Counterfeit or pirated and smuggled product in Medical device Industry
By Afzal Kamal-Ediror,Medgate Today Quite relevant topic, as India is at the cusp of becoming MedTech Power courtesy to policies of aatmanirbhar Bharat. A good MedTech ecosystem being shaped up by emerging MedTech entrepreneurship and start ups
By Afzal Kamal-Ediror,Medgate Today
Quite relevant topic, as India is at the cusp of becoming MedTech Power courtesy to policies of aatmanirbhar Bharat.
A good MedTech ecosystem being shaped up by emerging MedTech entrepreneurship and start ups must be supported by vigilant and proactive regulatory mechanism to ensure ethical and level playing field.
Though counterfeit, pirated and smuggled products are quite common place in pharma but in IVD and MedTech segments, these generally come in garb of refurbished equipment . However there is speculation that locally assembled, and imported sundry MedTech critical components also go under the radar. These manufacturing manipulations lead to sales of IVD and MedTech equipment along with refurbished equipment in lower tiers of the markets. As customers in these tiers are not aware and unable differentiate new products from refurbished and counterfeit products , post market survillance data never come to the fore.
Interestingly these equipment get their regular feed of consumables and after sales back up from legitimate suppliers as for them its source of revenue and continuity of customer relations.
Another dimension is adulterations (dilution) of Reagents, also a regular in largely imported reagents. Sink test is already common practice in healthcare so enormity of problems remain unreported.
While impact on healthcare and govt exchequer is proportional, but former adversely impacts the health of patients. Faulty equipment and diluted reagents delay or harm the recovery process which results into more unaffordable out of pocket expenses for patients. Irony is medico-legal activism is still in a nascent stage in India.
Some suggestions to check these spurious healthcare products are :
1. End to end digitization of processes & systems involved in manufacturing, marketing & post marketing
2. Ensure the data from above is analysed & displayed by each on their website by every manufacturer for all their categories of products.
3. Stringent policies & regulation
4. Regular investigation & monitoring
5. Making post marketing surveillance studies mandatory till the last mile end user for every category of products.