The implementation of new track and trace system by the Union Commerce Ministry on all pharma exports will go a long way in putting a check on the exports of spurious drugs.
If everything goes as planned, then India will be the first country in the world to have such a track and trace system in place that will help the customers to keep a tab on the source of the medicines from beginning to the end of its journey.
The track and trace system which was implemented by the government for the secondary and tertiary level packaging involves two phases. The first part of which is to adopt barcodes on the packaging which is already implemented in the country, successfully. Whereas the second part of the implementation of the track and trace system, waiting for the whole process to be complete through authentication of barcodes, is still underway.
To ensure effective implementation of the track and trace system throughout the country for the exports and domestic use of the pharma products, the Commerce Ministry and Health Ministry is understood to be working closely to implement the second phase of track and trace system, i.e. authentication of barcode, for the tertiary and secondary level packaging. According to sources, the interim report on track and trace system will be submitted to the ministry soon for further evaluation on this matter
India exports over $ 10 billion worth of drugs annually. The government wants to increase that figure manifold in the next few years by taping the booming generics market in the developed world. Industry experts say the only way Indian pharma firms can tap the market is by ensuring quality, and adopting the trace and trace system.
At present the government is understood to be in the last leg of reviewing the final expert committee report submitted by the task force, set up by the Union health ministry which has in detail highlighted the ways to implement the track and trace system throughout the country. The task force chaired by H G Koshia, who is also the commissioner, Food & Drugs Control Administration (FDCA) of Gujarat, had submitted the final report for review few months back after painstakingly going through multiple interactive meetings with the stakeholders.
The said report suggests ways to develop software for drug manufacturing and tracking system so that it will enable the government to effectively introduce a unique ID, bar coding and SMS alert system in the country to prevent any incidence of counterfeit. It is understood that the Commerce ministry has already given a go ahead sign for the same and is waiting for the health ministry’s decision on the expert committee report so as to authenticate the barcodes for its deserved purpose.
Both the ministries are already understood to be engaged in high level discussions to get into an understanding on the same at the earliest. According to Rajeev Kher, additional secretary, ministry of commerce and industry, the main reason why they are yet to implement the second phase of the track and trace system for the exports is to ensure that the industry is not affected due to dual implementation if done separately.
“We completely understand the position of the industry in dealing with the same and want to ensure that the government will always consider only the best of their interest before adopting or implementing any provisions. We also acknowledge that it will be more feasible for the industry economically if the implementation of the authentication process for trace and trace system is adopted simultaneously for both exports and domestic use” Kher informed.
Further he also clarified that the government is committed towards its cause for ensuring only safe and efficacious medicines and thus safeguarding the interest of the patients. Dr PV Appaji, director general, Pharmexcil pointed out that, at present, there is a lot of unwanted confusion on the stand taken by the government on the track and trace system which is undue as the government is stern on its decision.
“There is no second guess on whether the system will be in place or not, in fact if you notice the system is already in place for secondary and tertiary level packaging, the delay is only because these are complicated issues wherein procedures needs to be well defined for effective results. Though the government is keen on adopting the track and trace system in all the levels of packaging, they are now contemplating on how to go about with this strategically as it needs a more scientific approach to suit the needs of the customers”,Dr Appaji said.
The Commerce Ministry had made compulsory implementation of the tertiary level barcoding on packaging from October 1, 2011 and secondary level barcoding for pharma exports from January 1, 2013 simultaneously, to tackle with the allegations made by some importing countries on the questionable authenticity of the some drugs exported from the country as being counterfeit or of sub-standard quality.
In the meanwhile the union commerce ministry's decision to extend the implementation of barcode on primary level packaging by pharma companies to July 1, 2014 was a happy tiding to the Indian exporters, especially the small and medium companies, as it could help them save a lot of money. As per earlier notification of the ministry, the exporters were to implement barcode on primary level packaging with effect from July 1, 2013 which has now been deferred by the ministry by one year.
The exporters feel that the extension for bar-coding on primary level packaging on export consignments indicates a strong interest on the part of the governments to address this issue at the earliest. The exporters have been advocating for the total exemption of the 2D bar codes on primary level packaging for some time.
It is understood that in the face of the strong objection from the industry on the issue of 2D bar codes, the government may go for a further extension, probably, for another year from 2014 to 2015 or may even completely call off their plan to implement the same.