Pharmaceutical Legislation in India

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PHARMACEUTICAL
LEGISLATION IN INDIA

Contents

• Purpose of Pharmaceutical
legislation

• Chopra Committee

• Drug Enquiry Committee

• Bhore committee

• Bhatia committee

• Mudaliar committee

• Hathi committee

Intended learning objectives

At the
end of this lecture, the student will be able to:

• Explain history of pharmaceutical
legislations in India

• Discuss the history of pharmaceutical units
and its development

Legislation

• Legislation is law which has
been enacted by a legislature or other governing body

• Legislation aids government in
organising society and protecting citizens

• It determines the rights and
responsibilities of individuals and authorities to whom
the legislation applies

Legislation Vs Regulation

Legislation

Regulation

Passed by the
legislative body of a country

Regulations are
issued by the government, by an individual minister

General framework of
principles within which the government is expected to act

It’s a part of
legislation

The process of
preparing or reviewing legislation is usually long and complex

The preparation and updating of regulations
is a more dynamic process

What is the purpose of Pharmaceutical legislation?

To ensure that we receive drugs of required quality,
tested and evaluated for safety and efficacy for their intended result

History of Pharmaceutical units

Year

Name of Founder

Name of shop/ Industry

1811

Mr. Bathgate (East India Company)

Chemist Shop in Calcutta

1821

Mr. Smith Stainstreet and Co.

Apothecary Shop

1901

Acharya Praffula Chandra Ray (Calcutta)

The Bengal Chemicals and Pharmaceutical Works

1903

Prof. T.K Gajjar

Factory at Parel

1907

Prof. Kotibhaskar

Alembic Chemical works, Baroda

1943

Amba
lal Sarabhai

Sarabhai
chemical Works

R. N. Chopra Committee

Reasons for formation of R. N. Chopra Committee:

Units
were not sufficient to fulfill the requirements of Indian Public
Drugs
were imported form UK, Germany and France
During
first world war cheaper drugs were imported into India, which increased
the demand for indigenous drugs
Unhealthy
competition grew up and Indian market was flooded with inferior quality
drugs

Public
pressurized government to introduce effective legislation to control
import, manufacture, distribution and sale of drugs
There
was no legal and effective control on pharmacy profession
Hence
to have a comprehensive legislation, the Indian government appointed a ‘Drug Enquiry Committee’ under the chairmanship of Col. R.N.
Chopra in 1931. this was formally known as Chopra Committee

Recommendations of Drug Enquiry Committee

Formation
of Central Pharmacy Council (PCI) and State Pharmacy Council
Creation
of Drug Control Machinery (DCM)
Establishment
of well-equipped Central Drug Laboratory (CDL) and State Drug Laboratory
A
central law to control drugs and pharmacy profession
Appointment
of an advisory board to advise Government in making rules
Setting
up the courses for training of pharmacists and prescribing minimum
qualifications for registration as pharmacists
Registration
of every patents and proprietary medicines manufactured in India and
imported from abroad
Bringing
of crude single drugs as well as compounded medicines used in the
indigenous systems of treatment under control
Development
of the drug industry in India
Compilation
of an Indian Pharmacopoeia

Implementations:-

q Due
to Second World War in 1939, there was delay in introduction of the
legislation

q Government
was reluctant to implement the recommendations of DEC and the public was
pressurizing the government

q Finally
an Import of Drug Bill was introduced in 1937

q This
bill dealt with only import of drugs and manufacturing and sale of drugs was
not included

Scope and objective

• Drug
bill was introduced in 1940 in legislative assembly, and Drug Bill 1940
was passed, which came to force in 1947

• Since
then act was amended many times and at present it covers the provisions related
to Drugs, Cosmetics, Ayurvedic, Unani and Homeopathic medicines

• The
present Drug and Cosmetic Act is an improved version of the Drug Act,
1940. The main objective of this act was to regulate the import,
manufacture, distribution and sale of drugs and cosmetics in India

• The
Central Government made several rules entitled the Drug and Cosmetic
Rules 1945. These act and rules were amended from time to time

• The
Pharmacy act 1948 was passed with the main objective to regulate the
profession of Pharmacy in India

• In
1954 the Drug and Magic Remedies Act was passed with the main aim to
control certain types of advertisements related to drug and to prohibit certain
types of advertisements related to magic remedies

• Medicinal
and Toilet Preparations (Excise duty) Act, 1955 was passed providing
for the levy and collection of duties of excise on medicinal and toilet
preparations containing alcohol, opium Indian hemp or other narcotic drugs

• Central
government implemented Drug Price Control order 1987

• In
1985 the Narcotic and Psychotropic Substance Act, was passed. The main
objective of this act was to consolidate and amend the laws relating to
narcotic drugs and Psychotropic substance

