Amity Institute of Pharmacy

Amity Institute of Pharmacy

B.Pharm, V Sem

Pharmaceutical Jurisprudence
Module V (Part I)

Pharmaceutical Legislations
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Pharmaceutical Legislations
History
• The manufacture of modern drugs in India started by the end of the 19th century.

• During 1920-1930 a number of reports of harmful substitutes and adulterants were

identified to be marketed in place of genuine drugs.

• In the early part of the 20th century, there was practically no legislative control on drugs
as well as on the profession of pharmacy.

• There was no control over the manufacturing sale and distribution of drugs in India. As
there were no restrictions on the quality of drugs that were being imported, manufacturers
abroad took advantage and flooded the Indian markets with adulterated & spurious drugs.
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• Although the Opium Act-1878, the poison act-1919 and the dangerous drugs act-1930
were enforced but these were specific in nature and were inadequate in controlling the
chaotic conditions prevailing at that time.

• In 1927, a resolution was passed by the council of states to recommend to the Governor
General in Council to take immediate steps to control the indiscriminate use of drugs and
to legislate for the standardization of the preparation and sale of drugs.

• The government of India in pursuance of the resolution appointed a committee known as

the Drugs Enquiry Committee in 1928.

• Government of India on 11th August 1930, appointed a committee under the

chairmanship of Late Col. R.N. Chopra to see into the problems of Pharmacy in India and
recommend the measures to be taken.
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• This committee published its report in 1931.

• It was reported that there was no recognized specialized profession of Pharmacy. A set of
people known as compounders were filling the gap.

• Just after the publication of the report Prof. M. L. Schroff initiated

pharmaceutical education at the university level in the Banaras Hindu
University.

• In 1935 United Province Pharmaceutical Association was established

which later converted into Indian Pharmaceutical Association.

• The Indian Journal of Pharmacy was started by Prof. M.L. Schroff in

1939.
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• All India Pharmaceutical Congress Association was established in 1940.

The Pharmaceutical Conference held its sessions at different places to
publicize Pharmacy as a whole.

• Govt. brought ‘Drugs Bill’ to regulate the import, manufacture, sale and
distribution of drugs in British India. This Bill was finally adopted as
‘Drugs Act’ of 1940.

• The Drugs Act has been modified from time to time and at presents the provisions of the
Act cover Cosmetics and Ayurvedic, Unani and Homeopathic medicines in some respects.

• The present Drug and Cosmetic Act 1945, 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.
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Important milestones in drug legislation in India

 The Poisons Act – 1919

 The Drugs Act – 1940
 The Drugs and Cosmetics Act - 1945
 The Pharmacy Act – 1948
 Drugs & magic remedies act - 1954
 Medicinal & Toilet Preparation Act – 1955
 Prevention of Cruelty to Animal Act – 1960
 Indian Patent Act – 1970
 Narcotic & Psychotropic Substances Act – 1985
 Drug price control order – 1995
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Drugs Enquiry Committee/Chopra Committee

The government of India appointed a committee called as the Drug Enquiry Committee
under the Chairmanship of Col. R.N. Chopra on 11th August 1930 to study the issues
related to the profession of pharmacy and its various aspects in India.
This Drug Enquiry Committee was later known by the name ‘Chopra Committee’.

Some of the recommendations of the Chopra committee are as follows:

• This committee recommended development of Central & State Pharmacy council whose
function was to look after the training and education of pharmacy professionals and also
maintain the register containing the name and the address of the registered pharmacist.

• The drug control machinery departments at the centre and branches in all states were
recommended by this committee.
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• The committee also proposed the need for a well-equipped Central Drug Laboratory
(CDL) with well-qualified staff and experts.

• The committee suggested appointing an advisory board to advise the government in

making rules to carry out the objectives of the Act.

• Framing the academic curriculum for educating pharmacy students and also providing
training for them to become registered pharmacists.

• The committee provided a basis for registration of patent and proprietary medicines
manufactured in India or imported from outside the country.

• Inclusion of drug products used in indigenous systems and crude drugs of plant and
animal origin.
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• Pharmaceutical industry development plans in India.

• The committee also suggested compiling Indian Pharmacopoeia.

Actions are taken by Government on the Chopra Committee Recommendations:

The following pharmaceutical legislation and actions of the central government can be traced
to the above said recommendations:
• Passing Drugs Act in 1940 for regulating the import, manufacture, distribution, and sale of
drugs. The Drugs Rules were framed in 1945 to give effect to the provisons of the Act.

• In 1948, Pharmacy Act framed regulations for prescribing minimum educational

qualifications for the profession and practice of pharmacy.
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• Government drug testing laboratories were setup both in State and Central level.

