CONTEMPLATION ON APPROVED DRUGS IN INDIA FROM 1999 THROUGH 2011

摘要

Objective: There is a change in the regulatory environment after a system of product patents in India since 2005. The objective of this study was to analyse the trends of drug approval in India during the period of 1999 to 2011. Materials and Methods: The information about drug approvals was primarily obtained from the Indian regulatory agency website. For the drug products identified, the drugs were classified into fourteen main Anatomical Therapeutic Chemical (ATC) groups, single or combination products, types of dosage form, approvals for additional strength, approvals for additional indication and approvals for new dosage form. Results: We identified 1506 approvals by the DCGI from 1999 to 2011, with a mean of 115.84±83.24 (SD) approvals per year (Median approvals per year: 79; Range: 23-264). The ATC groups containing over 10% of total approvals were N (nervous system), with 232 (15.4%); J (antiinfective for systemic use), with 204 (13.54%); A (alimentary tract and metabolism), with 192 (12.74%) and C (cardiovascular system), with 186 (12.35%). Since 2004, there is a rising trend for approval of products having drugs in combination. Total 448 new drugs were approved during the period of 1999 to 2011, with a mean of 34.46±8.14 (SD) new drug approvals per year (Median new drug approvals per year: 36; Range: 22-53). Conclusions: These results show that there is a rising trend of approval for fixed dose combinations. The pattern of 'new drug' approval was flattened around the years when patent policy change was introduced