Pharmaceutical legislations

1. Pharmaceutical Legislations

2. Pharmaceutical Legislations
• A brief review and Introduction,
• Study of drugs enquiry committee,
• Health survey and development committee,
• Hathi committee and
• Mudaliar committee
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3. Legislation
■ Legislation is law which has been promulgated (enacted) by a legislature or other governing
body or the process of making it.
■ Law intends for regulation and control of various aspects of life.
■ These aspects might be social, economical and political.
■ Pharmaceutical legislation is a mixed legislation, which overlappingly covers both social and
economic aspects.
■ Types of Legislation.
■ There are four basic types of legislation that are handled by Parliament.
■ They include bills, simple resolutions, joint resolutions and concurrent resolutions.
■ A bill is the most common type of legislation and can be either permanent or temporary.
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4. Objective
■ To ensure that the patients receive drugs of required quality, tested
and evaluated for safety as well as efficacy for their intended use.
■ Pharmaceutical legislation is associated with the health of the society.
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5. A brief review
■ In 1811 first chemist shop opened by Mr. Bathgate, who came to India with East India
company in Calcutta.
■ In 1910 they have started manufacture of tincture and spirits.
■ In 1821 another firm, Smith Stanistreet and Co. started apothecary shop and started
manufacturing in 1918.
■ In 1901 Bengal Chemical and Pharmaceutical works,
a small factory was started in Calcutta by Acharya P.C. Ray.
■ In 1903 Prof. T. K. Gajjar opens a small factory at Parel for the development of
Pharmaceutical units and Alembic chemical works Ltd. at Baroda.
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Apothecary: a person who prepared and sold medicines and drugs

6. A brief review
■ These units were not sufficient to fulfil the need of Indian public. Hence most of
the medicines were being imported from abroad mainly UK, France and Germany.
■ In first world war the need was changed, cheaper drugs were imported from
abroad.
■ Demand of indigenous drug was also improved.
■ Competition becomes unhealthy and Indian marked flooded with inferior,
substandard and even harmful drugs.
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7. A brief review
■ By considering this issue, public made the government to take a notice of such situation of
drug trade and industry and think of introducing an effective legislation to control,
manufacture, distribution and sales of drugs.
■ The Opium Act, 1878, the poison act 1919 and the dangerous drugs act, 1930 were in force.
■ The government of India in pursuance to 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. This committee published its report in 1931. It was reported that
there was no recognized specialized profession of Pharmacy.
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8. A brief review
■ A set of people known as compounders were filling the gap. Just after
the publication of the report Prof. Mahadeva Lal Schroff (1902-1971 or
rightly called as Prof. M. L. Schroff is renowned for the title of pioneer
and father of Indian Pharmacy Education) 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.
■ All India Pharmaceutical Congress Association was established in 1940.
■ The Pharmaceutical Conference held its sessions at different places to
publicize Pharmacy as a whole.
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9. A brief review
■ 1937: Government of India brought ‘Import of Drugs Bill’; later it was withdrawn.
■ 1940: Government 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’.
■ 1941: The first Drugs Technical Advisory Board (D.T.A.B.) under this act was constituted.
■ Central Drugs Laboratory was established in Calcutta 1945: ‘Drugs Rule under the Drugs Act of
1940’ was established.
■ The Drugs Act has been modified from time to time and at present the provisions of the Act cover
Cosmetics and Ayurvedic, Unani and Homeopathic medicines in some respects.
■ 1945: Government brought the Pharmacy Bill to standardize the Pharmacy Education in India,
■ 1946: The Indian Pharmacopoeial List was published under the chairmanship of late Col. R. N.
Chopra. It contains lists of drugs in use in India at that time which were not included in British
Pharmacopoeia.
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10. A brief review
■ 1948: Pharmacy Act 1948 published.
■ 1948: Indian Pharmacopoeial Committee was constituted under the chairmanship of late Dr. B. N.
Ghosh.
■ 1949: Pharmacy Council of India (P.C.I.) was established under Pharmacy Act 1948.
■ 1954: Education Regulation have come in force in some states but other states lagged behind.
■ 1954: Drugs and Magic Remedies (Objectionable Advertisements) Act 1954 was passed to stop
misleading advertisements (e.g. Cure all pills).
■ 1955: Medicinal and Toilet Preparations (Excise Duties) Act 1955 was introduced to enforce
uniform duty for all states for alcohol products.
■ 1955: First Edition of Indian Pharmacopoeia was published.
■ 1985: Narcotic and Psychotropic Substances Act has been enacted to protect society from the
dangers of addictive drugs. Government of India controls the price of drugs in India by Drugs Price
Order changed from time to time.
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11. Study of Drugs Enquiry Committee (DEC)
■ This committee was appointed by Indian Government in 1931.
■ A Committee chairman was Lt. Col. R. N. Chopra.
■ This committee is also called as DEC or Chopra committee.
