Pharmaceutical legislation in India

Pharmaceutical legislation in India is the first chapter of Pharmaceutical jurisprudence subject of second year diploma in pharmacy.

1. Anti-Protozoal Drugs SECOND YEAR diplomA in pharmacy Genesis Institute of Pharmacy, Radhanagari Pharmaceutical Jurisprudence (Subject Code: 0814) Presentation on Pharmaceutical Legislation in India Presented by Miss. Shweta N. Kalebere Lecturer, Genesis Institute of Pharmacy

2. Pharmaceutical Jurisprudence JURIS + PRUDENTIA Law intends to regulate and control various aspects of social life. Social Economical Political Pharmaceutical Legislation is such a mixed legislation, which covers both social and economic aspects of society. LAW KNOWLEDGE

3. Purpose of Pharmaceutical Legislation In India: To ensure that the patients receive drugs of required quality, tested and evaluated for safety and efficacy for their intended result.

4. O rigin and Nature of Pharmaceutical Legislation in India LAW CREATED BY PARLIAMENT Year Name of Founder Name of shop/Industry Year of commencement of manufacturing 1811 Mr. Bathgate(East India Company) Chemist shop in Calcutta 1910 1821 Mr. Smith Stainstreet and co. Apothecary shop 1918 1901 Acharya Prafula Chandra Ray( Calcutta) Bengal Chemicals and Pharmaceutical Works - 1903 Prof. T. K. Gajjar Factory at parel Alembic chemical Works, Baroda - HISTORY OF PHARMACEUTICAL UNITS

5. Year Act Name 1878 Opium Act 1919 Poisons Act 1930 Dangerous Drug Act

6. DRUG ENQUIRY COMMITTEE (D.E.C.) 1931 To have a comprehensive legislation, the Indian Government appointed a ‘Drug Enquiry Committee’ Under the chairmanship of col. R.N. Chopra in 1931.This was formally known as Chopra Committee. Chairman : Lt. Col. R. N. Chopra

7. Reasons For Formation of Chopra Committee Units were not Sufficient to fulfill the Requirements of Indian Public. Drugs were imported from UK, Germany and France .

8. During First world war cheaper drugs were imported into India, which increased the demand for indigenous drugs. Unhealthy competition grew up and Indian market was flooded with inferior quality drugs.

9. Public pressurized Govt. to introduce effective legislation to control import, manufacture, distribution and sale of drugs. There was no legal and effective control on pharmacy profession.

10. Recommendations The formation of Central Pharmacy Council and the provincial (state) Pharmacy Councils which would look after the education and training of professionals. These councils would maintain the register containing the names and addresses of the Registered Pharmacists.

11. The D.E.C. suggested the creation of drug control machinery (Departments) at the Centre with branches in all the states.

12. The establishment of a well-equipped Central Drug Laboratory (CDL) with competent Staff and experts for an efficient and speedy working of Drug Control Department. Setting of the test laboratories in all states to control the quality of the production of drugs & pharmaceuticals.

13. Appointment of an advisory board to advice the Govt. in making rules. The drug industry in India should be developed. Setting of courses for training in pharmacy. Priscribing minimum qualification for registration as pharmacists

14. Scope and Objectives of Pharmaceutical Legislation Scope It is related with legal system which regulate the conduct of pharmacy business & practice of profession of pharmacy. A thorough understanding of all laws pertaining to pharmacy is essential & all legal aspects must be satisfied by those who wish to practice the pharmacy business. It helps the pharmacist to understand their legal & ethical responsibilities & their by avoid the danger of unnecessary legal proceedings. 1. 2. 3.

15. The patient should get the drugs of good quality which are tested & evaluated for safety purpose. It also covers the legal aspect relating to manufacture of drugs in pharmaceutical industries, their storage, sale, distribution. The pharmaceutical Legislation safeguards the health of the people by making right medication by controlling pharmacy business & Profession. 4. 5. 6.

16. To promote health care by regulating the manufacture of good quality drugs. To make these drugs available to the public at reasonable prices & through qualified person. To safeguard the people from misleading & false advertisements relating to drugs & remedies. To regulate the profession of Pharmacy. To Promote the Indigenous research technology. Objectives

17. Drug bill was introduced in 1940 in legislative assembly, and drug Bill 1940 was passed, which came to force in 1947. Since then drug act was amended many times and at present it covers the provisions related to Drugs, Cosmetics, Ayurvedic, including Unani and Homeopathic medicines.

18. The present Drug and Cosmetic Act is an improved version of the Drug Act, 1940 . The main objective of this act was to regulate - Import Manufacture Distribution Sale of drugs and cosmetics in India. The Central Government made several rules entitled the Drug and Cosmetic Rules 1945 . These act and rules were amended from time to time.

19. The Pharmacy act 1948 was passed with the main objective to regulate the profession of Pharmacy in India. In 1954 the Drug and Magic Remedies Act was passed with the main aim to control certain types of advertisements related to drug and to prohibit certain types of advertisements related to magic remedies.

20. Medical and Toilet preparations(Excise duty) Act, 1955 was passed providing for the levy and collection of duties of excise on medicinal and toilet preparations containing alcohol, opium Indian hemp or other narcotic drugs. Central Government Implemented Drug Price Control Order 1987.

21. In 1985 Narcotic and Psychotropic Substance Act , was passed. The main objective of this act was to consolidate and amend the laws relating to narcotic drugs and Psychotropic substance.

22. Other Acts Included Were- Prevention of Food Adulteration Act, 1954 and Rules The industries (Development and Regulations) Act, 1951 The Industrial Employment (Standing Order) Act,1946 and rules Industrial Dispute Act,1947 Factory Act, 1948 The Indian patent and Design Act 1970 The Trade and Merchandise Mark Act, 1958 The Epidemic Diseases Act,1897 Shops and Establishments Acts of respective states  

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