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DRAP's campaign against spurious drugs continues.

ISLAMABAD -- Drug Regulatory Authority of Pakistan (DRAP), as part of its special campaigns against spurious drugs in the country, has completed testing of 1,71,375 samples at its laboratories during two years and nine months. According to an official of DRAP, the authority has conducted different campaigns each year especially two campaigns of three months duration (March-2017 to May-2017 and August 2017-November 2017) against spurious drugs in collaboration with provinces and Federal Investigation Agency (FIA) where cases were launched and stocks were seized. He said that Inspectors have collected and tested 53,371 samples during nine months of 2017 while 43,933 samples were tested in 2015 and 74,071 during 2016. Of the total, the authorities concerned found 538 samples substandard in 2015, 813 in 2016 and 446 during nine months of 2017. The samples declared spurious included 252 in 2015, 97 in 2016 and 63 during three quarters of 2017.The authority also launched cases in drug courts and their number was 3,903 in 2015, 3,446 in 2016 and 1,452 in nine months of 2017. The number of cases decided by drug courts was 1,656 in 2015, 2,446 in 2016 and 884 in nine months of 2017. The drug courts also imposed Rs 202 million fine which included Rs 70 million in 2015, Rs 100 million in 2016 and Rs 32 million in three quarters of 2017. During the period, 21 drug manufacturing licenses were suspended or cancelled. Their break-up was two licenses suspended or cancelled in 2015, 11 licenses in 2016 and eight licenses in nine months of 2017.

He said that the authorities concerned also suspended production activities of 40 units which included four in 2015, 20 in 2016 and 16 in 2017.

Good Manufacturing Practices Inspection

(GMPI) were also conducted during the period which included 937 GMPI in 2015, 1059 in 2016 and 784 GMPI in nine months of 2017.

Highlighting the other steps taken by Ministry of National Health Services, Regulations and Coordination to curb sale of spurious and fake drugs in the country, the official said that the DRAP has strengthened monitoring system by appointing Federal Inspector of Drugs (FIDs) throughout the country.

Regular monitoring is being done by field offices while campaigns against spurious drugs and fake drugs are conducted regularly.

He said that the federal government has initiated process of World Health Organization (WHO) pre-qualification of Central Drugs Testing Laboratory (CDL), Karachi to strengthen quality control of drugs used in the country.

The two phases of Quality Management System (QMS) have been completed. Proficiency test has also been conducted and results submitted in June, 2017 to WHO while WHO audit is expected in first quarter of 2018.

He said that the DRAP in 22nd Meeting of Policy Board approved creation of new posts for section of Quality Management System (QMS) and vigilance section for further strengthening the implementation of DRAP Act, 2012.

The federal government has notified Bar Coding System (Serialization) for prompt identification

of spurious or counterfeit drugs at every level. It would be easily detectable whether product is genuine

or spurious by use of smart phone application by patient, retailer, wholesale and regulator. This 2D Data

Matrix system on the pharmaceutical products will serve as a tool for the eradication of spurious, illegal and unregistered drugs, he added.

He said that the DRAP is vigilant to minimize sale of spurious medicines and fake drugs in collaboration of provinces and security agencies. Federal and provincial governments have initiated strict measures against the menace of spurious and fake drugs, he added.
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Publication:The Frontier Star (Northwest Frontier Province, Pakistan)
Date:Jan 20, 2018
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