Challenges In Export And Import Of Temperature Controlled Pharmaceuticals From India

1. Challenges in Export and Import of
Temperature Controlled
Pharmaceuticals from India
Chilukuri Maheshwar
Anglo Eastern Maritime Academy
10th Annual Cold Chain & Temperature
Management Global Forum
Chicago, 24-28 September 2012

2. Movie clip

3. India - Among 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

4. Features of Emerging Economies
Flips
• 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.
Flops
• Asia has lesser public spending ratios because of less extensive
public insurance coverage and benefit packages
• Competing expenditure needs and constrained revenue raising
capacity

5. Public Health Care Spending

6. Challenges and Solutions - Emerging
Economies
CHALLENGES SOLUTIONS
• Lower average life expectancy • Increase public health spending
and Higher infant mortality • Improve the general health safety
• Limited funds to improve net
health standards • Importance and expansion of
• Less extensive health coverage primary and preventive health care
• Ill aligned incentives • Incentives for health care providers
(motivation) for health care • Focus on providing most essential
providers health services
• Large informal labour market • Improve efficiencies of existing
• Lower General awareness health care systems by leveraging
levels about sanitation and economies of scale.
hygiene

7. INDIA’S SYMBIOTIC RELATIONSHIP WITH USA
• Over 40% of the generics prescribed are from India
• To ensure continued supply of the low cost quality generics from India, the
US FDA has opened India office
• 1 out of 5 US FDA inspections for approvals are in India
• Share of generics in the overall US market expected to rise to 21-22% by
2015 from around 12-15% now.
• Which means pharma exports from India will double every three years
• Indian firms have about 35% of the total ANDA approvals in the US
• Based on their marketing and distribution networks and manufacturing
capacities, Indian firms could see as much as 15-28% annual growth from
the US, predict experts.
• To overcome the recent shortage of cancer drugs J & J’s Doxil in USA, the US
FDA sought Sun Pharma’s help in providing their chemotherapeutic drug
Lipodox from India
• This opens up opportunities for Indian drug generic makers as close to 287
essential drugs are estimated to be in short supply in the US.
29

8. GLOBAL RECOGNITION
• Bill Clinton's foundation, Clinton Health
Access Initiative (CHAI) got further
discounts from Indian generic
manufacturers that reduced the cost of
combination drug treatments for AIDS,
which can reach thousands of dollars
per year in the West, to as low as $120
a year per patient.
• Many Indian companies are part of this
agreement where Lamivudine,
Stavudine, Zidovudine, Nevirapine will
be supplied to a few African countries.
• India has highest number of approvals
from the US President's Emergency
Plan for AIDS Relief (PEPFAR).
8

9. ADVANTAGE INDIA
• India manufactures and exports
medicines from all therapeutics
groups.
• Many original innovator companies
source their discovered drugs from
Indian companies.
• India is a world leader in anti-AIDS
and anti-TB segments and for some
of the latest patented medicines
like Glitazones, Celecoxib, Statins,
Montelukast and many anti-cancer
drugs
9

10. COLD CHAIN in Pharma
• Worldwide sales of vaccines predicted to rise
to $35 billion by 2014
• Huge growth of temperature sensitive
vaccines is driving the development of novel
technologies for transportation and logistics
such as thermo stable vaccines, solar “battery
free” refrigerators, “zero energy” cold chain
Pharma/Biotech electric vehicles and longer-term passive
Cold Chain storage containers.
Process • Development of sub-sectors such as biotech,
medical devices, clinical trials and diagnostics
are fuelled by high levels of innovation.
leading to individual customer-centric
solutions
• India, with $ 2.36 bill. in biopharma market is
set to become one of top 5 producers of
biopharmaceuticals in the world by 2020.
10

11. COLD CHAIN IN PHARMA (contd…)
• Driven by regulations, more pharma products require
temperature control handling from refrigerated to ambient to
cold, broadening the cold chain market.
• Break in cold chain for most products may result in value
erosion financial loss, but break in cold chain of Pharma
products (vaccines, life saving drugs etc) could be fatal
for patients
• Retailers and Logistic providers may become the weakest
link in supply chain of drugs by the time it reaches the end
consumer, if proper care is not taken
• A study by UK-MHRA reveals that 43% of critical and major
product deficiencies are related to ineffective temperature
control and monitoring during storage and transportation.
• WHO recently maintained that 25% of all vaccine products
arrive at their final destination in a degraded state.
11

12. COLD CHAIN in Pharma (contd…)
• The distribution process must be validated to ensure that
there is no negative impact to the safety, efficacy or quality
of the drug substance
• GMP environment requires that all processes that might
impact the safety, efficacy or quality of the drug substance
must be validated, including storage and distribution of the
drug substance.
• More than 50% of the problems faced by manufacturers
and retailers in cases of rejections of pharma products as
‘not of standard quality’ by regulatory authorities is due to
not giving due importance to Good Distribution & Storage
Practices.
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13. ‘Cold’ Chain System
• High protection is good, but appropriate protection is better!
• Majority of commonly recommended vaccines require storage
temperatures of 35 F - 46 F (2 C - 8 C) and must not be exposed to
freezing temperatures, which can irreversibly reduce the potency of
vaccines.
• Physical changes are not always apparent after exposure to freezing
temperatures and visible signs of freezing are not necessary to result
in a decrease in vaccine potency.
• An estimated 17%--37% of providers expose vaccines to improper
storage temperatures, and refrigerator temperatures are more
commonly kept too cold than too warm
• Although the potency of the majority of vaccines can be affected
adversely by storage temperatures that are too warm, these effects are
usually more gradual, predictable, and smaller in magnitude than
losses from temperatures that are too cold.
13

14. 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.

