Pharmaceutical Legislation In India
The Purpose of Pharmaceutical Legislation In
India
The purpose of Pharmaceutical Legislation is to
guarantee that patients obtain medications that have been examined and assessed
for both safety and effectiveness according to their intended purpose. This
indicates that Pharmaceutical Legislation is closely linked to the well-being
of the community.
Historical Origin
In approximately 1811, a chemist's shop was established
in India by Mr. Bathgate, who arrived in the country as part of the East India Company
stationed in Calcutta. Progressing a century further, around 1910, this
enterprise initiated the production of tinctures and spirits.
In a parallel vein, another business named Smith
Stanistreet and Co. founded an apothecary shop in 1821, subsequently venturing
into manufacturing in 1918. Bengal Chemical and Pharmaceutical Works, a modest
factory, commenced operations in Calcutta in 1901 under the guidance of Acharya
Prafulla Chandra Ray. Concurrently, in 1903, Professor T. K. Gajjar spearheaded
the establishment of a small factory in Parel, which subsequently catalyzed the
growth of additional pharmaceutical entities such as the Alembic Chemical Works
Ltd. in Baroda. However, these undertakings proved inadequate to satisfy the
healthcare needs of the Indian populace. During that era, the majority of
medicinal products were imported from overseas, primarily the United Kingdom,
France, and Germany.
The situation underwent transformation with the advent
of the First World War. This period witnessed the importation of more
affordable drugs from foreign sources, alongside escalating demands for
domestically produced medications. Indigenous and foreign companies engaged in
competition, striving to manufacture more economical alternatives to imported
drugs. Consequently, this scenario bred cutthroat competition, flooding the
Indian market with substandard, low-quality, and even hazardous drugs. Responding
to this concern, the public impelled the government to address the alarming
state of the pharmaceutical trade and industry, urging the implementation of effective
regulations governing the import, production, distribution, and sale of drugs.
Although the Opium Act of 1878, the Pia Act of 1919,
and the Dangerous Drugs Act of 1930 were already in place, they proved
insufficient in comprehensively regulating the chaotic and undesirable
conditions prevailing at the time. Hence, as the 20th century commenced, the
pharmacy profession lacked substantial legal oversight. As the pharmaceutical
sector expanded rapidly and the market burgeoned, the necessity for more
comprehensive legislation became evident. Thus, with the intent of formulating
all-encompassing regulations, the Indian government embarked on a mission to
develop comprehensive legislation.
An 'Investigative Committee on Pharmaceuticals' was
established in 1931, led by Lt. Col. R. N. Chopra (referred to as the Chopra
Committee or D. E. C.). The primary purpose of this committee was to conduct
inquiries and provide suggestions to effectively oversee the production,
importation, distribution, and vending of drugs, prioritizing public health.
The committee's recommendations are outlined as follows:
Recommendations
In their comprehensive report consisting of
approximately 90 proposals, the following notable recommendations were made:
1. The formation of a Central Pharmacy Council and
Provincial Pharmacy Councils was suggested, entrusted with the responsibility
of supervising the training and education of professionals within the
pharmaceutical sector. These councils would curate a registry featuring the
names and details of Registered Pharmacists.
2. The Drugs Enquiry Committee emphasized the
establishment of centralized drug control bodies at the national level, with
corresponding branches in each state to regulate pharmaceutical operations.
3. The committee also advised the establishment of a
well-equipped Central Drug Laboratory (CDL), staffed by proficient personnel
and experts, to ensure the efficient functioning of the Drug Control
Department. Smaller laboratories were advised to function under the guidance of
the Central Drug Laboratory.
Due to the onset of World War II in 1939, the
implementation of legislation based on the Drugs Enquiry Committee's
recommendations faced delays, despite being deemed urgent by the Indian
Government. This prompted increased public demand and pressure for the
recommendations to be executed.
Eventually, an 'Import of Drugs Bill' was introduced in
the Legislative Assembly in 1937, focusing on the regulation of drug imports.
The Government chose to refer the Bill to a Select Committee. However, the Bill
was limited in scope, addressing only the importation aspect while sidestepping
the issues surrounding drug manufacture and sale. Consequently, the Select
Committee advocated for a comprehensive legislative approach encompassing not
only import controls but also the regulation of drug production, sale, and
distribution within the nation.
