The Indian Drug Manufacturers' Association (IDMA) has urged the Union commerce ministry not to make the track and trace rule mandatory as the industry as well as government is facing various issues and practical difficulties in implementing the track and trace mechanism.
The association has recently written to Rita Teaotia, commerce secretary, asking to reconsider the implementation of barcoding scheme as it could hamper export activities without providing any significant benefits.
IDMA has informed that it is not only difficult for the industry to implement track and trace rule but also the government is facing problems. The DCGI has been appointed as the nodal authority for exporters to seek exemption from printing of barcodes as per rules 2(i) to (iv) public notice no 52/2015-2020 dated January 5, 2016. The DCGI vide a letter (F. No 7-5/2016/BC/005 dated March 7, 2016) has communicated inability to take care of barcoding and this has affected the export performance of the industry considerably.
It is understood that the office of DCGI, which is already overloaded and understaffed, will not be able to provide data or list out countries seeking exemption. It would be more prudent to make the exemption as the rule, and stipulate that specific format and markings on labels of pharma packs need only be complied with if stipulated by any country for exports, said the IDMA.
S V Veerramani, president of IDMA, says, “Also many of our companies manufacture products for foreign companies on contract manufacturing (neutral labelling) and such requirements of barcode are not stipulated by these foreign companies. We reiterate that most countries do not have any track and trace requirement, and Indian track and trace guidelines can be implemented only after their acceptance of these guidelines.”
He further explained that till date, no other country has mandated such a need for barcoding of all pharma packs, as the information provided on the label of the packs for regulatory compliance is sufficient for tracking and tracing. It is very difficult task to identify countries and their regulations that will specify any need, or otherwise, of our system of barcoding.
The industry by and large, is tried its best to comply with barcoding on tertiary and secondary packs, though the compliance is reportedly only about 30 per cent. The problems are faced by the SMEs as well as non SMEs as there is no support or help provided by vendors in implementing the parent child relationship. We have asked the ministry of commerce not to make the rule mandatory, the companies will slowly and later implement the said rule, said Veerramani.