Shruti Bhat PhD, MBA, Operations Excellence Expert
  • Home
  • About Shruti
  • Books
  • Insights
  • Operational Excellence
  • Research
    • Innovation Management
    • Leading Research and Development
    • Developer's Diary
  • Case Studies
  • Tools
    • Whitepapers
    • Articles >
      • Business Transformation
      • Process Improvement
      • Business Continuity
      • Change Management
      • Digital Transformation
      • Quality Improvement
    • Checklists and Templates
    • Free eBook
    • Videos
  • Blog
  • Engage Shruti
    • Consulting >
      • Operational Excellence Consulting
      • Business Transformation Consulting
      • Innovation Management Consulting
    • Workshops
  • Contact

Gambia cough syrup tragedy: How can we stop such catastrophe?

10/9/2022

0 Comments

 
Gambia cough syrup tragedy- how to stop such catastrophe
Dozens of child deaths have been reported recently in African country The Gambia. The deaths are allegedly linked to cough syrups containing unacceptable levels of diethylene glycol and ethylene glycol.
 
Diethylene glycol and ethylene glycol are known toxic items and are ‘source-related’ impurities of the solvent used in the cough formulation. At the outset, for those new to this topic, let me briefly explain what is meant by ‘source- related’ impurities- There are broadly two types of impurities in drug products- (1) Source-related impurity and (2) Impurities arising as a result of product manufacturing and/or generated during the shelf-life of a product. These impurities are referred to as degradation products.
 
The source-related impurities are traces of substances in the raw material in lieu of its manufacturing. These source-related impurities cannot be totally avoided but must be controlled and must be within permissible limits mandated in the pharmacopoeia. Further, these source-related impurities must be within acceptable limits in the finished formulation (whenever that raw material is used) at all times until after the expiration of that finished formulation.
 
Same goes for the degradation products, they too (if present) must be within limits stated in the product monograph. If the impurity levels get higher than accepted limits, it can cause minor to critical safety concerns.
 
Coming back to this unfortunate incident…

​Deaths linked to diethylene glycol from cough syrup was first reported in the year 1937 in the United States, the ill-famous ‘Elixir Tragedy’.
 
Since that incident, regulators and pharma companies worldwide have put in stringent cGMP (current good manufacturing practices) criteria in drug product development thru manufacturing as well as post-marketing surveillance. The fundamental objective of cGMP is to ensure quality, efficacy and safety in drug product at all times until after its expiration. An incident such as this one, prima facie means a break-off from the norms i.e. non-compliance to the cGMP process.
 
Also, cGMP does not mean ‘best practices’ implemented only during manufacturing. cGMP is a wide-spectrum best practice and is applicable to all upstream and downstream processes of a product’s lifecycle. Non-compliance in adhering to these ‘best practices’ at any stage of the upstream and/or downstream processes can lead to mishaps, even fatalities.
 
So, what happened in this case? Why so many people died after taking a cough syrup? Why did the syrups have unacceptable quantities of diethylene glycol in them? As a member of the pharma fraternity such questions came my way (from friends and acquaintances) for the past few days. Since this matter is under investigation by competent authorities, we'll know in the coming days. But our objective as responsible pharma professionals, is not to just find out what happened in this unfortunate case, but also proactively ensure that such situations do not happen in the future.
 
In fact, I shall say- selling a safe product to the consumer is the seller’s prime responsibility, no two ways about it. Hence, not just drug products, but all products must have the desired quality attributes and must be safe in the hands of the user.  But how can companies ensure this?
 
There are several ways to achieve this. But the surest and fastest route is to- Start implementing QbD (quality-by-design) in the product’s value chain, and mistake-proof all processes in the product’s supply chain.
 
Mistake-proofing means you don’t leave any scope for errors to happen while working the process. For example, try putting a two-pin or a three-pin plug into a socket. It won’t fit-in unless inserted the right way. Another example of process mistake-proofing is a washing machine. If you were to flip open a washer’s door while it was running its cycle, the machine immediately stops. But the moment you shut back the door it re-starts! Such mistake-proofing with a plug's or washer's design and operation is to prevent accidents i.e. consumer safety.
 
