Speech by CG at China-India Pharmaceutical Business Convention

[17 May 2019; 0900 hrs]

印度驻沪总领事瑞峰先生在中印制药项目对接交流会致辞

2019年5月17日上午9时

Namaskar!! Dajia Hao!! Good Morning!!

大家早上好！

Friends, ladies and gentlemen,

朋友们、女士们、先生们：

It gives me great pleasure to be here among all of you. I acknowledge long and varied experience as well as great expertise in yours field of work and take this opportunity to welcome you all.

今天能在此与大家汇聚一堂，我深感荣幸。各位都是社会各行业的专业精英，我欢迎大家莅临交流会。

It is important to note that in the year 2015, Governments all over the world pledged towards implementation of Agenda 2030 which is also called as Sustainable Development Goals. India and China played lead role in shaping the agenda and reflecting the challenges and opportunities for the developing countries. SDG Goal No. 3 calls for ‘Ensuring healthy lives and well-being for all at all ages’. I consider this deliberation as an outcome of the commitment of two largest and fastest growing developing countries toachieve access to safe, effective, quality and affordable essential medicines and vaccines for all.

2015年，全球各政府都在积极实现联合国《2030年可持续发展议程》。印度和中国在制定该议程中发挥了重要的领导作用，成为广大发展中国家的利益诉求代表。《2030年可持续发展议程》的第三号目标便是“保障所有人的健康生活与福祉”。我认为，印中作为世界上最大的发展中国家，如果能实现为人民提供安全、有效、质优且平价的医药，便是为实现该目标做了巨大贡献。

This aspect of Health for all has been given due consideration by the Leadership of China and so as the drug regulators and policy makers. We understand that the Chinese drugs regulators recognized that unless greater market access is given to foreign companies and the obsolete, unwarranted as well as artificial barrier are removed, achieving affordable healthcare in China will not be feasible.

如今，中国领导层和药品监管决策层十分重视公共健康。中国药品监督机构也意识到，只有进一步向海外制药公司开放市场，废除不必要的制度障碍，才能有助于中国建设平价医保体系。

China is one of the fastest growing pharmaceutical markets in the world and India’s advantage in this sector makes it a natural choice for sourcing of affordable, cost-effective and lifesaving drugs by China. However, this complementarity between our two countries remains under exploited. With ageing population, rise in non-communicable disease and commitment to provide quality medicines at affordable price through ‘Healthy China 2030 policy; China certainly provides room for Indian pharma sector to expand its market presence. It’s up to us to explore this with a spirit of win-win for all.

中国是全球发展最快的医药市场之一，而印度作为制药大国，自然能为中国提供质优价廉的药品资源。印中两国在医药领域的合作潜力巨大，尚待挖掘。随着中国社会老龄化加深、非传染性疾病增加，以及国家出台《“健康中国2030”规划纲要》；中国成为印度制药行业的重要海外市场。在这样的背景下，我们肩负着推动印中医药双赢合作发展的任务。

Chinese Pharma market in 2015 was valued at US$ 102 bn and it is expected to grow up to US$ 152 bn by 2019. India’s advantage in pharmaceuticals would make it a natural choice for China to source high quality and affordable lifesaving drugs from India. Our exports of pharma products has crossed $ 19 bn last year with exports reaching 200 destinations and only fraction of it has come to China. Currently India is third largest pharma industry by the way of volume of production and 10^th largest by value. China is ranked 17^th in the list of destinations where India exports pharma products while India ranks 30^th in the list of Chinse sourcing pharma products.

2015年，中国医药市场的估值为1020亿美元，预计到2019年将增至1520亿美元。印度在制药业方面的优势，能为中国提供质优价廉的药品，成为中国可靠的合作伙伴。去年，印度的医药产品出口已超过190亿美元，出口目的地达到200个国家，但其中只有一小部分进入了中国。目前，按产量计算，印度是第三大制药工业国，按价值计算，印度是第十大制药工业国。中国在印度的药品出口国中排名第17位，而印度在中国的药品采购国中排名第30位。

Accordingly, in April 2018, Cooperation in the field of pharmaceuticals was identified as one of the important component during the Strategic Economic Dialogue between NDRC and NITI Aayog held in Beijing and a working group was constituted. This working group was expected to bring tangible outcomes by making all out efforts to understand China’s regulatory and procurement systems and assess how Indian pharma products can increase its market share.

