islamabad - The anti-dengue vaccine recently suspended in Philippines was registered in Pakistan on the recommendations of World Health Organization, said Drug Regulatory Authority Pakistan chief on Thursday.

The Chief Executive Officer DRAP, Dr. Aslam Afghani said this in a press briefing held here about the three year performance of the drug regulatory institution.

Dr. Aslam said that anti-dengue vaccine (Sanofi) was registered nearly six months earlier and included the recommendations of WHO. He said the company applied for the registration more than a year before and local experts of the registration board also approved the vaccine in their assessment.

He added that provinces including Punjab and Khyber Pakhtunkhwa had also asked for the early import of vaccine after registration but WHO suspended in Philippines after it reacted in children.

“Although no mass deaths were reported in Philippines, adverse reaction of the drug was observed in children,” he said.

The risky anti-dengue vaccine (Sanofi) was administered to more than 730000 children in Philippines which put the children’s lives in danger. WHO in December last year had suspended the administration of the vaccine and announced to probe the matter.

Pakistan Young Pharmacist Association (PYPA) and Pakistan Drug Lawyers Forum (PDLF) accused the DRAP officials for registration of the said vaccine allegedly against financial benefits from the company.

Talking to The Nation, CEO DRAP said that anti dengue vaccine is administered to the patient to prevent him/her from a second attack from the disease. He said the vaccine is administered after the ‘seropositive’ test.  Dr. Aslam said that Philippines authorities however administered the vaccine in routine immunization which put the lives of people in danger.  CEO DRAP also added that new recommendations of WHO will be issued in the month of April.

Dr. Aslam also informed media that Central Drug Testing Laboratory will be soon established in the federal capital as Federal Medical and Dental College has handed over the land to DRAP.

He said it will be second laboratory in the country and its PC-4 has been sent to Planning Division for approval.

Responding to the alleged financial embezzlements in DRAP by a number of officials, he said that two officials have been terminated from services and nine are facing inquiry under Efficiency and Disciplinary rules.

The CEO denied all allegations of financial misappropriations levelled against him in different investigating departments including FIA and NAB. He said that 1018 FIRs have been lodged and an accumulated fine of Rs. 203.63 million has been charged from the culprits involved in the business of counterfeit, spurious and falsified drugs.

Through the enforcement of Quality Control’s regulations, around 53371 samples were collected and analyzed by its inspectorates and Central Drug Laboratory and Provincial Drug Laboratories, he added.

“A cumulative fine of Rs. 203.63 million has been imposed and 1018 FIRs are launched against the culprits in the last three years (2015-2017), said Dr. Aslam. 

The CEO said that Registration Board considers new formulations, Anti-Cancer drugs, antiretroviral drugs, Thalassemia, blood products and blood bags etc., in order to provide latest treatment options to the patients in need. New drugs for treatment of Hepatitis-C were registered keeping in view the prevalence of the disease in the country.

In accordance with Drug Pricing Policy 2015, MRPs of 192 new drug formulations and 198 additional packs of registered drugs were determined in year 2016, and subsequently approved by Federal Govt. Similarly, in 2017, Federal Govt. granted the approval of 113 cases of fixation of prices of new drug formulations and 132 additional packs of registered drugs, added Dr. Aslam.

The CEO further added that resultant approaches for regulation of therapeutic goods including medical devices, Health and OTC products, and Pharmaceutical and Biological drugs contributed towards overall increase in the efficiency of the authority.

This is evident from the recently published reports of WHO and USP PQM determining DRAP as the fastest growing regulatory authority in the region.