The countdown to the year-end is making several drug-exporters nervous. And that’s because a Government diktat mandating pharmaceutical exports to carry bar-codes on their cartons, or secondary packages, is coming into force from January .
A three-tier track-and-trace technology was outlined by the Government after fake “Made in India” drug consignments — that had originated in China — found their way into Nigeria.
The bar-code issue, however, landed at the Madras High Court, as drug-makers said bar-coding was neither feasible nor fool-proof and would not solve the problem of fake drugs in the international market.
With two weeks to go for the January 1 deadline, drug exporters hope for some clarity from the Court – as the case is scheduled to come up for hearing this week, a drug-exporter told
Not prepared
Several drug-exporters have yet to start putting bar-codes on their secondary packs, says a small exporter on condition of anonymity. The huge investments by companies in bar-coding equipment and related infrastructure will not achieve what the Government wants – to protect Indian medicine brands from being copied.
Having a bar-code on its package does not guarantee that the medicine is safe , nor does it prevent the bar-code from getting copied, says the exporter. A bar-code merely aids better inventory management, he adds.
Besides, will the Government compensate an exporter if a counterfeit of a lead Indian product is found despite the bar-coding, the exporter asks, adding that exporters fight their own battles in protecting their products in international markets.
In fact, the exporter says, the added investment and cost of rejections could push up the cost of the product by between 20 and 30 per cent. This makes the product unviable compared to those from Bangladesh or China, the exporter says. Some industry representatives are exploring the option of shifting manufacturing facilities to Sri Lanka, Nepal or Bangladesh if the going gets tough locally, he adds.
Extended timelines
Bar-coding on drug exports has been contentious from the beginning, and the Government has relented in the past by giving exporters extended timelines. Bar-codes on tertiary packs finally kicked-in from October 2011, while primary packs are slated for June 2013.
With little time left, a meeting is slated this week between Government, industry and Pharmexcil (Pharmaceuticals Export Promotion Council of India), to try and resolve the deadlock.
jyothi.datta@thehindu.co.in