■ The committee was asked to make enquiries in the said matter and
then to make recommendations for smooth control of manufacture,
import, distribution and sale of drugs in the interest of public health.
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12. Reasons for formation of Chopra Committee
■ Units were not sufficient to fulfil 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.
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13. Indigenous Medicine
■ Indigenous medicine is the sum total of the knowledge, skills, and practices based
on the theories, beliefs, and experiences indigenous to native cultures, whether
explicable or not, used in the maintenance of health as well as in the prevention,
diagnosis, improvement or treatment of physical and mental illness including, but
not limited to alternative, complementary, holistic, and integrative approaches.
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14. Recommendations of Drug Enquiry Committee
■ 90 recommendations with report was submitted by the committee.
■ Important Recommendations:
– Formation of Central Pharmacy Council and State pharmacy council which would look
after the education and training of professionals. Councils would maintain the register
containing names and addresses of the registered pharmacist.
– Creation of drug control machinery (Departments) at the centre and branches in all
states.
– Establishment of a well-equipped Central Drug Laboratory (CDL) at Kolkata with
competent staff and experts for an efficient and speedy working of Drug Control
Department. Small laboratories would work under its guidance.
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15. Implementations
• Due to Second World War in 1939, there was delay in introduction of the legislation.
• Government was reluctant to implement the recommendations of DEC, and the
public was pressurizing the government.
• Finally, an Import of Drug Bill was introduced in 1937.
• This bill dealt with only import of drugs and manufacturing and sale of drugs was
not included.
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16. 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 drug act was amended many times and at
present it covers the provisions related to Drugs, Cosmetics, Ayurvedic, including 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.
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17. Scope and Objective
• 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.
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18. Other acts included were
• Prevention of food Adulteration act, 1954 and rules.
• The Industries (Development and Regulations) Act, 1951.
• The Industrial Employment (Standing order) Act 1946 and rules.
• Industrial Dispute Act, 1947.
• Factory Act, 1948.
• The Indian Patent and Design Act 1970.
• The Trade and Merchandise Mark, 1958.
• The Epidemic Disease Act, 1897.
• Shops and Establishment acts of respective states.
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19. Overview of Outcomes of DEC
• Enactment of Import of Drugs Bill 1937.
• Drugs and Cosmetic Act 1940 and Rules 1945.
• Pharmacy Act 1948
• Drugs and magic remedies (objectionable advertisement) Act 1954 and Rules 1955.
• Medicinal & Toilet Preparations (Excise Duties) Act 1955 and Rules 1956.
• Publications of first edition of Indian Pharmacopoeia in 1st edition 1955 based on British
pharmacopoeia 1948.
• 1st Edition – 1955, 2nd Edition – 1966, 3rd Edition – 1985, 4th Edition – 1996,
5th Edition – 2007, 6th Edition – 2010, 7th Edition – 2014, 8th Edition – 2018.
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20. Health Survey and Development Committee
• This committee, known as the Health Survey and Development Committee,
was appointed in 1943 with Sir Joseph Bhore as its Chairman.
• It laid emphasis on integration of curative and preventive medicine at all
levels.
• It made comprehensive recommendations for remodelling of health services
in India.
• Aim: The major aim of the committee was to survey then existing position
regarding the health conditions and health organisation in the country and to
make recommendations for future development, in order to improve
the public health system in India.
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21. Guiding principles adopted
• No individual should be denied to secure adequate medical care because of
inability to pay,
• Facilities for proper diagnosis and treatment,
• Health programme must lay special emphasis on preventive work,
• As much medical relief and preventive health care should be provided to the
vast rural population.
• Health services should be located close to the people to ensure maximum
benefit to the community.
• Doctor should be a social physician protecting the people.
• Medical services should be free to all, without distinction.
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22. Observations made by the Bhore Committee
• Health status of the country as indicated by various indicators was poor,
• Mortality rates were very high,
• Life expectancy at birth was about 27 years,
• Incidence of communicable diseases was very high,
• Many of the health problems were preventable,
• Committee stated that health and development are interdependent,
• Improvement in sector other than health will also lead to improvement in health like
water supply, sanitation improvement, nutrition, elimination of unemployment.
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23. Recommendations by Bhore Committee
submitted in 1946
1. Integration of preventive and curative services of all administrative levels.
2. Development of Primary Health Centres in 2 stages including Short-term measure and long-term
measures.
3. Major changes in medical education which includes 3 month training in preventive and social
medicine to prepare “social physicians”.
4. Abolition of the Licentiate in Medical Practice qualifications and their replacement by a single
national standard Bachelor of Medicine and Bachelor of Surgery (MBBS) degree.
5. Creation of a major central institute for post-graduate medical education and research: which was
achieved in 1956 with the All-India Institute of Medical Sciences (AIIMS).
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24. Development of Primary Health Centres in 2 stages
a. Short-term measure: One primary health centre as suggested for a population of 40,000.
