There is an increasing focus and adoption of risk based approach and quality metrics in multi product manufacturing by Indian pharma companies to align with global compliance levels. In order to arrive at risk based assessments the pharma companies need to adopt a mitigation plant to identify, analyse and evaluate the risk.

These were the delibrations at the Bio Pharma Landscape conference which is a part of analyatica Anacon India and India Lab Expo which started in Mumbai on April 25 by Muenchen India.

This is the regional maiden edition of analytica Anacon India and India Lab Expo, the market leading trade fairs for laboratory technology, analysis, biotechnology and diagnostics held in Mumbai from April 25-26, 2018. The expo attracted over 4,000 visitors and showcased over 100 national and international exhibitors from Germany, USA, China, Japan and Korea.

Know how on using a Robust Data set that meets quality risk management principles to enable manufacturing to change from one product to another was also discussed.  

While Satya Chandra Sekhar, vice president, corporate quality and pharma, Reliance Life Sciences spoke on methods to enhance product efficiency without sacrificing quality or safety, Dr Reba Chhabra, deputy director, Quality Control, National Institute of Biologicals (NIB) gave an overview on Haemaovigilance Programme of India (HvPI) which was launched on December 10, 2012 by NIB  to track adverse reactions associated with blood transfusion and blood product administration.

The pan-India programme aims to identify trends in adverse blood reactions and events, thereby to form blood transfusion policy and raise awareness of blood transfusion hazards.

HvpI in the country involves blood banks across the country to register online with a unique ID and password to uplink with the server based in NIB, Noida for reporting blood related adverse reactions in both blood recipients and blood donors, Dr Chhabra explained.

The exhibition had a grandeur opening with the presence of eminent industry players like Satya Chandra Sekhar, vice president and head, Reliance Life Sciences, Dr. Reba Chhabra, deputy director quality control and head, National Institute of Biologicals, ministry of health and family welfare, Government of India, Sampath Srisailam, senior group leader, Syngene International Limited, Dr. Dibyendu Saha, senior science, standards liaison - Global Biologics, United States Pharmacopoeia and Vijay Nag Thota, deputy peneral manager – Biologics Regulatory & Product Strategies, Hetero Drugs and Bhupinder Singh, CEO, Messe Muenchen India.

The analytical instrument industry is majorly import driven with 83% share in 2016, expected to come down to 74% by 2020 having CAGR 22% between 2012-2020 with major importing nations like China, USA and Europe, as per a recent report by Euro Asia Consulting.

Bhupinder Singh, CEO of Messe Muenchen India said, “Analytical instruments industry can be made into a robust eco-system by creating competitive positioning through driving sectors’ growth, R & D, local manufacturing focus and government policies. Demand for customized instrumentation from end-user segments such as the pharmaceutical and biotechnology sectors is primarily driving the analytical instruments market in India.”

The Mumbai edition of analytica Anacon India and India Lab Expo saw participation from leading companies such as Airtech Corporation, Anatek Services, Chromline Equipment, Genet Bio Co., Hally Instruments, Jiangsu Skyray Solutions Co., Ltd., Japan Analytical Instruments Manufacturers' Association, S. V. Scientific, United States Pharmacopeia, Art Lab Equipments, Simson Pharma, Waters India Pvt. Ltd. – TA, Instruments Division and Sarstedt AG & Co. KG., Agilent Technologies India Pvt. Ltd., Biolinx Lab Systems Pvt. Ltd., Glassco Laboratories Equipments Pvt. Ltd., Kevi Labtrech, India., Shimadzu Analytical (India) Pvt. Ltd., Simson Pharma, India., Toshvin Analytical Pvt. Ltd., Unichrome Associates, India.
“The analytical industry is one of the smallest segments in India but is one of the most crucial industries. There is a huge opportunity for entrepreneurs to ‘Make in India’. Focus of Food & Drug Administration and Medicine & Healthcare Products Regulatory to improve safety standards. There is a necessity for entrepreneurs, government and organizations to brainstorm and invest in creating the appropriate environment.” further added by Bhupinder Singh.

Analytical instruments demand to be majorly driven by technological advancement of machines, government funding, FDI in pharma along with stringent regulations resulting in steady growth. 100% FDI under the automatic route in Greenfield pharma and Pharma 2020 vision aims to make India as a global hub for end to end drug discovery.

The event also had a series of conference programmes focusing on in-depth discussions on the development, challenges and implementation of quality standards pertaining to bio-pharma process.

The flagship edition of the trade fair will continue to take place in Hyderabad and is scheduled for September 6-8, 2018 at HITEX, Hyderabad.

India remains heavily import dependent (70-80%) to meet Analytical instruments demand, wherein high end equipment are imported, while local manufacturing is limited to basic to medium technology equipment. Analytical instrument industry is evolving with trends such as smart technology adoption, miniaturization, portable instruments and customization; customization being highly demanding by end users. Indian analytical instruments industry is emerging (2 Billion EUR) and has potential opportunities mainly driven by shifting customer focus, foreign player’s footprint and emerging application sectors.