Under the agreement, India-headquartered NKP Pharma will provide hardware for pharmaceutical packaging lines, and Systech will provide product serialisation, product safety, and consumer and brand protection services that meet US and EU traceability regulations.
Systech – which operates worldwide – said it sees increased business opportunity in the Indian market.
“Systech’s entry into India was a strategic business decision combined with the fact that its…technologies would greatly benefit the Indian pharmaceutical industry as it continues to grow,” Systech director Harry Saint-Preux told us.
“The agreement with NKP Pharma is consistent with these goals,” he added.
Serialisation in India
The Indian Ministry of Commerce implemented a progressive serialisation and barcoding requirement, starting with shipping cases and migrating down to the saleable pack level, said Systech’s regulatory strategist Dirk Rodgers.
“Regionally specific serialisation regulations are rapidly rolling out and Indian pharma must meet them to ensure full compliance in order to continue serving a global market,” said the firm.
The mandate is designed to mitigate the risk introduced by the appearance of counterfeit medicines in Africa with a ‘Made in India’ label, said Rodgers.
However, the company said serialisation regulations in India – which are enforced at a regional level – are less demanding and require less “intense validation exercises” than US and EU regulations.
According to Saint-Preux, the indigenous software industry in India has not had the benefit of a lengthy timeframe to create mature offerings that can withstand regulatory scrutiny.
“Therefore, the first challenge is to wean the Indian pharmaceutical industry away from local solutions upon which they had become dependent, to ones that can withstand audit and therefore provide the ultimate in risk mitigation,” he said.
A competitive market?
One of the main challenges in implementing serialisation technologies in India is competing with the pricing of local suppliers, Saint-Preux told us.
“India is well regarded as a source for software development and therefore not surprisingly, the [Indian Ministry of Commerce] mandate produced a plethora of local companies that tried to fill that requirement,” he said.
“Systech is in a position of being able to sell its coveted technologies at competitive pricing with its global competitors…the challenge however arises from the local technology providers.”
According to Saint-Preux the requirement of full and unfettered regulatory compliance is motivating the industry to select solutions that will meet the global compliance demands.
“The road to making a convincing case that risk mitigation must triumph over cost has been a challenge for global players, but one that is now reaching a beneficial conclusion,” he told us.
Last week, the US passed its Drug Supply Chain Security Act (DSCSA) serialisation deadline, requiring drugmakers to comply to track and trace regulations to help protect the pharma supply chain.
Both marketing authority holders (MAHs) and CDMOs that have not yet implemented serialisation requirements may be offered a one-year grace period, until November 2018.