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[行业动态] 中印谈判争取给印度特定药品以加速审评审批(1-3年)

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药士
发表于 2018-8-15 16:28:49 | 显示全部楼层 |阅读模式

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本帖最后由 beiwei5du 于 2018-8-15 16:41 编辑

Indo-China talks put on fast track to bring down drug approval timeline & import tariff on priority therapeutics

Laxmi Yadav, Mumbai
Monday, August 13, 2018, 08:00 Hrs  [IST]
In an attempt to boost pharma exports to China, the Union commerce ministry has initiated talks with China Food and Drug Administration (CFDA) to fast track drug approval process and waive off import tariff on a slew of therapeutic areas including cardiovascular, gastrointestinal, diabetes, neurology and respiratory diseases in line with oncology segment.

China had earlier exempted 28 drugs including cancer medicines from import tariff. Earlier the import duty on these drugs was 5-6 per cent.

It is learnt that a higher level delegation of the Commerce Ministry and Pharmaceuticals Export Promotion Council of India (Pharmexcil) has recently called on CDFA and China Chamber of Commerce for Import & Export of Medicines & Health Products seeking reduction in drug approval timeline from 5-7 years to 1-3 years and exemption on import duty on several therapeutic areas which remain priority for Chinese population.

The delegation sought one year timeframe for CFDA approval of Indian units approved by US FDA and EU authority and three years for the rest of manufacturing companies. India is a global leader in specialty generics. Speedy approval will provide opening to Indian drug makers to market their economically priced drugs in China.

“We are optimistic in terms of breaking through the Chinese market. The Chinese authority assured us that they would consider our demands positively,” sources from commerce ministry said.

Meanwhile, exporters have welcomed the government initiative to boost India's drug export to China. Swift regulatory permissions in China would enable Indian companies to increase revenue at a time when pricing pressure and regulatory hurdles have taken toll on US sales. Over the next 5 years, there is a tremendous opportunity for Indian players to tap highest market share in China, said a member of committee of administration (CoA), Pharmexcil.

We have appealed to the government to take steps with Chinese counterpart to reduce custom duty on certain therapeutic areas providing Indian companies room to grow, he said.

A Pharmexcil delegation led by its assistant director Murli Krishna is expected to visit China on August 22 to interact with stakeholders and take the discussion further.

The Indian pharmaceutical industry is trying to find ground in China which is the world's second-largest pharmaceutical market. In 2017 the market stood at US$ 122.6 billion with growth tipped to reach US$ 145 billion to US$ 175 billion by 2022, according to health-care information company IQVIA.

The talks are going on to iron out opaque regulatory issues thereby helping Indian companies make inroads in the Chinese market which constitutes one per cent of India's export worth US$ 17.3 billion in 2017-18. There is realisation on both sides Chinese regulatory authority and general public that Indian generics are of high quality and cheaper. This augurs well for Indian plants approved by US FDA, Japan, EU, South Korea etc, said the CoA member.

In 2016-17 India's total export to China valued at US$ 146 million including bulk drugs and drug intermediates (US$ 104.30 million), drug formulations and biologics (US$ 23.23 million), Ayush (US$ 0.59 million), herbal products (US$ 5.31 million), surgical (US$ 2.57 million).

During April-January 2017-18 India's export to China stood at US$ 170 million as compared to US$ 114 million export during the same period last year.

In 2016-17 India's import of pharmaceuticals from China touched US$ 1948.367 million including Ayush and herbal products (US$ 0.083 million), bulk drugs and drug intermediates (US$ 1818.988), drug formulations and biologicals (US$ 128.630 million), surgicals (US$ 0.216 million).

In 2017-18 (upto October), the country's import of pharmaceuticals from China valued at US$ 1220.679 million including Ayush and herbal products (US$ 0.034 million), bulk drugs and drug intermediates (US$ 1146.600 million), drug formulations and biologicals (US$ 73.291 million), surgicals (US$ 0.754 million).

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药士
 楼主| 发表于 2018-8-15 16:34:45 | 显示全部楼层
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药士
 楼主| 发表于 2018-8-15 16:54:03 | 显示全部楼层
本帖最后由 beiwei5du 于 2018-8-15 16:56 编辑

Pharma exports up 3 pc to $17.3 billion in 2017-18PTI|Aug 09, 2018, 04.17 PM IST


Higher growth in outbound shipments helps create employment opportunities, earn foreign exchange and boost economic activities.

