DRAP accused of registration delays for local drugs

Drug regulator refutes allegations, terms them an attempt to pressure body

ISLAMABAD: Young pharmacists and a lawyers’ forum have alleged that the drug regulator is only registering expensive medicines manufactured or imported by multinational companies while local manufacturers are deliberately not being allowed to register drugs, creating an artificial shortage of cheap lifesaving drugs.

They urged to fix the price of key lifesaving drugs.

Addressing a joint press conference in Islamabad on Tuesday, representatives of the Pakistan Young Pharmacist Association (PYPA) and the Pakistan Drug Lawyers Forum (PDLF) claimed that there was a shortage of over 200 lifesaving medicines in the market and that this artificial shortage had been created by the Drug Regulatory Authority of Pakistan (DRAP) with ‘malafide’ intention to pressurise the government into increasing the prices of medicine.

PDLF President Noor Mahar alleged around 200 to 1,000 drug manufacturing local companies were awaiting registration of drugs for the past six years. He argued that this delay in registration of drugs was causing a shortage of cheap medicines for critical diseases such as blood deficiency, hepatitis, tuberculosis and some lifesaving drugs used during surgery and for anaesthesia.

He added that DRAP and the Ministry of National Health Services had been working to formulate ways to increase profits of the ‘Club of 50’.

Mahar further alleged that top officials of DRAP and the Ministry of National Health Services had been delaying registrations of hepatitis medicines since 2012. He claimed that in every meeting of the Drug Registration Board, a new technique was introduced on the instructions of senior officials to delay registration of economical hepatitis medicine.

Pakistan Pharmacist Association General Secretary Dr Haroon Yousaf claimed that registration of drugs had been delayed while import permissions were given illegally to two companies to loot poor hepatitis patients.

He further claimed that the registrations granted were for medicines which were far more expensive than alternative manufactured by local companies. He pointed out that under Article 25 of the Constitution, registration of economical brands cannot be denied.

“The worst example is the registration of Sofosbuvir, which was delayed for three years. The registration of Sofosbuvir + Ledipasvir was granted on October 5, 2015, to two local companies but registration letters have yet to be granted while Illegal permits were granted to import and sell the medicine at Rs1,956 since 2015,” Dr Yousaf said.

“Similarly, illegal import permits were granted to import Daclatasvir, Simeprevir and Sofosbuvir + Valpatasvir to sell them at exorbitant prices,” he claimed to add that while a 400mg tablet of Sofosbuvir cost between Rs220 to Rs1,357, it would have cost only a fraction if local manufacturers were granted registration.

Similarly, a 60 mg tablet of Daclatasvir would cost only Rs18 instead of Rs340 it does currently.

They urged to fix the price of hepatitis medicine at Rs40 for Sofosbuvir, Rs18 for Daclatasvir, Rs29 for Simeprevir, Rs75 for Sofosbuvir + Ledipasvir and Rs98 for Sofosbuvir + Valpatasvir.

They also alleged that the stent pricing policy was also deliberately delayed to maximise profits of some companies while the patients were continued to be charged exorbitant prices. They urged the government to fix the price of stents imported from USA, Canada, Australia and Europe to Rs3,000-Rs4,000 per stent while those imported from China be fixed between Rs800-Rs1,000 per stent.

Meanwhile, DRAP CEO Aslam Afghani refuted all allegations. He maintained that generic drugs had been registered in unprecedented numbers. He added that such a blame games were meant to pressurise DRAP to let violators go free.

“All claims, if you check one-by-one, will prove baseless and wrong,” he added.

Published in The Express Tribune, April 5^th, 2017.