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Regulatory reforms and improvements in enforcement is causing difficulties for violators of drug regulations and laws: DRAP’s Spokesperson

Islamabad, January 04, 2018 (PPI-OT):Recent regulatory reforms and improvements in enforcement is causing difficulties for violators of Drug regulations and laws. The government is sincerely implementing the approved policies agreed with stakeholders to sustain supply of medicines for people. Our Drug Pricing Policy was developed with stakeholders as a transparent, fair and aimed to ensure the supply of medicines for public. The federal cabinet approved annual increase @ 2.08 % for scheduled drugs and 2.91% for non-scheduled drugs according to consumer price index in line with is international practice. It is totally incorrect that after Drug Pricing Policy since 2015, price were ever increased by 15% or so.

The allegations of embezzlement of record is also totally baseless and without any substance. There is no record missing from DRAP pricing or registration rather DRAP has started process for computerizing the decades old manual records, for improving the existing manual system for automation and transparency, which is disturbing miscreants. The spokesperson said Registration Board registered Dengue vaccine a few months back after recommendations of WHO for countries having high prevalence of dengue. Same vaccine is recently registered in 17 countries of world including Australia, Brazil, Indonesia etc.

After news of Philippines regarding adverse effects of dengue vaccine in routine immunization program, Registration Board again reviewed recent recommendations of WHO and decided to adopt latest WHO guidelines for the administration of Dengue vaccine under strict medical supervision as it is not banned in any part of the world. It is pertinent to mention further that Dengue vaccine will be available in market after fixation of price. However, final decision will be taken keeping in view parameters of safety, efficacy and quality and in consultation with provincial governments, so that patients could be saved especially who are exposed second time to dengue virus which is more fatal.

Responding to WHO alert on Celias milk powder recall, a strong and urgent approach was adopted by DRAP and Ministry of National Health Services, Regulations and Coordination in close collaboration with WHO country office and their international center and accordingly the concerned batches were immediately recovered. Companies, federal and provincial health departments published the recall advertisements and directives.

It was also directed to Federal and Provincial inspectors through respective health departments to immediately coordinate and enforce the recall. Resultantly an effective recall was arranged. WHO also appreciated the timely actions taken by DRAP. Unfortunately, an inspector who was also sent directive for action but instead of that after 2 days of directives attempted to make recall efforts disputed and confused through un-official and wrong communications.

DRAP has an efficient mechanism for public health concern medicines and disposed of all such pending applications including hepatitis, etc. It is important to inform that person claiming as President YPA is involved in heinous crime of illegal manufacturing of banned sex drugs (dapoxetine) under the name of Everlong alongwith unauthorized manufacturing of about 13 unregistered drugs (Esper 40/30, Sankol Plus, Penboll Plus, Syrup MT.D, Chill tablet, M.Plus tablet, Samprid tablet, multiple brands of Letrozole with brand names of REAP capsule, LINK tablet, LINK capsule and LEENA tablet) and violations of licensing rules. Recently Government of Baluchistan has sent a reference to DRAP highlighting that M/s Everest has launched more 10 un-registered products which are hazardous for ailing patients. As soon DRAP initiated action against these illegal drugs, these unscrupulous elements has initiated another false campaign for their ulterior motives to pressurize DRAP officers.

For more information, contact:
Principal Information Officer,
Press Information Department (PID)
Tel: +92-51-9252323, +92-51-9252324
Fax: +92-51-9252325, +92-51-9252326
Email: piopid@gmail.com
Website: www.pid.gov.pk