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China's slow and ambiguous drug approval system causing discomfort for Indian drug companies.


Date: 05-06-2019
Subject: China's slow and ambiguous drug approval system causing discomfort for Indian drug companies
Indian drug makers who are lining up big plans for China, the world's second largest market for medicines after the US, may have to temper that excitement, as approvals are still hard to come by, in addition to lack of transparency in the approval process.

A team from Pharmaceuticals Export Promotion Council (Pharmexcil) – the agency under Ministry of Commerce & Industry that works for promotion of pharmaceutical exports – will soon be meeting the Chinese authorities to take up the matter of expediting approvals.

"There is no clarity in the (Chinese drug approval) system like in US and Europe or even in India where we get to know where our file is, we don't get to know anything at all. Indian industry is at a loss, on what is the current status of the registration. From the time on they announced relaxation (of Indian drug imports), it's been almost 8 months, but we have no clue about the approval," said Dinesh Dua, Chairman, Pharmexcil.

Chinese government is said to have assured India of expediting the process of drug approvals to less than 12 months, for filings made from US and Europe approved manufacturing sites.

"We are not losing heart. We know that China as an elephant needs to be woken up, by coaxing, counselling and moderating," Dua said.

Indian pharma companies are pinning hopes on Chinese market as next lever for growth, with its key US export market reaching saturation levels with intense pricing pressure.

India is asking China for greater market access to sell its pharmaceutical products with a view to bridge the trade imbalance in Chinese favour. After years of ballooning trade deficits with China, India finally saw it coming down by $10 billion in the fiscal year ended March 2019 to $53 billion. But it’s still a long way to go when it comes to pharmaceuticals.

India's export of pharmaceutical products to China remained at miniscule $41 million in FY18, compared to the overall size of Indian pharmaceutical exports that stood around $17.28 billion. Meanwhile China exports billions of dollars' worth active pharmaceutical ingredients and intermediates to India. In FY18, as per the data of commerce ministry, India imported organic chemicals worth $7 billion and pharmaceutical products worth $127 million.

Raining filings

Meanwhile, Indian companies which have the largest network of USFDA approved sites, have started filings in China to get pie of the action.

According to the International Trade Administration (ITA) of the US Department of Commerce, Chinese pharmaceutical market is forecasted to grow from USD 108 billion in 2015 to USD 167 billion by 2020. Generic drug sales constitute about 64 percent or USD 68 billion of total sales.

It’s estimated that Indian companies have made around 300 filings in China, focusing on oncology, cardiovascular, respiratory and few high end antibiotics. Sun

For instance, Sun Pharma, Dr Reddy’s, Cipla, Lupin, Zydus Cadila and Torrent Pharma among others are all filling products, setting up manufacturing units and tying-up with local partners to distribute drugs in China. Dr Reddy's made a small breakthrough with the approval of generic clot-buster drug Clopidogrel in China, the company is lining up a portfolio of 70 products for China, which are in filing process.

Source: moneycontrol.com

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