Pharmaceutical legislation
Jurisprudence: The study of fundamental principle is called jurisprudence. In General sense jurisprudence includes knowledge of law while in the technical sense. It is the science of the first principle of civil law.
Forensic pharmacy: The word “forensic” is derived from the Latin term” forensic” meaning “forum” means “public place” or market place.
Drug Enquiry Committee:
The government of India pursuance to the resolution appointed a committee known as Drug Enquiry Committee with Col.Ramnatha.N.Chopra as its chairman in 1928.
Recommendation of Chopra Committee:
1.A central law to control drug and pharmacy profession.
2.Setting up of testing laboratories in all states to control quality of production of drugs and pharmaceutical and a central laboratory to control the quality of imported drugs and also to act as expert a referee in case of sample sent by local government.
3.Appointment of advisory board to advice the government in making rules to carry out the objectives of the act.
4.Setting up the course for training of pharmacist and prescribe minimum qualification for the registration as the pharmacist.
5.Registration of every pattern and proprietary medicine manufacture in India or imported from outside country.
6.Bringing of crude single drug as well as compounded medicine used in the indigenous system of treatment under control.
7.Development of the drug industry in India.
8.Gradual reduction of manufacturing in medical stores.
9.Completion of an Indian Pharmacopoeia.
DRUG CONTROL ADMINISTRATION
(1)Organization and Function
(a)Central Administrative body
(b)Inspectorate Service
(c)Regulatory Service
(d)Public Relation and consumer affairs department
(e)Laboratory Service
(2) Prohibition, offense, Penalties and legal procedures
(3)Powers to make Rules and Regulation
(4)Repeals of other laws and regulation
DRUG LAWS EVALUTION
(A)Pre-Constituent laws
(B)Post Constituent laws
(A)Pre-Constituent laws:
These laws were passed before independence of India and state government is empowered to make change on it with the permission of president.
(B)Post Constituent laws:
These laws were passed after independence of India and state government is not empowered to make change on it.
HEALTH SURVEY AND DEVELOPMENT COMITTEES:
(1) Mudaliar Committee:
The concern of the Health Survey and Planning Committee (Mudaliar Committee 1962) was limited to the development of the health services infrastructure and the health care at the primary level. It felt the growth of infrastructure needed radical transformation and further investment. Another major shift came in the Third Plan (1961-66) when family planning received priority for the first time. Increase in the population became a major worry and was seen as a hurdle to the development process. Although the broad objective was to bring about progressive improvement in the health of the people by ensuring a certain minimum level of physical well-being and to create conditions favorable for greater efficiency, there was a shift in focus from preventive health services to family planning. During the Fourth Plan (1969-74), efforts were made to provide an effective base for health services in rural areas by strengthening the PHCs. The vertical campaigns against communicable diseases were further intensified.
(2)Bhatia Committee:
Government of India in 1953 appointed a committee under the chairmanship of Major General S.L.Bhatia which is called as Bhatia committee to make comprehensive enquiry in to the working of Pharmaceutical industry & to recommend what steps the Government should take to establish it on sound lines in the interest of the country ‘s health care delivery & economy.
(3)Hathi Committee:
Indian Government has setup Hathi committee under the chairmanship of Jaysukhlal Hathi to take comprehensive look into the drug industry and to enquiry in to the various facets of drugs in India. The report of this committee covered all aspects ranging from licensing, Price control, Imports, role of foreign sector and quality control. It encouraged the development of indigenous industries, It also further controlled price of a large number of drugs in the interest of the consumer.
(4)Bhore committee:
In 1943, Indian Government appointed a committee under the chairmanship of sir Joseph Bhore to make a survey of existing position in respect to the health care delivery organization in India and to make recommendation for future developments.
Recommendation of Bhore committee:
(1)Setting up central drug laboratory
(2)Establishment of all India Pharmaceutical council and provincial Pharmaceutical Council representing the pharmaceutical trade, education.
(3)Starting of revised courses of study for:
(a)Licentiate Pharmacist
(b)Pharmaceutical Technologist
(c)Graduate Pharmacist
(4)Rigid enforcement of the Drugs and cosmetic act, 1940 through country.
