pharmaceutical legislations unit 4 sem.4 b.pharm .pdf

1. Pharmaceutical
Legislations
A brief review, Introduction, Study of drugs enquiry
committee, Health survey and development
committee, Hathi committee and Mudaliar committee.

2. Introduction
• At the end of the ‘19th century’ and early ‘20 century’ use of Allopathy system
increases.
• Drugs of natural origin: Veg., mineral oil & animals.
• At he time, profit becomes main motive than service.
• Overdose of quinine.
• Drugs are badly adulterated like “Satonine”.
• “India becomes a land of quacks doctors, quack medicine mongers, quacks
dentists, quack of medicine, quacks of opticians, quack of faith healers”
• There was practically no legislation to control on drugs as well as on the
pharmacy profession.

3. ORIGIN AND NATURE OF
PHARMACEUTICALS LEGISLATION OF INDIA
Earlier, all the allopathic system of medicine was brought by Britisher’s to our
country and allopathic medicines were mainly imported.
To have some control on the import, the British Rulers introduced.
 The Indian Merchandise Marks Act 1889.
 The Sea Customs Act 1898.
 Indian Tariff Act 1894.
 The Opium Act 1878.
 Poison Act 1919.
The resolution of pharmaceutical legislation was passed by the council of the state to be
Governor-General in council to urge all provisions Government's to take immediate steps
to control indiscriminate use of drugs.

4. Drugs Enquiry Committee.
There were wide spread cases of adulterated drugs, quack medicines, spurious medicines which
are being imported into the country, the viceroy appointed a committee on 11th August 1930, under
the chairmanship of Col. R.N. Chopra.
• This Committee is also known as “Viceroy committee/R.N. Committee/Drug Enquiry
Committee”.
• The report was published in 1931.
• Subjected in this committee in chairmanship R.N. Chopra:
01. Enquire the extent to which drugs of impure quality or defective strength were being imported,
manufactured or sold in India.
02. Recommend steps for controlling import, manufacture and sale in public interest.
03. Enquire into the necessity of legislation to restrict the profession of pharmacy to qualified
persons and to make recommendations.

5. Cont.
The drugs Enquiry Committee the legislations relating to drugs in force
were:
 Poisons Act 1919.
 Dangerous Drugs Act 1930.
 Opium Act 1818.
Which were specific in nature and there was a need for a comprehensive
legislations to control the import, manufacture and sale of drugs.

6. Recommendations
• A Central law to control drugs and pharmacy profession.
• Setting up of test laboratories in all states to control the quality of production of
drugs and pharmaceuticals and a control laboratory to control the quality of
imported drugs and also to act as expert referee in case of disputed samples
sent by local Governments.
• Appointment of an Advisory Board to advise the government in making rules to
carry out the objects of the Act.
• Setting up of courses for training in pharmacy minimum qualifications for
registration.
• Registration of every patent and proprietary medicines of undisclosed formula
manufactured in India or imported from outside the country.

7. • The crude single drugs as well as compounded medicines used in
indigenous system of treatment, should be brought under control.
• The drugs industry in India should be developed.
• Gradual reduction of manufacture in medical stores depots.
• Compilation of an Indian Pharmacopoeia.
• The Cinchona department should cultivate cinchona.

8. Outcomes of this Committee Reports
• Enactment of Import of Drugs Bill 1937.
• Drugs and Cosmetics Act 1940 & rules 1945.
• Drugs and Magic remedies (Objectionable advertisement)Act
1954, and rules 1955.
• Medicinal & Toilet Preparations (excise duties) Act, 1955 & rules
1956.
• Publications of first edition of Indian Pharmacopoeia in 1955 based on
British Pharmacopoeia 1948.

9. Health Survey & Development
Committee
 This committee was appointed by the Government of India in October 1943
under the chairmanship of Sir Joseph Bhone to make a survey of the existing
position in respect of health organization in the British India and to make
recommendation for future developments. Some of the recommendations of the
committee are as follow:
1. The establishment of an Act India Pharmaceuticals council and provincial
pharmaceuticals councils representing the pharmaceuticals trade, educations and
other pharmaceuticals interests.
2. Enactment of legislation designed to protest the public from incompetence, to
safeguard the interests of qualified pharmacists and to raise the professional
standing of pharmacists engaged in the handling of drugs.
3. Measures for registration of pharmacists.

10. 4. Measures for maintaining disciplinary control over the practice and profession
of pharmacy.
5. Revised courses of study:
 Licentiate pharmacists.
 Graduate pharmacists.
 Pharmaceuticals laboratory.
6. Setting up of a Central Drugs Laboratory.
7. The Drugs Act 1940 should be brought into operations throughout the
country and rigidly enforced.
8. The questions of the requirement of the country in drugs and of the medical
requests should be examined by a small committee.

11. Types of Committee
• Bhore committee.
• Bhatia committee.
• Mudaliar committee.
• Hathi committee.

12. HATHI COMMITTEE
• Indian Government has setup Hathi committee.
• Under the chairmanship “Jaysukhlal Hathi”.
• To take comprehensive look in to the drug industry and to enquiry into
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.

13. MUDALIAR COMMITTEE
• In June 1959, the Government of India appointed the health Survey
and Planning Committee.
• Under the chairmanship of “Dr. A. Lakshman Swami Mudaliar”.
• Based on its recommendations drugs prepared according to
indigenous systems of medicines were brought within the preview of
Drugs and Cosmetics Act 1940.