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India to open drugs database to global regulators

Economic Times:  June, 2015

Hyderabad: Drug regulators and retailers across the world will soon be able to access a large database that India is building on domestic pharmaceutical manufacturers. India has decided to throw open the database to global stakeholders following concerns over spurious drugs emanating from the country.

The government had earlier introduced barcoding on export consignments of medicines to help trace their point of origin.

Now it has mandated all drug exporters to adhere to labelling of prescribed manufacturing data on various levels of packaging from October 1 while temporarily exempting barcode labelling on primary packaging.

A senior commerce ministry official said a pilot project will begin at the end of this month for uploading data provided by some select medicine exporters, even as an expert group will recommend technologies for the socalled track and trace system within four months.

India had exported medicines worth $15.2 billion (about Rs 97,000 crore) in 2014-15, an increase of 5% over the previous year's figure.

PV Appaji, director general of Indian Pharmaceuticals Export Promotion Council (Pharmexcil), said the medicine exporters will upload data pertaining to the parent-child relationship for all the three levels of packaging — primary, secondary and tertiary — along with the movement of goods in the supply chain.

Sun Pharma, Wockhardt and Unichem are among the medicine exporters that have come forward to upload their barcoding data on the central server of National Informatics Centre, Appaji said. "We are talking to a few more top exporters including Dr Reddy's Laboratories, Mylan Labs, Sandoz and Aurobindo PharmaBSE 3.30 % to take part in the pilot project," he said.

Appaji is the member secretary of the expert group on technology that comprises the commerce ministry's joint secretary Sudhanshu Pandey, pharmaceuticals department's joint secretary Sudhansh Pant and the Drug Controller General of India. He is also a member secretary of the expert committee group set up for finding the right technology for implementation of the track and trace system for export of drug formulations.

Indian Drug Manufacturers' Association president SV Veeramani said the industry players were waiting for clarity on technologies and guidelines for uploading the manufacturing data and its data security features. "India is the first country to implement the barcode system in the world. We are in principle willing to participate while incurring additional expenditure to comply with the new mandatory process, but we are not sure of its benefits."

Appaji said the commerce ministry is scheduled to organise a meeting on Friday in Mumbai to providing clarity to various stakeholders.