Even as the commerce ministry is all set to implement barcoding on primary packs of pharma products meant for export as per GS1 and GTIN standards from April 2017, anti counterfeiting experts have advised the authorities to maintain adequate infrastructure at check points-- ports and airports to ensure effective implementation of barcoding.

Currently, the government has made it mandatory for pharma exporters to put barcoding on secondary and tertiary pharma products but custom personnel in absence of adequate resources and training are not able to keep vigil on barcoding on pharma products in an effective manner. Government needs to strengthen existing facilities at check points before actively if it has to implement barcoding on primary pack level, said an anti-counterfeiting expert.

“There should be check points at custom level. Custom personnel have little idea how to make sure that pharma products being exported abroad are complying with GSI and GTIN standards. Custom personnel should be properly trained for the same. Without this, implementation of barcoding on primary packs may not succeed. Drug regulators conducting inspection of manufacturing plants should also be provided adequate training to ensure barcoding compliance at manufacturers' packaging line level,” said K N Ramprasad, regional business manager (South India), Optel Vision, a Canada based inspection and serialization solution provider.

In India Optel Vision has to its credit 15 top pharma companies including Apotex, Mylan, Sandoz, Pfizer.

Meanwhile implementation of barcoding on primary packaging level is very challenging as with the available technology. One cannot implement barcoding on primary packs of the pharma products having 3x5 and 5x5 mm size. With the technology available in the global market today, the smallest size of packs where 2D code can be put is 8x8 mm. If one goes for barcoding on pack which is lesser than 8x8 mm, then it will become very expensive. Many companies are not able to afford barcoding on packs measuring 8x8 mm as it costs them Rs.2-2.5 crore per printing line i.e putting code on mono carton and from mono cartons to bundles, said Ramprasad.

Given the technology limitation, implementing barcoding on packs of 2 ml vials is not possible as of now. Putting barcode on 5 ml vials is comfortable to some extent. Viscosity of liquid in small bottles hampers barcoding. On the other hand, there is no better printing technology as of now to facilitate barcoding on small blisters due to challenges associated with various types of packaging like aluminum foils, plastics. Barcoding can be done on embedded blisters but this is under development. Hence its very challenging for pharma companies to put barcoding on primary packs as per GTIN and GS1 standards, he added.

With the mandatory requirement for exporters to put in place GS1 and GTIN codes on secondary, tertiary packs and upload data on DAVA portal to maintain the parent-child relationship for secondary and tertiary packs, a number of drug companies are still seeking exemption from barcoding on secondary packs.

Few well organised distributors and retailers in the country are equipped with the system to decode the data and upload it on DAVA portal in time ensuring that it is complete and authentic. Rest are facing resource crunch and may not able to adopt the practice. Besides this, speed of central server wherein consumers send code on drug packs to ensure its authentication is another issue, he opined.

As of now there is no mandatory labelling and printing on primary packaging. Big pharma companies exporting to regulated markets are complying with barcoding on secondary and tertiary packs due to high business risks. Affordability is major issue deterring pharma companies from adopting anti-counterfeiting technologies which is quite expensive.

Anti-counterfeiting solution providers like Opel Vision, are planning to set up assembly facilities in India to reduce assembly cost and engineering cost to make the technology affordable, he informed.

The government has also stepped up efforts to check authenticity of medicine being imported and exported and ensure that pharma companies comply with barcoding on pharma packs. For this, the government is conducting training programme for customs officials to educate them about anti-counterfeiting programme. The government is also planning to set up 8 minilabs at airports and ports. CDSCO is periodically conducting workshop for drug inspectors to train in anti-counterfeiting mechanism, said a senior CDSCO official.

He further said that India, an electronic hub, is able to deal with challenges faced by pharma companies while implementing barcoding on primary packs. Exemptions will be given to companies to facilitate implementation of barcoding on primary packs of pharma products meant for export considering technology constraints.