PDF(Pubmed)
Abstract：
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
摘要：
■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。印度一项关于生物类似药批准的研究发现，87%的药物用于治疗非传染性疾病。这项研究旨在确定2017年至2021年在印度批准的新药以及发病率和死亡率的十大原因，并检测两者之间是否存在任何不一致。
使用从中央药物标准控制组织网站访问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。描述性统计用于比较药物批准和主要疾病。
■在研究期间批准了126种药物。抗肿瘤药物占批准的19.84％，抗菌药物18.25%,和心血管药物9.52%。缺血性心脏病和慢性阻塞性肺疾病是发病率和死亡率的两个主要原因。腹泻病,下呼吸道感染,药物敏感结核病是十大原因之一。十种抗菌药物,包括四种抗结核药物,在此期间获得批准。两种药物被批准用于罕见疾病。
我们的研究表明，批准的药物在很大程度上符合普遍的疾病负担，并且没有观察到明显的不一致。一些疾病,如缺血性卒中/颅内出血，需要进一步努力提出新的药物治疗方案。
使用从中央药物标准控制组织网站访问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。描述性统计用于比较药物批准和主要疾病。
■在研究期间批准了126种药物。抗肿瘤药物占批准的19.84％，抗菌药物18.25%,和心血管药物9.52%。缺血性心脏病和慢性阻塞性肺疾病是发病率和死亡率的两个主要原因。腹泻病,下呼吸道感染,药物敏感结核病是十大原因之一。十种抗菌药物,包括四种抗结核药物,在此期间获得批准。两种药物被批准用于罕见疾病。
我们的研究表明，批准的药物在很大程度上符合普遍的疾病负担，并且没有观察到明显的不一致。一些疾病,如缺血性卒中/颅内出血，需要进一步努力提出新的药物治疗方案。
