Comparison of new drug approval by regulatory agencies of US, EU and India

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

Drug lag for antineoplastic and immunomodulating agent approvals in India compared with the US and EU approvals

Background: There is a tremendous amount of research being conducted on development of new drugs for cancer therapies. The drug development of cancer therapies has dramatically increased over the past few decades. The present study was undertaken to assess the drug lag for new antineoplastic and immunomodulating agents in India compared with that in the United States (US) or European Union (EU).Methods: The new drugs approved in the US, EU and India between 2011 and 2015 were identified and information was gathered primarily from the websites of regulatory agencies of the three regions. For the drug products identified, the drugs were classified into fourteen main Anatomical Therapeutic Chemical (ATC) groups, review classification and approval date. We assessed the absolute and relative drug lag for new antineoplastic and immunomodulating agents approved in the three regions (with the ATC code L).Results: Of the 67 new antineoplastic and immunomodulating agents, 63 (94.02%) were approved in the United States, 58 (86.56%) in the European Union and 18 (26.86%) in India. The US was the first to approve 59 (88.05%) out of the 67 new antineoplastic and immunomodulating agents, the EU was the first to approve 7 (10.44%) and India was the first to approve 1 (1.49%). The median approval lag for India (18.36 months) was higher as compared to the United States (0 month) and European Union (6.02 months).Conclusions: This study confirms that India lag behind the US and EU regions in terms of total number of new drug approvals for antineoplastic and immunomodulating agents. There is a substantial approval delay in India compared to the US and EU regions. Further detailed analyses are necessary to find the reasons and impacts of drug lag for new antineoplastic and immunomodulating agents in India

A drug utilization study of analgesics for management of postoperative pain in patients admitted at a tertiary care teaching hospital

Background: Postoperative pain is very common and develops naturally as a warning. After surgery, its development can be predicted and should be prevented and treated. Besides the disagreeable aspects and physiological repercussions of postoperative pain, it delays ambulation and hospital discharge. Despite the drugs and anesthetic techniques available, the prevalence of postoperative pain is still high.Methods: Pain assessment was done by BP cuff inflation method and Numerical rating scales both pre and postoperatively.Results: Complain of postoperative pain is more in female patient. Over all complain of postoperative pain was observed more in 31-45 year age group. Complain of postoperative pain was more at 18 hour time interval. Postoperative pain complains was more in patients undergoing general surgery. Postoperatively out of 310 patients 298 patients were received diclofenac only and 18 patients were received diclofenac + tramadol combination of these 112 and 13 patients complained of post-operative pain respectively.Conclusions: 112 patients from diclofenac only received group and 13 patients from diclofenac + tramadol received group complain of post operative pain. Post-operative pain control at 12 hours is sufficient but high post-operative pain scores at 18 hour of post-operative time interval suggesting needs of additional pain control. Majority of study patients received single analgesic (Diclofenac sodium)

Contemplation on new drug approvals by U.S. FDA, 2011-2015

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

Drug lag for antineoplastic and immunomodulating agent approvals in India compared with the US and EU approvals

Background: There is a tremendous amount of research being conducted on development of new drugs for cancer therapies. The drug development of cancer therapies has dramatically increased over the past few decades. The present study was undertaken to assess the drug lag for new antineoplastic and immunomodulating agents in India compared with that in the United States (US) or European Union (EU).Methods: The new drugs approved in the US, EU and India between 2011 and 2015 were identified and information was gathered primarily from the websites of regulatory agencies of the three regions. For the drug products identified, the drugs were classified into fourteen main Anatomical Therapeutic Chemical (ATC) groups, review classification and approval date. We assessed the absolute and relative drug lag for new antineoplastic and immunomodulating agents approved in the three regions (with the ATC code L).Results: Of the 67 new antineoplastic and immunomodulating agents, 63 (94.02%) were approved in the United States, 58 (86.56%) in the European Union and 18 (26.86%) in India. The US was the first to approve 59 (88.05%) out of the 67 new antineoplastic and immunomodulating agents, the EU was the first to approve 7 (10.44%) and India was the first to approve 1 (1.49%). The median approval lag for India (18.36 months) was higher as compared to the United States (0 month) and European Union (6.02 months).Conclusions: This study confirms that India lag behind the US and EU regions in terms of total number of new drug approvals for antineoplastic and immunomodulating agents. There is a substantial approval delay in India compared to the US and EU regions. Further detailed analyses are necessary to find the reasons and impacts of drug lag for new antineoplastic and immunomodulating agents in India

Comparison of new drug approval by regulatory agencies of US, EU and India

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