• Establishment of Government advisory boards such as the Drugs Technical Advisory

Board (DTAB) and Drugs Consultative Committee (DCC).

• Drugs and Medicines of Indigenous system of medicines have been brought under the
control of Drugs Act, 1940.

• Registration of all the drugs and formulations that are sold in India.

• Official Indian Pharmacopoeia was developed.

• The Drugs and Magic remedies Act in 1954, Medicinal and Toilet preparations Act in 1955
and Narcotic Drugs and Psychotropic Substances (NDPS) Act in the year 1985 were
implemented.
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Health Survey and Development Committee/ Bhore

Committee
• The Health Survey and Development Committee under the chairmanship of Sir Joseph
Bhore (Bhore Committee) was set up in 1943 and published its report in 1946.

• The aim was to survey then existing position regarding the health condition and health
organization in the country and to make recommendations for future development in order
to improve public health.

• An important recommendation of the Bhore Committee was to have an enactment (Act)

with the objective of raising the interests of qualified pharmacists and thereby protect the
interests of public.

• It was made as the committee found that incompetent people were handling drugs and
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• The Bhore Committee suggested that the profession of pharmacy should be reserved for
the pharmacists and the pharmacists should restrict their work to the professional activities
of their profession.

• It was also suggested that pharmacists should not be permitted to undertake functions like
prescribing medicines and administration of anaesthetics.

• The committee also recommended for a revision of the pharmacy education in the country
as the standard of training for those entering into the practice of pharmacy was
unsatisfactory.

• An All India Pharmaceutical Council and Provisional Pharmaceutical Council was

established in order to represent the pharmaceutical trade, education, and other
pharmaceutical interests.
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The following recommendations were made:

• Integration of preventive and curative services at all administrative levels.
• Development of Primary Health Centres (PHC) in 2 stages:
1. Short-term measure – one PHC was suggested for a population of 40,000. Each PHC
was to be staffed by 2 doctors, 1 nurse, 4 public health nurses, 4 midwives, 4 trained
dais, 2 sanitary inspectors, 2 health assistants, 1 pharmacist and 15 other class-4
employees. The first was established in 1952. Secondary health centres were also
proposed to provide support to PHCs and to coordinate and supervise their
functioning.

2. A long-term programme – setting up primary health units with 75 – bedded hospitals

for each 10,000 to 20,000 population and secondary units with 650 – bedded
hospitals, again regionalised around district hospitals with 2500 beds.
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• Major changes in medical education which included 3 months of training in ‘preventive

and social medicine’ to prepare "social physicians".

• Abolition of the Licentiate in Medical Practice (etc) qualifications and their replacement
by a single national standard MBBS degree.

• Creation of a major central institute for PG medical education and research: which was
achieved in 1956 with AIIMS.

• Enactment of legislation designed to protect the public from incompetence, to safeguard

the interests of qualified pharmacists and to raise the professional standard of
pharmacists engaged in the handling of drugs.
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• Measures for registration of pharmacists.

• Measures for maintaining disciplinary control over the practice and profession of
pharmacy.

• Starting of revised courses of study for: Licentiate Pharmacists, Graduate Pharmacists,

Pharmaceutical Technologists

• Setting up of Central Drugs Laboratory.

• The Drug Act 1940 should be brought under operation throughout the country and rigidly
enforced.

• The question of the requirement of the country in the drugs and of the medical requisites
should be examined by a small committee.
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• Based on the recommendations of the Chopra Committee and the interim findings of the
Bhore Committee, the Government of India brought forth the Pharmacy Bill in 1945 and
after three years of continuous efforts and discussions at various levels, it took the shape
of the Pharmacy Act 1948.

• The first Pharmacy Council of India was constituted in 1949 under the provisions of the
Pharmacy Act.

• It was provided in the Pharmacy Act that within three years of its
coming into force, the States should constitute their Pharmacy
Councils and within three years of that the Education Regulations
would take effect.

• However, many states took their own time to constitute the Pharmacy
Councils.
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Health Survey and Planning Committee/ Mudaliar committee

• This committee was appointed in June 1959 under the chairmanship of Dr. A.
Lakshmanswamy Mudliar and this committee was also known as Health Survey and
Planning Committee.

• To access the state of the healthcare field and to measure the progress achieved after
implementing the suggestions of the Bhore committee of 1946.

• It recommended the inclusion of indigenous systems of medicine under the supervision

of the Drugs Act. Based on its recommendations, drugs prepared according to indigenous
systems of medicine were brought within the purview of Drugs and Cosmetics Act, 1945.

• The committee submitted its report of recommendations in 1961.

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Objectives
• To assess the performance in health sector since the submission of Bhore Committee
report.
• To evaluate the progress made in the first 2 plans.
• To make recommendations for the future path of development of health services.

