Laws regarding manufacture, marketing and prescription of drugs .

1. HARIPRIYA UPPALA
DEPARTMENT OF PHARMACOLOGY
S.V.M.C, TIRUPATI.
DRUG LEGISLATION

2. SOURCES
 Katzung – Basic and Clinical Pharmacology
 CDSCO website
 FDA website

3.  HISTORY
 DRUG LEGISLATIONS IN USA
 INDIAN DRUG LEGISLATION
 US DRUG REGULATORY
 INDIAN DRUG REGULATORY

4. In USA...
 Pure Food and Drug Act of 1906 became law in
response to revelations of unsanitary and unethical
practices in the meat-packing industry.
 The Federal Food, Drug, and Cosmetic Act of
1938 - a reaction to deaths associated with the use of a
preparation of sulfanilamide marketed before it and its
vehicle were adequately tested.
 The Kefauver-Harris amendments of 1962 -
the result of a teratogenic drug disaster involving
thalidomide.

5. In INDIA...
 Manufacture of modern drugs in India - end of 19th
century.
 Bengal Chemical and Pharmaceutical works at
Calcutta - by Acharya P. C. Ray 1901
 Alembic Chemical works at Baroda - by prof. T. K.
Gajjar

6.  1920-1930 a number of reports of harmful substitutes and
adulterants were identified to be marketed in place of genuine
drugs.
 According to Indian Medical gazette - no control over the
manufacturing sale and distribution of drugs in India.
 No restrictions on quality of drugs that are being imported.
 Unscrupulous manufacturers abroad took advantage and flooded
the Indian markets with adulterated & spurious drugs.
 Lt. Col. H. A. J Gidney in the legislative council demanded for the
control of adulterated drugs.
 On september 4, 1928 he moved for leave to adjourn the house
for the consideration of the "Gigantic Quinine fraud".

7.  Drugs enquiry committee constituted under the
chairman ship of Col. R. N. Chopra as Chairman , Shri C.
Govindan Nair as secretary and Dr. B. Mukharjee as
assistant secretary.
Objectives
 To enquire & check the quality of drugs
 To suggest remedial measures in preventing
adulteration.
The committee submitted its report in 1931.

8.  1937 – “Import of drugs” bill by EIC. Later withdrawn.
 1940 - The Drugs Bill was introduced in the Parliament,
based on the recommendation of D. E. C
 The Drugs Act, 1940 was enacted which was latter
amended to the Drugs and Cosmetics Act, 1940.
 Later on, Drugs Enquiry Committee & Health Survey and
Development Committee lead foundation for
The Pharmacy Act, 1948.

9. DRUG LEGISLATIONS IN USA
 Pure Food and Drug Act of 1906 - Prohibited
mislabeling and adulteration of drugs.
 Opium Exclusion Act of 1909 - Prohibited
importation of opium.
 Amendment (1912) to the Pure Food and Drug Act –
Prohibited false or fraudulent advertising claims.
 Harrison Narcotic Act of 1914 - Regulations for
use of opium, opiates, and cocaine (marijuana added
in 1937).

10.  Food, Drug, and Cosmetic Act 1938 - Required
that new drugs be safe as well as pure (but did not
require proof of efficacy). Enforcement by FDA.
 Durham-Humphrey Act 1952 - Vested in the
FDA the power to determine which products could
be sold without prescription
 Kefauver-Harris Amendments (1962) to the
Food, Drug, and Cosmetic Act: Required proof of
efficacy as well as safety for new drugs and for drugs
released since 1938; guidelines for reporting of
information about adverse reactions, clinical testing,
and advertising of new drugs.

11.  Comprehensive Drug Abuse Prevention and Control
Act (1970) :- Outlined strict controls in the manufacture,
distribution, and prescribing of habit-forming drugs; drug
schedules and programs to prevent and treat drug addiction.
 Orphan Drug Amendments of 1983: Provided incentives
for development of drugs that treat diseases with less than
200,000 patients in USA.
 Drug Price Competition and Patent Restoration Act
of 1984 –
 Abbreviated new drug applications for generic drugs.
 Required bioequivalence data.
 Patent life extended by amount of time drug delayed by FDA
review process.
 Cannot exceed 5 extra years or extend to more than14 years
post-NDA approval.

12. Dietary Supplement Health and Education Act
(1994)
 Standards with respect to dietary supplements
 Prohibited full FDA review of supplements and
botanicals as drugs.
 Required the establishment of specific ingredient
and nutrition information labeling
 Allows unregulated advertising.

13. Bioterrorism Act of 2002
Enhanced controls on dangerous biologic agents and
toxins. Seeks to protect safety of food, water, and drug
supply.
Food and Drug Administration Amendments Act
of 2007
 Granted FDA greater authority over drug marketing,
labeling, and direct-to-consumer advertising;
requiredpost-approval studies, established active
surveillance systems, made clinical trial operations and
results more visible to the public.

