SPURIOUS DRUGS IN INDIA: COMPARISON WITH EUROPE AND USA, SYSTEMATIC REVIEW
S. UMESH
Regulatory Affairs Group, Department of Pharmaceutics, JSS College of Pharmacy, Mysuru, JSS Academy of Higher Education and Research, Mysore, 570 015, Karnataka, India.
V. BALMURALIDHARA *
Regulatory Affairs Group, Department of Pharmaceutics, JSS College of Pharmacy, Mysuru, JSS Academy of Higher Education and Research, Mysore, 570 015, Karnataka, India.
K. C. SWATHI
Regulatory Affairs Group, Department of Pharmaceutics, JSS College of Pharmacy, Mysuru, JSS Academy of Higher Education and Research, Mysore, 570 015, Karnataka, India.
H. V. RAGHUNANDAN
Pharmaceutical Quality & Amp, Regulatory, RC2 Pharma Solutions, (Partnership Firm), 1268 Srirampura 11 Stage 1st Cross, Mysuru, India.
*Author to whom correspondence should be addressed.
Abstract
India has a bigger problem of spurious and substandard drugs, which result in life threatening issues, financial loss of consumer and manufacturer and loss in trust on health system. In view of the fact that the conversion of credible medication into unsatisfactory medication can cause a number of adverse effects from mild to direct and to severe. To provide information regarding track and trace of the spurious drugs in India in comparison with United States (USA), and Europe (EU). India is the largest producer to no-exclusive drugs. Also, potentially, 12-25% of all given prescriptions in India are contaminated, unsatisfactory or fake. The Directorate General of Health Administrations, Ministry of Health and Family Welfare, Legislature of India is united to decrease the spurious drugs. Legal foundation is discussed and Guidelines for making a move on tests of not of standard quality in the light of upgraded punishments under the medications and beautifying agents (revision) act and future investigation plan and the comparison of spurious drugs in India, US and Europe. In perspective on above perceptions and information acquired compared with US and Europe, we may conclude that, the state medication control associations made 13 rules to minimize the spurious and substandard drugs in India. Central drug standard control organization (CDSCO) done nationwide overview in India in 2017, from the review we come to know 3% sedates in India is unsatisfactory.
Keywords: Spurious drugs, NSQ drugs, D&C act, indian regulatory system, policies.