Speech by CG at workshop on Regulatory Systems in Pharma Sector

[21 June; 0900 hrs]

Mr. Xu Jinghe, Deputy Commissioner of China’s NMPA, friends from Indian and Chinese Pharma industry,

Ladies and gentlemen,

Namaskar!! Dajia Hao!! Good Morning!!

It gives me great pleasure to be here among all of you. I acknowledge the rich experience as well as great expertise which you possess in your respective field of work. I, on behalf of my colleagues Mr. Shymal Mishra, Director General, Commerce, Dr. Madeep Bhandari, Director General, Health, Mr. Prashant Lokhande, Counsellor at the Embassy of India, Beijing, and Dr.SE Reddy, Drug Controller General of India, takes this opportunity to welcome you all.

The issue regarding access to Indian pharma products has been under discussion at the highest level. However, we are yet to see any significant improvement in India’s pharma exports to China. There has been an effort to simplify the procedures, but it being a work in progress, certain critical gaps remained unaddressed.

Today’s India-China Drug Regulation meeting is an outcome of joint efforts of China’s Drug regulator NMPA, Its Ministry of Commerce, trade body CCCMPHIE and Indian side represented by Ministry of Health and Ministry of commerce. This is a good opportunity for the Indian companies to understand China’s regulatory and procurement system. We are happy to note that many Chinese companies are also present to learn more about Indian regulatory system. I deeply appreciate the NMPA China for conceptualizing and participating in this event.

China has the largest population base, so as the diverse health needs of its population. The leadership of China under the ‘Healthy China- 2030 policy aims to provide quality medical care at affordable cost to the common citizens of this country. This is an area where the experts feel that cooperation with India would be a win-win situation for all.

Indian pharma sector has emerged as one of the most vibrant pharma sectors globally. India’s contribution in providing ‘quality drugs at affordable price’ has been appreciated by global community making its exports of pharma products touching $20 bn. Because of our strengths in IT sector, the world used to call India as ‘office of the world’. In addition, now it is known as ‘pharmacy of the world.’

We have been exporting to quality conscious markets such as US, EU and Japan etc. However, surprisingly our exports of pharma products to China is negligible. It is worth examining to see that why in spite of having real complementarities in this product, which was rightly depicted in the hugely popular Chinese movie named ‘Dying to Survive’ (wo bu shi yao shen), the presence of Indian pharma products in China is so negligible.

Let me share some points and request all of you to look for response as well as clarifications and solutions to these outstanding issues:

1. There is a difference in treatment given to locally produced drugs and those produced outside. Generics which are locally produced and having US FDA approvals gets priority review. These benefits are not extended to the drugs produced outside China. This should be favorably considered for the Indian companies.
2. The proposal for Bio-equivalence waiver for drugs already approved by US/EU/Japan, should also be favorably considered for the Indian companies.
3. Sometime back, several Provinces of China reviewed their bidding processes for drugs procurement and priority being given to procurement from local Chinese companies supplying drugs that meet international standards. This would deny market access for premium quality generic drugs from India. Now we hope that with 4+7 policy extending to other cities of China, it will provide equal opportunity to the Indian companies.
4. We are given to understand that recently China’s State Council has decided to relax some of the norms regarding clinical trials in China to ensure better availability of drugs to the Chinese patients. NMPA is requested to elaborate on this issue and guide the Indian pharma industry on how to capitalize of this emerging regulatory scenario.

Indian side have been engaged with various Chinese authorities including MOFCOM, NMPA, NHSA and provincial governments to promote exports of our pharma products. We would like to enhance this engagement at the level of drug regulators.

We believe that today’s event is just a beginning and we will witness more vigorous engagements in this sector in near future.

I once again extend my warm welcome to the senior officials from NMPA, NHSA, CCCMPHIE of China and Ministry of Health and India’s Chief Drug regulator, Indian and Chinese pharma companies and other delegates to this event and wish the programme a great success.

Thank you!!