14. INDIAN DRUG LEGISLATION
 The Drugs and Cosmetics Act, 1940
 The Pharmacy Act, 1948
 The Drugs and Magic Remedies (Objectionable
Advertisement) Act, 1954
 The Narcotic Drugs and Psychotropic Substances Act,
1985
 The Medicinal and Toilet Preparations (Excise
Duties) Act, 1956
 The Drugs (Prices Control) Order 1995 (under the
Essential Commodities Act)

15. 1. The Drugs and Cosmetics Act 1940.
Objective: Regulate the import, manufacture,
distribution and sale of drugs.
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.

16. 2. The Pharmacy Act 1948
The Pharmacy Act was passed in 1948 and was amended in 1959,
1976 and 1984.
Aim - To regulate the profession of Pharmacy in India.
The Central Government constitutes a Central Pharmacy Council
of India consisting of following members:
a) Six members from the Teachers of pharmacy.
b) Six members from practicing pharmacists or Pharmaceutical
Chemists holding degree of diploma.
c) One member elected by the Medical Council of India.

17. d) The Director-General of Health Services.
e) The Director of the Central Drugs Laboratory.
f) The Chief Chemist, Central Revenues.
g) One member to represent each state elected by
members of State Councils who shall be a
registered pharmacist.
h) One member to represent each State
Government who shall be either registered medical
practitioner or a registered pharmacist.

18. 3. The Drugs and Magic Remedies
(Objectionable Advertisements) Act 1954
To control the Advertisements regarding drugs
Prohibits the advertising of remedies alleged to
possess magic qualities and to provide for matters
connected therewith.

19.  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; and
b) 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 impression
regarding 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.

20.  Whoever contravenes the provisions of this Act shall, on
conviction, be punishable with imprisonment which may
extend to six months, with or without fine.
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 for
distribution among registered medical practitioners or to a
hospital or laboratory
d) Government advertisements.

21. 4. The Narcotic Drugs and Psychotropic
Substances Act, 1985
 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 and for matters
connected therewith.
 Includes:
1. Narcotic drugs
2. Psychotropic substances
3. Controlled Drugs

22. NDPS ACT 2014 amendment
 To relax restrictions placed by the Act on Essential Narcotic
Drugs (Morphine, Fentanyl and Methadone), making them
more accessible for use in pain relief and palliative care.
 Contained measures to improve treatment and care for
people dependent on drugs.
 Removed the NDPS Act's imposition of a mandatory death
sentence in case of a repeat conviction for trafficking large
quantities of drugs.
 Increased the punishment for "small quantity" offences
from a maximum of 6 months to 1 year imprisonment.

23. There are some other laws which have a bearing on
pharmaceutical manufacture, distribution and sale in
India. The important ones being:
 The Industries (Development and
Regulation) Act, 1951
 The Trade and Merchandise Marks Act, 1958
 The Indian Patent and Design Act, 1970
 Factories Act

24. REGULATORY BODIES
 Regulatory authorities are bodies having the power
to regulate.
 In the ICH-GCP guidelines, the regulatory
authorities includes the authorities that review
submitted clinical data and those that conduct
inspections.
 These bodies are sometimes referred to as competent
authorities.

25. US DRUG REGULATORY
 The FDA is the administrative body that oversees the
drug evaluation process in the USA and grants
approval for marketing of new drug products in USA.
 To receive FDA approval for marketing, the
originating institution or company (almost always
the latter) must submit evidence of safety and
effectiveness.

26. INDIAN DRUG REGULATORY
 Medicines in India are regulated by CDSCO -
Central Drugs Standard Control Organization under
Ministry of Health and Family Welfare.
 Headed by Directorate General of Health Services
CDSCO regulates the Pharmaceutical Products
through DCGI - Drugs Controller General of India at
Chair.

27.  Under Retail and Distribution: - Drugs classified under 5
heads
1. Schedule X drugs – Narcotics
2. Schedule H and L – Injectables, Antibiotics,
Antibacterial
3. Schedule C and C1- Biological Products-example
Serums and Vaccines
 Under Manufacturing Practice
1. Schedule N - List of the equipment for the efficient
running of manufacturing wing, qualified personnel
2. Schedule M

28.  Functions of CDSCO:
1. Approval of new drugs and clinical trials
2. Import Registration and Licensing
3. Licensing of Blood Banks, LVP’s, Vaccines, r-
DNA products & some Medical Devices
4. Amendment to D &C Act and Rules
5. Banning of drugs and cosmetics
6. Grant of Test License,
7. Personal License,
8. NOCs for Export
9. Testing of Drugs