FEEBLE REGULATORY AFFAIRS WEAKEN THE BACKBONE OF INDIAN DRUG INDUSTRIES
Journal Title: International Journal of Drug Regulatory Affairs - Year 2014, Vol 2, Issue 4
Abstract
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 for total quality management as primary criteria to prevent sub-standard products which do not fall under official specifications. However, there are many areas where immediate regulatory measures are desired. Central Drugs Standard Control organization (CDSCO) is the prime regulatory authority for the purpose of enforcement according to the Drugs and Cosmetic Act 1940 and Rules 1945, with its amendments. There is no established system for monitoring the Physician’s samples as it generally moves from medical representatives to patients via medical professionals. Fixed dose combinations are approved by Drug Controller General of India without proper dose schedule and indications. Metered dose inhaler is presented without dose counter, so that user cannot read how many doses remain. The capacity of CDSCO/the licensing authority/ controlling authority at both national and state level need to be matched with Pharmaceutical Industry in term of man power, infrastructure and training to provide safe and effective drugs to the patients. In the present review, those areas have been highlighted along with some possible solutions such as more stringency and uniformity in drug regulatory policies, use of software to identify duplicate and misbranded medicines, speedy functioning of drug regulatory authorities etc.
Authors and Affiliations
Dipak Kumar Mal, Samrat Chakraborty, Biswajit Mukherjee
Keywords
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