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Shardul Nautiyal, Mumbai May 30 , 2019
The China-India joint summit held recently discussed bilateral trade to improve Indo- China pharma industry and address issues like long product registration time and high fees for product registration in China’s drug regulatory system, among other issues.

Besides this, other relevant key issues related to transparency in public procurement system in China and clinical trial related approvals were also deliberated at the summit organised under the aegis of Indian Pharmaceutical Association (IPA), Shengjie and SaSPinjara, China between May 16 and May 17, 2019 at Pullman Shanghai South, China.

The summit was focused on enhancing export business for both the nations across the globe.

Senior health ministry official from Government of Gujarat Punamchand Parmar was invited as the Chief Guest of the summit and Gujarat Food and Drugs Control Administration (FDCA) Commissioner Dr Hemant Koshia was invited as Guest of Honour.  Among other dignitaries, Dr. Anil Kumar Rai, Consulate General of India, Shanghai also attended the inauguration ceremony.

Dr Koshia delivered a speech on “Regulatory Overview of India- Feasibility for Import and Export” and discussed about regulatory practices in India and Gujarat State. He advocated for a more rationale policy on requirement and mandate for new clinical trial data to get approvals in China.

During his address, Dr Koshia pinpointed that clinical trials and bio-equivalence (BE) studies of Indian pharma are accepted by US FDA-EU but not by China NMPA. There is also a greater need for an accountable and transparent public procurement policy in China, he said, adding that generating new clinical trial data is time consuming and is capital intensive for an Indian company.

“Added to it is the challenge of acceptance of Indian firms having US FDA- EU-Japan approvals. Besides this, the other grave concern is that Chinese companies are allowed for contract manufacturing in India but Indian companies are not allowed to do so,” explained Dr Koshia.

During the technical session, Parmar delivered a keynote address on “India-China Pharmaceutical Cooperation Feasibility: Overview on Policy and Acceleration Path” and discussed various aspects related to India-China pharmaceutical trade and issues.

More than 800 delegates coming from pharmaceutical Industries and academicians from across the globe participated in the summit.

Exhibitors of clinical research organisations (CROs), solution providers, equipment manufacturers, representatives from API (bulk drugs), biologicals, formulation industries attended the summit from India, China and USA. During the summit Indian and Chinese participants interacted and understood their current issues related to India-China trade.

India is highly dependent on China as it sources more than 80 per cent of its APIs from China. However on the other hand, India’s exports to China is very less as compared to the latter. However, of late, there is a slow surge in the Indian pharmaceutical exports to China.

As per the statistics provided by Pharmexcil, India’s pharmaceutical exports to China which stood at US$ 145.45 million in the year 2016-17 has shown a considerable growth of 37.52 per cent and stood at US$ 200.02 million in the year 2017-18.

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