A RELIABLE TEMPERATURE CONTROLLED SUPPLY CHAIN IN EMERGING ECONOMIES

Chilukuri Maheshwar

Anglo Eastern Maritime Academy

Genesis

1970s- LEDCs ( Less Economically Developed Countries)

Term changed to Emerging Markets or Emerging Economies – indicates countries in transitional stage between developing to developed countries

Regions of the world that are experiencing rapid informationalization under conditions of limited or partial industrialization: 2008 Emerging Economy Report

2010: CATEGORY BETWEEN FULLY DEVELOPED AND DEVELOPING

Emerging Economies

BRIC: Brazil, Russia, India & China BRICS: Brazil, Russia, India China & South

Africa BRIICS: Brazil, Russia, India, Indonesia, China

& South Africa BRICKET BRICM BRICK Next Eleven CIVETS

Importance of Emerging Economies

Perceived as growth centres of the future Drivers of future economic growth Bullish investor confidence Show higher economic growth rate

compared to developed countries Expected to play a greater role in areas

like financial markets, consumption of goods and services, trade and commerce, sustainable development, innovation, infrastructure development and research.

Features of Emerging Economies

Lower public health spending Competing expenditure needs and

constrained revenue raising capacity Asia has lesser public spending ratios

because of less extensive public insurance coverage and benefit packages

Public Health Care Spending

Challenges of Emerging Economies

Lower average life expectancy and Higher infant mortality

Limited funds to improve health standards Less extensive health coverage Ill aligned incentives (motivation) for

health care providers Large informal labour market Lower General awareness levels about

sanitation and hygiene

Solutions for Emerging Economies

Increase public health spending Improve the general health safety net Importance to primary and preventive health

care Incentives for health care providers Expansion of basic health care Focus on providing most essential health

services Where already an extensive health care system

is in place, the improve efficiencies by leveraging economies of scale.

Pharmaceutical Cold Chain

Complex drugs and pharmaceutical products market expected to grow to U.S. $900 billion by 2012 and $1.2 trillion by 2014.

Life-saving products like vaccines : $35 billion market by 2015

25 percent of all healthcare products are temperature-sensitive, meaning they require refrigeration during transportation and storage from manufacturer to end user.

By 2014, $16 billion worth of biological and vaccine shipments will require temperature-controlled rooms during transit.

Short window of viability, which makes rapid transport essential.

Monitoring temperatures and maintaining the proper packaging environment during transport are critical to maintaining the viability of these high-value shipments.

Pharma Markets

Effective cold chain shipping is critical, as pharma and biopharma cold chain shipments in markets worldwide are expected to grow dramatically in future.

Emerging Economies are the drivers of volumes

South Asia seen as the fastest growing cold chain shipment volume region

Cold Chain Infrastructure less developed here, losses maximum in this region

Vaccines One of the first and foremost tools for

preventive health care is Vaccination. In 2005, nearly half of all vaccines got

ruined in transit due to poor cold chain services: WHO

Degree of Knowledge about Vaccine storage in Developed Countries: A Case

To assess the knowledge and practice of vaccine storage and handling in primary care physicians' offices, a cross-sectional study was conducted in Canada from August to December 1992. Staff responsible for vaccine storage were interviewed about their knowledge and practices of vaccine handling and storage. Refrigerators were inspected to document refrigerator temperature and vaccine storage conditions.

Out of a total of 135 respondents, less than 7 answered all questions related to vaccine storage and handling correctly, and only 11 refrigerators had thermometers. 1/3 of refrigerators had temperatures outside the recommended range of 2-8 degrees C. Older refrigerators were more likely to have inappropriate temperatures than newer ones.

The Study concluded that knowledge and practice of vaccine storage and handling are often inadequate in primary care physicians' offices.

Maintenance of Vaccine Cold Chain in Developed Countries – A Case

Maintaining the vaccine cold chain is an essential part of a successful immunization programme, but in developed countries faulty procedures may occur more commonly than is generally believed.

A survey was conducted in 1999 in a health district in central Italy to assess the methods of vaccine transportation and storage. Of 52 primary vaccination offices inspected, 39 (76.5%) had a refrigerator for vaccine storage but only 17 (33.3%) kept records of received and stored doses.

None of the seven main offices selected for monitoring had a maximum and minimum thermometer and none monitored the internal temperature of the refrigerator.

Moreover, other faulty procedures, such as the storage of food and laboratory specimens in vaccine refrigerators and the storage of vaccines on refrigerator door shelves, indicated that the knowledge and practice of vaccine storage and handling were often inadequate

India: Polio Vaccination Movement

1996: Polio Eradication Program started

2000: Expected Global Eradication of Polio

2007: 866 Polio cases reported

Fresh Polio cases are still being reported.

One of the reasons for the failure of Polio Vaccination program in India is the absence of an effective cold chain which rendered the vaccine ineffective

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No. of Polio Cases reported

Why such losses in this region?

