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.