NEW DELHI: India’s central drug regulator is creating a working group to critically appraise its proposal to set up a “trace and track” mechanism to weed out fake medicines from the market using unique codes.
The working group, comprising pharmaceutical association representatives and members of the Central Drugs Standard Control Organisation, is to submit its report on the problems and “suitable solutions” by October, according to a person aware of the development.
The move follows the Drugs Technical Advisory Board’s approval to a proposal for a “trace and track” mechanism during a meeting held on May 16. The proposal entails a 14-digit number to be printed on the labels of the top 300 pharmaceutical brands unique to each strip and bottle sold in the market.
Once implemented, patients will be able to check whether the medicines they purchase are genuine through a text message to a number provided on the labels by companies marketing the drug.
`“The major objectives are to create fear in the minds of counterfeiters and build up the image of the Indian pharma industry,” stated the minutes of a meeting chaired by the Drug Controller General of India on June 25. The introduction of this authentication system will however “actually increase” the workload of regulators, the minutes of the meeting noted. “The technology proposed to be used for authentication, technology provider, service provider has to be decided by the pharmaceutical forum ..
During the meeting, industry representatives and contract manufacturers raised concerns over the costs op operating such a system requiring them to print unique codes on shortlisted brands. Several companies that had already introduced such an authentication system said the number of people using this system was “very low.” “The concept is acceptable in principle, subject to addressing the IT concerns, cost effectiveness and operability,” one of the representatives said.
Serialisation would increase the cost for contract manufacturers and make their business “unviable,” they said. MSME enterprises sought subsidies for the “additional cost” manufacturers have to bear.