An Introduction to various Pharmaceutical Legislations
India has a long history of different systems of medicine followed in the country
A- Ayurvedic system of medicine is very ancient in India and is followed even now.
B- Unani or Tibbi system of medicine was introduced in India by Muslim Rulers during 12th – 13th centuries.
C- Homeopathic system of medicine was introduced in India during 16th and 17th century by Portuguese rulers in India.
D- The Modern or so called Allopathic system of medicine was introduced by British Rulers by late 19th and early 20th century.
However
there were no strict acts or Rules and Regulations over the import or
export, manufacture and sale of drugs under any of these types of
medicines until the early 20th century which had resulted in a large
number of adulterated, misbranded, substandard and spurious drugs either
imported or manufactured and sold in the country.
1) The earliest known Act is ‘Opium Act‘of 1857
which was further amended in 1878. This Act was meant for mainly
controlling the interstate and international smuggling of Opium to
prevent its abuse though it is also used for medicinal purpose (this Act
is now deleted).
2) ‘Poisons Act’
of 1919 was implemented to prevent and control the misuse of different
types of poisons meant for destroying or killing household insects,
pests, and also agricultural insects instead started being used for
committing crimes, suicides, etc..
3) ‘Dangerous Drugs Act’ of 1930 -
This Act was implemented by the Central Government to include ‘Opium’,
‘Coca’ and ‘Hemp’ or ‘Cannabis’ to prevent and control the abuse and
illicit trafficking or interstate or international smuggling of these
drugs for recreational purpose at a very high price rather than using
them for medicinal purpose (this act is also deleted now).
4) N.D.P.S Act or Narcotic Drugs and Psychotropic Substances Act 1985 – This
Act was implemented by the Central Government in 1985 in order to
include all three types of narcotic drugs namely ‘Opium’, ‘Coca’ and
‘Hemp’ but also to include a number of naturally and synthetically
produced psychotropic substances meant for the treatment of Psychiatric Disorders
or illnesses which were also started being abused for producing
hallucinogenic affect (a temporary sense of wellbeing) thereby deleting
the earlier ‘Dangerous Drug Act’ of 1930. Stringent Rules and
Regulations with severe punishment for offences were included in this
Act.
5) Drugs And Cosmetics Act 1940 and its rules 1945 – When
Allopathic system of medicine (modern system) was introduced in India
by British Rulers in the late 19th and early 20th century (approximately
by 1880 – 1920), the medicines used in this system for the prevention
and treatment of a large number of diseases like malaria, typhoid,
cholera, plague, etc. prevailing in those days could cure them quickly
and thereby this system became very popular and demand for such
medicines increased to a great extent by the public. This demand led to
the import or manufacture and sale of a large number of adulterated,
spurious, misbranded and substandard drugs in the country. Unfortunately
there were no strict rules and regulations to curb or prevent such
illegal activities in India unlike western countries where there were
already stringent rules over the manufacture and sale of drugs. In the
mean time, the then British Government was forced to constitute a
committee under the chairmanship of Colonel R.N Chopra in 1930 which was
named as ‘Drugs Enquiry Committee’ to look in to the matter and report
the same to the Central Government. Accordingly the Drugs enquiry
Committee carried out a thorough survey throughout the country and
submitted its report in 1931. The report clearly stated the following
points :-
A- The entire country is flooded with all sorts of substandard, adulterated and spurious drugs.
B- The majority of the doctors were quacks.
C- The drugs are distributed and sold by unqualified pharmacists.
D- There is a strong need for an Act to be implemented with strict rules and regulations over the import and export, manufacture, distribution and sale of drugs.
E- There is also a strong need for a separate act to be implemented for uniform education and training for would be Pharmacists including their registration
Accordingly
the Central government implemented The Drugs and Cosmetics Act in 1940
and its rules in 1945 which not only included all the systems of
medicines i.e. Allopathic, Ayurvedic, Unani and Homeopathic systems of
medicines but also cosmetics under the said act.
6) Drugs Price Control Order 1966, 1970, 1979, 1987, 1995, 2011, 2013, 2020 –
When the ‘Drugs and Cosmetics Act’ was implemented in 1940 there was no
cap or control over the wholesale and retail prices for bulk drugs and
finished drugs meant for sale. This loophole in the Act was misused by
many importers and manufacturers of drugs thereby leading to a huge
increase in the prices of drugs sold in the market with a huge/high
profit margin (100% – 500%) for mainly importers and manufacturers and
partly for wholesale and retail dealers also, thereby making it almost
impossible for a common man to purchase high cost drugs. This unhealthy
and unethical practice by the importers and manufacturers forced the
central government to implement ‘The Drugs Price Control Order’ first in
1966 which has been amended several times as mentioned above and a
large number of drugs and medical devices were included in this order so
that these are supplied at a reasonable price to the
customers/patients.