Pharma companies must couple cGMP with mistake-proofing; that is, apply appropriate error-proofing measures to all its technical and business processes.
 
Some of the promising and time-tested error-proofing tools are Poka Yoke, FMEA, Visual Management, CAPA etc. I’ve separate posts on Poka Yoke and Visual Management, do check them out …

  1. Improve Process Efficiency with Visual Management
  2. Mistake-Proofing Pharmaceutical Product Development, Manufacturing and Logistics, Cost Savings via Poka Yoke
  3. Mistake-Proofing Pharmaceutical Products: What can we learn from Valsartan, Losartan and Irbesartan recalls?
  4. Valsartan, Irbesartan, Losartan Product Recalls- What are the Lessons for Pharmaceutical Industry?

News update- Subsequently, a report in India's one of the leading newspaper Economic Times stated that the Medicines Control Agency MCA and The Gambian drug regulatory authorities have not yet found definitive links between the deaths and the cough syrup, and that the cause of child deaths is still unknown.

Follow Shruti on Twitter, Facebook, YouTube, LinkedIn

Categories:  Life Sciences | Mistake-Proofing

Keywords and Tags:
#Gambiatragedy #coughsyruplinkeddeaths #diethyleneglycol #mistakeproofingprocesses #cGMP #PokaYoke  #FMEA #VisualManagement  #GambiaChildDeaths
Get In Touch
0 Comments

Your comment will be posted after it is approved.


Leave a Reply.

    Shruti Bhat, global leader in business turnaround, operational excellence and continuous improvement
    To contact Dr. Shruti Bhat text or WhatsApp at 1.403.969.6219

    New Book Released!

    Revolutionizing Industries with Lean Six Sigma

    Shruti's YouTube Channel ...

    Picture

    Blog Categories

    All
    3D Printing
    Agile
    Artificial Intelligence
    Automation
    Biotechnology
    Books
    Business Continuity
    Business Turnaround
    Case Studies
    Change Management
    Checklists
    Chemical Industry
    Continuous Improvement
    Design Thinking
    Digitalization
    Drug Delivery
    External News Links
    Hall Of Fame
    Healthcare
    Hoshin Kanri
    HR Development
    Innovation
    Insights
    ISO
    Just In Time
    Kaizen
    Leadership
    LEAN
    Lean Six Sigma
    Life Sciences
    Machine Learning
    Manufacturing
    Medical Devices
    Mistake Proofing
    Motivational Cards
    MSMEs
    Nanotechnology
    Operational Excellence
    Packaging
    Patents
    Personal Products
    Process Improvement
    Product Development
    Productivity Increase
    QbD
    Quality Management
    R&D Leadership
    Robotics
    Service Industry
    Six Sigma
    Strategy
    Supply Chain Logistics
    Telecom Industry
    Templates
    TQM
    Videos
    Voice Of Customer
    Whitepaper
    Workshops

    Shruti's books...

    Picture
    top ten strategic decision-making tools for operational excellence
    shruti bhat, business process management, continuous improvement
    kaizen for pharmaceutcials, medical devices and biotech industry book by Dr Shruti Bhat
    Book on Continuous improvement tools by Dr Shruti Bhat
    kaizen for leaders, continuous process improvement tool to increase profit and organizational excellence by shruti bhat
    kaizen, shruti bhat, continuous improvement, quality, operations management
    how to lead a successful business transformation
    leading organizations through crisis
    emotional intelligence
    how to overcome challenges of creating effective teams
    modular kaizen Vs Blitz kaizen
    How to increase employee engagement as a new boss

Connect with Dr. Shruti Bhat at- ​Twitter, YouTube, LinkedIn​

© Copyright 1992- 2025 Dr. Shruti Bhat ALL RIGHTS RESERVED.
See Terms and Conditions for details on this site usage.
Subscribe to Operational Excellence Academy YouTube Channel
​Subscribe to Operational Excellence Academy YouTube Channel
SHRUTI BHAT, CONTACT
Click to connect.
Created by Macro2Micro Media