Sourcing Comparators / Biosimilars have always been an Achilles heel in any Clinical trial. These seeming simple products are the “Check Nuts” that can make the entire trial go haywire if supply is delayed. The challenge of sourcing Comparators / Biosimilars gets compounded especially for large multicentric trials.
Traditional source markets such as US / EU have seen increased regulations and tightening of supply chain thereby severely constricting supply. Each vial or pack can now be tracked by the manufacturer / brand owner through the entire supply chain under the new barcoding systems. Thereby making it extremely difficult to divert stock for Trials without alerting the innovator or brand owners.
Emerging markets such as India have always posed a challenge due concerns about similarly or equivalence with the innovator sold in US / EU markets.
One company stands out as a pioneer in Clinical trial supplies from India and is working to change this perception by putting out facts in the open. GNH India has been successfully supplying to a number of Global trials with comparator / biosimilars sourced from the Indian market.
We spoke to Dr. Piyush Gupta, MBBS, MBA – Associate Director – Business Development at GNH.
Dr. Gupta says “There’s a mindset at play here. People think that if a product / brand is being sold in India it’s going to of poor quality and standard. This is absolutely untrue in the pharma business.
No manufacturer is going to risk is reputation, brand and most importantly violate laws and sell substandard products in India”.
To prove his point Dr. Gupta says: CoPP (Certificate of Pharmaceutical Products) an essential requirement to register any new drug in any country including India is the key. At the time of registering (introducing) a new product in India the Innovator / Brand has to provide a CoPP from the FDA (Food and Drug Administration) of the Originating Country (Country where the product is manufactured).
A CoPP issued by FDA of Origin country essentially states that product being supplied (exported) is the exact same in the specification as the one being in a country of Origin. Without this CoPP from FDA of Origin, FDA of importing country will not allow registration of a brand / innovator / Generic in importing country.
This fact is very well known to the manufacturers but regretfully not to the Clinical trial industry, which largely runs on Outsourced contracts.
GNH India is an Award winning Global full-line wholesaler Audited by SGS France for WHO cGSDP practise and carries over 135,000 product lines, shipping to over 180 countries wold wide.
Ms. Saba Malim,
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