What Indian pharma cos want from Xi: China must open up to Indian generic drugs

eijing: China should open up to and remove all barriers to internationally accept Indian generic drugs, Indian pharmaceutical experts said ahead of Chinese President Xi Jinping’s maiden visit to India tomorrow.

The Indian government should ask China to deliver on its assurance of reducing the trade imbalance and promote greater imports from India, representatives of a few Indian Pharma firms told PTI.

Expectations are that Xi’s visit will result in large- scale investments in India besides addressing the yawning trade imbalance which averaged at about $35 billion year out of about $67 billion annual bilateral trade.

Representatives of Indian Pharmaceutical companies in China said that the Communist nation could consider providing a “green channel entry” for established Indian drug manufacturing companies whose facilities are already U S Food and Drug Administration (USFDA) or UK MHRA-compliant.

This move will not only boost Indian exports but also to provide affordable and life saving medicines to the Chinese population who are challenged with rising cost of hospital care.

There are only a handful Indian companies Dr Reddys, Ranbaxy, Sun Pharma & Aurobindo present in Beijing.

With $14.7 billion Pharma exports last year many of the drugs produced by India’s leading pharmaceutical companies have been welcomed in the US, EU, Russia, and Africa.

However, the existing regulatory regime and the cumbersome drug registration procedure in China has dampened enthusiasm among Indian companies seeking entry into China.

Both sides know the problem and solution and it is time for action.

The President’s visit could be a great opportunity to address the issue once for all, he said. Currently India is the biggest importer of Active Pharmaceutical Ingredients, (API) from China.

While licences and registration timelines for Chinese APIs are granted by the Indian Drug Regulatory Authority in about four to six months, it takes roughly about five to six years for established Indian pharma firms to register their products in China.

Some suggestions to minimise product approval gestation times include to follow the US, EU guidelines or those of BRICS nation, which now Chinese officials attach lot of significance.

Though China insists that there on no barriers for Indian firms to enter, there is wariness on the part of many Indian pharmaceutical companies whose representatives say the entry has become very difficult as the market in China is heavily skewed in favour of multinational firms, which have an overbearing presence in China.

Vaidyanathan Viswanath, a Beijing-based Indian Pharma Consultant with about 3 decades experience in the pharmaceutical industry across Asia – primarily China and India said that, Indian companies in China, have had limited success primarily because they ail from an “Identity Crisis”.

“Neither are the Indian companies the so-called Innovative Foreign Pharma Players with original research products selling at premium prices nor are they the domestic Chinese players with low-priced generics and tremendous market access capabilities. They are caught in between with very little space to manoeuvre,” he said.

Elaborating on problems faced by Indian Generic industry in China, Viswanath said China’s status as one of the largest pharmaceutical market rests mainly on the size of its population, rather than its market maturity.

Indian generic companies should consider forces that may influence the attractiveness of the China market in the years ahead, he said.

On whether China can deliver on their high expectations for growth, Viswanath said the Indian companies are averse to risk taking due to issues related to market access, drug registration and pricing.

About the opportunities for Indian generics in China, Viswanath said Indian firms in the present scenario should look for partnerships and acquisitions with the local Chinese firms.

In this way, they would compete in the lower-tier segment and capture productivity gains, he said.

In order to improve the current situation, K Nagaraj Naidu, the Indian Consul General in Guangzhou who was previously involved in lengthy negotiations with Chinese said that among the measures that China’s Food and Drug Administration, (CFDA) can consider to is to arrange audit and inspections of manufacturing facilities of Indian Pharmaceutical companies and approve those which are in compliance with China’s New GMP guidelines.

Once a facility is approved through this procedure, drugs manufactured at those facilities may be allowed entry into the Chinese market, he said.

To lessen the drug registration timelines, he suggested that Indian companies which have already conducted a Bio-equivalence (BE) or Clinical Testing (CT) in developed countries or in India (population size-wise comparable to China), the requirement for a local BE-CT should be waived.