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Challenges in Implementing Compliant Cold Chain in Emerging Markets : Case Study India
Rajesh Pednekar,
Pharma Supply Chain Expert
4th Annual Symposium Time & Temperature Controlled Pharmaceutical Logistics, Brussels, 19th March 2015
E : [email protected] / [email protected]
Mobile / Whatsapp : +91 98202 16568 / 99202 16568
Disclaimer :Views are personal
Agenda
Global scenario
India Pharma Future
Cold Chain Challenges
Mitigation Strategies
GST
Other Markets
Conclusion
Global scenario
Global pharma scenario
IndiaAt Inflection Point
Indian Pharma Future
India & SurroundingGeographical and Climatic Diversity
The Challenge
Temperatures at
45,000 feet:
10°F / -12 C
Mumbai, India
Kathmandu,
Nepal
?90°F 32C Below
0° C
India & Sub - ContinentTransport Diversity
Cold Chain Supply Chain in Indian Sub - ContinentChallenges
India & Sub - ContinentRegulatory Pressure , however Infrastructure Playing Catch-up
IndiaLagging Infrastucture
Lagging Logistics Infra-structure ….
Lack of sustained investment in planned infrastructure like warehouses, transport centers, ICDs etc
Cold Chain infrastructure is very sporadic. The concept of “Integrated Cold Chain” is non existent
Major investments on these infrastructures have come from Government agencies like CWC, SWC, CONCOR etc
Current private sector initiatives are small and sporadic
Private sector warehousing are of poor quality,small, fragmented and does not meet infrastructure standards
No quality standards or benchmarks are followed in infrastructure creation
Need for Cold Chain Supply Chain ComplianceVery High Stakes
Optimising the Cold chain Supply Chain : Routes and Site LocationsHubs – Sub Hubs Model
Indian Sub – Continent
Optimising the Cold Chain Supply Chain: ISCLeveraging nearby Indian Metro Cities
For entire Indian Sub – Continent , use India as base location leveraging different cities for their proximities to nearby countries
Nepal : Use New Delhi as Export Hub
Bhutan & Bangladesh : Use Kolkata as Export Hub
Sri Lanka : Use Mumbai or Chennai as Export Hub, depending the location of your National Hub
These cities have a developed eco-system of vendors / service providers for exports to those countries
Developing a successful Cold Chain for ISC – General Guidelines
Develop Standard Operating Procedures for the entire Cold Chain. Do not assume that knowledge exists even with reputed service providers.
Train “ALL” people on SOPs. Only trained people should be allowed to handle cold chain products.
Qualify your Cold Rooms by Professional Agencies. Re-Qualification must be done twice a year.
24 X 7 Continuous Temperature Monitoring.
Dedicated Power Back-ups with separate power back-up for Cold Room and Alarm/ Hooter. Test Power Back-ups at night / holidays for effectiveness.
Preventive Maintenance : Maintain critical spares inventory for speedy replacement.
Contingency Plans : Personnel should be trained in a documented procedure in cases of Cold Room break-down. Keep list of other Cold Room Warehouses handy.
Developing a successful Cold Chain for ISC :Regulatory (Customs / ADC / FDA )
Minimize issues that could lead to them:
• Customs delays, import permits, etc.
Convince Customs / Assistant Drug Controller ( ADC) to give top priority to clear export / import Of Cold Chain Products
Assign/clarify all responsibilities:
• Transport Provider / Importer / Broker, etc.
• Have approval to import prior to shipping
• Provide specific delivery instructions (is a temperature controlled truck needed?)
Request documents clearance in advance to speed up Customs clearance. Also request inspection of stocks in the Cold Room itself to prevent excursions.
Arrange for requested samples in advance in proper cold chain packaging instead of opening the cold chain packing of the consignment.
Treat “Controlled Ambient “ same as Cool Chain ie. 8 to 25 Degrees
Be aware of Regulatory Trends
Developing a successful Cold Chain for Indian Sub- Continent : Transportation
Involve your QA Department from the very beginning
Qualification to be conducted twice – in summers and winters
Vendors should have worked with pharmaceutical products and should have adequate fleet for back-up
Refeer Vans should be roadworthy and should have „Fitness Certificate „ issued by Regional Transport Office ( RTO).
Insist on drivers having mobile phones with national roaming.
Train the drivers in thier „ Regional Language‟.
Developing a successful Cold Chain in Indian Sub-Continent : Storage at Local & Country Distributors / Stockists : Tips & Tricks
Keep Power source under Lock and Key to prevent accidental shut downs.
Place water-filled plastic containers in the lower shelves and door- this reduces warming periods when the door is opened.
Keep medicines in plastic containers – This allows easy identification, thereby minimising the time the door is open.
Local Authorities Concerns & Precautions :What do FDA Inspectors Look for During an Audit?
Product storage conditions
Standard Operating Procedures (SOPs)
Temperature monitoring in warehouse
Validation of Walk-In Coolers, freezers, refrigerators and Cool Rooms
Procedure for investigations and actions in the case of temperature excursion from the set parameters
India If Fuel Taxes and Power Costs increase at this rate …..
India & Sub – Continent Keeping our cool…
Wishing you all a very
Happy and Prosperous New Year 2015 !
Rajesh Pednekar
Linkedin: rajeshpednekar
Email: [email protected] / [email protected]
Mobile / W’app : +91 98202 16568 / 99202 16568
Skype: raj_pednekar
