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SaSPinjara sees Indian pharma needs ample guidance for China market entry going by regulatory approval challenges

SaSPinjara Life Sciences, the technical and business consultation provider for the pharma business in the global market, now sees that for Indian companies, China regulation is still very complex. Only companies with experience in the Chinese market have a certain advantage.

It will take at least five years from the establishment of a joint venture to the final launch of the product, as drug approval takes three years. Indian companies also need to develop drugs targeting the Chinese market, which is another challenge, said Sachin Marihal, co-founder and chairman, SaSPinjara Life Sciences.

India’s top pharmaceutical companies have always regarded the United States as their main market and have been unable to open up trade in China for a long time, with government regulation being the biggest obstacle, he added.

Agreeing with Marihal was Aravind P, chief technical officer, SaSPinjara Life Sciences who said that even after policy reforms by the Chinese regulatory authority, still companies from India face  challenges in registering into this market, as compared to the US and EU regions.

China is currently a semi mature market compared to the United States.  Indian multinational pharmaceutical companies, entering the Chinese market now have a great opportunity. This is because a wide basket of medicine portfolio has entered the list of volume based centralized procurement in China, Marihal told Pharmabiz.

There is a huge market potential in China. To this end, Pharmacodia Global Data base has initiated its state-of-the-art incubation center in China, which will help to provide land, ready facility, investment, government funding, market access, regulatory access, joint venture opportunity and all related support to international companies for better long-term strategy growth, noted Aravind.

Currently, Saspinjara has positioned itself as a channel partner to enter China and has just opened business avenues for Indian pharma. The company has been in discussions with a couple of Indian pharma companies during the recent CPhI Shanghai 2023 held in mid-June to help them better understand China market, investment, regulatory, disease mapping and related access strategy.

On how interested Indian pharma companies would be keen to invest in China with the ongoing Union government’s Make in India programme gaining momentum, Marihal and Aravind noted that the support provided varies in different regions of China. It is important to ensure that the interests of foreign investors are protected. This includes establishing a mechanism for optimizing the legal protection of the business environment, actively creating a fair market for domestic and foreign companies to compete. 

There is need to ensure that foreign-invested enterprises have equal access to production factors such as human resources, capital, land use rights, and natural resources in accordance with the law, and participate in market competition fairly, they added.

Compared to other regulated markets, China is the most stringent in regulations for pharmaceutical products and volume of products requirement is also high.  There are many different business models where several opportunities are available for foreign companies to utilise. Here the Pharmacodia Global platform can help companies to enter China, said Marihal and Aravind.

Tuesday, July 11, 2023

Source: pharmabiz.com