NEW YORK – First it was bar-codes. Now, medicine shipments out of the country will bear the track and trace technology.
A series of quality lapses by Indian drug makers, which have been under fire in the US and Europe for poor standards at factories and spurious drugs, is causing anxiety in the ministry of commerce and the department of pharmaceuticals.
Emcure Pharmaceuticals is the latest to face an import alert by the US health watchdog, Food and Drug Administration, last week.
In the last six months, several Indian drug makers have received recall letters or import alerts on quality concerns raised by the American regulator.
The government has now decided to use the track and trace technology to keep tabs on all Indian drug exporting firms, including high-profile ones such as Sun Pharmaceuticals, Wockhardt and Dr Reddy’s.
The idea is that beginning October, the companies will adhere to prescribed manufacturing data on various levels of packaging. Commerce ministry has formed an expert group to recommend within next two months, technologies for the programme.
The industry is waiting for clarity on technologies and guidelines that are to be adopted.
“We are planning to build a database on domestic manufacturers that will be open for regulators and retailers across the globe,” said a senior official from the department of pharmaceuticals. “Now, global importers would be able see the status of their consignments and scrutinise the steps taken to ensure quality during the manufacturing.”
The procedure would also help Indian drug makers track their exports, and ensure that their shipments are not tampered with.
India is the first country to implement the bar-code system, whereby government-mandated bar-coding of mono cartons (each individual carton) of drugs shipped out of the country, which began this month.
The government is worried that frequent incidents of this nature are tarnishing brand India pharmacy. Drug-makers have expressed reservations about the findings of global health regulators while hauling up their products.