Drug regulations in India- A critical analysis

5^th International Conference and Exhibition on Pharmaceutical Regulatory Affairs

August 03-05, 2015 Orlando, USA

K V S Sarma

University of Law, India

Posters-Accepted Abstracts: Pharmaceut Reg Affairs

Abstract :

The regulation of medicines in UK probably began in the fifteenth century to make sure that they were not contaminated or defective. �Medicinal Products� are defined as �any substance or combination of substances presented as having properties for treating or preventing disease in human beings.� Before making any medicine in the market clinical trials are necessary not only in India but in the entire world. A clinical trial is a scientific investigation to evaluate the effect of new drugs or vaccines other than health interventions, by administering these to human volunteers. Generally, clinical trial has three phases before manufacture of drugs. In the beginning of the current century Drug Industry was practically non-existent in India and pharmaceuticals were being imported from abroad. After the First World War manufacturing of drugs started in India. To control the manufacture, distribution and sale of drugs and medicines the Government passed the following two Acts. a) The Poisons Act, 1919; b) Dangerous Drugs Act, 1930. The Government also adopted The Opium Act, 1878. Drugs Act was passed in the year 1940. By passing Narcotic Drugs and Psychotropic substances Act in the year 1985 it repealed all previous Acts. The other Acts which are regulating the manufacture, sale, import, export and clinical research of drugs and cosmetics are as follows: a) The Drugs and Cosmetics Act, 1940; b) The Pharmacy Act, 1948; c) The Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954; d) The Medicinal and Toilet Preparations (Exercise Duties) Act, 1956; e) The Drugs (Prices Control) Order, 1995 (Under the Essential Commodities Act).

Biography :

Email: kolluru_sarma@yahoo.co.in