ABSTRACT
Background: India is one of the major destination for conducting clinical trials. The Drug Controller General of India (DCGI) is the governing body responsible for all pharmaceutical-research and regulatory issues in India. While conducting clinical trials in India, regulations have come to ensure safety and wellbeing of the study subjects in the trial. The present study was planned to see the number of trials approved by DCGI and their trend over the last 8 years in view of new regulatory guidelines. Methods: Data obtained from website of the Regulatory Authority i.e. Central Drugs Standard Control Organization (CDSCO) regarding DGCI Approval of clinical trials from 2007 till 2014 are noted for analysis. Results: Total 1799 Trials Approved. 2007 had lowest approvals with 3 clinical trials & 2010 being highest with 500 trial approvals. Mean ± SD Approval of 224.88 ± 172.46 with Median rate of 206 per year was observed. Trend of Trials approved by DCGI shows sharp peak around 2008-2010 which follows sharp fall around 2013. Conclusion: The present study highlights the impact of these new regulations on Clinical Trials registered for approval of DCGI.
ABSTRACT
Background: The drug approval regulations in India have changed since 2005 with new regulations for the conduct of clinical trials from 2013 onward. The present study was planned to see the number of drugs approved by Drugs Controller General of India (DCGI) and their trend over the last 16 years in view of new regulatory guidelines. Methods: Data obtained from website of the regulatory authority, i.e., Central Drugs Standard Control Organization regarding DGCI approval of drugs in India from 1999 until May 2015 was noted for analysis. Results: We identified 1716 drug approvals by the DCGI from 1999 to 2015, with a mean of 100.94±83.80 (standard deviation) approvals per year (median approvals per year: 57; range: 3-270). There is a rising trend for approval of drugs as a single agent, as well as in combination from 2004 showing a peak in 2008 with a decline from 2010 onward. Thus, very few drugs have been approved in last 3 years. Conclusions: Thus, the present study highlights the changing scenario of drug approval, with few drugs being approved for clinical practice in the last 3 years.
ABSTRACT
Background: Cardiovascular diseases are the most prevalent cause of death and disability in developed and developing countries. There is a wide variation in the prices of hypolipidemic drugs marketed in India. Thus, a study was planned to find out variation in cost in the oral hypolipidemic drugs available in India either as a single drug or in combination and to evaluate the difference in cost of various brands of the same oral hypolipidemic drug by calculating percentage variation in cost in Indian rupees. Methods: Cost of oral hypolipidemic drugs manufactured by different pharmaceutical companies, in the same strength and dosage forms was obtained from “Current Index of Medical Specialties” July-October 2014 and “Indian Drug Review” Vol. XXI, Issue No.4, 2014. The difference in the maximum and minimum price of the same drug manufactured by different pharmaceutical companies and percentage variation in cost per 10 tablets was calculated. Results: Percentage variation in cost for hypolipidemic drugs marketed in India was found to be atorvastatin (10 mg): 1108.33%, simvastatin (5 mg): 709.09%, rosuvastatin (10 mg): 431.91%, lovastatin (10 mg): 287%, fenofibrate (200 mg): 163.58%. Among the combination therapy, variation in cost was atorvastatin + fenofibrate (10+160 mg): 233.33%, atorvastatin + ezetimibe (20+20 mg): 132.90%, rosuvastatin + fenofibrate (10+145 mg): 105.56%. Conclusion: There is a wide difference in the cost of different brands of oral hypolipidemic drugs available in India. The clinicians prescribing these drugs should be aware of these variations in cost to reduce the cost of drug therapy.