Just days after stopping tens of companies across the country from manufacturing medicines made with the raw material "Ranitidine" - including Zantac - and recall all such products already on the market over the report of United States Food and Drug Administration (FDA) that the medicine could cause cancer, the Drug Regulatory Authority of Pakistan (DRAP) on Monday said that it was further investigating and evaluating the situation in assistance with "international bodies."
Talking to reporters after addressing the conference titled "Medication Safety: Connecting Academia & Practice," which was organized by Pakistan Society of Health System Pharmacists (PSHP) at a local hotel, DRAP chief executive officer Asim Rauf said that the regulatory body showed immediate reaction over reports about raw material Ranitidine - including Zantac - and made move for larger interest of the industry as well as the consumers.
"Now going forward we are in close contact with the international bodies and further investigating the matter," he said. "There is nothing to worry about because the DRAP has made assured that not a single piece of such medicine would be available in the market after the alert was issued. Apart from issuing orders and directives, we have smart and vigilant teams on ground in assistance with the respective provincial government to keep checks on any wrongdoing or violations of the regulatory framework."
Earlier, addressing the conference the DRAP chief briefed the participants about the role of the regulatory body to from protecting rights of a common man to easing environment of doing business for the pharmaceutical companies. The drugs watchdog, he said, always kept the medication safety as its key priority which on one hand assured healthy environment of medication and on the other keep professionals abreast with internationally-recognized practice sharing few measures taken by the DRAP on these lines.
"DRAP is already doing membership of WHO Uppsala Centre for access to Vigiflow, which is global database system for pharmacovigilance reporting and this access supports regulators and medical professionals with latest safety information about the drugs," said Rauf.
"Very recently, a thorough review for valsartan containing drugs was also carried out to determine the impact of NDMA and NDEA levels on long-term clinical outcomes in the patients." This effort of DRAP was acknowledged at international forums and this review was published by a prestigious international journal Therapeutic Advances in Drug Safety.
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