According to a press statement, the spokesman said that a technical system was being evolved for protection of public from spurious and counterfeit drugs.
“Pharmaceutical manufacturers are required to emboss 2D barcode data matrix on their registered drug products from all batches manufactured after December 15, 2017. By virtue of notification 470(I)/2017, issued by DRAP on June 15, 2017, it is mandatory for all market authorisation holders of pharmaceutical drugs will emboss 2D barcodes on their products. Barcodes will be according to the standards of GS-I embedding Product Identification Code (GTIN) and will carry the expiry date, batch number and price on the secondary packaging of the drugs,” he said.
The companies will maintain a database of bar-coding information of their products and will also submit it to DRAP.
The information will be linked to DRAP online portal: Drug Regulatory Information System (DRIS).
Pharma companies and market authorisation holders of products will access the portal through a validated account, without any subscription fee,” the statement said.
Federal Minister for National Health Services Saira Afzal Tarar on Tuesday expressed satisfaction that major initiatives taken by the Health Ministry were now being implemented and would give a major boost to eradicating spurious and counterfeit drugs.
In this regard, DRAP IT professionals arranged training sessions for technical personnel of pharma manufacturers in all provincial headquarters. The first training session was held in Karachi on October 30.
It was attended by representative from national and multinational companies and their associations including Pharma Bureau and Pakistan Pharmaceutical Manufacturers Association. Subsequent sessions were arranged in Lahore, Peshawar and Islamabad.
The focal person from Division of Management Information System of DRAP conducted the training and answered the technical queries regarding the firms’ online registration through the software. DRAP is also working on developing a complete track and trace system as per international practices.
“A step-wise approach has been adopted while taking stakeholders on board. In the second phase, barcoding will also be mandatory for primary and tertiary packaging of drugs. In third phase, each pack will contain a unique serialization code along with 2D data matrix.
All these steps will be very helpful to eradicate the menace of spurious, substandard, falsified and counterfeiting drugs form market of Pakistan. The training material is also available on the website of authority,” it said.
Published in Daily Times, November 1st 2017.
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