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Global Regulators can Now Access Drug Database of Indian Pharmaceutical Manufacturers

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Published on : Jun 24, 2015

India is building a large database on domestic pharmaceutical manufacturers which will be accessed by drug retailers and regulators across the globe. The decision of the government to let the global drug retailers and regulators to access the data can be traced back to the concerns over manufacturing of fake drugs in the country. In the past, the government had introduced barcoding of medicines to be exported to locate their point of manufacturing. Now, it has been mandated for all drug exporters to comply with labelling prescribed manufacturing data from October this year. Barcode labelling on primary packaging has been temporarily exempted. 

According to a senior commerce ministry official, a pilot project will be started by the end of this month to upload the data provided by some of the selected medicine exporters. Within the next four months, an expert group will advise on the technologies for the track and trace system. According to the reports, in 2014-15, India exported medicines worth US$15.2 billion which was an increase of 5% over the figures reported in the previous year. PV Appaji, who is the director general of Pharmexil, mentioned that the medicine exporters will be required to upload data regarding the primary, secondary, and tertiary levels of packaging as well as the movement of goods through the supply chain. 

Among the medicine exporters who have come forward to upload the barcoding data on the server, Wockhardt, Unichem, and Sun Pharma are the prominent names. Appaji said that talks are going on to include some other medicine exporters such as Mylan Labs, Sandoz, Aurobindo Pharma, and Dr Reddy’s Laboratories. According to SV Veeramani, the president of Indian Drug Manufacturer’s Association, India is the first nation to implement such barcode system in the world. However, manufacturers are not sure about the benefits of the system.