Busting - Mythsin Comparator Sourcing

By

DR. PIYUSH GUPTA (MBBS, MBA)

ASSOCIATE DIRECTOR – BUSINESS DEVELOPMENT
GNH USA

IN THIS PRESENTATION

Why do we need Comparators ?
Common myths, common assumptions USA
Costly sourcing mistakes – increasing trial cost and time
Take an informed decision – Based on facts
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 USA and need to be imported
    - If available in USA – they cannot be called comparators
  - Common Assumptions:
    - Trial will be invalid if comparators are sourced from USA
    - The formulation in USA is not same as US / EU or is different from the original marketed in US / EU
1. Regulatory facts for drug registration in USA
  - 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
1. Costly Mistakes
  - Importing: Most of Comparators get imported into USA even though they are locally available many a time.
  - Most comparators are priced at half the price in USA 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
  - Think local : Most Comparators available in USA
  - We supply Comparators to over 60 countries globally
  - Large quantities available with ease in USA
  - Most Comparators in USA have been duly registered and licensed in USA by CDSCO after taking CoPP and FSC on record
  - This ensures that exact same formulation marketed in CoO is marketed in USA too
  - Cold chain maintenance, Storage, Handling is done under Manufacturer’s supervision for official imports.
  - Cost effective, Cost Competitive, Economical and Fast
Role of specialised Wholesalers
- GNH USA 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 !!

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