15. Pharma Markets and Vaccines
• 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
• 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

16. India: Polio Vaccination Movement
• 1996: Polio Eradication 2500
Program started
• 2000: Expected Global 2000
Eradication of Polio
• 2007: 866 Polio cases 1500
reported
• Fresh Polio cases are still 1000 No. of Polio Cases
being reported. reported
• One of the reasons for the 500
failure of Polio Vaccination
program in India is the 0
absence of an effective cold
Year 1998
Year 1999
Year 2000
Year 2001
Year 2002
Year 2004
Year 2005
Year 2006
Year 2007
Year 2003
chain which rendered the
vaccine ineffective

17. CHALLENGES UNIQUE TO INDIA
• In the hot climate of India it is definitely a challenge
maintaining product temperature throughout the distribution
network, with external temperatures easily over 30 C
• India's cold-chain market is still in its developing stages, and
thus there is a lack of temperature-sensitive services from
the point of origin to the point of consumption.
• Sub segments like medical devices, biotech, clinical trials
etc. to which India contributes about 8% of world's pharma
output is expected to grow to a $ 50 billion market by 2020.
17

18. 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

19. Addressing the Challenges
• Understanding and compliance of 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

20. Distribution Chain

21. 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).

22. How to handle the Last Mile?
Challenges Opportunities
• Smaller Quantities • Extension of Cold Chain
• Lack of availability of right till the end
recognised Cold Chain • Innovative Methods of
• Field Difficulties Maintaining Cold Chain
• Dusty atmosphere • Indigenous Methods of
Preservation
• High ambient Heat
• Innovation and use of
• Language Barrier Technology in
• Social Barriers communication
• Unavailability of Grid Power

23. Pharmaceutical Sector vs
Agricultural 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

24. Features of an Effective Cold Chain
• Temperature Measurement, Monitoring,
Control and Recording
• Traceability
• Accountability
• Transparency
• Effective Communication
• Networking and Involvement

25. The Pharma Export Process

26. Partners in Temperature Controlled
Pharma Products Export Process
• Manufacturer
• Ground Transport
• Airport
• Airline
• Destination Airport
• Forwarder’s Terminal
• Intermediate Stops & Transfers
• Distributor’s Warehouse
• Consumer Outlet
• End Consumer

27. Challenges in the Export
Process - Manufacturer
• Good Quality Raw Materials,
• Controlled Manufacturing Practices,
• Cleanliness,
• Dust Free Atmosphere,
• Strict Quality Control
• Good Packaging,
• Traceability
• Storage in Required Temperature and
Atmospheric Conditions

28. Challenges in the Export
Process – Ground Transport
• Delicate Handling while loading into truck
• Correct Stacking and Stowage inside the Truck
• Transportation under Required Temperature
and Atmospheric Conditions
• Prevent deterioration and Ensuring Durability
of the Packaging

29. Challenges in the Export
Process – Departure Airport
• Delicate handling during unloading from the
truck
• Storage under Recommended Temperature
and Atmospheric Conditions during the
waiting period
• Careful handling during transfer into the
aircraft

30. Challenges in the Export
Process – Airline
• Correct Stacking and Stowage inside the
Aircraft
• Adequate Lashing and Securing of the
Packages to prevent movement and vibration
• Maintenance of Correct Temperature and
Atmospheric Conditions during the flight
• Regular Monitoring and Recording of
Temperature and other conditions

31. Challenges in the Export
Process – Destination Airport
• Delicate handling during unloading from the
aircraft
• Storage under Recommended Temperature
and Atmospheric Conditions during the
waiting period of arrival formalities and
documentation
• Careful handling during transfer into the
Forwarder’s Terminal

32. Challenges in the Export
Process – Forwarder’s Terminal
• Maintenance of Correct Temperature and
Atmospheric Conditions during the period of
stay in Forwarder’s Terminal
• Regular Monitoring and Recording of
Temperature and other conditions

33. Challenges in the Export Process –
Intermediate Stops & Transfers
• Careful handling during transfers
• Correct Stacking and Stowage during transfers
• Adequate Lashing and Securing of the
Packages to prevent movement and vibration
during transfers
• Maintenance of Correct Temperature and
Atmospheric Conditions
• Monitoring and Recording of Temperature and
other conditions

34. Challenges in the Export Process
– Distributor’s Warehouse
• Maintenance of Correct Temperature and
Atmospheric Conditions during storage
• Monitoring and Recording of Temperature and
other conditions during storage
• Maintaining Traceability
• Cleanliness and Dust Free Atmosphere

35. Challenges in the Export Process
– Consumer Outlet
• Maintenance of Correct Temperature and
Atmospheric Conditions during storage
• Monitoring and Recording of Temperature and
other conditions during storage
• Maintaining Traceability
• Cleanliness and Dust Free Atmosphere
• Careful handling
• Easy Accessibility
• Simple and Efficient Documentation during
Dispensing

36. Challenges in the Export
Process – End Consumer
• Maintenance of Correct Temperature and
Atmospheric Conditions during storage
• Small quantities – easy to store and handle
• Careful handling
• Maintaining the Required Documentation and
Records
Remember, The Process ends only after the
product is finally used by the End Consumer

37. Introspection
• Do we have something in Pharma Supply Chain identical to
360 Quality and Zero Damage Concepts in Northern Europe
for Perishable Export Cargo
• 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?

38. End Consumer
This could be our End Consumer!

39. Acknowledgements
• UK P&I Club
• Cold Chain India Summit 2012 Hyderabad, 7th -
8th June 2012: VISIONING INDIA AS GLOBAL
GENERICS SUPPLIER: DAARA B PATEL
SECRETARY – GENERAL, INDIAN DRUG
MANUFACTURERS’ ASSOCIATION (IDMA)
MUMBAI, INDIA

40. Namaste
Thank you