Pharmaceutical Jurisprudence
UNIT - 1 :- Drugs and Cosmetics Act, 1940 and It's Rules 1945.
Pages :- 17 no.s DOWNLOAD PDF
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UNIT - 2 :- Drugs and Cosmetics Act, 1940 and It's Rules 1945.
Pages :- 27 no.s DOWNLOAD PDF
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UNIT - 3 :- Pharmacy Act –1948, Medicinal and Toilet Preparation Act –1955, Narcotic Drugs and Psychotropic substances Act-1985 and Rules.
Pages :- 48 no.s DOWNLOAD PDF
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UNIT -4 :- Study of Salient Features of Drugs and Magic Remedies Act and its Rules.
Pages :- 26 no.s DOWNLOAD PDF
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UNIT -5 :- Pharmaceutical Legislations, Code of Pharmaceutical ethics, Medical Termination of Pregnancy Act.
Pages :- 29 no.s DOWNLOAD PDF
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INTRODUCTION :
The drugs and cometics act 1940 and rules 1945 have been passed to regulate the import, manufacture, distribution and sale of drugs and cosmetics. All the operations related to drugs should be done by qualified persons. To have a check, on search operation the central and state government are established the state and central drug control authorities. Drug and cosmetics rule have been divided into 18 parts, each belong with a particular subject. There are two schedules to the act and 25 schedules to the rules.
PHARMACY ACT –1948:
- Objectives, Definitions, Pharmacy Council of India; its constitution and functions, Education Regulations, State and Joint state pharmacy councils; constitution and functions, Registration of Pharmacists, Offences and Penalties
- Medicinal and Toilet Preparation Act –1955: Objectives, Definitions, Licensing, Manufacture In bond and Outside bond, Export of alcoholic preparations, Manufacture of Ayurvedic, Homeopathic, Patent & Proprietary Preparations. Offences and Penalties.
- Narcotic Drugs and Psychotropic substances Act-1985 and Rules: Objectives, Definitions, Authorities and Officers, Constitution and Functions of narcotic & Psychotropic Consultative Committee, National Fund for Controlling the Drug Abuse, Prohibition, Control and Regulation, opium poppy cultivation and production of poppy straw, manufacture, sale and export of opium, Offences and Penalties.
Pharmaceutical Legislations
History :-
In the early part of the 20th century, there was practically no legislative control on drugs as well as on the profession of pharmacy. Although the Opium Act-1878, the poison act-1919 and the dangerous drugs act-1930 were inforce, these were specific in nature and grossly inadequate in controlling the chaotic conditions prevailing at that time. In 1927, a resolution was passed by the council of states to recommend to the Governor General in Council to usage all Provisional Governments to take immediate steps to control indiscriminate use of drugs and to legislate for the standardization of the preparation and sale of drugs. 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. A set of people known as compounders were filling the gap. Just after the publication of the report Prof. M. L. Schroff (Prof. Mahadeva Lal Schroff) 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. Govt. 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. The first Drugs Technical Advisory Board (DTAB) under this act was constituted. Central Drugs Laboratory was established in Calcutta 1945 and ‘Drugs Rule under the Drugs Act of 1940’ was established. The Drugs Act has been modified from time to time and at presents the provisions of the Act cover Cosmetics and Ayurvedic, Unani and Homeopathic medicines in some respects.
Introduction
Pharmaceutical Legislations generally includes provisions relating to the manufacturing, importing, distribution, marketing, prescribing, labeling, dispensing, and sometimes pricing of pharmaceutical products, as well as the licensing, inspection, and control of personnel and facilities. A regulatory authority is usually established for administrative control. Medicine registration is often a major element in legislation, to ensure that individual products meet the criteria of efficacy, safety, and quality. Countries that need to introduce comprehensive legislation can seek guidance from WHO guidelines.
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