Tiêu đề 1. PHARMACEUTICAL LEGISLATIONS – A BRIEF REVIEW.pdf ✅

PHARMD GURU Page 1 INTRODUCTION:  Law can be defined as a rule of action established by authority, nation or a State.  It regulates and controls the various aspects of social life leading to social, economical and political legislations.  In ancient time, there were no written laws for the society and the Indian society was governed by traditions and social customs.  Even in the area of drugs and pharmaceuticals, the effective law did not exist then in India.  The drugs of vegetable, animal and mineral sources were empirically prepared and no any scientific system of development, standardization, storage and usage of drugs was present.  In the absence of any law, the practice of manufacturing of substandard, spurious, adulterated and even impotent drugs was prevalent in India. Thus, the need of pharmaceutical legislation was felt.  Pharmaceutical legislation is a legislation which covers various laws enacted from time to time by the Government for the regulation of education, practice and pharmaceutical industry for promoting health care system and safeguarding public health. Thus, it is concerned with the social, economical and health aspects of the society. OBJECTIVES: The main objective of the pharmaceutical legislation is to ensure that the patient receives the required quality of drug which is previously tested and evaluated for its safety and efficacy. In addition to this, other objectives of the pharmaceutical legislation are: 1. To promote the health care system by regulating the manufacture and supply of good quality drugs PHARMACEUTICAL LEGISLATIONS – A BRIEF REVIEW
PHARMD GURU Page 2 2. To regulate the profession and business of pharmacy 3. To safeguard the public from such advertisements of drugs that makes false claim for the drug or gives the misleading information about the drug 4. To promote the indigenous research technology and 5. To control the prices of drugs. HISTORICAL BACKGROUND:  Indian system of medicine along with Unani system started to decline with the advent of Allopathic system, which came in India with East India Company in 19th century.  In India, the first Chemists shop was started by Mr. Bathgate who came along with the East India Company in 1811. This unit started the manufacturing tinctures and spirits in 1910.Acharya Prafulla Chandra Ray founded Bengal Chemicals and Pharmaceutical Works Ltd in 1901.  A small factory was started by Prof. T. K. Gajjar at Parel in 1903. However, these pharmaceutical units were not sufficient to fulfill the need of Indian public. Therefore, drugs were imported from abroad i.e. U.K., France and Germany.  With the advancing years, profits rather than service became the main motive of the traders. Cheaper, adulterated drugs manufactured in the various parts of the world were imported from India due to which Indian market got flooded with the inferior and substandard drugs.  During 1927-29, The Indian Medical Gazette reported that there was absolutely no control over manufacture, imports, sale or distribution of drugs in India. Several deaths had been reported due to spurious drugs and adulteration like chalk powder tablets were very common. This situation in India was in contrast with other countries of the world.  The pharmacy profession was fully controlled in England by the Pharmaceutical Society of Great Britain while United States of America by state laws which required only well qualified and licensed pharmacists to dispense, compound or sell drugs, medicines or poisons that too in registered pharmacies.
PHARMD GURU Page 3  Even though the OpiumAct, 1878, the PoisonsAct, 1919 and Dangerous DrugsAct, 1930 were in existence but they were not much effective.  Indian public noticed this situation and asked Government to make an effective legislation to control the import, manufacture, distribution and sale of drugs.  Due to the adverse reports and protests done by the people within and outside the country regarding this, British Government was forced to initiate action for drug legislation.  Finally, Government appointed Drugs Enquiry Committee (DEC) in 1931 under the chairmanship of Lt. Col. R. N. Chopra and asked the Committee to look into this matter and make an effective legislation to control the import, manufacture, distribution and sale of drugs.  DEC studied all the matters and made the following recommendations: 1. DEC recommended the legislations to control drugs and other remedies whether belonging to British Pharmacopoeia (B.P.) or not. 2. DEC recommended the formation of Pharmacy Council of India and provisional State Pharmacy Councils which would look after the education and training to all pharmacists. It also, recommended that those Councils would maintain the register which contains names and addresses of persons whose name is for time being entered in the register of pharmacist for a State. 3. It also recommended the creation of drugs control machinery at different centers with branches in all States. 4. It also recommended the establishment of Central Drugs Laboratory for test or analysis of samples of drugs with a competent and expert staff for smooth and speedy work of laboratory. It also recommended the establishment of small scale laboratories which would work under the guidance of Central Drugs Laboratory.  Initially, the Government was reluctant to implement these recommendations submitted by the committee in 1931 but these findings brought uprising in the country and spurred activity in teaching institutions, industry and the profession.
PHARMD GURU Page 4  Later, the Import of Drugs Bill was passed by Government in 1937. It was concerned with the import of drugs only and was not associated with the manufacture, distribution and sale of drugs. Therefore, this bill was criticized from all the quarters and was ultimately withdrawn.  Finally, The Drugs Bill was introduced by the Government in 1940 and was adopted after in depth deliberations as The Drugs Act, 1940 which was later amended as the Drugs and CosmeticsAct, 1940. SCOPE OF PHARMACEUTICAL LEGISLATIONS: 1. Drugs and Cosmetics Act, 1940: As per the recommendations of DEC, to control the import, manufacture, distribution and sale of drugs and cosmetics, Drugs and Cosmetics Act, 1940 came into existence. 2. The Pharmacy Act, 1948: The need of the qualified and trained pharmacists and their registration to respective Councils was re-emphasized by the Health and Development Committee, 1945 constituted under the Chairmanship of Justice Bhore. The foundations were laid for The Pharmacy Act based on the recommendations of Drugs Enquiry Committee and Health Survey and Development Committee. The Pharmacy Act, 1948, came into existence with the objective to regulate the profession and business of pharmacy. 3. Drugs and Magic Remedy (Objectionable Advertisements)Act, 1954: The uncontrolled and unrestricted advertisements related to drugs and medicines were freely published making obscene, false and exaggerated claims for their medicines. Hence, Drugs and Magic Remedy (Objectionable Advertisements) Act, 1954 came into existence with the objective to control and prohibit such advertisements of drugs which makes false claim for the drug or which gives the misleading information about the drug.