Each PHC was to be manned by 2 doctors, one nurse, four public health nurses, four
midwives, four trained dais, two sanitary inspectors, two health assistants, one
pharmacist and fifteen other class IV employees. Secondary health centre was also
envisaged to provide support to PHC, and to coordinate and supervise their functioning.
b. A long-term programme: Also called the 3 million plan) of setting up primary health
units with 75 – bedded hospitals for each 10,000 to 20,000 population and secondary
units with 650 – bedded hospital, again regionalised around district hospitals with 2500
beds.
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25. Implementation of recommendations
of Bhore Committee
■ The proposals of the committee were accepted in 1952 by the government of newly
independent India. Though most of the recommendations of the committee were
not implemented at the time, the committee was a trigger to the reforms that
followed.
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26. Outcomes of Bhore Committee
■ The committee was instrumental in bringing about the public health reforms
related to peripheral health centres in India.
■ Primary Health Centres were built across the nation to provide integrated
promotive, preventive, curative and rehabilitative services to entire urban as well as
rural population, as an integral component of wider community development
programme.
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27. Significance and Importance of
Bhore Committee Report
■ Important landmark in public health in India.
■ Initiated the concept of integrated development and comprehensive
health care.
■ Idea of primary health care.
■ The three-tier pattern of health care services.
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28. Hathi Committee
■ Government of India constituted a Committee on 08-02-1974 consisting of 15
members under the chairmanship of Mr. Jaisukhlal Hathi.
■ The purpose was to take comprehensive look into the drug industry and to enquiry
in to the various facets of drugs in India.
■ After conducting various meetings, the committee submitted its report in the year
1975.
■ The report of this committee covered all aspects ranging from licensing, price
control, imports, role of foreign sector and quality control.
■ It encouraged the development of indigenous industries, it also further controlled
price of a large number of drugs in the interest of the consumer.
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29. Hathi Committee
■ Health is a fundamental human right.
■ The Constitution of India directs the State to regard the improvement of public
health as among its primary duties.
■ The Five-Year Plan have been providing the framework within which the Centre
and States have developed their health services infrastructure and programmes.
■ The National Health Policy of 1983 marks a significant step in the national
endeavour to improve public health.
■ It reiterates India’s commitment to the goal of “Health for all by the year 2000
A.D.” through the universal provision of comprehensive primary health care
service.
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30. Hathi Committee
■ The attainment of this goal requires an accelerated development of all inputs to
the health care system, including essential and lifesaving drugs and vaccines of
proven quality.
■ Drugs alone are not sufficient to provide health care.
■ However, if rationally used, they do play an important role in protecting,
maintaining and restoring the health of the people and in controlling population.
■ The Indian Pharmaceutical Industry has, therefore, a vital role in serving the basic
health needs of the people.
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31. Hathi Committee
■ The Report of the Hathi Committee (1975) is an important landmark in the
development of the Indian Pharmaceutical Industry.
■ The Hathi Committee emphasized the achievement of self-sufficiency in
medicines and of abundant availability at reasonable prices of essential
medicines.
■ Since 1975, the Indian Pharmaceutical Industry has grown to be the most
diversified and vertically integrated pharmaceutical industry in the entire Third
World.
■ The country has achieved self-sufficiency in formulations and also in a large
number of bulk drugs.
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32. Mudaliar Committee
■ Government of India appointed a ‘Health Survey and Planning committee’ in 1959
towards the end of the 2nd five-year plan to assess the state of the healthcare field
and to measure the progress achieved after implementing the suggestions of the
Bhore committee of 1946.
■ Dr. A. L. Mudaliar was the chairman of the committee. The committee submitted its
report in 1962.
■ It was appointed to assess the recommendations of Bhore Committee and to
suggest the action plan to implement the same.
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33. Mudaliar Committee
■ It recommended that Primary Health Centre should provide with all three public health
care services namely curative, preventive and promotive services.
■ Each Primary Health Centre would cater to population of 40,000 as suggested by Bhore
Committee.
■ It also suggested that one health worker should be appointed for every 10,000 persons.
■ “All India Health Service” body should replace the earlier “Indian Medical Service”.
■ The Committee felt that existing Private Health Centres should be improved before new
ones were opened.
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34. Mudaliar Committee
The committee found out that the level of healthcare provided was unsatisfactory and gave the following
recommendations
■ Consolidation of advances made in the first two five-year plans,
■ Create an ‘All India Health service’ similar to ‘Indian Administrative service’,
■ Strengthening of the district hospital with specialist services to serve as central base of regional services,
■ 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 and health officers.
■ Each primary health centre not to serve more than 40,000 population,
■ To improve the quality of health care provided by the primary health centres,
■ Integration of medical and health services recommended by the Bhore Committee; and constitution of an All
India Health Service on the pattern on Indian administrative service.
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