7月17日至19日,2026中巴医药及医疗健康B2B投资大会在巴基斯坦举办,****管理局(DRAP)发布原料药产业专项推介报告,披露本国原料药市场高度依赖进口的产业现状,推出专属监管绿色通道、财税补贴、产业园配套等全套扶持政策,面向中国原料药企业释放进口替代、区域出口双重投资红利。
From July 17 to 19, the 2026 China-Pakistan Pharmaceutical and Healthcare B2B Investment Conference was held in Pakistan. The Pakistan Drug Regulatory Authority (DRAP) released a special promotional on the active pharmaceutical ingredients (API) industry, revealing the country's heavy reliance on imported APIs. It introduced a full set of support policies including exclusive regulatory green channels, fiscal and tax subsidies, and industrial park facilities, offering Chinese API companies dual investment benefits in import substitution and regional exports.
一、市场缺口显著,本土原料药产业发展空间广阔
报告显示,巴基斯坦拥有2.55亿人口,国内医药市场2024年规模达44亿美元,行业预测2030年将扩容至66亿美元。****制药厂商超700家,其中包含10家跨国药企、650余家制剂生产企业,形成稳定的本土原料药内需市场。
当前巴国原料药供应高度依赖进口,85%原料药需求依靠海外采购,本土仅量产40余种原料药,进口替代市场空间巨大。巴方规划落地年产5000****工厂,重点布局对乙酰氨基酚、布洛芬、环丙沙星、阿替洛尔等口服固体制剂通用原料药,产品满足本土600余家制剂厂采购需求,同时可辐射南亚、中亚开展出口贸易。
1. Significant Market Gap, Broad Development Space for the Domestic Active Pharmaceutical Ingredients (API) Industry
The shows that Pakistan has a population of 255 million, with the domestic pharmaceutical market reaching $4.4 billion in 2024, and the industry is projected to expand to $6.6 billion by 2030. Currently, there are over 700 licensed pharmaceutical manufacturers nationwide, including 10 multinational pharmaceutical companies and more than 650 formulation manufacturers, forming a stable domestic market demand for APIs.
At present, Pakistan's API supply is highly dependent on imports, with 85% of API demand met through overseas procurement. Domestically, only more than 40 types of APIs are produced in large quantities, indicating a huge market space for import substitution. Pakistan plans to establish standardized API factories with an annual production capacity of 5,000 tons, focusing on general APIs for oral solid formulations such as paracetamol, ibuprofen, ciprofloxacin, and atenolol. These products will meet the procurement needs of over 600 domestic formulation manufacturers and can also extend to export trade in South Asia and Central Asia.
二、完善法规体系,设立原料药专属监管窗口提速审批
巴基斯坦依托成熟法律框架规范原料药全链条生产许可管理,核心法规包含《2012年DRAP法案》《1976年药品法》及配套许可注册规则,DRAP药品许可部门统筹全部生产资质审批工作,划分五大生产许可证类型:基本原料药生产许可、半基本生产许可、制剂生产许可、分装许可、实验研发生产许可。
针对原料药投资者,DRAP推出专属便利化监管举措:
1. 设立原料药单一联络窗口,一站式办理场地审批、布局图审核、危险品经营许可证(DML)、原料药产品注册、cGMP认证全流程业务;
2. 标准化DML审批流程:企业提交图纸与申请材料→现场核查→评审小组核验→许可委员会审批→发放官方资质文件,全程支持线上申请进度追踪;
3. 推行风险分级核查机制、标准化SOP流程,开放申报前咨询服务,出口导向型原料药企业享受审批快车道;
4. 监管标准全面对标国际cGMP,****政府部委保障外资项目落地时效。
2. Improve the Legal System and Establish a Dedicated Regulatory Window for Active Pharmaceutical Ingredients (APIs) to Accelerate Approval
Pakistan relies on a mature legal framework to regulate the entire production licensing chain of APIs. The core regulations include the "DRAP Act 2012," the "Pharmaceuticals Act 1976," and supporting licensing and registration rules. The DRAP Drugs Licensing Department oversees all production qualification approvals and divides production licenses into five types: basic API production license, semi-basic production license, formulation production license, repackaging license, and experimental research and production license.
