Indian Drug Manufacturers' Association (IDMA) has urged the Directorate General of Foreign Trade (DGFT) to make the provision of maintaining of data in the parent child relationship between secondary and tertiary packaging optional or to keep in abeyance as it is difficult for the manufacturers or exporters to provide all the infrastructure to create or upload all the data on DAVA (Drug Authentication and Verification Application) portal till October.

The suggestion was made after the DGFT amended Para 2.89 A of Handbook of Procedure, 2015-20, as notified on Public Notice No. 4/2015-20 dated 01.04.2015. As per Para 2.98 A (ii), the manufacturer or exporter shall maintain the data in the parent-child relationship for three levels of packaging i.e. primary, secondary and tertiary packaging and their movement in its supply chain. However, maintenance of parent-child relationship between primary and secondary packaging is optional.

Para 2.98 A(iii) states that the data shall be uploaded on the central portal of the government of India by the manufacturer or exporter or its designated agency before release of the drug formulations for sale or distribution.

S V Veerramani. president of IDMA says, “The requirement of maintenance of data in parent-child relationship between secondary and tertiary packaging has however not been made optional and it must be noted that this criterion has been incorporated with sufficient discussion and deliberation with the industry. It does not add value at the moment from the standpoint of authentication by the end user, as the 2 D barcode on the carton when decoded will surely confirm the authenticity or otherwise of the pack.”

He further adds, “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 they have managed to come to terms with barcoding of tertiary and secondary packs, investing time and money in an aggregation unit and additional scanners that will be required for the parent child relationship will burden them with no added advantage. Besides, since the cartons would need to be scanned in the shipper after packing, the activity will be offline and manual thereby reducing the output by more than 20 per cent.”

He also explained that since the onus of uploading the data on the DAVA portal is on the manufacturer or exporter would not be aware about the end point sale of his products if they are not properly tracked and the information uploaded on his server. Consequently, how is a manufacturer or exporter supposed to upload the data in time ensuring that it is complete and correct? As the manufacturer or exporter will be dependent on the supply chain for correctness of the data so every link in supply chain, whether local or global, will also need to be held mandatorily responsible to provide the correct/complete data to the manufacturer or exporter in a fixed time so that the manufacturer or exporter can further upload the same on the central portal in time to ensure that the data uploaded is truly authentic.

IDMA has also suggested the DGFT to make Pharmexcil as nominee for obtaining permission to avail the option of printing the barcode in exporter's format, so that it reduces the burden on DCGI. As per the provision under clause 2 (V) which states “Where the government of the importing country has mandated or formally notified its intention to mandate a specific requirement and the exporter intends to avail the option of printing the barcodes in their format after duly obtaining the permission of DCGI or its nominee.” So the IDMA suggested Pharmexcil, with their experience in regulatory requirements of all countries be assigned with this responsibility for avoiding delays.

Source:pharmabiz.com