Merchant Hamid A, Babar Zaheer-Ud-Din, Hussain Izhar M
Department of Pharmacy, School of Applied Sciences, University of Huddersfield, Queensgate, Huddersfield, HD1 3DH, UK.
Health Services Academy, Park Road, Chak Shahzad, Islamabad, 44000, Pakistan.
J Pharm Policy Pract. 2022 Dec 22;15(1):104. doi: 10.1186/s40545-022-00501-4.
The Drug Regulatory Authority of Pakistan (DRAP) in response to the public outcry on increasing medicines prices in the country issued notifications to direct healthcare professionals to prescribe medicines with their generic names. Like DRAP, many regulators in the low- and middle-income countries (LMICs) are also inspiring from the west to legally enforce generic prescribing in a bid to reduce the out-of-pocket public expenditures. However, there are pitfalls in the LMICs drug regulatory framework, which if left unaddressed can severely jeopardise the foreseen benefits of medicines prescribing by generic names. This article critically appraises the impact of prescribing by generic names regulations in LMICs and highlights the key considerations that are vital to address before legally enforcing generic prescribing. The ethics, regulatory compliance, and good governance are the key to success; better generics for a better tomorrow.
巴基斯坦药品监管局（DRAP）针对该国药品价格不断上涨引发的公众强烈抗议，发布通知要求医疗保健专业人员使用药品通用名开处方。与DRAP一样，许多低收入和中等收入国家（LMICs）的监管机构也受到西方启发，试图通过法律强制推行通用名处方，以减少公众自付费用。然而，LMICs的药品监管框架存在缺陷，如果不加以解决，可能会严重危及通用名处方所预期带来的益处。本文批判性地评估了LMICs通用名处方规定的影响，并强调了在法律强制推行通用名处方之前必须解决的关键考虑因素。道德、监管合规和良好治理是成功的关键；优质仿制药，美好明天。