Bhore committee

• In
1943 under the chairmanship of Sir Joseph Bhore

• To
make a survey of existing position in respect to health care delivery in India

• 7
key recommendations:

• Establishment
of All India Pharmaceutical Council and Provincial Pharmaceutical Council

• Enactment
of legislation designed to protect the public from incompetence, safeguard the
interests of qualified pharmacists and
to raise the professional standard of pharmacists

• Suitable
measures for maintaining disciplinary control over the practice and profession of pharmacy and for registration
of pharmacists

• Starting
of revised courses of study for Licentiate Pharmacists, Graduate Pharmacists, Pharmaceutical
Technologies

• Setting
up of Central Drugs Laboratory

• Rigid
enforcement of Drugs and Cosmetics Act 1940 throughout the country

Bhatia committee

• In
1953 under the chairmanship of Major General S.L.Bhatia formed Pharmaceutical
Enquiry committee to enquire into the working of pharmaceutical industry
and to recommend what steps the Govt.
should take to establish it on sound lines to improve the country’s economy

• In
June 1954, 212 recommendations were submitted and most of the recommendations
were implemented

Mudaliar committee

• In
1959 under the chairmanship of Dr. A.Lakshmanaswamy Mudaliar

• Inclusion
of indigenous systems of medicine under the purview of Drugs Act

Hathi committee

• Under the chairmanship of Jaisukh Lal
Hathi to review the various facets of drug industry in India

• Report
covers licensing, price control, imports, QC, role of foreign sector etc

• Encourages development of indigenous
industries

• Controlled the prices of large number of drugs
in public interest

Indian Pharmacopoeia

v Bengal
Pharmacopoeia and General Conspectus of Medicinal Plants – 1844

v 1st
Pharmacopoeia of India – 1868

v British Pharmacopoeia -1885

v Indian Pharmacopoeia Committee – 1948

v The Indian Pharmacopoeia (1^st
Edition) – 1955

v The
Indian Pharmacopoeia (2^nd
Edition) – 1966

v The
Indian Pharmacopoeia (2^nd
Edition) – 1975 – Supplement

v The
Indian Pharmacopoeia (3^rd
Edition) – 1985

v The
Indian Pharmacopoeia (4^th
Edition) – 1996

v The
Indian Pharmacopoeia (5^th
Edition) – 2007

v The
Indian Pharmacopoeia (6^th
Edition) – 2010

v The
Indian Pharmacopoeia (7^th
Edition) – 2014

v The
Indian Pharmacopoeia (8^th
Edition) – 2018

Other acts included were

v Prevention
of food Adulteration act, 1954 and rules.

v The
Industries (Development and Regulations) Act, 1951.

v The
Industrial Employment (Standing order) Act 1946 and rules.

v Industrial
Dispute Act, 1947.

v Factory
Act, 1948.

v The
Indian Patent and Design Act 1970.

v The
Trade and Merchandise Mark, 1958.

v Shops
and Establishment acts of respective states.

Indian Pharmaceutical Industry

Industry background

The Indian pharmaceuticals market increased at a CAGR of
17.46 per cent during 2005-16 with the market increasing from US$ 6 billion in
2005 to US$ 36.7 billion in 2016 and is expected to expand at a CAGR of 15.92
per cent to US$ 55 billion by 2020.

By 2020, India is likely to be among the top three
pharmaceutical markets by incremental growth and sixth largest market globally
in absolute size.

India’s cost of production is significantly lower than that
of the US and almost half of that of Europe. It gives a competitive edge to
India over others.

Issues for the Industry

} Between
2012-2018, the “patent cliff” will wipe an estimated $148 billion off
pharmaceuticals industry revenues due to many drugs coming out of patents

} Rising
cost of R&D, the cost of bringing a molecule to market globally is
estimated to be from $800 million to $4 billion.

} On
average, out of every 10,000 molecules been developed; only one or two are
likely to reach the market.

} Increasing
government pressure, with harsher price controls and taxes.

} European
Medical Agency (EMA) and the US Food and Drug Administration (USFDA) are
focusing on risk management; thereby putting pressures on profitability of
pharmaceutical companies.

} Reaching
the rural market, which is very large in India, the pharmaceutical companies
have to work with innovative marketing and sales tools to reach these markets.

} The
contribution from the government in the areas of health care is not
satisfactory, which is only 1.2 percent of the GDP and healthcare
infrastructure development not up to the expectation in India.

Summary

• To ensure that the patients receive drugs of
required quality, tested and evaluated for safety and efficacy for their
intended result

• Formation
of Central Pharmacy Council and State Pharmacy Council. (PCI)

• Creation
of Drug Control Machinery (DCM)

• Establishment
of well-equipped Central Drug Laboratory, and State Drug Laboratory (CDL)