Home »Business and Economy » Pakistan » Serialization and barcode’ systems: pharma industry seeks extension

  • News Desk
  • Jul 25th, 2017
  • Comments Off on Serialization and barcode’ systems: pharma industry seeks extension
The pharmaceutical industry representatives have called upon the Drug Regulatory Authority of Pakistan (DRAP) to review its directive giving just six months to the medicine manufacturers to adopt systems of "serialization and barcode" for the medicinal products in the country, as this deadline is even shorter than the timelines prescribed by regulatory bodies in the developed world for adopting similar technological mechanisms.

This was one of the main demands made by speakers at the 3rd Pakistan Pharma Summit organized by Pakistan Pharmaceutical Manufacturers' Association (PPMA) here at a local hotel on Monday. Speakers maintained that in June this year the DRAP had issued a directive making it binding upon the Pharma industry to adopt within six months the system of serialization which includes barcodes for medicines to ensure authenticity and quality of drug products being sold in the market. "The regulatory bodies from across the globe are planning to implement the process of serialization in their systems by the year 2020/2021 in order to protect patients from the menace of counterfeit drugs. Learning that the DRAP has plans to employ serialization process a lot quicker than the USA and Europe is encouraging but it comes with a word of caution," said Haroon Qassim in his introductory remarks at the summit. "We believe that an entire ecosystem has to be built before venturing into the complexities of this magnificent tool as being over ambitious sometimes carries undesirable consequences. We appreciate the DRAP for its futuristic approach but it should work as a partner with the industry rather confronting and issuing SROs (statutory regulatory orders)," said Qassim.

By the year 2020/21, it is expected that 75 per cent of the world's pharmaceutical supply chain will be covered under 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," he said. The summit chairman said that the industry and regulatory agencies should work together to ensure maximum benefit to patients whilst minimizing risks. He said, "There is also a need for objective dialogue on regular basis between regulators and the industry to resolve and dissolve all emerging challenges and issues for a win-win scenario." Former chairman of PPMA Jawed Akhai said that six months given by the DRAP to adopt systems of serialization and barcode for medicinal products was too less as only those Pharma companies would be able to abide by this deadline, which had been working on such technological innovations for the last several years.

He said pharmaceutical companies for the last several decades had been contributing one per cent of their gross profits towards the Central Research Fund (CRF) being maintained by federal government as funds available with the CRF should be used to help out Pharma industry to adopt modern systems like serialization and barcode systems for medicinal products. He said the DRAP should not delay any more decisions on important affairs related to industry including grant of licenses and doing registration for manufacturing and introducing new medicines in Pakistani market for the maximum benefit of ailing citizenry.



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