The pharma exporters in Karnataka has welcomed the Union Commerce Ministry's decision to defer  implementation of trace & track system for exporters by six months to November 15.  

A communication from Directorate General of Foreign Trade(DGFT) dated May 9, 2018  stated all drugs manufactured after November 15,2018 can be exported only if both tertiary and secondary packaging carry bar code as applicable and the relevant data is uploaded on the central portal.
 
Exporters stated the ministry's action would safeguard the interests of all exporters. However, there is a major element of expenditure incurred for the small scale industries (SSIs) to revise the packaging format. But the big benefit for the sector is that it will give the much-needed genuineness of Indian pharma products in the international market.

Under paragraph 2.04 of the DGFT handbook of procedures for period between 2015-2020 mandated this implementation for export of formulations across large, medium small scale industries.

But breather for the industry is that the amended version under paragraph 2.90-A, states that drug packs having a manufacturing date on or before November 15,2018 are exempted from maintenance of data in patent-child relationship for three levels of packaging and its uploading on the central portal.
 
According to Jatish N Sheth, director Srushti Pharma and past president, Karnataka Drugs and Pharmaceutical Manufacturers Association(KDPMA), the latest notice will give the required authenticity to the drugs packs manufactured in India for exports. The positive side is the transparency of an Indian product. But the negative side is that equipment for this packaging is  costly. Therefore the DGFT should fine tune this requirement, he added.
 
The regulation is meant for benefiting the exports. The Trace and Track was devised following the 2012 issue when some African countries detected counterfeit medicines with an Indian label which ultimately was traced to manufacturers from China, explained Sheth.
 
While Trace and Track is advantageous, its frequent postponement to implement by the industry defeats the purpose. It is obvious that there are teething problems to put into practice. The government should now identify the specific challenge and address the issue for the industry. Many companies including Srushti are already adopting parent-child relationship for its export packs, said Sheth.

Kaushik Desai, pharma consultant said that this is more of a commercial guidance but equally important. Number of export pharmaceutical consignments were held up at the customs for want for information on parent-child relationship packaging and difficulty on uploading the required information on DAVA (Drugs Authentication and Verification Application) portal. Therefore, this extension of implementation benefits companies in the short term. However?, ?there is need for a long term solution where a practical approach is needed to ensure compliance with, involvement of all stakeholders and creation of 24x7 efficient helpline to take care of any issues with DAVA portal and support in meeting export timelines.