Open AccessFEEBLE REGULATORY AFFAIRS WEAKEN THE BACKBONE OF INDIAN DRUG INDUSTRIES
Author(s) -
Mal Dipak Kumar,
Samrat Chakraborty,
Biswajit Mukherjee
Publication year - 2018
Publication title -
international journal of drug regulatory affairs
Language(s) - English
Resource type - Journals
eISSN - 2321-7162
pISSN - 2321-6794
DOI - 10.22270/ijdra.v2i4.10
Subject(s) - outsourcing , business , enforcement , regulatory authority , regulatory affairs , drug control , quality (philosophy) , public administration , medicine , pharmacology , law , marketing , political science , philosophy , epistemology
India is emerging as a global outsourcing power house in almost all fields including Drugs and Pharmaceutical sector.Now it becomes a hub to conduct clinical trials and contract researches. Pharmaceutical industry currently opts fortotal quality management as primary criteria to prevent sub-standard products which do not fall under officialspecifications. However, there are many areas where immediate regulatory measures are desired. Central DrugsStandard Control organization (CDSCO) is the prime regulatory authority for the purpose of enforcement accordingto the Drugs and Cosmetic Act 1940 and Rules 1945, with its amendments. There is no established system formonitoring the Physician’s samples as it generally moves from medical representatives to patients via medicalprofessionals. Fixed dose combinations are approved by Drug Controller General of India without proper doseschedule and indications. Metered dose inhaler is presented without dose counter, so that user cannot read how manydoses remain. The capacity of CDSCO/the licensing authority/ controlling authority at both national and state levelneed to be matched with Pharmaceutical Industry in term of man power, infrastructure and training to provide safeand effective drugs to the patients. In the present review, those areas have been highlighted along with some possiblesolutions such as more stringency and uniformity in drug regulatory policies, use of software to identify duplicate andmisbranded medicines, speedy functioning of drug regulatory authorities etc.