PHARMACOLOGY

 TOXICITY STUDIES ::

A number of incidents in different parts of the world such as series of deaths associated with the use of sulfonamides in U.S.A. in 1938 phocomelia (sealed limbs in babies) by thalidomide use in Europe during 1957-1960 etc made Government authorities to bring some check on the introduction of new drugs for the safety of the patients Food and Drug Control Administration of different countries regulates the introduction of newer drugs of course it is impossible to certify a drug to be absolutely safe but it is possible to identify most of the hazards likely to be associated with use of the drug and to place some statistical limits on frequency of such events in polution under study 

    Discovery of a new drug that is therapeutically useful and goes in to clinical setting is a life time dream for a medicinal chemist pharmacologist and pharmacist Currently new drug discovery process involves combinatorial chemistry computer aided drug design (CADD) quantitative structure activity relationship (QSAR) ADME-T and bioinformatics Biotechnological tools and molecular biology techniques are applied in addition to in -vivo and in-vitro methods of drug screening for pharmacological evaluation of drugs At the end of the pharmacological testing and molecular or biotechnological evaluation of a compound one may get the lead molecule i.e. a leading candidate for a successful new drugs However the real challenge for the scientist starts now when one has to carry out animal toxicity testing (pre-clinical /Non -clinical toxicity study ) and the study in human beings (Clinical study /Trial) All these studies are to be carried out as per the regulatory requirements in india they are governed by Drugs Controller General if India (DCGI) New Delhi Director -General of indian Council of Medical Research New Delhi Drugs and Cosmetics act of 1988 (Schedule Y) narrates the guidelines for carrying out not only the animal studies but also the clinical trials