17PCBPP25 PHARMACEUTICAL JURISPRUDENCE
Upon completion of the course the student shall be able to
- Understand various concepts of the pharmaceutical legislation in India
- Know various rules drafted in Drug and Cosmetic Act, Pharmacy Act, NDPS Acts, relevant to pharmacy practice.
- Know the Consumer Protection Act, PFA Act, DPCO,.
- Understand the labeling requirements and packaging guidelines for drugs and cosmetics
Detailed syllabus and Lecture wise Program
1) A brief review of Pharmaceutical legislations. 01 hr
- A Study of various pharmaceutical and related legislations with more emphasis on aspects relevant to community & hospital pharmacy practice in India. Study the aspects only from practical angle, with examples, case studies, etc :
2) Drugs and Cosmetics Act-1940 and Rules 1945 1 5 hrs
- Duties & Responsibilities of Drug Inspectors, other officers, and obligations of the pharmacy to them
- Brief about DTAB, DCC, Drug testing laboratories
- Various drug licences for retail pharmacy, requirements to start a pharmacy/medical store, application forms, issue of licence, display of licences, duration of licences, laws related to stocking, handling and sale of drugs and devices
- Various schedules under the Act & Rule – study in brief –those relevant to pharmacy practice
- Labelling requirements of drugs – various aspects
- Spurious, misbranded, adulterated, counterfeit drugs – various aspects related to this, how to recognize, role of the pharmacist
- Import of drugs for personal use
- Various documents to be maintained under the Act & Rules by a pharmacy
- Storage requirements, handling expired goods
- Various punishments under the Act
- Practical study of Prescription and non-prescription drugs, market samples, examine for labeling, etc.
- Laws relating to various traditional systems/ medicines approved in India
- Banning of drugs
3)Pharmacy Act – 1948 03 hrs
4) Medicinal and Toilet Preparation Act-1955 04 hrs
5) Narcotic Drugs and Psychotropic Substances Act – 1985 04 hrs
6)Drugs and Magic Remedies (Objectionable Advertisements) Act and Rules, 1954 02 hrs
7) Essential Commodities Act 02 hrs
8) Drugs Prices Control Order 02hrs.
9)Prevention of Cruelty to Animals Act, 1960 02 hrs
10)Consumer Protection Act , 1986 02 hrs
11)Prevention of Food Adulteration Act & Rules, laws relating to Dietary Supplements, Food supplements, etc 02 Hrs
12) The Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Amendment Act, 2003 02 Hrs
At the end of the course, the student will be able to
CO.1 Defend Professional ethics
CO.2 Understood the various concepts of the Pharmaceutical Legislation in India.
CO.3 Justify the various parameters in the Drug and Cosmetic Act and rules.
CO.4 Explain the various concepts of Drug policy, DPCO, Patent and Designing act.
CO.5 Express about the salient features of different laws which have been prescribed by the Pharmacy Council of India from time to time including International Laws.
Text books (Theory)
- Mithal , B M. Textbook of Forensic Pharmacy. Calcutta :National; 1988.
Reference books (Theory)
- Singh, KK, editor. Beotra’s the Laws of Drugs, Medicines & cosmetics. Allahabad: Law Book House;1984.
- Jain, NK. A Textbook of forensic pharmacy. Delhi: Vallabh prakashan ;1995.
- Reports of the Pharmaceutical enquiryCommittee
- I.D.M.A., Mumbai. DPCO1995
- Various reports ofAmendments.
- Deshapande, S.W. The drugs and magic remedies act 1954 and rules 1955. Mumbai: Susmit Publications;1998.
- Eastern Book Company .The narcotic and psychotropic substances act 1985, Lucknow: Eastern;1987.