7) Pharmacy Act 1948 – As
mentioned under ‘The Drugs Enquiry Committee’ report of 1931 that there
is a strong need for providing proper education and training for the
pharmacists and also to provide registration of such duly qualified
pharmacists, a separate act is needed to be implemented, the Central
Government accordingly implemented The Pharmacy Act in 1948 to provide
uniform education and training including their registration and also to
regulate and recognise the institutions providing pharmacy education.
8) Drugs and Magic Remedies Act 1954 (D.M.R Act) or Objectionable Advertisements Act –
This Act was implemented by the Central Government in the year 1954 in
order to curb/prevent unhealthy/unethical practice of advertising and
prescribing certain types of ‘drugs’ and ‘magic remedies’ which falsely
claim to possess a miraculous/magical power of curing any type of
diseases (which is unfortunately very common even now in India by quack
doctors, manthriks, tantriks, etc.)
9) Excise Duties Act 1955 or Medicinal and Toilet Preparations Act (M and T.P Act) –
This Act was implemented by the Central Government in 1955 to prevent
the misuse of alcohol and narcotic substances supplied for the
manufacture and sale of drugs and cosmetics at a subsidised price or
with total exemption of excise duty for certain drugs under this act
with strict rules and regulations and severe punishment for offences.
10) Medical Termination of Pregnancies Act 1971 (M.T.P Act) –
This Act was implemented by the Central Government for providing
termination of unwanted pregnancies legally due to various reasons like
failure of contraceptives or negligence during family planning or due to
rape etc. with certain rules and regulations prescribed under this act
for the termination of pregnancy in women.
11) Prevention of Cruelty to Animals Act 1970 –
This act was implemented for preventing unnecessary use of animals for
experimental purpose and also to prevent unnecessary infliction of pain
to animals during their use for experiments or research and to take care
of them properly. Accordingly various guidelines have been prescribed
for using animals under this Act.
12) Indian Patents Act or Intellectual Property Rights Act 1970 - This
Act was implemented by the Central Government by making provisions for
getting a patent or invention to be registered by any individual or a
company who might have invented a new drug and wants to get it patented
or registered in his/company’s name only, so that others don’t claim a
right over such a patented or invented drug.
13) Code of Pharmaceutical Ethics is
framed by the Pharmacy Council of India (P.C.I.) which is also known as
Code of Moral Principles to be followed by a pharmacist in his career.
Such moral principles to be followed by a pharmacist include :-
A- How a Pharmacist should behave himself in relation to his job
B- How he should behave himself with relation to his trade.
C- How he should behave himself in relation to medical profession and
D- How he should behave himself in relation to his own profession.
Though
these ethics are not covered by a legal act, it is the moral principles
which are required to be followed by a pharmacist as expected by P.C.I
in specific and as expected by public in general.
14)
Other than the above mentioned acts, rules and regulations, etc. a
pharmacy student is also expected to learn a lot of information provided
under ‘New Drug Policy’ of 1986, 1991, 1996, etc. and the
‘Pharmaceutical Industries Policy’ of 2012 framed by the central
government in order to have a greater understanding of how the Central
Government is also encouraging the ‘Pharmaceutical Sector’ which is
growing rapidly in India with a huge market potential both in India and
abroad. India had a market share of hardly Rs.10 crores worth of drugs
in 1947 which has now grown to a staggering Rs.1,00,000 crores in
domestic market and at least another Rs.50,000 crores worth of drugs
exported to other countries by 2020.
Drugs Enquiry Committee
When it was brought to the notice of Central Government by eminentpersonalities and NGO’s that the country was flooded with all sorts of
adulterated, spurious and misbranded drugs throughout the country during
the early stages of 20th century, the then British Government was forced to
constitute a committee and named it as Drugs Enquiry Committee under the
chairmanship of Lt. Cl. R.N. Chopra in 1929 to carry out a survey on the drugs
and pharmaceuticals imported, manufactured and sold in India. Accordingly
after an extensive study and survey throughout the country, the Chopra
Committee submitted its report in 1931 and recommended the following
important steps to be taken by the Central Government:-
1) To implement a Central Act to control the import, manufacture and sale
of drugs in India including establishment of Central Drugs Testing
Laboratories for ensuring the quality and standard of Drugs including
establishment of Drugs Technical Advisory Board, Central Drugs Control
Department and State Drugs Control Department for the efficient
implementation of the Act. Accordingly the Drugs and Cosmetics Act was
implemented in 1940.