High Ambient temperature Poor transport infrastructure Lack of knowledge and awareness Poor roads and poor connectivity Dusty atmosphere Non availability of refrigerated carriers Difficult Geographical terrain Cold Chain Infrastructure is a Non priority sector for the

administration as there are more important priority areas where funds need to be deployed

Less evolved cold chain shipment regulations Unreliable grid power

Challenges

Multiple international and country specific cold chain shipment regulations

Set up a cold chain infrastructure in place Training of the various stakeholders

including public at large Establishing a network of partners who

can look after the cold chain shipment at various stages before reaching the end consumer

Distribution Chain

Distribution Challenges

Distribution in emerging markets presents three particular challenges: • Improving forecast accuracy and data reliability for estimating vaccine or drug demand • Maintaining product stability throughout the distribution chain, including requirements for cold-chain continuity• Managing the dispensing of medical products to patients in the “last mile” of the distribution chain (i.e., the stage where products are delivered from the wholesaler or pharmacy to the consumer).

How to handle the Last Mile?

Challenges Smaller Quantities Lack of availability of

recognised Cold Chain Field Difficulties Dusty atmosphere High ambient Heat Language Barrier Social Barriers Unavailability of Grid

Power

Opportunities Extension of Cold

Chain right till the end Innovative Methods of

Maintaining Cold Chain

Indigenous Methods of Preservation

Innovation and use of Technology in communication

A seamless gap-free cold chain

This can be achieved at the Last mile using Refrigerated Containers for the final last mile transportation of the drugs and vaccines.

Already Refrigerated Containers are being used in ocean transportation of the export of pharma products.

However, for applications over land in the local terrain, to suit the local environmental and climatic conditions, with the present power availability and road infrastructure, they need to be adapted suitably with necessary modifications.

Specifications Of A Standard 20 Feet Refrigerated Container

External Dimensions: 20x8x8.5 Ft. Internal Dimensions: 18x7.5x7 Ft. Internal Volume: 1000 Cu. Ft. Payload Capacity: 21350 Kgs Gross Weight: 24000 Kgs Temperature : -25 To +35 Deg C Power Consumption: 3 Kwh

Solar Powered Refrigerated Containers

Why Solar Power Depleting Fossil Fuels Growing

Environmental Concerns

Erratic and Unreliable Grid Power

Myth about Solar Power Solar PV power is very

expensive

Following the Moore’s law, it is expected that with the new generation technology with concentration equivalent of more than 1,600 times the sun's energy onto solar cells, it would be possible to produce electricity at a wholesale cost of US $0.05 per kilowatt-hour (kWh)

SOLAR CHILL PROJECT

Affordable, easy to use refrigerators that can keep vaccines at safe temperatures within the infrastructure limitations of developing countries are an important tool in improving vaccine delivery.

Already some inroads have been made in the direction.

Solar Chill is a global initiative that has developed a climate- and ozone-friendly portable vaccine cooler that is powered by solar energy and which will directly help improve the health of children in developing countries when used to transport vaccines and drugs to the remote and inaccessible parts.

PATH (Programs for Appropriate Technologies in Health)

An international, nonprofit organization and a partner in Solar Chill project

Develops safer injection technologies such as auto-disposable syringes, pre-filled injection devices, and medical waste systems making injection safety an attainable goal for many struggling health systems.

Helping to refine the vaccine distribution cold chain including identifying cold chain weaknesses, finding ways to overcome cold chain problems, and identifying improved cold chain refrigeration systems.

Developed affordable, easy to use refrigerators that can keep vaccines at safe temperatures within the infrastructure limitations of developing countries are an important tool in improving vaccine delivery.

Vaccine Vial Monitor (VVM)

Conceptualized the vaccine vial monitor (VVM), now used globally to increase vaccine efficacy and reduce wastage.

A heat-sensitive label changes color as it is exposed to heat and helps health workers decide whether or not the vaccine has been damaged by heat. It also reveals breaks in the vaccine distribution cold chain.

Overcoming Distribution Challenges

Improving demand planning and forecast accuracy

Improving market reliability

Using Information technology tools.

Setting up Information networks.

Innovative Cold-chain distribution strategies

Maximizing existing infrastructure

Alleviating dependency on temperature control.

Shortening the last mile of distribution

Supply-chain innovations

Alternative delivery systems.

Strengthening local health systems.

Agricultural Sector vs Pharmaceutical Sector

Economic Losses more severe in Pharma sector

Administering a damaged vaccine or drug is far more dangerous

Erosion of the sense of security in vaccination

Pharma Volumes smaller to justify air transportation over ocean transportation

Urgency of requirement in case of vaccines and drugs

Features of an Effective Cold Chain Temperature Measurement, Monitoring,

Control and Recording Traceability Accountability Transparency Effective Communication Networking and Involvement

360 Quality Code and Zero damage Concept for Perishable Cargo

Set of voluntary standards for specialised reefer shipping lines and their service providers.

