Busting Myths in comparator sourcing

By

DR. PIYUSH GUPTA (MBBS, MBA)
ASSOCIATE DIRECTOR – BUSINESS DEVELOPMENT
GNH INDIA
MUMBAI, INDIA

BUSTING-MYTHS

IN THIS PRESENTATION
  1. Why do we need Comparators ?
  2. Common myths, common assumptions
  3. Regulatory facts for Drug registration in India
  4. Costly sourcing mistakes – increasing trial cost and time
  5. Take an informed decision – Based on facts
  6. Role of specialised wholesalers
    1. Why do we need Comparators
      • WMA (World Medical Association) Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects – 1st adopted in June 1964
      • Ther e can be 1000s of other marketing or regulatory answer, but the core change started from Helsinki Declaration
      • It will be a good for all RnD units, CROs to maintain a copy of this declaration as it will add to your compliance value.
    1. Common myths – Common Assumptions
      • Common Comparators – Innovators, Pre Qualified Generic, Bio Similar,
      • Focus of this presentation will be mainly on Innovators
      • Common myths:
        • Comparators (Innovators) are available only in US / Europe
        • Pr oducts with NDC number or PZN or POM numbers can only be called comparators
        • Comparators are not available in India and need to be imported
        • If available in India – they cannot be called comparators
      Comparator Example

      Comparator-Example

      • Common Assumptions:
        • Trial will be invalid if comparators are sourced from India
        • The formulation in India is not same as US / EU or is dif ferent from the original marketed in US / EU
      No one is above suspicion – let see how

      No-one-is-above-suspicion

    1. Regulatory facts for drug registration in India
      • CDSCO – link for new product registrations:
        • http://www.cdsco.nic.in/writereaddata/Guidance%20documents.pdf
        • CoPP a must – Certificate of Pharmaceutical Product (CoPP : The certificate of pharmaceutical product (abbreviated: CPP or CoPP) is a cer tificate issued in the format recommended by
          the World Health Organisation (WHO), which establishes the the pharmaceutical product and of the applicant for this certificate in the exporting country)
        • FSC a must – Free Sale cer (A document required in certain countries or for certain commodities (such as phar that the specified impor ted goods are normally and freely
          sold in the exporting countr markets and are approved for export).
        • Do you think CDSCO will register imported product without these to important documents ?
        • What do these documents prove or demonstrate ?
        • Why is CDSCO or any registration authority in the world wants these two documents ?
      Time consuming – Imports

      Time-consuming-Imports

    1. Costly Mistakes
      • Importing: Most of Comparators get imported into India even though they are locally available many a time.
      • Most comparators are priced at half the price in India as compared to US / EU
      • Import process, logistics, Import clearance, ADC clearance require tremendous amount of time, effort and money
      • In our experience pharma companies, RnD units, CROs are paying about 4X the cost and time for comparator imports as against local sourcing
    1. Take an informed decision
      Take-an-informed-decision

      • Think local : Most Comparators available in India
      • We supply Comparators to over 60 countries globally
      • Large quantities available with ease in India
      • Most Comparators in India have been duly registered and licensed in India by CDSCO after taking CoPP and FSC on record
      • This ensures that exact same formulation marketed in CoO is marketed in India too
      • Cold chain maintenance, Storage, Handling is done under Manufacturer’s supervision for official imports.
      • Cost effective, Cost Competitive, Economical and Fast
  1. Role of specialised Wholesalers
    • GNH India is a specialised Wholesaler in Clinical trial arena
    • WHO cGDP complaint warehouse operations
    • Qualified QP on site
    • Storage, handling, packing and dispatch done under direct supervision of QP
    • Mapped storage area, calibrated warehouse equipments
    • Validated shipping systems, reports on file
    • Complete traceability, audit trail and archiving of all purchases and sale transactions for a period of 7 years
Myths – Busted !!

BUSTING-MYTHS
thank-you

Other Resources

Biotech Week Boston 2016: Little know facts - Comparator Sourcing from Emerging Market

view & download

Biotech Week Boston 2016: Little know facts - Comparator Sourcing from Emerging Market

Comparators The “Check Nut” of Clinical Trials

view & download

Comparators  The “Check Nut” of Clinical Trials

Our Services

Comparator Sourcing for Clinical Trials

Comparator Sourcing for Clinical Trials

GNH India brings over 10 years of experience in Comparator Sourcing services from India and RoW markets. Our Service included...
Read More
Name Patient Supply

Name Patient Supply

With rapidly changing lifestyle and ever increasing stress levels, disease patterns have seen a shift towards rarer and more un...
Read More
Validated Cold Chain Shipment

Validated Cold Chain Shipment

With shifting of pharma industry from synthetic molecules to biologic, proteins etc. temperature maintenance has become as important as the...
Read More
Clinical Trials Supply

Clinical Trials Supply

STOP SOURCING..... START SMART SOURCING...... COME STRAIGHT TO THE SOURCE. GNH India brings over 10 years of experience in clinical...
Read More
Dossiers and Stability Studies

Dossiers and Stability Studies

STABILITY STUDIES STABILITY, BA / BE STUDIES Due to our active involvement in Manufacturing and interaction with various laboratories and manufacturers...
Read More
Pharmaceutical Contract Manufacturing

Pharmaceutical Contract Manufacturing

GNH Provides Contract Manufacturing services for: Generic Medicines with following quality levels: US FDA / UK MHRA approved facilities WHO GMP...
Read More
Pricing

Pricing

PRICING POLICY Terms of sales are typically prepaid, unless otherwise noted in quotation. The preferred method of payment is wire...
Read More
Pharmexcil
DB
FIEO-2016
SiteLock

Copyright © 2021 GNHIndia .com. All Rights Reserved. Please read Legal Notice for further details.

Disclaimer: Product names, logos, brands and other trademarks featured or referred to are the property of their respective trademark holders.