Challenges in Implementing Compliant Cold Chain in Emerging Markets : Case Study India

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1 Challenges in Implementing Compliant Cold Chain in Emerging Markets : Case Study India Rajesh Pednekar, Pharma Supply Chain Expert 4 th Annual Symposium Time & Temperature Controlled Pharmaceutical Logistics, Brussels, 19 th March 2015 E : rajpednekar@hotmail.com / rajpednekar2@gmail.com Mobile / Whatsapp : / Disclaimer :Views are personal

2 Agenda Global scenario India Pharma Future Cold Chain Challenges Mitigation Strategies GST Other Markets Conclusion

3 Global scenario

4 Global pharma scenario

5 India At Inflection Point

6

7 Indian Pharma Future

8 India & Surrounding Geographical and Climatic Diversity

9 The Challenge Temperatures at 45,000 feet: 10 F / -12 C? Kathmandu, Nepal 90 F 32C Below Mumbai, India 0 C

10 India & Sub - Continent Transport Diversity

11 Cold Chain Supply Chain in Indian Sub - Continent Challenges

12 India & Sub - Continent Regulatory Pressure, however Infrastructure Playing Catch-up

13 India Lagging Infrastucture

14 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

15

16 Need for Cold Chain Supply Chain Compliance Very High Stakes

17 Optimising the Cold chain Supply Chain : Routes and Site Locations Hubs Sub Hubs Model

18 Indian Sub Continent

19 Optimising the Cold Chain Supply Chain: ISC Leveraging 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

20 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.

21 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

22 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.

23 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.

24 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

25 India If Fuel Taxes and Power Costs increase at this rate..

26 India & Sub Continent Keeping our cool

27 Wishing you all a very Happy and Prosperous New Year 2015! Rajesh Pednekar Linkedin: rajeshpednekar rajpednekar@hotmail.com / rajpednekar2@gmail.com Mobile / W app : / Skype: raj_pednekar

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