Track & Trace system to be in place soon to ensure quality

Aiming to control the export of counterfeit drugs from the country, the ministry of commerce is contemplating to implement the track and trace system for all the medicines that are exported from India. The stakeholders have already submitted their reports to the technical experts in the Committee of Administration (CoA) of Pharmexcil on the technology to be used for implementation. Soon after getting clearance from the committee the final draft would be sent to the ministry of commerce for the approval.
 

The idea behind having a track and trace system is not only to stop the menace of manufacturing of fake drugs but also to stop the counterfeit drugs which are infiltrating into the drug supply chain.

In the draft submitted to CoA, the stake holders have identified three technologies out of which the best would be selected by the authority for the implementation. According to the reports, three technologies that are selected for final approval are Hologram, 2D Barcode and Digital mass serialisation or Unique number. After due diligence, one of the three would be soon finalised by the competent authority.

The proposal to have a track and trace system for all the medicines that are exported from India was put forth by the ministry about six months back and they have been involved in discussion with the industry since then. According to N R Munjal, president, IDMA, “All the stake holders as requested by the ministry have already submitted their reports to Pharmexcil last month. Once the CoA clears the draft it would be sent to the ministry for final approval and once that is done we can expect a notification from the DCGI's office in the coming months. After lot of deliberation and study we have selected three separate technologies that are being considered for implementation of which one would be finalised.”

Dr P V Appaji, executive director, Pharmexcil informed, “Though this system will help to keep a tab on the counterfeiting, we hope that adopting this technology will not burden the industry financially in anyway. We have requested and advocated to the government to look for an affordable and adoptable technology that would be industry friendly.”

He informed that they are closely working with the government to ensure that the technology that would be adopted shall be economically viable for the industry. “We are working towards implementing a system that would not cause economic burden to the small scale industry or the exporting companies. We have suggested to the government that when the system is implemented it should be adopted in phased manner. That is, country wise rather than uniformally as it will give more time for the companies to adopt to the changes,” Dr Appaji added.

The industry has been advocating to adopt a technology that would limit the cost of implementation to minimal. Munjal informed that the government had ensured that the initial cost of implementation will be reimbursed by the government for two to three years and they will put some mechanism in place to see to the implementation.

According to a survey that was carried out by the Central Drugs Standard Control Organization (CDSCO), prevalence of spurious drugs sold across pharmacy outlets in the country was estimated at 0.046 per cent. Though the quantum of spurious drugs is not significant, it is necessary to have an anti counterfeit measure in place so that quality of the medicines that are exported from India are not compromised putting the reputation of Indian manufacturers in question.