RESUMO
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.
RESUMO
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.
RESUMO
Acquired immune deficiency syndrome (AIDS) is a disease caused by human immunodeficiency virus and characterized by profound immunosuppression that leads to opportunistic infections, secondary neoplasms, and neurologic complications. AIDS is among the leading causes of death worldwide. Current therapeutic options are directed only toward management of AIDS, but not toward its prevention or cure. In addition, it also possesses numerous problems like drug resistance, drug toxicity, drug interactions, non-adherence to therapy, life-long and expensive treatment, etc. Recent years in drug development have shown promising prospects for prevention/ treatment/cure of AIDS like histone deacetylase inhibitors, Vpu ion channel inhibitors, viral decay acceleration, maturation inhibitors, tat antagonists, gene/stem cell therapy, and antiretroviral vaccines.
RESUMO
Background: AIDS is one of the most prevalent causes of death due to infectious origin which requires a lifelong therapy. There is variation in prices of antiretroviral drugs available in Indian market. Thus, a study was planned to find out variation in prices of antiretroviral drugs either as a single drug or in combination and to evaluate the difference in cost of various brands of the same antiretroviral drugs by calculating percentage variation in cost in Indian rupees. Methods: Cost of antiretroviral 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 was calculated. Results: Percentage variation in cost for antiretroviral drugs marketed in India was found to be zidovudine (100 mg) - 436%, lamivudine (100 mg) - 268%, tenofovir (300 mg) - 149.5%, didanosine (250 mg) - 73.75%, indinavir (400 mg) - 35.26%. Among the combination therapy, price variation was lamivudine + zidovudine (150 + 300 mg) - 314%, lamivudine + stavudine (150 + 40 mg) - 105%, lopinavir + ritonavir (133.3 + 33 mg) - 25%. Conclusion: There is wide variation in the prices of antiretroviral agents available in the market. Regulatory authorities, pharma companies, physicians should maximize their efforts to reduce the cost of drugs.