Challenges in Implementing Compliant Cold Chain in Emerging …€¦ · Challenges in Implementing Compliant Cold Chain in Emerging Markets : Case Study India Rajesh Pednekar, Pharma

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