At Present the Following Acts and Rules Made

8/8/2019 At Present the Following Acts and Rules Made

1/32


2/32

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


3/32

SOMEOTHER LAWS

The Industries (Development

and Regulation) Act, 1951

The Trade and MerchandiseMarks Act, 1958

The Indian Patent and Design

Act, 1970 Factories Act


4/32

How they impact on pharmaceutical industry ?


5/32

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.


6/32

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.


7/32

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


8/32

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


9/32

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


10/32

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


11/32

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


12/32

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.


13/32

SCHEDULE Y WHAT IT COVERS AND ITS AFFECT ONPHARMACEUTICAL INDUSTRY IN INDIA


14/32

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


15/32

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


16/32

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.


17/32

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


18/32

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


19/32

RESPONSIBILITIES OF SPONSOR, INVESTIGATOR AND

ETHICS COMMITEE


20/32

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.


21/32

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


22/32

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.


23/32

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.


24/32

APPLICATION FOR PERMISSION UNDER FORM 44, REGULAR AUTHORITIES, FESS AND

TEST LICENCE


25/32

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)


26/32

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


27/32

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


28/32

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


29/32

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 :


30/32

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


31/32

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


32/32

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

Documents

At Present the Following Acts and Rules Made