1. Evolution of Pharmaceutical and Drug Legislation in
India.
2. The Pharmacy Act 1948.
3. Code of Pharmaceutical Ethics.
4. Consumer protection Act 1986.
5. Narcotic and Psychotropic substances Act 1985.
Drugs and Cosmetics Act 1940 and Drugs & Cosmetic Rules
1945 (also amendments).
1.
Administration of the Act – The controlling and licensing regulation at
state level and central level (the organisation, function and duties of state
and central drug control authorities).
2.
Drugs & Cosmetic Act Rules – the provisions related to
a.
The manufacture of drugs (other than homeopathic) including schedule C,
C(1), F, F(1) and X drugs and cosmetics.
b.
The sale and distribution of drugs (other than homeopathic) including
schedule C, C(1), F, F(1) and X drugs and cosmetics.
Drugs & Cosmetics Act Rules
1. (i.) The import and export of drugs & cosmetics.
(ii) Labelling and
packing requirements for all categories of drugs & cosmetics.
2. (i.) List of schedules to the Drugs &
Cosmetics Rules.
(ii.) Detailed
study of schedule M (new), U and Y.
3. Medicinal &
Toilet preparations (Excise Duties) Act 1955.
1.
Drugs and magic Remedies (Objectionable Advertisments) Act 1954.
2.
Prevention of Food Adulteration Act 1954 (salient features)
3.
The Factories Act 1948 and the Amendment (salient features.).
IPR’s and Patent Laws
1.
Intellectual Property Rights – a brief introduction to various
IPR’s.
2.
Indian Patent Act 1970 and the Amendments to the Act (upto date with
reference to WTO Agreement)
a.
Introduction & Objectives
b.
Inventions and Not inventions according to the Act.
c.
Procedure of obtaining patent for drugs and pharmaceuticals.
3.
Drug Price Control Order (Latest).
4.
Pharmaceutical Policy 2002.