India looks to technology to secure generic drug exports

India's government is looking at applying anticounterfeiting technologies to exported medicines in order to restore the battered reputation of its domestic pharmaceutical manufacturers.

The country is desperate to shake off its image as a hub for counterfeit and substandard drugs and restore faith in India's drugmakers - which export 40,000 crore (around $8.5bn) worth of medicines every year and are a critical source of essential drugs for the developing world.

Pharmexcil, a trade group representing drug exporters set up by the Ministry of Commerce and Industry, is being consulted on the proposal and asked to comment on feasible methods of tracking or authenticating medicine shipments sent overseas.

In an interview with SecuringPharma.com, Pharmexcil executive director Dr. P. V. Appaji (pictured) said that India's Commerce Secretary Rahul Khullar has voiced "extreme displeasure and anxiety" at the allegations that India is a major supplier of counterfeit medicines.

At a high-level meeting organised by the country's Ministry of Commerce and Industry earlier this month, Khullar said it was time to tackle the issue head-on, and look into the use of a technological approach to support the trade in legitimate Indian drugs and help stamp out the supply of spurious medicines.

There have been several incidents in which counterfeit medicines labelled as being made in India in fact originated from other countries, said Appaji.

The best-documented case was uncovered by Nigeria's national regulatory authority NAFDAC, which concluded that the fakes - which contained no active ingredients - were sourced from China. Meanwhile, there are unconfirmed reports of similar cases in other countries, he added.

A report published yesterday in The Hindu newspaper describes another incident in which a counterfeit version of V. S. International's Ciprotab (ciprofloxacin) - believed to originate in China - was seized by NAFDAC officials at Nigeria's Abuja airport.

"The Minister said at the meeting he wants to take a tough line on this issue, and investigate thoroughly whenever there is a report of substandard drugs from India," said Appaji.

"Also, he has asked Pharmexcil to conduct a survey of various anti-counterfeiting and security measures available in India, both from a technological and economic perspective, and report back as soon as possible," said Appaji.

At the moment it is unclear whether the overall objective is a traceability approach, or the use of an authentication technology that would allow genuine Indian-made products to be verified in the countries they are distributed.

"We want to identify the various technologies available, their strengths and weaknesses, and whether they are viable in the Indian pharmaceutical sector, particularly with regard to the cost of deployment" he said.

The message from the government at the moment is that anti-counterfeiting technology should be a mandatory requirement for Indian-made medicines - at least those destined for one or two countries identified as being at high-risk of medicines counterfeiting, said Appaji, who also noted it is still not clear whether this will be applied to all medicines or just select, high-risk products.

Pharmexcil has retained consultancy firm Candle Partners to carry out the study in consultation with India's major pharmaceutical manufacturers, and hopes to deliver a report to the Ministry within the next two or three months.


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