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印度通过生产关联激励(PLI)计划加强制药自力更生能力

India Strengthens Pharmaceutical Self-Reliance Through Production Linked Incentive (PLI) Scheme

Medgate Today 等信源发布 2025-03-17 15:45

可切换为仅中文


Government’s Initiative to Reduce Import Dependence on China and Boost Domestic API Manufacturing

政府减少对中国进口依赖并促进国内API制造业发展的举措

The Government of India is taking decisive steps to enhance domestic manufacturing of Active Pharmaceutical Ingredients (APIs), Key Starting Materials (KSMs), and Drug Intermediates (DIs) through the Production Linked Incentive (PLI) Scheme. This initiative is aimed at reducing India’s heavy reliance on imports, particularly from China, for essential pharmaceutical ingredients, ensuring a more resilient and self-sufficient healthcare ecosystem..

印度政府正在通过生产关联激励(PLI)计划,采取果断措施加强活性药物成分(API)、关键起始物料(KSM)和药物中间体(DI)的国内制造。此举旨在减少印度对基本药物成分进口的严重依赖,特别是来自中国的进口,从而确保建立更具韧性和自给自足的医疗保健生态系统。

Background and Significance of the PLI Scheme for Pharmaceuticals

制药行业PLI计划的背景及意义

India is one of the largest producers of generic medicines in the world, supplying nearly 20% of the global demand. However, the country has historically depended on imports for nearly 70% of its APIs and intermediates, making the pharmaceutical supply chain vulnerable to global disruptions. The COVID-19 pandemic further underscored the need for domestic capacity building to avoid supply chain disruptions and ensure uninterrupted access to essential medicines..

印度是全球最大的仿制药生产国之一,供应了全球近20%的需求。然而,该国历史上近70%的原料药和中间体依赖进口,使制药供应链容易受到全球性中断的影响。新冠疫情进一步凸显了加强国内生产能力的必要性,以避免供应链中断并确保基本药物的持续获取。

In response, the Government of India launched the PLI Scheme for Pharmaceuticals in 2020 with an initial financial outlay of ₹6,940 crore ($850 million). The scheme is designed to provide financial incentives over a six-year period (2021–2027) to encourage the domestic production of critical bulk drugs, APIs, and DIs that are vital for India’s pharmaceutical industry..

对此,印度政府于2020年推出了制药行业的生产关联激励计划(PLI Scheme),初始财政拨款为694亿卢比(8.5亿美元)。该计划旨在六年期间(2021-2027年)提供财政激励,以鼓励国内生产对印度制药产业至关重要的关键原料药、活性药物成分(API)和药物中间体(DI)。

Key Achievements Under the PLI Scheme

PLI计划下的关键成果

1. Boosting Domestic API Production

1. 促进国内API生产

As of March 2025, domestic production of 38 critical APIs has already begun, significantly reducing dependence on imports.

截至2025年3月,国内已经开始生产38种关键API,大大减少了对进口的依赖。

APIs such as Penicillin G, Clavulanic Acid, and several high-value antibiotics and analgesics—previously imported from China—are now being produced within India.

像青霉素G、克拉维酸和几种高价值的抗生素和止痛药等之前从中国进口的药物,如今在印度国内已经能够生产。

The country has witnessed a 50% reduction in import dependence for several high-demand drug ingredients.

该国对几种高需求药物成分的进口依赖减少了50%。

2. Establishment of Greenfield Manufacturing Plants

2. 建立绿地制造工厂

Under the PLI Scheme, 35 new greenfield manufacturing facilities have been sanctioned across various states, including Gujarat, Maharashtra, Himachal Pradesh, and Andhra Pradesh.

根据PLI计划,已经批准在包括古吉拉特邦、马哈拉施特拉邦、喜马偕尔邦和安得拉邦在内的各邦建立35个新的绿地制造工厂。

Two major bulk drug parks have been approved in Himachal Pradesh and Tamil Nadu, aimed at consolidating pharmaceutical ingredient production and ensuring cost competitiveness.

已批准在喜马偕尔邦和泰米尔纳德邦建立两个主要的原料药园区,旨在整合制药原料生产并确保成本竞争力。

These plants will contribute to the production of APIs like Atorvastatin (cholesterol-lowering drug), Acyclovir (antiviral medication), and Metformin (diabetes treatment), helping to fortify the domestic pharmaceutical landscape.

