This is a translations as part of the China India Networked (CIN) Newsletter. View past editions and sign up here.
<aside> 🔌 The China India Networked (CIN) Newsletter is by me, Dev Lewis. I'm a Fellow at Digital Asia Hub and Yenching Scholar at Peking University, where i'm conducting research on the Social Credit System and data governance.
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<aside> 🏥 Title: After 10 years of Defeat, Indian Pharma begins in New Campaign Armed for Success Author: Suping Ma and Sizhuo Huang Original Publisher: The Southern Weekly Date: August 22, 2019 Source: https://mp.weixin.qq.com/s/LULESDNoWCr_pkJIEZr0oA
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In the summer of 2018 the Chinese film Dying To Survive told the story of a group of cancer patients who, unable to afford "genuine" anti-cancer drugs in China, go to India to get their hands on 'copy-cat' drugs, bringing the issue of affordability of drugs under the glare of the public eye in China.
India is known as the "World's Pharmacy" with its generic drugs sold to more than 180 countries and regions around the world, performing well in high-end markets such as Europe, the US, and Japan. Whats embarrassing is that this whole time they have not been able to make a dent in the Chinese market.
At present there are only about 200 Indian medicines officially listed in China, most of them of the 'unprocessed' type. In the past two decades only 45 Indian finished drugs have been approved in China, none of which are anticancer drugs.
However, since June 2019, the entry of Indian generic drugs have suddenly picked up speed. In just two months a number of Indian pharmaceutical companies have successively made moves to enter the Chinese market. On July 16, 2019, Indian pharmaceutical giant Cipla announced that it would establish a joint venture company in China. Half a month later another Indian generic drug company, Strides, followed suit. Indian pharmaceutical giant Sun Pharmaceuticals, in June and August 2019, announced two consecutive agreements with China Kangzhe Pharmaceutical to cooperate on generic drugs and innovative product patenting. Even Natco manufacturer of the generic drug Gefitinib (product name: Iressa), of Dying To Survive fame*,* took its shot at the Chinese market through a launched a clinical trial in the Chinese market in cooperation with a Chinese hospital.
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The entry of India's generic drugs accelerated following the China-India Drug Regulatory Exchange Conference held in Shanghai on June 21, 2019. The strong lineup of companies sparked an unprecedented level of attention.
The leaders of both country's Food and Drug Administration personally led the team and participated in the whole process, with leaders of the Drug Registration Division, the Drug Evaluation Center and other relevant departments, all present. The main organizer of the conference was the China Chamber of Commerce for Import and Export of Medicines and Health Products (CCCMHPIE).
The conference was on an invite-only basis invitation system, and many enterprises had to go to great lengths to get a ticket. A total of 35 Indian pharmaceutical companies and 30 domestic pharmaceutical companies were selected to participate. As the nodal agency for trade in medical industry between the two countries, the CCCMHPIE has done a lot of work in harmonizing policy for the entry of Indian medicine into China. The China-India Drug Regulatory Exchange Conference is a major event launched by the them nearly half a year after it began placing special focus on the regulatory demands of Indian pharmaceutical companies.
At that time, the "World Pharmaceutical Raw Materials China Exhibition" had just ended in Shanghai and some Indian pharmaceutical companies had returned to India but to avoid missing this rare opportunity, they sent their marketing or legal department heads to participate. “Despite the inability to visit the site, they felt that the agenda of the meeting was so important that they got their colleagues to live steam it off their phones,” said Guo Xiaodan, secretary general of the CCCMHPIE. The meeting lasted for 9 hours, with a lot of time allocated by the Chinese side towards introducing and explaining the import drug registration regulations, overseas inspections, and recruitment procedures.
"India has a lot of complaints, but it is mainly concentrated in two aspects", Meng Dongping, vice president of the Medical Insurance Chamber of Commerce, told Southern Weekly. One is that generic drugs already approved for listing in Europe and the United States can be approved in China on fast-track. The second is to be able to participate in the national medical insurance negotiations to get Indian drugs to be eligible for national procurement.
An Indian Embassy press briefing conveyed the urgency of the situation. "The Indian ambassador to China hopes that China will provide a clear road map for India to enter China. The regulatory authorities of the two countries should make such meetings the norm in the future."
However, a representative from the State Food and Drug Administration told the Southern Weekly that “it is not necessary to overstate any emphasis on Indian generic drugs into China”. The drug regulatory department will not give preferential policies to a single country, nor will it go out its way to set thresholds. Communication with drug regulatory authorities from around the world is not new.