The fourth day of the ongoing National Workshop on Clinical Pharmacology, in the department of Pharmacology, PGIMER, Chandigarh, began with hands on practical exposure on pharmacokinetics and pharmacodynamic exercises. The lecture session started with the Dr.Sumedh Gaikwad from Themis who deliberated lecture on Fixed Dose Combination Drugs.
He spoke on the scrutiny of fixed drug combination drug applications after approval of which they are released into the market, the once which are proposed to be combined for the first time in a fixed ratio, or changes in the once already in the market is done by Central Drugs standard and control organization (CDSCO). He spoke about various application procedures to be followed during the approval process .He spoke regarding the documents needed to be submitted for the requirement of clearance.
To conduct clinical trials in India, one must follow the schedule Y of Drugs and Cosmetics Act, which mandates following Indian GCP (drafted in 2001 by the Drugs Controller General of India) and the ICMR guidelines for biomedical research. Dr.Lekha Saha, Assistant Professor, Department of Pharmacology, PGIMER, Chandigarh delivered lecture on Pharmacoeconomics. These are studies done to evaluate the cost effectiveness of a drug over other used for the same disease condition. She emphasized on the use of medicines those cost less yet achieve the same clinical benefit. Prof.P.P.Khosla from Meerut delivered a lecture on Quality of Life in Clinical Trials. This was regarding the improvement of life of patients due to drugs which go through the trials.
He explained that there are various tools and techniques available with the help of which excellent information about patient can be obtained Mr Arapan Datta , from Pfizer delivered lecture on clinical trial data management. He discussed the importance on various data handling procedures in drug development and also requirements of various drug regulatory agencies. Dr.Samir Malhotra, Additional Professor of the department spoke on issues related to clinical trials of biologic drugs. Biologic are drugs which are produced through biologic processes. He discussed how these biologics differ from the common drugs. He also spoke on the difficulties faced during development of these drugs.