The report of the committee recorded that the disease control programmes had some
substantial achievements in controlling certain virulent epidemic diseases.

This committee found the conditions in PHCs to be unsatisfactory.

Most of the PHC's were understaffed, large numbers of them were being run by Auxiliary
nurse midwifes or public health nurses in-charge.
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The Committee was sub-divided into different sub-committees to deal with different
subjects like:
1. Medical care
2. Public health
3. Control of communicable diseases
4. Population control
5. Professional education and research.
6. Indigenous system of medicine
7. Drugs and medical supplies
8. Legislation
9. Health administration
10. Medical research
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Recommendations
• Consolidation of advances made in the first two five years plans.
• Strengthening of the district hospitals with specialist services to serve as central base of
regional services.
• Strengthening existing primary health centres rather than creating new ones.
• Regional organizations in each state between the headquarters organization and the
district in charge of a Regional Deputy or Assistant Directors-each to supervise 2 or 3
district medical or health officers.
• Each PHC not to serve more than 40000 populations.
• To improve the quality of health care provided by PHC.
• Integration of medical and health services.
• Constitution of an All India Health service on the pattern of Indian Administrative
Services.
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• To solve the population problem, family planning services provided to the people.
• Strengthening of educational & propaganda aspects of family planning movement. Each
& every health worker should be oriented in method of family planning.
• One medical college at least 5 million population.
• Teacher –students ratio should be 1:5 in medical colleges.
• An integrated method of teaching involving professors of both clinical & para-clinical
subjects.
• A research unit in every medical college should be set up and one statistics unit in every
research institute.
• Universities should accept the standard laid down by Indian Medical Council.
• Registration is a must before starting the medical practice.
• Health Administration: At the Central level, State level and District level.
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Hathi Committee
• The government constituted a Committee in February 1974 to monitor various factors of
the drug industry in order to promote the growth of the drug industry.

• The government constituted this Committee in the context of large-scale expansion of the
drugs and pharmaceuticals industry, with a view to ensuring the regulated and rapid
growth of drug manufacture and further all essential drugs are made available to the
consumers at reasonable prices.

• This committee consists of 15 members under the chairmanship of Mr. Jaisukhlal Hathi,
which had Members of Parliament along with officials and non-officials as members, to
enquire into various facets of the drugs industry in India.
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• The terms of reference included progress made and status achieved by the industry, role
of public sector, growth of indigenous industry, including the small scale, technological
requirements, quality control measures, pricing of drugs etc.

• Almost all the aspects of the drugs and pharmaceutical industry were critically examined
by Hathi Committee with a view to achieve self-sufficiency and to serve the national
interest.

• After conducting various meetings, the committee had submitted its report in the year
1975.

• The report contained 224 recommendations spread over 8 chapters on various aspects of
pharmaceutical Industry.
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Recommendations
• It recommended measures to ensure that the public sector achievers a leadership role in
the manufacture of basic drugs, formulations and in R&D.

• It recommended measures to support the growth of the drug industry, especially that of
the Indian and small-scale industrial sectors.

• It examined the arrangements for the flow of new technology into the industry and make
necessary recommendations.

• It recommended measures for effective quality control of the drugs and for helping the
small-scale units.
• Recommended selective price control on prices of drugs.
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• Examined the step taken to decrease the price for the consumer and to recommend more
such measures to rationalize the prices of basic drug formulations.

• Committee recommended providing information related to production, stock, costs, sales

on a regular basis to allow the govt. to act in an efficient and rapid way.

• Recommended developing an effective and continuing monitoring system for the

industry in order to attain the essential objectives.

• The thrust of recommendations related to re-emphasizing the leading role for the public
sector.

• Recommended setting up of National Drug Authority.

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• Build up Testing facilities for combined food and drugs and centres should assist finance.

• Legal-cum-intelligence cell for Spurious drugs, adulterated drugs etc.

• States should have adequate no of Inspectors with a proper salary, sufficient to attract
good talents and they should have proper knowledge of preparations of injectables,
antibiotics, vaccines, sera etc.

• Drug Advisory Board shall be constituted comprising representative from medical

profession, police dept, social workers, industry and trade.

• Recommended preference to the Indian Sector over the foreign sector.

• It encouraged the development of indigenous production of raw materials.
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REFERENCES

• Agarwal SP and Khanna R., Pharmaceutical Jurisprudence and Ethics, 5th ed, reprint.
New Delhi: Birla Publications Pvt. Ltd., 2005.

• Jain NK, A text book of Forensic Pharmacy, 8th ed, reprint. Delhi: Vallabh Prakashan;
2014.

• Mithal BM, A text book of Forensic Pharmacy, 10th ed, reprint. Delhi: Vallabh
Prakashan; 1998.