Industry group seeks amendments to India's barcode plans

A trade group representing India's medicine exporters has asked for a series of amendments and exemptions from the country's plans to introduce a barcoding scheme for exported 'drugs & pharmaceuticals'.

Among the assertions put forward by India's Pharmaceutical Export Promotion Council (Pharmexcil) - a trade organisation representing exporters of allopathic and traditional medicines - that Ayurveda, Siddha and Unani (ASU) medicines should be exempted from the scheme introduced in January 2011 mandating a track-and-trace system for all exports.

The body claims ASU medicines are not affected by counterfeiting and falsification, so there is no need to implement the system, which is aimed at shoring up India's reputation as a supplier of quality medicines at a time when it has also been linked as a manufacturing hub for counterfeit and spurious medicines.

It also argues that many ASU products are exported as dietary supplements or 'nutraceuticals', foods and personal care products so should not fall under the 'drugs & pharmaceuticals' category. Moreover, the barcoding scheme may conflict with existing coding systems for products destined for distribution in grocery and related retail channels.

Last month, Pharmexcil polled its member companies in order to develop a "detailed representation" to the Indian government requesting modifications to the track-and-trace notification (see also India sets challenging timeframe for barcoding drug exports).

In addition to the scope of medicine types included in the new regulation, Pharmexcil member companies have expressed concerns about the short deadline for introduction (July 1, 2011) and other issues such as the possible need to link primary, secondary and tertiary packaging, which makes an already-complex coding project even more so.

While noting that the government seems determined to push the track-and-trace project through in order to strengthen the reputation of Indian-made medicines in international markets, there does seem to be some room for manoeuvre, according to Pharmexcil executive director Dr. P. V. Appaji.

"The government was very open … to consider suggestions from the industry/Pharmexcil, to ensure smooth and hassle-free implementation of the notification," said Appaji in a statement.

"It may [also] favourably consider implementation of the notification in a phased manner, if considered essential."