Barcode helps in tracking and tracing sub-standard or counterfeit medicines. The Indian pharma industry is a leading supplier of generic medicines globally, exporting medicines to over 200 countries.
In order to ensure quality and safety of Indian drugs that will further boost exports, the government has asked big pharma companies to implement barcoding from April 1, 2016 and small pharma companies have been asked to implement track and trace system from April 1, 2017.
CIPI reaction
However this has drawn sharp response from Confederation of Indian Pharmaceutical Industry (CIPI), an apex body of small scale manufacturers of drugs and pharmaceuticals.CIPI is planning to take up the issue with Union ministry of commerce and Pharmaceuticals Export Promotion Council (Pharmexcil) to exempt the SSIs from its implementation.
CIPI, which time and again made representations to the ministry urging it not to make it mandatory for SSIs to implement barcoding for exports, will once again take up the matter with the ministry.
Currently, CIPI is scrutinising the proceedings of a meeting held by Pharmexcil on implementation of barcoding in Mumbai on May 13.
"Once we have gone through it, the issue will be taken up with the ministry", said CIPI executive secretary Sudesh Kumar in a telephonic interaction with Pharmabiz.
The ministry in a notification had directed small scale pharma exporters to print 14 digits Global Trade Item Number (GTIN) along with batch number, expiry date and 2D barcode on secondary packs and 1D or 2D barcode on tertiary packs and maintain the data in the parent-child relationship for all three levels of packaging—primary, secondary and tertiary packaging and their movement in its supply chain from April 1, 2017. However, it is optional to maintain parent-child relationship between primary and secondary packaging. The small scale exporters have also been directed to upload the same in Drug Authentication and Verification Application (DAVA) portal up to March 31, 2017.
On June 29, 2015, the ministry had launched DAVA portal to create an integrated platform for implementation of the track and trace system for export of drugs. Manufacturers/ exporters have to upload data on the DAVA portal.
SSI woes
Kumar, citing reasons for exempting the SSI units from implementation of barcoding said “A huge chunk of small-scale pharma companies export drugs to third world countries lacking facility to scan bar code on packaging of pharma products to ensure its authenticity. The countries do not have required manpower and resources to implement track and trace system. Hence there is no mandatory requirement for bar coding on packs of pharma products exported to low income countries. Given the circumstances, it is futile for us to abide by the ministry's notification.”
On the other hand, establishing parent-child relationship between secondary and tertiary packs of pharma products as per the government norm will put a heavy financial burden on small scale pharma units without serving any purpose. The companies exporting products to developed countries like the US and Europe have already implemented track and trace system which is mandatory to export there, he said.
Having known that it does not serve the purpose of authentication or that of supply chain verification when the market place is not ready, insisting on having this requirement will discourage the SMEs from following the requirements, since even before some of SMEs exporting products to developed countries managed to come to terms with barcoding of tertiary and secondary packs, making it compulsory for all SMEs will burden them with no added advantage, he added.