Launched by a group of specialised reefer operators (Specialised Reefer Shipping Association - SRSA) including Great White Fleet Ltd, Green Reefers ASA, NYKLauritzenCool AB, Seatrade Group N.V., STAR Reefers Ltd. (Blue Star Line) and Universal Reefers Ltd./Cape Reefers in 2006

Aims to meet customer needs by promoting the highest standard of quality and cargo care; on reefer vessels, in port terminals and in liner trades.

Recognises that the specialised reefer shipping lines and their service providers have to work jointly to achieve this goal.

Brings transparency in the supply chain of perishables on the basis that in a collaborative supply chain everyone involved should assume responsibility for their activities and take corrective action to eliminate defects.

Main Features of 360 Quality Code

Implementing practices and using equipment in terminals and ships that will prevent damage to cargo

Uniform way of establishing damage and following an agreed action plan when damaged cargo or cargo with exceptions is presented to the terminal and ship

Uniform way of recording exceptions at reception, loading, unloading and delivery of cargo.

Establishing local working procedures for ports of loading and unloading which are compatible with the requirements of the Code

Establish quality teams in ports who will analyse the damages their cause and introduce preventive measures

Provide feedback upstream in the supply chain

360 Quality Association

A body dedicated to improving Food Safety and Food Quality in the specialised reefer shipping has been formed.

Main task - to develop guidelines for the implementation of the 360 Code and develop it further to meet the needs of the market.

Developed Uniform Guidelines for auditors and certification bodies that will audit the terminal and ships.

Classification societies and other accredited bodies that meet the approval of the 360 Quality Association will certify the shipping lines and the port terminals according to certification procedures.

Checkpoints in the supply chain & feedback to partners Checkpoints are established in the supply chain to

monitor the condition of the cargo and prevent damaged cargo from coming onboard and recording accurately the exceptions at the time of delivery.

The terminals and stevedores record the exceptions at the checkpoints in a properly structured database which allows to analyse the exceptions to reach the Six Sigma method for improving quality.

Lays down the conditions for inspection and recording of exceptions, for measures taken, and communication to everyone involved of the results – all in a uniform way and by using properly structured data.

Makes the transport process transparent and provides a firm base for taking corrective action at one or more points in the supply chain.

Zero Damage Concept

Zero Damage - a mindset in which we develop respect for the products we carry along with the livelihood of all partners in the production and supply chain.

Zero Damage is an industry standard adopted by SRSA members and is a part of 360 degree Quality Initiative of SRSA.

Motivates people to take care of the cargo all along the way.

A drive against reefer cargo claims and aims to enhance Customer Satisfaction.

Reminds about respect for cargo and equips the crew members with the knowledge and expertise in cargo care, Reefer Cargo losses have been reduced substantially by use of Zero Damage Concept.

Zero Damage Concept

Procedures have been clearly spelt out so that the cargo is handled economically, efficiently, professionally and carefully.

Checkpoints in the supply chain ensure that responsibility is handed over smoothly removing any ambiguity and enhancing transparency.

Whenever any cargo damage occurs, answers are sought as to WHY, WHERE and WHEN the damage had occurred reinforcing the commitment “Whoever is responsible for damage is accountable for the damage”.

Reefer Cargo Export Supply Chain

The various partners who can influence the supply chain are:

Farmer/grower Packing Station Truck Terminal or Cold

store in Load Port Stevedore in Load

Port Port Captain

Vessel Stevedore in

Discharge port Terminal or Cold

Store in Load Port Truck Distribution

Centre Supermarket

Start of the Supply Chain - Farmer

Being his livelihood, the grower/farmer takes very good care of the cargo.

Regular quality checks will be carried out during the various stages of the growing or production process.

Start of the Supply Chain

Refrigeration of the product at the grower’s end is highly recommended as the grower has no control over its handling and storage after it is sold and leaves his hands.

It buys the growers that extra shelf life time that the wholesaler and retailer might reduce with poor handling procedures.

A grower who can meet the challenges of preserving the quality from field to dinner table will be able to expand his marketing opportunities and will be able to compete better in the market place.

If a product does not hold up in the distribution chain, often the grower is blamed for poor handling practices.

End of the Supply Chain - Supermarket

Even the truck driver who takes the cargo to the final destination point - a supermarket or a local grocery store has a role to play in the Quality System.

Introspection

Do we have something identical in Pharma Supply Chain?

Do we have a clear understanding of the export process?

Have we identified and enpowered all the partners in the Supply Chain?

Have responsibilities been clearly identified? Is there Transparency? Is there Accountability? Is there Traceability? Does free flow of communication exist? Finally, are we always keeping the end consumer

in sight all through the process?

End Consumer

This could be our End Consumer!

THANK YOU

Namast

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