Challenges in Export and Import of     Temperature Controlled   Pharmaceuticals from India            Chilukuri Maheshwar ...
Movie clip
India - Among emerging economies                • BRIC: Brazil, Russia, India                  & China                • BR...
Features of Emerging Economies          Flips•   Perceived as growth centres of the future•   Drivers of future economic g...
Public Health Care Spending
Challenges and Solutions - Emerging                Economies    CHALLENGES                        SOLUTIONS•   Lower avera...
INDIA’S SYMBIOTIC RELATIONSHIP WITH USA• Over 40% of the generics prescribed are from India• To ensure continued supply of...
GLOBAL RECOGNITION    • Bill Clintons foundation, Clinton Health      Access Initiative (CHAI) got further      discounts ...
ADVANTAGE INDIA     • India manufactures and exports       medicines from all therapeutics       groups.     • Many origin...
COLD CHAIN in Pharma                       •   Worldwide sales of vaccines predicted to rise                           to ...
COLD CHAIN IN PHARMA (contd…)•   Driven by regulations, more pharma products require    temperature control handling from ...
COLD CHAIN in Pharma (contd…)• The distribution process must be validated to ensure that  there is no negative impact to t...
‘Cold’ Chain System• High protection is good, but appropriate protection is better!• Majority of commonly recommended vacc...
Pharmaceutical Cold Chain• Complex drugs and pharmaceutical products market expected  to grow to U.S. $900 billion by 2012...
Pharma Markets and Vaccines• Effective cold chain shipping is critical, as pharma  and biopharma cold chain shipments in m...
India: Polio Vaccination Movement• 1996: Polio Eradication        2500  Program started• 2000: Expected Global          20...
CHALLENGES UNIQUE TO INDIA• In the hot climate of India it is definitely a challenge  maintaining product temperature thro...
Why such losses in this region?• High Ambient temperature• Poor transport infrastructure• Lack of knowledge and awareness•...
Addressing the Challenges• Understanding and compliance of Multiple  international and country specific cold chain  shipme...
Distribution Chain
Distribution Challenges• Distribution in emerging markets presents three  particular challenges:  • Improving forecast acc...
How to handle the Last Mile?    Challenges                      Opportunities•   Smaller Quantities          •   Extension...
Pharmaceutical Sector vs           Agricultural Sector• Economic Losses more severe in Pharma  sector• Administering a dam...
Features of an Effective Cold Chain• Temperature Measurement, Monitoring,  Control and Recording• Traceability• Accountabi...
The Pharma Export Process
Partners in Temperature Controlled     Pharma Products Export Process•   Manufacturer•   Ground Transport•   Airport•   Ai...
Challenges in the Export     Process - Manufacturer•   Good Quality Raw Materials,•   Controlled Manufacturing Practices,•...
Challenges in the Export Process – Ground Transport• Delicate Handling while loading into truck• Correct Stacking and Stow...
Challenges in the Export  Process – Departure Airport• Delicate handling during unloading from the  truck• Storage under R...
Challenges in the Export     Process – Airline• Correct Stacking and Stowage inside the  Aircraft• Adequate Lashing and Se...
Challenges in the ExportProcess – Destination Airport• Delicate handling during unloading from the  aircraft• Storage unde...
Challenges in the ExportProcess – Forwarder’s Terminal• Maintenance of Correct Temperature and  Atmospheric Conditions dur...
Challenges in the Export Process – Intermediate Stops & Transfers • Careful handling during transfers • Correct Stacking a...
Challenges in the Export Process  – Distributor’s Warehouse• Maintenance of Correct Temperature and  Atmospheric Condition...
Challenges in the Export Process      – Consumer Outlet• Maintenance of Correct Temperature and  Atmospheric Conditions du...
Challenges in the Export  Process – End Consumer• Maintenance of Correct Temperature and  Atmospheric Conditions during st...
Introspection• Do we have something in Pharma Supply Chain identical to  360 Quality and Zero Damage Concepts in Northern ...
End ConsumerThis could be our End Consumer!
Acknowledgements• UK P&I Club• Cold Chain India Summit 2012 Hyderabad, 7th -  8th June 2012: VISIONING INDIA AS GLOBAL  GE...
NamasteThank you
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Maheshwar, Chilukuri Challenges In Export And Import Of Temperature Controlled Pharmaceuticals From India

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Maheshwar, Chilukuri Challenges In Export And Import Of Temperature Controlled Pharmaceuticals From India

  1. 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. 2. Movie clip
  3. 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. 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. 5. Public Health Care Spending
  6. 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. 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. 8. GLOBAL RECOGNITION • Bill Clintons 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 Presidents Emergency Plan for AIDS Relief (PEPFAR). 8
  9. 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. 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 chainPharma/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. 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. 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. 12
  13. 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. 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. 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. 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. 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• Indias 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 worlds pharma output is expected to grow to a $ 50 billion market by 2020. 17
  18. 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. 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. 20. Distribution Chain
  21. 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. 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. 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. 24. Features of an Effective Cold Chain• Temperature Measurement, Monitoring, Control and Recording• Traceability• Accountability• Transparency• Effective Communication• Networking and Involvement
  25. 25. The Pharma Export Process
  26. 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. 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. 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. 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. 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. 31. Challenges in the ExportProcess – 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. 32. Challenges in the ExportProcess – 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. 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. 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. 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. 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. 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. 38. End ConsumerThis could be our End Consumer!
  39. 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. 40. NamasteThank you

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