Forensic pharmacy: The word “forensic” is derived from the Latin term” forensic” meaning “forum” means “public place” or market place.
Drug Enquiry Committee:
The government of India pursuance to the resolution appointed a committee known as Drug Enquiry Committee with Col.Ramnatha.N.Chopra as its chairman in 1928.
Recommendation of Chopra Committee:
1.A central law to control drug and pharmacy profession.
2.Setting up of testing laboratories in all states to control quality of production of drugs and pharmaceutical and a central laboratory to control the quality of imported drugs and also to act as expert a referee in case of sample sent by local government.
3.Appointment of advisory board to advice the government in making rules to carry out the objectives of the act.
4.Setting up the course for training of pharmacist and prescribe minimum qualification for the registration as the pharmacist.
5.Registration of every pattern and proprietary medicine manufacture in India or imported from outside country.
6.Bringing of crude single drug as well as compounded medicine used in the indigenous system of treatment under control.
7.Development of the drug industry in India.
8.Gradual reduction of manufacturing in medical stores.
9.Completion of an Indian Pharmacopoeia.
DRUG CONTROL ADMINISTRATION
(1)Organization and Function
(a)Central Administrative body
(b)Inspectorate Service
(c)Regulatory Service
(d)Public Relation and consumer affairs department
(e)Laboratory Service
(2) Prohibition, offense, Penalties and legal procedures
(3)Powers to make Rules and Regulation
(4)Repeals of other laws and regulation
DRUG LAWS EVALUTION
(A)Pre-Constituent laws
(B)Post Constituent laws
(A)Pre-Constituent laws:
These laws were passed before independence of India and state government is empowered to make change on it with the permission of president.
(B)Post Constituent laws:
These laws were passed after independence of India and state government is not empowered to make change on it.
HEALTH SURVEY AND DEVELOPMENT COMITTEES:
(1) Mudaliar Committee:
The concern of the Health Survey and Planning Committee (Mudaliar Committee 1962) was limited to the development of the health services infrastructure and the health care at the primary level. It felt the growth of infrastructure needed radical transformation and further investment. Another major shift came in the Third Plan (1961-66) when family planning received priority for the first time. Increase in the population became a major worry and was seen as a hurdle to the development process. Although the broad objective was to bring about progressive improvement in the health of the people by ensuring a certain minimum level of physical well-being and to create conditions favorable for greater efficiency, there was a shift in focus from preventive health services to family planning. During the Fourth Plan (1969-74), efforts were made to provide an effective base for health services in rural areas by strengthening the PHCs. The vertical campaigns against communicable diseases were further intensified.
(2)Bhatia Committee:
Government of India in 1953 appointed a committee under the chairmanship of Major General S.L.Bhatia which is called as Bhatia committee to make comprehensive enquiry in to the working of Pharmaceutical industry & to recommend what steps the Government should take to establish it on sound lines in the interest of the country ‘s health care delivery & economy.
(3)Hathi Committee:
Indian Government has setup Hathi committee under the chairmanship of Jaysukhlal Hathi to take comprehensive look into the drug industry and to enquiry in to the various facets of drugs in India. The report of this committee covered all aspects ranging from licensing, Price control, Imports, role of foreign sector and quality control. It encouraged the development of indigenous industries, It also further controlled price of a large number of drugs in the interest of the consumer.
(4)Bhore committee:
In 1943, Indian Government appointed a committee under the chairmanship of sir Joseph Bhore to make a survey of existing position in respect to the health care delivery organization in India and to make recommendation for future developments.
Recommendation of Bhore committee:
(1)Setting up central drug laboratory
(2)Establishment of all India Pharmaceutical council and provincial Pharmaceutical Council representing the pharmaceutical trade, education.
(3)Starting of revised courses of study for:
(a)Licentiate Pharmacist
(b)Pharmaceutical Technologist
(c)Graduate Pharmacist
(4)Rigid enforcement of the Drugs and cosmetic act, 1940 through country.
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