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Introduction: We came across patients inquiring with oncologists about cheap copy medicines. These were of recently licensedinnovator drugs that should have been available from original company holding their patents. In fact these copy medicines weremanufactured in our neighboring countries and made available in India. We investigated further and this manuscript puts together thestartling information that we were able to find regarding the thriving grey market for fake generic medicines.
ABSTRACT
Abstracts: Background:Fixed Dose Combinations (FDCs) are combinations of two or more active drugs in a single form. Prescribing FDCs has become a routine affair in medical practice. Combination drugs increase the compliance of patient to the treatment, decrease the pill burden, but may also lead to increase in the cost of the treatment and side effects. There has been increase in the irrational FDCs in the recent past. The rationality of a fixed dose combination is the most controversial and debated issue in today’s clinical practice. The eighteenth essential medicine list (EML) of WHO includes 25 FDCs while as the 2011 national list of essential medicines (NLEM) of India includes only18 FDCs. Contrary to this Indian market is flooded with FDCs, the scientific rationale for most of these remains unknown. In India, a fixed dose combination of drugs is considered a “NEW DRUG” and has to be approved by Drugs Controller General, India (DCGI). However, the Indian laws governing the approval and marketing of FDCs are not properly defined, the pharmaceutical manufactures take advantage of these loopholes and market combination that have no pharmacological rationale.
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.