For API investors, DRAP has introduced dedicated facilitation regulatory measures:
1. Establish a single liaison window for APIs to handle site approvals, layout plan reviews, hazardous substance operation permits (DML), API product registration, and cGMP certification in a one-stop process;
2. Standardize the DML approval process: companies submit drawings and application materials → on-site inspection → verification by review panel → approval by licensing committee → issuance of official qualification documents, with full support for online application progress tracking;
3. Implement a risk-based inspection mechanism and standardized SOP procedures, offer pre-submission consultation services, and provide expedited approval channels for export-oriented API companies;
4. Fully align regulatory standards with international cGMP, and coordinate with various government ministries to ensure timely implementation of foreign-invested projects.
三、多维投资优势凸显,宏观产业基础适配中国药企布局
1. 宏观经济基本面稳定
巴国持续推进经济改革,主权信用评级持续改善,通胀、汇率维持多年低位,预测2050年GDP可达3.3万亿美元;依托中巴经济走廊,外资营商环境持续优化,经济特区提供专项招商激励。
2. 优质低成本劳动力储备
**64%人口低于30岁,拥有全球第七大规模劳动力,每年新增200万高校毕业生,储备大量制药工程师、药剂师、化学研发人员,制药行业现有从业人员超10万人,人力成本具备竞争优势。
3. 成熟医药产业配套
本土已形成完整制剂产业生态,现成下游客户**充足;政府出台专项原料药促进政策,大力扶持本土原料药制造、技术引进与产业创新。
Ⅲ. Multi-dimensional Investment Advantages Become Prominent, Macro Industrial Foundation Aligns with Chinese Pharmaceutical Companies' Layout
1. Stable Macroeconomic Fundamentals
Pakistan continues to promote economic reforms, sovereign credit ratings are continuously improving, inflation and exchange rates remain at low levels for many years, and GDP is projected to reach $3.3 trillion by 2050; relying on the China-Pakistan Economic Corridor, the foreign investment business environment is continuously being optimized, and economic zones provide special investment incentives.
2. High-quality, Low-cost Labor Reserve
64% of the national population is under 30 years old, possessing the world’s seventh-largest labor force, with 2 million new university graduates each year, providing a large reserve of pharmaceutical engineers, pharmacists, and chemical researchers. The pharmaceutical industry currently employs over 100,000 people, giving labor costs a competitive advantage.
3. Mature Pharmaceutical Industry Ecosystem
A complete local formulation industry ecosystem has been established, and downstream customer resources are abundant; the government has introduced special policies to promote the production of active pharmaceutical ingredients (APIs), vigorously supporting local API manufacturing, technology introduction, and industrial innovation.
四、全方位财税、基建激励政策落地,大幅降低投资成本
依托2022年获批原料药扶持政策与《促进药品及相关原材料本土生产国家政策(草案)》,巴方为中国原料药投资者提供短期、长期双重激励:
短期财税支持
-原料药生产原料、中间体、生产设备免征进口关税,下调原材料销售税;
-本土原料药产品设置保护性关税,规避海外低价产品冲击;
-出口融资计划(EFS)、长期低息融资机制(LTFF)并行,企业可留存15%出口离岸收入;
-项目最高可获得总投资额70%本地配套贷款,****工厂总投资约6000万美元,自有资金仅需1800万美元;项目投产后年营收可达8500-9000万美元,内部收益率稳定在18%-20%。
IV. Comprehensive Fiscal, Tax, and Infrastructure Incentive Policies Implemented, Significantly Reducing Investment Costs
Relying on the 2022 approved API support policies and the "National Policy for Promoting Local Production of Pharmaceuticals and Related Raw Materials (Draft)", Pakistan provides both short-term and long-term incentives for Chinese API investors:
Short-term Fiscal and Tax Support
-Exemption from import duties on API raw materials, intermediates, and production equipment, reduction of sales tax on raw materials;
-Protective tariffs set on locally produced API products to avoid the impact of low-priced overseas products;
-Export Financing Scheme (EFS) and Long-Term Financing Facility (LTFF) run in parallel, allowing enterprises to retain 15% of export offshore earnings;
-Projects can obtain local supporting loans up to 70% of total investment. A planned 10,000-ton API plant has a total investment of about 60 million USD, requiring only 18 million USD of own funds; after the project is operational, annual revenue can reach 85-90 million USD, with an internal rate of return stable at 18%-20%.
