China manufactures most of the bulk drugs pharma industry requires-Ravi Uday Bhaskar

India has exported pharmaceuticals worth $200.02 million in FY18, with a recorded growth of 37.52 per cent.
While we have imported $2251.84 million of APIs and intermediates during the same period, India could try to reduce this trade gap by increasing our exports, which probably is possible by strengthening our bulk drug industry as India’s formulation industry (excluding biopharma) is certainly ahead of China and remains our key strength. Bilateral trade talks, though, to an extent help to reduce trade imbalance, it is only our strengths in the sectors that China wants  could really bridge it.

China manufactures most of the bulk drugs, including those involving advanced chemistry skills. They have huge capacities of manufacturing units and also of substantial number, many of them do not meet high regulatory standards prescribed by best of the regulatory agencies across the world. China is now moving towards the best regulatory standards and is already a Pharmaceuticals Inspection Co-operation Scheme (PICS) member as an observatory. It is making efforts to implement PICS guidelines in its pharma manufacturing industry.

As a part of these efforts, many manufacturing units have been notified to upgrade their standards within a stipulated time or leave the stage. From May 2018, local administrative authorities are also empowered to inspect the manufacturing facilities and impose a fine of $150 per every tonne of non-treated effluents. All these resulted in shortages of many products, both bulk drugs and formulations which is forcing China to import. This is one of the factors for India’s exports to China’s growth in FY18.

Pharmexcil activities in promoting exports to China

• Pharmexcil in association with China Chamber of Commerce of Import & Export of Medicines and Health Products (CCCMHPIE) CCCMHPIE organised India-China Pharmaceutical Conference & Business Meet during August 20-21, 2018 at Shanghai, China. It was attended by 27 Indian pharma manufacturers and 100 Chinese companies.
• During the above conference, Pharmexcil signed a Memorandum of Understanding with CCCMHPIE and the objective of this MoU is to set up a long-term partnership and cooperation between CCCMHPIE and Pharmexcil for promoting the exchange, cooperation and trade in pharma products between the member companies of both India and China and to enable greater market access.
• Pharmexcil and CCCMHPIE further to the MoU signing, have designated the focal points. Established Information Desk for greater market access of pharma from India and representing the issues being faced by India side.
• Pharmexcil extended invitation to MOFCOM and CDE during the Business Meet to host CFDA (NMPA) training programme in India. Closely pursuing with CCCMPHIE and our Embassy at Beijing, China to organise the NMPA training programme this year either in China or in India.
• In December 2018, Pharmexcil in association with China Chinopharma (CSC Corporation), Shanghai, China organised one-day workshop on ‘Regulatory Practice and Onsite Audit Requirements from NMPA’ in Hyderabad. About 200 members from 120 companies have participated in the workshop.

Import dependence of APIs

Pharmexcil, with support from Department of Commerce, formed a thinktank and brought CSIR labs and industry on one platform for devising strategies to reduce the dependence on China and to make India self-sufficient by developing technology to manufacture intermediates, KSMs indigenously. Convened interactive meetings with CSIR and industry and identified top 30-40 APIS, KSMs and intermediates required to be developed indigenously. Presentation was made to Secretary, Commerce and other departments on the key products (import dependent) and technologies to be
developed.

Submitted application for study proposal for developing DPR on import dependence under MAI Scheme.

• The objective of the study is to identify the APIs, KSMs and intermediates that are critical for the nation and the delivery mechanism for R&D, manufacturing and competitiveness
• An indicative roadmap on how to execute this opportunity (suggested partners for technology, R&D, manufacturing, the type of KSM/intermediates/API complex that can be created) Way forward
• NMPA cooperation is to be solicited for fast-track registration of medicines from India
• CDSCO has to outreach drug regulatory authorities abroad and sign MoUs and mutual agreements for cooperation by overseas FDAs. There is a dire need for CDSCO and NMPA to work closely, exchange information and dialogue regularly, which can yield positive results for Indian companies and facilitate fast-track registration.
• Flexibility in the government procurement of various provinces by China side will facilitate India side for bidding in the tenders.
• Establishing manufacturing units in China and also explore the possibilities of joint ventures.
• Identification of API clusters and manufacturing of largely dependent APIs, intermediates and KSMs in India with support from government and companies manufacturing these products to be given exclusivity rights for few years.

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