Needs Relaxation: Pharma Firms Ask DRAP to Revise Barcode Deadline

Pakistan Pharmaceutical Manufacturers’ Association (PPMA) has urged the Drug Regulatory Authority of Pakistan (Drap) to review its directive that gives six months to drug manufacturers for adopting ‘serialisation and barcode’ for their products, calling the deadline very short.

Drap has made it binding on the pharmaceutical industry to adopt within six months the system of serialisation, which includes barcodes for medicines, in order to ensure authenticity and quality of products sold in the market.

“Drap’s plan to employ the serialisation process is encouraging, but it is a lot quicker than that in the US and Europe,” a press release quoted PPMA former chairman Haroon Qassim as saying.
Executives of the pharmaceutical industry gathered on Monday to discuss challenges at the 3rd Pakistan Pharma Summit.

Qassim believes that an entire ecosystem has to be built before venturing into complexities of this magnificent tool as being over-ambitious sometimes carries undesirable consequences.

“Drap … should work as a partner with the industry rather than confronting and issuing Statutory Regulatory Orders (SROs),” he added.

By the year 2020-21, it is expected that 75% of the world’s pharmaceutical supply chain will be covered by various regulatory mandates.

Compliance with these regulations will require companies to invest in new technology, make major process changes and potentially restructure their supply chains. “This is a tall order, are we ready for that?” he asked.

The industry and regulatory agencies should work together to ensure maximum benefits to patients while minimising risks. There was also a need for objective dialogue between regulators and the industry to resolve all emerging challenges for a win-win scenario, he added.

Another former PPMA chairman Jawed Akhai said the six-month time frame given by Drap to adopt the system of serialisation and barcode was inadequate as only those companies would be able to meet the deadline that had been working on such technologies for several years.

He pointed out that pharmaceutical companies for several decades had been contributing 1% of their gross profits to the Central Research Fund being maintained by the government. These funds should be used to help the industry adopt modern systems like serialisation and barcode.

Drap Chief Executive Officer Dr Muhammad Aslam urged the pharmaceutical industry to frame a fresh strategic plan, adopt technological advancements and comply with regulatory requirements to meet the highest quality standards being maintained in other countries.