为此，2018年4月，中国国家发改委与改造印度国家研究院（NITI Aayog）在北京举行战略经济对话，将药品领域合作确定为重点发展领域，并成立工作组。该工作组将致力于研究中国的药品监管和采购体系，并评估印度制药产品如何增加在中国市场的份额，从而带来切实的成果。

The issue regarding access to Indian pharma products was also discussed between PM Modi and President Xi Jinping at Wuhan informal summit in April 2018. We are yet see any significant improvement in India’s pharma exports to China, however; we are optimistic and consider this as work in progress.

2018年4月莫迪总理与习近平主席武汉会晤时，也讨论了中国如何向印度制药品开放市场的问题。但是，我们目前还未看到印度药品出口中国的大发展；我们期待未来该领域有积极发展，我们也将携手推进相关工作。

Let me share some of the information available to me and request all of you to look for response as well as amicable solutions to the outstanding issues in the upcoming sessions:

下面，我将向大家分享一些信息，并请大家就下述问题提出见解：

Indian pharmaceutical companies in China face regulatory hurdles such as prolonged and unpredictable timelines for drug registration, demand for submission of detailed clinical trial data, and requirement for revealing the drug formulation process at the time of filing for registration.

印度在华制药企业面临的监管障碍包括:药品注册申请时间过长、无法预测、需要提交详细的临床试验数据、在申请注册时需要提供药品制作配方等。

Though NMPA has changed its regulatory framework to align with ICH, the rules are favoring locally manufactured generics putting the Indian pharma sector at disadvantage.

虽然国家药品监督管理局已进行改革，使其监管框架适应“国际人用药品注册技术协调会”（ICH）的标准。但是，药管局的制度规则还是倾向于中国国产仿制药，对印度制药部门不利。

In addition, our information suggests that Quality Consistency Evaluation for generics is required even for already approved molecules.

另外，根据已有信息，我们呼吁对所有仿制药，即便是已经通过审核上市的仿制药，进行质量一致性评估。

There is a difference in treatment given to locally produced drugs and those produced outside. Generics which are locally produced and having US FDA approvals gets (i) property review and (ii) Bio-equivalence waiver. These benefits are not extended to the drugs produced outside China.

中国对国产药品和进口药品实行区别对待。中国国产药品如果获得美国食品药品监管局的审批通过，便可免去性能审查和生物等效性审查。然而，这一豁免政策却没有惠及外国生产的药品。

The proposal for Bio-equivalence waiver for drugs already approved by US/EU/Japan, should not be subjected to further studies.

经美国、欧美、日本审批通过的药品豁免生物等效性审查，这一倡议应该尽快得到批准。

We note that several Provinces of China reviewed their bidding processes for drugs procurement and priority is now being given to procurement from local Chinese companies supplying drugs that meet international standards. This would deny market access for premium quality generic drugs from India.

我们还注意到，中国部分省份修改了药物采购招标程序，优先采购中国制药企业生产的、符合国际标准的药品。此举无疑为印度优质仿制药进入中国市场增添了阻碍。

We are given to understand that recently China’s State Council has decided to relax some of the norms regarding clinical trials in China to ensure better availability of drugs to the Chinese patients. We need to see if this measure would be useful for India’s pharma exports to China.

目前，中国国务院决定放宽药物临床测试要求，以更好满足中国市场的需求。我们希望该优化政策也能惠及帮助印度药品进入中国。

It has been indicated that the recently constituted National Health Care Security Administration is bringing in major reforms in the procurement system such as 7+4 initiative to aggregate demand from the 4 centrally administered cities and 7 major cities. There is likelihood that such system will be expanded to other cities.

八、 据悉，最近成立的国家医疗保障局正在药品采购制度方面进行重大改革，例如7+4倡议，以满足4大直辖市和7个主要城市的总需求。预计未来，该制度体系将引进其他城市。

To sum up, I must say that many changes are in the pipeline and the coming days will be full of opportunities, as well as throw varied degree of uncertainty. Therefore, a closer cooperation and continued communication and consultation, as happening today would be the best option. My advise to all of you will be to use this opportunity to understand each other’s priorities and challenges; try to clarify doubts and look for best possible options for cooperation.

总而言之，未来机会和挑战并存，同时不确定性增加。因此，密切的合作，加强沟通和交流在当今的环境下显得十分重要。我在此呼吁大家借此次交流会互相加深了解、消除疑虑，为未来的合作铺平道路。

I thank the organizers for holding this event and wish you all a fruitful session

感谢组织此次交流会的主办方，并预祝大会顺利进行。

Thank you!!

感谢大家！！