PHARMACOVIGILANCE IN CLINICAL RESEARCH: PAST, PRESENT AND FUTURE
Journal Title: International Journal of Drug Regulatory Affairs - Year 2016, Vol 4, Issue 4
Abstract
The growing clinical research after the product patents rights for the pharmaceutical industries as per the trade related aspects of intellectual property rights agreement and adverse drug reaction monitoring of the marketed drugs have raised many ethical and regulatory issues regarding the promotion of new drugs in Indian markets. It becomes vital to understand the history, growth and evolution of the regulatory aspects of drugs which are handled by multiple Ministries and Departments of the Government of India. Although amendment to Schedule Y, registration of Ethics committee, registration of Clinical Trials, Speeding up review process, Pharmacovigilance (PhV) programme for India and Inspection of clinical trial sites have been started by the various regulatory agencies. India’s growing partaking in multinational trials, this artifact explores potential areas of Indian pharmacovigilance, requiring reform and provides recommendations for building a robust safety reporting system. (1) Despite global focus on Development Safety Update Report, local regulators are not yet insistent on real-time update of a drug's cumulative safety profile. Issues like reporting requirements for generic trials, pregnancy reporting and lenient timeline for death/life-threatening events need attention. (2)
Authors and Affiliations
Chauhan Pratibha, Yadav Ashish, Kirodian Babita
Keywords
Related Articles
- EP ID EP337075
- DOI 10.22270/ijdra.v4i4.188
- Views 118
- Downloads 0
CRITICAL SURVEY ON THE GUIDELINES UNDER RECOMMENDATION OF CHILD RESISTANT PACKAGING FOR PHARMACEUTICAL PRODUCTS
Child resistant packaging is an integral part of packaging industry. In order to reduce the risk of poisoning in children due to accidental ingestion of hazardous chemicals like over - the - counter (OTC) medications, ho...
Differentiation between the Regulatory paths placed on Mouthwashes in the US and EU
Regulating oral rinses has been and still is a topic of debate and confusion. Oral rinses are products that are mainly used for cleaning, perfuming and changing the appearance of the teeth, which in turn improves the ind...
TECHNOLOGY DVELOPMENT FOR POLYMER MODIFICATION TO ENHANCE SOLUBILITY OF POORLY SOLUBLE DRUG
Solubilization of poorly soluble drugs is a frequently encountered challenge in screening studies of new chemical entities as well as in formulation design and development. Solubility of some drugs is very less; these dr...
A PARADIGM SHIFT IN DRUG REGULATIONS IN TAIWAN
Across Asia, a convergence of economic trends, government policies and greater awareness among the general public of healthcare issues has created an environment that is poised for dramatic growth and change. Taiwan, for...
REGULATORY REQUIREMENTS OF ‘SIMILAR BIOLOGICS’ FOR MARKETING AUTHORIZATION IN INDIA
Present article signifies the exigency for regulation and regulatory bodies involved in development of biosimilars. The principle for development of biosimilars included opting adequate reference product, manufacturing p...