长期基建配套保障
规划建****园区,统一配套共享污水处理、废弃物处理、自备发电、蒸馏提纯、环境控制系统等公共设施;出台专项政策扶持石脑油裂解项目,完善医药上游中间体产业链;入驻经济特区企业可获取专属工业用地、稳定工业电力供给。
Long-term infrastructure support
Plan and construct large-scale active pharmaceutical ingredient industrial parks, with unified and shared public facilities such as wastewater treatment, waste disposal, self-provided power generation, distillation and purification, and environmental control systems; introduce special policies to support naphtha cracking projects and improve the upstream pharmaceutical intermediate industry chain; enterprises entering the special economic zone can obtain exclusive industrial land and stable industrial power supply.
五、未来产业发展规划
巴方明确原料药产业五大发展方向:深化监管体系改革、搭建跨部门协同审批机制、完善原料药产业园基础设施、持续加码财税投资激励、推动原料药领域产学研创新**。DRAP将持续优化原料药外资准入流程,依托中巴产业**平台,吸引中国原料药龙头企业落地建厂,补齐本土原料药供应链短板,打造南亚区域****基地。
5. Future Industrial Development Plan
The Pakistani side has clarified five major development directions for the API (Active Pharmaceutical Ingredients) industry: deepening the reform of the regulatory system, establishing a cross-departmental collaborative approval mechanism, improving the infrastructure of API industrial parks, continuously increasing financial and tax investment incentives, and promoting industry-university-research innovation cooperation in the API sector. DRAP will continue to optimize the foreign investment access process for APIs, relying on the China-Pakistan industrial cooperation platform to attract leading Chinese API companies to establish factories, fill gaps in the local API supply chain, and create a South Asian regional base for API production and export.
茂本公司(中国)是一站式综合经贸服务企业,核心覆盖境内外会展全流程运营、大宗商品双向贸易、全球跨境供应链配套、海外投资项目四大核心业务。
公司依托成熟的海内外产业**网络,深度联动中国-非洲、中国-巴西、中国-****协会、产业园区与政企平台,可为中外企业提供国际展会策划招商、B2B供需对接、粮油/机电/新能源/医药等品类大宗贸易撮合、国际物流清关仓储、海外投资调研、PPP项目规划、外资落地合规代办一体化解决方案,助力国内企业出海拓市,同步引进海外优质农副产品、特色产业**对华流通,深度服务中巴经济走廊跨境经贸与双边产业**。
Mallbem Company (China) is a one-stop comprehensive economic and trade service enterprise, with core businesses covering four major sectors: full-process operation of domestic and overseas exhibitions, two-way bulk commodity trade, global cross-border supply chain supporting services, and overseas investment projects.
Relying on a mature network of domestic and international industrial resources, the company deeply connects business associations, industrial parks, and government-enterprise platforms in markets such as China-Africa, China-Brazil, and China-Southeast Asia. It can provide an integrated solution for Chinese and foreign enterprises, including international exhibition planning and investment promotion, B2B supply and demand matching, bulk trade matching in categories such as grain and oil, electromechanical products, and new energy, international logistics, customs clearance and warehousing, overseas investment research, PPP project planning, and compliance services for foreign investment localization. This helps domestic enterprises expand overseas markets while simultaneously introducing high-quality overseas agricultural and sideline products and specialty industrial resources to China, deeply serving cross-border trade and bilateral industrial cooperation along the China-Brazil economic corridor.