这些工厂将有助于生产阿托伐他汀(降胆固醇药物)、阿昔洛韦(抗病毒药物)和二甲双胍(糖尿病治疗药物)等原料药,从而加强国内制药领域。

3. Reduction in Import Dependence on China

3. 减少对中国进口的依赖

India’s API imports from China, which previously accounted for nearly $3.5 billion annually, have already started to decline due to increased domestic production.

由于国内产量增加,印度从中国进口的原料药已开始下降,此前每年进口额接近35亿美元。

By 2027, the government aims to cut API imports by 75%, reducing risks associated with external supply disruptions.

到2027年,政府计划将API进口减少75%,降低与外部供应中断相关的风险。

4. Attracting Investments and Job Creation

4. 吸引投资和创造就业机会

The scheme has mobilized over ₹2,500 crore ($300 million) in private sector investments, with more companies expanding their manufacturing capacities.

该计划已动员超过2500亿卢比(3亿美元)的私营部门投资,更多公司正在扩大其制造能力。

The initiative has created over 25,000 direct jobs and an estimated 50,000 indirect employment opportunities across the pharmaceutical sector.

该计划已创造了超过 25,000 个直接就业岗位,并在制药行业估计创造了 50,000 个间接就业机会。

Several domestic and international pharma companies have set up API production units in India, enhancing the country’s role in the global pharmaceutical supply chain.

几家国内外制药公司在印度设立了API生产单元,增强了该国在全球医药供应链中的作用。

Government’s Commitment to Strengthening Healthcare Infrastructure

政府致力于加强医疗基础设施

The Government of India remains committed to achieving pharmaceutical self-reliance as a part of its broader Atmanirbhar Bharat (Self-Reliant India) vision. The PLI Scheme is strategically designed to not only enhance domestic drug manufacturing capacity but also boost exports, making India a global hub for pharmaceutical ingredients..

印度政府仍然致力于实现制药业的自力更生,作为其更广泛的“自力更生印度”愿景的一部分。生产关联激励(PLI)计划经过战略性设计,不仅旨在提升国内药物生产能力,还促进出口,使印度成为全球制药原料的中心。

Speaking about the progress of the PLI scheme, Union Minister for Chemicals and Fertilizers, Dr. Mansukh Mandaviya, stated:

工业和化学品部部长曼苏赫·曼达维亚博士在谈到生产挂钩激励计划的进展时说道:

“The success of the PLI Scheme marks a new era for India’s pharmaceutical sector. By strengthening domestic production of APIs and bulk drugs, we are ensuring affordable, high-quality medicines for our citizens while positioning India as a global leader in pharma manufacturing.”

“PLI计划的成功标志着印度制药行业的新时代。通过加强原料药和大宗药物的国内生产,我们正在确保为公民提供价格实惠、高质量的药品,同时将印度定位为全球制药生产的领导者。”

Future Roadmap and Policy Expansion

未来路线图与政策扩展

The next phase of the PLI Scheme aims to extend incentives for biopharmaceuticals, gene therapies, and advanced drug formulations, further expanding India’s pharmaceutical capabilities.

PLI计划的下一阶段旨在为生物制药、基因治疗和先进药物制剂提供激励措施,进一步扩大印度的制药能力。

The government is also exploring collaborations with research institutions and private companies to develop indigenous alternatives to imported raw materials.

政府还在探索与科研机构和私营企业合作,开发进口原材料的本土替代品。

Plans are underway to enhance pharmaceutical R&D funding to develop next-generation APIs, biosimilars, and novel drug formulations, making India not just a manufacturer but also a global innovator in healthcare solutions.

计划正在实施中,以增加对制药研发的资金投入,开发下一代原料药、生物类似物和新型药物制剂,使印度不仅仅是一个制造商,而且成为全球医疗保健解决方案的创新者。

Conclusion

结论

The PLI Scheme’s success underscores India’s growing pharmaceutical self-sufficiency and global competitiveness. With the rapid expansion of domestic API production, reduced dependence on imports, and a thriving investment climate, India is poised to strengthen its position as the “Pharmacy of the World” while ensuring national health security..

生产关联激励计划的成功凸显了印度制药自给自足能力的提升和全球竞争力的增强。随着国内原料药生产的快速扩张、进口依赖的减少以及投资环境的蓬勃发展,印度准备在确保国家卫生安全的同时,进一步巩固其“世界药房”的地位。