Sustainable EHS program at Pharma supply chain

1. RT 229 Global Supply Chain and Social
Responsibility-Lessons Learned
Developing Sustainable EHS
Programs for Pharmaceutical
Industry Supply Chain in India and
China
Maharshi Mehta, CSP, CIH, International Safety
Systems, Inc. maharshi.mehta@issehs.com
USA-India-China-Mexico-Brazil
www.issehs.com

2. Agenda
 Background
 Challenges
 Approaches Adopted
 Lessons Learned
 Future
 Conclusions

3. Background
 In One study, China and India ranked two most
desirable outsourcing countries among Pharmaceutical
corporations
 More than 200 contract manufacturers (CM) in India
 One Pharmaceutical corporation plans to have 30% of
their products made by third party
 Driving Force:
– Low-cost of production and a pool of scientific
talents
– Price Control
“Worldwide revenue for contract manufacturing..pharmaceutical
industry estimated at $100 billion in 2004..expected to rise at an
average annual growth rate of
10.8% to $168 billion in 2009”

4. Challenges
 CM Concerns:
– In-house EHS competency not available
– Difficult to implement EHS mandates from parent
company
– Cost of doing business
 Parent Company concerns:
– Liability arising out of “holding their hands”
– Public image if something goes wrong
– Lack of resources
– Product interruptions in case of fire or explosions

5. Approaches
 Parents companies conducting EHS audits
at CMs
 Providing CMs with corporate guidelines
 Requiring CMs to comply with local
regulations and corporate guidelines
 Removing CMs who are grossly violating
EHS standards

6. Approaches – Case Study
 Parent company identified major
concerns at a CM for process
safety and industrial hygiene
– Formaldehyde and solvents
handled in open blenders
 Stopped the process
 Locally available consultant
(CIH/CSP) assisted CM in risk
assessment and controls
 Consultants validated controls
 Risk reduced, process started

7. Approaches – Case Study
 Under contract with parent company, a qualified
locally available consultants conducted EHS audit
at 18 CMs
 Identified EHS risks
 Conducted exposure process safety risk
assessments
 Based on the findings of assessments, prepared
training manual on basic EHS
 Conducted train the trainer training for CM
representatives
 Assisted CMs in EHS with 7/24 helpline from
locally available EHS consultants

8. Approaches-Containment
Validation
 Parent company requirement from
API supplier:
– Before supplying API, conduct exposure
containment study
– Demonstrate API exposure will be below
OEL
– Then only supply material
 Consultant conducted containment
validation study
 Identified exposures
 Recommended controls
 Controls are being implemented

9. Lessons
 Providing corporate EHS mandates to CMs and conducting
audits alone would not reduce risk at CMs
 Sustainable approaches
– Empowering CMs by providing basic training on EHS
– Training has to be based on potential risk present at
CMs
– Limited assistance in risk assessment and control
– 7/24 helpline
– Periodic review
– Local availability of reliable consultants
– Requiring API suppler to conduct containment
validation
 Concerns for parent company liability in “holding hands”
is reduced if independent and qualified consultants are
involved

10. Future
 Ensuring EHS at CMs will continued to be
a challenging task
 Increasingly parent companies will have to
adopt innovative approaches in reducing
occupational risks at CMs
 Parent companies will have to have local
availability of company EHS staff and EHS
service providers

11. Conclusions
 To reduce occupational health risk at CMs,
requiring CMs to demonstrate exposures
below OEL is the best option
 Audits from parent company, empowering
CMs in EHS and providing limited EHS
assistance would reduce the risk at CMs