Ivermectin is an antiparasitic drug with a broad spectrum of activity, high efficacy as well as a wide margin of safety. It belongs to the family of avermectins. It binds to glutamate-gated chloride iron channels, which are present in invertebrate nerve and muscle cells, and causes the paralysis and death of the parasite. Ivermectin is approved by the US Food and Drug Administration, and used worldwide to treat patients with onchocerciasis and strongyloidiasis. It is also used against a wide range of endoparasites (nematodes) and ectoparasites (insects, acarine) of animals and humans. [Int J Basic Clin Pharmacol 2012; 1(3.000): 132-139

Background: The antineoplastic drugs are prescribed for the treatment of cancer, which is an important cause of mortality in India; therefore, a drug lag in the availability of antineoplastic drugs is a direct threat to life. The present study was undertaken to assess the drug lag for new antineoplastic agents in India compared with that in the United States (US) or European Union (EU). Methods: The new antineoplastic agents approved in the United States, European Union and India between 1999 and 2011 were identified and information was gathered primarily from the websites of regulatory agencies of the three regions. We assessed absolute and relative drug lag for new antineoplastic agents approved in the three regions. Results: Of the 70 new antineoplastic agents, 64 (91.42%) were approved in the United States, 54 (77.14%) in the European Union and 44 (62.85%) in India. The US was the first to approve 59 (84.28%) out of the 70 new antineoplastic agents, the EU was the first to approve 9 (12.85%) and India was the first to approve 2 (2.85%). The median approval lag for India (26.35 months) was higher as compared to the United States (0 month) and European Union (7.3 months). Conclusions: This study confirms that India's drug lag in the case of new antineoplastic agents is higher as compared to the US and EU. Further detailed analyses are necessary to find the reasons and impacts of drug lag for antineoplastic agents in India. [Int J Basic Clin Pharmacol 2012; 1(1.000): 13-21

This study confirms that there is a substantial drug lag in approval of new cardiovascular drugs in India compared with the United States and European Union. The impact of drug lag on health outcomes remains to be established.

Background: As per World Trade Organisation (WTO), from the year 2005, India granted product patent recognition to all new chemical entities (NCEs). This may affect the new drug approvals in India. The purpose of this study was to compare the new drug approvals in India with the United States (US) and the European Union (EU) regions. Methods: We obtained information about regulatory approval of new drugs in the US, EU, or India of last 5 years (from 2011 through 2015) from the publicly accessible databases of three regulatory agencies. For the drug products identified, the drugs were classified into fourteen main Anatomical Therapeutic Chemical (ATC) groups, review classification and approval date. Results: There were 509 new drugs approved from 2011 through 2015 by one or more of the three regulatory agencies. Total 182 new drugs were approved in US during the period of 2011 to 2015, with an average of 36.4 new drugs approved per year. For the same period a total of 257 new drugs were approved in the EU, with an average of 51.4 new drugs approved per year and in India a total of 70 new drugs were approved, with an average of 14 new drugs approved per year. There were more number of new drug approvals in antineoplastic and immunomodulating agents (L) ATC group in all the three regions (US= 66; EU= 61 and India= 17). Conclusions: For new drugs approved between 2011 and 2015, India has lagged behind the US and the EU in approval of new drugs. There was no difference in the patterns of new drug approvals with respect to the therapeutic areas.

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The objective of this study was to see the trends of new drug approvals by the U.S. FDA in last 5 years and find the therapeutic areas with higher new drug approvals. METHODS We obtained information about regulatory approvals by the U.S. FDA from publicly accessible databases at Drugs@FDA. 3 The definition of "new drug" included ABSTRACT Background: The U.S Food and Drugs Administration (FDA) is the world's leading drug regulatory authority. There are reports of more product pipelines in oncology therapy area. The objective of this study was to see the overall trends of new drug approvals by the U.S. FDA in last 5 years and find the therapeutic areas with higher new drug approvals. Methods: New drug approvals data obtained from publicly available databases of the U.S. FDA from 2011 through 2015. For the drug products identified, the drugs were classified into fourteen main Anatomical Therapeutic Chemical (ATC) groups, single or combination products, New Drug Application (NDA) chemical types, review classification and approval date. Results: There were 182 new drugs approved from 2011 through 2015 by the U.S. FDA with a mean of 36.4 approvals per year. Out of these 182 new drug approvals, 149 (81.87%) approvals were for new molecular entity (NME) and 33 (18.13%) for biologics license application (BLA). There were more number of new drug approvals in antineoplastic and immunomodulating agents (L) ATC group (n=66; 36.26% of total new drug approvals). Conclusions: For new drugs approved between 2011 and 2015, the U.S. FDA was first to approve majority of new drugs. There was upward trend of new drug approvals in antineoplastic therapeutic area.

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