2) To implement a Central Act for providing uniform education and training
in pharmacy for such candidates to enable them to be qualified
pharmacists and accordingly provide registration for such qualified
pharmacists as “Registered Pharmacists”. Accordingly the Pharmacy Act
was implemented in 1948.
3) To register every drug or medicine imported or manufactured in India.
4) To encourage development of Drugs and Pharmaceutical Industries in
India.
5) To prepare and publish our own Pharmacopia in the name Indian
Pharmacopia.
Accordingly almost all the recommendations of the committee have been
fulfilled by the Government of India.
Health Survey and Development Committee (Bhore Committee)
A lot of complaints were received by public and eminent personalities about
the existing poor Healthcare Delivery System in India during 1940s and to take
necessary steps to improve the Healthcare Delivery System so as to save the
lives of millions of people. Accordingly the then British Government appointed
a committee under the chairmanship of Sir Joseph Bhore to carry out a
thorough survey of the existing Healthcare Delivery System in India at that
time. Bhore Committee made an extensive survey as mentioned above and
made the following recommendations to the Central government:-
1. Integration of preventive and curative services at all administrative
levels.
2. Development of Primary Health Centres in 2 stages:
a) Short-term measure – one Primary Health Centre was 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. The first was established in 1952.
Secondary health centres were also envisaged to provide support to
PHCs, 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.
3. Major changes in medical education which included 3 months training in
preventive and social medicine to prepare "social physicians".
4. Abolition of the Licentiate in Medical Practice (etc) qualifications and
their replacement by a single national standard Bachelor of Medicine
and Bachelor of Surgery (MB BS) 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).
6. Major changes in nursing, pharmacy and other paramedical courses to
deliver healthcare properly and the best quality drugs to be supplied at
free of cost or at very reasonable prices to the poor patients.
Implementation
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 with a tremendous improvement in Medical,
Nursing and Pharmacy Education which in turn helped in providing proper
Healthcare Service to millions of people in India.
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 with a tremendous improvement in Medical,
Nursing and Pharmacy Education which in turn helped in providing proper
Healthcare Service to millions of people in India.
Mudaliar Committee
This committee known as the “Health Survey and Planning Committee”,headed by Dr. A.L. Mudaliar, was appointed to assess the performance in
health sector since the submission of Bhore Committee report. This committee
found the conditions in PHCs to be unsatisfactory and suggested that the PHC,
already established should be strengthened before new ones are opened
Strengthening of sub divisional and district hospitals was also advised. It was
emphasised that a PHC should not be made to cater to more than 40,000
population and that the curative, preventive and promotive services should be
all provided at the PHC. The Mudaliar Committee also recommended that an
All India Health service should be created to replace the erstwhile Indian
Medical service.
The committee also recommended strengthening of existing primary health
centres; community health centres and district hospitals so that they can act as
good referral centres accordingly to appoint sufficient number of qualified
doctors, nurses, pharmacists and other paramedical personnel in all these
hospitals.
Though most of the recommendations of the Mudaliar Committee have been
implemented by the Central and State Governments, we are still far behind the
expected goal of providing better healthcare service especially to the poor and
needy people.
Hathi Committee
In the context of large-scale expansion of the drugs and pharmaceuticalsindustry, with a view to ensuring the regulated and rapid growth of drug
manufacture and further with a view to ensuring that all essential drugs are
made available to the consumers at reasonable prices, Government
constituted a Committee in February, 1974. 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. 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.
The report of this committee which was submitted in 1975 covered all aspects
of Drugs and Pharmaceuticals in India ranging from import, manufacture, sale,
licensing, quality control and the role of Foreign Sector in the Pharmaceutical
Industries. The report was an important landmark in the development of
Pharmaceutical Industries in India leading to sufficient supply and availability
of all the drugs including Essential and Lifesaving medicines of best quality on a
continuous basis at controlled prices in the interest of the consumer. The
Licensing and Approval procedures were also simplified and hence we are
almost self-sufficient in the manufacture and supply of drugs as of today.
Examples: - Blood Bag Sachets, Platelet Storage Containers, Breast Implants,
Examples:- Testing Reagents, Reagent products, Calibration Materials, Testing
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.
The report of this committee which was submitted in 1975 covered all aspects
of Drugs and Pharmaceuticals in India ranging from import, manufacture, sale,
licensing, quality control and the role of Foreign Sector in the Pharmaceutical
Industries. The report was an important landmark in the development of
Pharmaceutical Industries in India leading to sufficient supply and availability
of all the drugs including Essential and Lifesaving medicines of best quality on a
continuous basis at controlled prices in the interest of the consumer. The
Licensing and Approval procedures were also simplified and hence we are
almost self-sufficient in the manufacture and supply of drugs as of today.
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