A descriptive study of new drug approvals during 2017-2021 and disease morbidity and mortality patterns in India.

Q2 Medicine
Perspectives in Clinical Research Pub Date : 2024-04-01 Epub Date: 2023-09-25 DOI:10.4103/picr.picr_109_23
Urvashi Gupta, Ashwin Kamath, Priyanka Kamath
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引用次数: 0

Abstract

Aim: Studies show the presence of a mismatch between drug research and disease burden. A study conducted in the European Union found that new drug development was restricted to certain diseases. A study of biosimilar approvals in India found that 87% of drugs were for treating noncommunicable diseases. This study aimed to determine the new drugs approved in India from 2017 to 2021 and the top ten causes of morbidity and mortality and detect the presence of any discordance between these.

Methods: A descriptive study was conducted using data on new drug approvals accessed from the Central Drugs Standard Control Organization website. The top ten causes of mortality and morbidity in India from 2015 to 2019 were identified from the Global Burden of Diseases database. Descriptive statistics were used to compare the drug approvals and the leading diseases.

Results: One hundred twenty-six drugs were approved during the study period. Antineoplastic drugs constituted 19.84% of the approvals, antimicrobials 18.25%, and cardiovascular drugs 9.52%. Ischemic heart disease and chronic obstructive pulmonary disease were the two leading causes of morbidity and mortality. Diarrheal diseases, lower respiratory tract infection, and drug-susceptible tuberculosis were among the top ten causes. Ten antibacterials, including four antitubercular drugs, were approved during this period. Two drugs were approved for rare diseases.

Conclusion: Our study showed that the drugs approved were largely in line with the prevalent disease burden, and there was no significant discordance observed. Some diseases, such as ischemic stroke/intracranial hemorrhage, require further efforts in bringing forth newer pharmacotherapy options.

印度 2017-2021 年新药批准情况及疾病发病率和死亡率模式的描述性研究。
目的:研究表明,药物研究与疾病负担之间存在不匹配。在欧盟进行的一项研究发现,新药开发仅限于某些疾病。对印度生物仿制药批准情况的研究发现,87%的药物用于治疗非传染性疾病。本研究旨在确定2017年至2021年印度批准的新药以及十大发病和死亡原因,并检测这两者之间是否存在任何不一致:利用从中央药品标准控制组织网站获取的新药批准数据进行了描述性研究。从全球疾病负担数据库中确定了 2015 年至 2019 年印度十大死亡和发病原因。使用描述性统计来比较药物批准情况和主要疾病:研究期间批准了 126 种药物。抗肿瘤药物占获批药物的 19.84%,抗菌药物占 18.25%,心血管药物占 9.52%。缺血性心脏病和慢性阻塞性肺病是发病和死亡的两大主要原因。腹泻病、下呼吸道感染和药物敏感性结核病位列十大病因。在此期间,包括四种抗结核药物在内的十种抗菌药物获得批准。有两种药物被批准用于治疗罕见疾病:我们的研究表明,批准的药物与流行病负担基本一致,没有发现明显的不一致。一些疾病,如缺血性中风/颅内出血,需要进一步努力推出更新的药物治疗方案。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Perspectives in Clinical Research
Perspectives in Clinical Research Medicine-Medicine (all)
CiteScore
2.90
自引率
0.00%
发文量
41
审稿时长
36 weeks
期刊介绍: This peer review quarterly journal is positioned to build a learning clinical research community in India. This scientific journal will have a broad coverage of topics across clinical research disciplines including clinical research methodology, research ethics, clinical data management, training, data management, biostatistics, regulatory and will include original articles, reviews, news and views, perspectives, and other interesting sections. PICR will offer all clinical research stakeholders in India – academicians, ethics committees, regulators, and industry professionals -a forum for exchange of ideas, information and opinions.
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