NEW DELHI: The government plans to make barcoding mandatory on all medicines sold locally in a bid to offset India’s growing reputation as a source of counterfeit medicines.
While the system is already in place for medical devices and export of medicines to ensure their authenticity and traceability, the Union health ministry plans to take a tough stance for the domestic market as well despite resistance from drug companies.
“In current times, our major concern in the pharmaceutical market is authenticity of drugs which is more important than traceability. In order to prevent counterfeit medicines in the country, we had proposed the idea of implementing barcoding back in 2015. Currently, this remains voluntary. But in the next phase of policy planning, we are planning to make it mandatory for all drug manufacturers to use barcoding in the domestic drug market as used in exports," said R. Chandrashekar, deputy drugs controller, Central Drugs Standards Control Organization (CDSCO) under the health ministry.
“About top 300 pharmaceutical brands are voluntarily using barcoding and other international standards for authentication. We issued a draft notification in 2015 for the same and sought feedback from the industry and stakeholders. The industry has been arguing over challenges in adopting the authentication techniques such as cost of equipment and infrastructure for adoption of barcoding. We will give some time to let them gradually adopt this," he said.
Globally, there are stringent regulations against fake drugs and medical devices, which could cause injury or fatality to patients. These rules also stipulate implementation of traceability by all stakeholders in healthcare supply chains from point of manufacture to their sale and consumption.
Health experts say it is imperative for the government to mandate drug makers to adopt and implement authentication, track and trace system using global standards and best practices with the country being identified as a source of counterfeit drugs by various bodies including the United States Trade Representative (USTR).
The slow adoption of barcoding for domestic sales of drugs impacts the authenticity of medicines, ability to monitor their ready availability, expiration, track and trace their recalls when needed. This is also one of the causes of avoidable medication errors, injuries or fatalities and proliferation of counterfeits.
“We are in active discussions with the Union health ministry and the department of pharmaceuticals for implementing barcoding of pharma products to facilitate track and trace, expiry management at point of sale by chemists and product authentication by consumers or patients in the domestic market," said Ravi Mathur, chief executive, GS1 India, a standards organization.
“This will be in line with what has been implemented in exports to bring harmonization in the pharmaceutical sector. This will enable Indian patients benefit and experience the same level of safety from drug authentication and track and trace system, as is available to foreign consumers," he said.
The office of the USTR recently highlighted that India has a growing problem of counterfeit medicines, in its annual ‘Special 301 Report’ on intellectual property protection and review of ‘notorious markets’ for piracy and counterfeiting released in April. The USTR report said almost 20% of all pharmaceutical goods sold in the Indian market are counterfeit.