LEGAL ASPECTS OF SPURIOUS DRUGS IN INDIA
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.
H. V. RAGHUNANDAN
Pharmaceutical Quality & Amp, Regulatory, RC2 Pharma Solutions, (Partnership Firm), 1268 Srirampura 11 Stage 1st Cross, Mysuru, 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.
*Author to whom correspondence should be addressed.
Abstract
India is very important in the manufacture of Common Place tablets and 12-25% of the drugs supplied worldwide are contaminated, substandard and counterfeit. As the sector produces powerful pharmaceutical components and finished goods, India along with VP Patrick Luke of the Global Fitness Applications of the US Pharmacopoeia Convention may be the leading individuals for counterfeit medicines in China. In this review article main aim is to provide overview information and to trace the spurious drugs along with the Indian market compare with the US and Europe market. Some legal aspects of maintaining an exceptional Standard of medicines. India made some preventive measures in the nation to fight against the poor quality of drugs, drugs in Indian market compare with the US and Europe market, definitions along with justification for change for not preferred satisfactory drugs, and its declaration procedure. In perspective on above perceptions and information acquired, we may conclude that it might be inferred that, the degree of misleading medications in retail drug store is much underneath the projections made by Central Drugs Standard Control Organisation (CDSCO). CDSCO formulate guidelines, according to which CDSCO classified tablets (non-high quality) are divided into 3 categories. Government attempted some preventive measures to limit the hazard from misleading and inadequate medications. By the comparison of drugs with US and Europe market, drugs in Indian market are safe and need more awareness amongst the public about the safety of medicines.
Keywords: Spurious drugs, Central Drugs Standard Control Organisation (CDSCO), medicines.