
o Vaccines are new drugs unless otherwise
certified
o Considered new drug for 4 years or
inclusion in IP
INVESTIGATIONAL NEW DRUG
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RESPONSIBILITIES OF SPONSOR, INVESTIGATOR AND
ETHICS COMMITEE
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RESPONSIBILITIES OF THE SPONSOR
Implementing and maintaining quality assurance systems-Good
Clinical Practice (GCP) Guidelines issued by CDSCO, INDIA
Sponsors are required to submit a status report on the clinical trial to
the Licensing Authority at the prescribed periodicity (annual).
In case of studies prematurely discontinued for any reason including
lack of commercial interest in pursuing the new drug application, asummary report should be submitted within 3 months. The summary
report should provide a brief description of the study, the number of
patients exposed to the drug, dose and duration of exposure, details
of adverse drug reactions and the reason for discontinuation of the
study or non-pursuit of the new drug application Any unexpected Serious Adverse Event (SAE)(as defined in GCP
Guidelines) occurring during a clinical trial should be communicated
promptly (within 14 calendar days)by the Sponsor to the Licensing
Authority and to the other Investigator(s) participating in the study.
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DEFINITION SAE / SADR / AE / ADR
SAE / SADR: An adverse event / adverse reaction associated withdeath, in patient hospitalisation, prolongation of hospitalisation,
persistant or significant disability or incapacity , a congenital anomaly or
birth defect or is otherwise life threatening
Adverse Event (AE ) : Any untoward medical occurrence (including a
symptom / disease or an abnormal lab finding) during treatment with a
pharmaceutical product in a patient or a human volunteer that does not
necessarily have a relationship with the treatment being given.
Adverse Drug Reaction (ADR) :
- Approved product: Noxious / unintended response at doses normally used
or tested in humans
- Unapproved product: Noxious / unintended response at any dose
- There is reasonable possibility that the adverse event is related with
medicinal product studied
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RESPONSIBILITIES OF INVESTIGATOR
Responsible for the conduct of the trial according to the
protocol and the GCPGuidelines and also for compliance.
Standard operating procedures are required to be
documented by the investigators for the tasks performed
by them.
Ensure that adequate medical care is provided to the
participant for any adverse events.
Report all serious and unexpected adverse events to the
Sponsor within 24 hours and to the Ethics Committee that
accorded approval to the study protocol within 7working
days of their occurence.
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RESPONSIBILITIES OF ETHICS COMMITTEE
Safeguard the rights, safety and well being of all trialsubjects.
Particular care to protect the rights, safety and well being
ofall vulnerable subjects
Obtain standard operating proceduresand maintain arecord
Ongoing reviewbased on periodic study progress reports
In case an ethics committee revokes its approval it must
record the reasons for doing so and at once communicatesuch a decision to the Investigator as well as to the
Licensing Authority.
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APPLICATION FOR PERMISSION UNDER FORM 44, REGULAR AUTHORITIES, FESS AND
TEST LICENCE
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REGULATORY AUTHORITIES
MINISTRYOF CHEM
& FERTILIZERS
NPPA
(NationalPharmaceutical
Pricing Authority)
Ministry Health ofHealth
HealthSecretory
CDL/CDTL
Gov. Drug Testing
Laboratories
Ministry of
Environment
Ministry ofScience &
Technology
DCGS
(Director General of
Health Services Health)
State Drug Regulatory Authority :FDA
DCGI
Drug Controller General
of IndiaPricing
Regulations
Additional
Secretary
GEAC
(Genetic
EngineeringApproval
Committee)
DBT
(Department of
Biotechnology)
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PROCESS
NOC FOR CT + Test
Licence for Import
APPROVAL FORM 45
(IMP FF)
APPROVAL FORM 45 A
(IMP RM)
APPROVAL FORM 46 (MFG
FF)
APPLICATION FORM 46 A(MFG
RM)
APPLICATIONFORM 44
-Imp ff
-Imp rm
-Mfg ff
-Mfg rm
-CT
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FEES
Import ff/ Mfg ff/ Import bulk + Mfg ff = Rs50,000/
of new drug
Application by same applicant, = Rs15,000/-
for modified dosage form or with new claim
Secondary applicants after 1 = Rs15,000/-year of approval
Import / Mfg FDC = Rs15,000/-
Conduct Clinical trial with ND/IND
Phase I = Rs50,000/-
Phase II = Rs25,000/- Phase III = Rs25,000/-
No separate fee to be paid along with application for
import /mfg based on successful completion
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APPLICATION IN FORM 44FORM 44
(See Rules 122A, 122B, 122D and 122DA)
Application for grant of permission to import or manufacture a NewDrug or to undertake clinical trialI/We.... of .., hereby apply for grant of permission for importand / or clinical trial or for approval to manufacture of a new drug orfixed dose combination or subsequent permission of already approvednew drug. The necessary information / data is given below :
1. Particulars of New Drug : Name of the drug : Dosage Form : Composition of the formulation : Test specifications :
o Active ingredients :o Inactive ingredients :
Pharmacological classification of the drug : Indications for which proposed to be used : Manufacturer of the raw material : Patent status
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FORM 44 Contd
2. Data submitted along with the application
A. Permission to market newdrug
1. Chemical and Pharmaceutical information2. Animal Pharmacology
3. Animal Toxicology4. Human / Clinical Pharmacology5. Exploratory Clinical Trials6. Confirmatory Clinical Trials7. Bioavailability / dissolution and stability data8. Regulatory status in other countries
9. Marketing information :(a) Proposed product monograph(b) Drafts of labels and cartons
10. Application for test license :
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B Subsequent approval / permission for manufacture of already
approved newdrug
a) Formulation :
a) Bioavailability / bioequivalence
b) Name of the investigator / centre
c) Source of raw mat and stability
b) Raw Material
Manufacturing Method
QC parameters, specs, stability
Animal toxicity
C Approval / permission for FDC
1. Justification
2. Pcokinetic / Pcodynamic data
3. Any other data
FORM 44 Contd
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FORM 44 Contd
D Subsequent approval or approval for new
indication newdosage form :
Number and date of Approval already granted
Justification
Data on safety, efficacy and quality
A total fee ofRshas been credited to the
Government under the Head of Account
(receipt enclosed)Signature
Designation
Date
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TEST LICENCE
Application :
Form 12 application
Material Justification Plan Treasury Challan ofRs 100 for first drug,
followed by Rs 50 for additional drug
Test Licence obtained in FORM 11