India's pharmaceutical exports grew merely 3 per cent to USD 17.3 billion in 2017-18 due to increasing regulatory concerns and pricing pressures in the global markets, including the US. The sector's exports in 2016-17 had declined to USD 16.7 billion as against USD 16.9 billion in the previous fiscal, according to commerce ministry data.
Import alerts by the US Food and Drug Administration, regulatory hurdles and currency fluctuation also contributed to slow growth in the overseas shipments, an industry expert said.
The US is the top destination for Indian pharma exports, followed by the UK. America accounts for about 25 per cent of the country's shipments. The other important destinations include South Africa, Russia, Nigeria, Brazil and Germany.
Although the government is working on measures to promote exports in Japan and China, tough registration and regulatory procedures there act as hindrance for domestic exporters.
The sector accounted for about 6 per cent in the country's total exports of USD 303 billion in 2017-18. It is one of the top five sectors in the exports segment.
Generic drugs form the largest segment of the Indian pharmaceutical sector, with 75 per cent market share (in terms of revenues).
India supplies 20 per cent of global generic medicines in terms of volume, making the country the largest provider of generic medicines globally.
Over 55 per cent of India's exports go to highly regulated markets.
Higher growth in outbound shipments helps create employment opportunities, earn foreign exchange and boost economic activities.






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药士
 楼主| 发表于 2018-8-15 17:00:58 | 显示全部楼层
本帖最后由 beiwei5du 于 2018-8-15 17:03 编辑

【热点话题】中印医药产业合作现状

原创:医保商会 中国医药保健品进出口商会


在今年4月召开的国务院常务会议上,李克强总理宣布从2018年5月1日起将抗癌药等药品关税降至零,加大对创新药及临床急需药品的进口。电影“我不是药神”的热播再次使抗癌药物进口成为热点话题,李克强总理随之作出批示,要求相关部门加快落实抗癌药降价保供等相关措施。同时,电影中提到的印度廉价仿制药引发业界思考。

印度“仿制药神话”的诞生根植于其本国的产业政策与制度安排,在印度仿制药走向全球市场的过程中,中国的优质原料药和医药中间体发挥了非常重要的支撑作用。

同为全球制药大国,中印两国医药产业竞合关系值得业界研究与思考,本文将带您了解中印医药产业合作现状。

中印医药贸易情况
2017,中印医药双边贸易总额为62.7亿美元,同比增长13.5%。其中,中国对印度出口53.8亿美元,同比增长12.9%;进口8.9亿美元,同比增长17%。中印医药双边贸易额占中国医药进出口总额的比重约为5.4%。

在与印度合作过程中,整体出口西药类取物随着印度制药产业链向下游延伸步伐的加快,以及国内成本的加大,其对原料药的需求也越来越迫切。目前,中国是印度最大的原料药进口国,占印度原料药进口的80%左右,印度也是中国最大的原料药出口目的地,占我原料药出口总额的15%。印度进口的三大类原料药抗生素类、维生素类、激素类50%以上来自中国。

2017年,中国从印度进口医药产品8.9亿美元,以西药原料、植物提取物和医院诊断与治疗设备为主,分别占我从印进口医药总额的57%、21.6%和10%。

2017年,我对印有医药出口实绩的企业超过7000家,以民营企业为主,占我对印医药出口总额的59%,但集中度相对较低。

印度药品在华现状

目前,在我国注册上市的印度药品有200多个,包括原料药和成品药,其中原料药国内采购较多,成品药在国内销售量不大。印度有不少特色成品药已经在国内销售包括降压药贝那普利,降糖药伏格列波糖,降脂药阿托伐他汀钙等,以及一些抗过敏药西替利嗪等。虽然印度抗癌药尚未在国内上市,但缓解胃肠胰内分泌肿瘤的药品奥曲肽已在国内上市销售。

2017年,我从印度进口原料药5亿美元,同比增长25.8%,进口成品药1700万美元,同比增长20%



更多医药国际化市场研究分析请联系我会
电话:010-58036287,58036283
Email:lihui@cccmhpie.org.cn   
    liuwh@cccmhpie.org.cn


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药士
 楼主| 发表于 2018-8-15 17:05:49 | 显示全部楼层
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药生
发表于 2018-8-16 08:07:11 | 显示全部楼层
我不是神药,这部电影不错。
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药生
发表于 2018-8-16 09:09:16 | 显示全部楼层
印度药品质量真的好吗
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