DRAP ‘denies’ vital medicine to hepatitis C patients

PYPA alleged that the DRAP is deliberating delaying registration of a low-priced hepatitis C drug.—Reuters/File

LAHORE: The Pakistan Young Pharmacists Association (PYPA) has alleged that the Drug Regulatory Authority Pakistan (DRAP) is deliberating delaying registration of a low-priced hepatitis C drug, ignoring the need of hundreds of millions of patients awaiting the medicine.

Flanked by the representatives of various other medical and allied associations at the Lahore Press Club on Friday, PYPA President Dr Nabeela Latif claimed that a company had offered a price of Sofosbuvir (hepatitis C drug) which was hundred times lower than that of the drug which had recently been registered by the DRAP.

She said the offer was made by the company keeping in view the affordability of the poor patients who were affected by hepatitis C.

Take a look: Drug registration delay affecting hepatitis patients

Sharing statistics in this regard, Dr Nabeela said Pakistan was recognised as one of the countries in the world with the highest prevalence of hepatitis C.

“It stands second after Egypt,” she said, adding that the prevalence of HCV in Pakistan was at least eight per cent, with much higher figures for certain population pockets.

“This translates into an estimated 16 million infected people, of which five million could have serious liver disease and 1.2 million could have developed liver cancer,” she said.

Dr Nabeela said oral treatment of hepatitis C had been developed in the world two years ago. Consequently, many companies applied to the DRAP for the registration of this drug in Pakistan.

She said M/s Everest Pharmaceuticals Islamabad had offered Rs398 price for each 400mg tablet which was the lowest compared to the other competitors. However, some elements in the DRAP managed to grant registration to the M/s Ferozsons Pharmaceuticals Nowshera which had offered Rs2,000 per tablet.

She alleged that an official of the DRAP, Javed Iqbal, particularly played a negative role in this regard and used influence to delay registration to the Everest company as the request is still pending there.

She revealed that the Ferozsons Laboratories was owned by the brother-in-law of one of the top leaders of the ruling government.

She said officials of the FIA including Usman Anwar and Mian Asif exerted pressure on the pharmaceutical companies including the Everest Pharmaceuticals not to pursue the case in the DRAP.

“The FIA officials also arrested some senior medics in Punjab for recommending the low-priced hepatitis C drugs at the behest of the Ferozsons Lab,” the PYPA president alleged.

Representatives of the medical associations expressed their concerns over the arrest of their colleagues by the FIA. They demanded that the prime minister and chief justice take notice of highhandedness of the FIA and DRAP for their alleged involvement in delaying the low-priced drug to oblige another company.

Dr Izhar Ahmed Chaudhry from the Pakistan Medical Association, Hafiz Ahsan Naseer from the Consumer Protection Society, Azhar Iqbal Butt from the Pakistan Pharmaceuticals Association, Dr Nazar Murshad from the Specialist Doctors Association Punjab, Dr Ihsan-ur-Rehman from the Medical Teachers Association Punjab, Noor Mehar from the Pakistan Pharmacists Association and Samiullah Khan Durrani from the Sunder Pharma Consortium were among the participants.

The Ferozsons Labs says Sovaldi tablets are being supplied to patients as part of Gilead sciences patient access program in Pakistan at a price of Rs1,153 per tablet since its registration in Pakistan.

“This breakthrough product for HCV was made available on a patient-name basis from August 2014 generally and even MNCs do not launch their original research products in developing markets at such a fast speed and after Sovaldi’s registration about 7,000 HCV patients are on treatment currently.

“One medicine which claims to be registered was sold through some selected points but actually was not registered and sold at Rs55,000. A patient of Dera Ghazi Khan approached us and claimed that a doctor sold him six packs of sovaldi which showed no response and was found counterfeit. On complaint, the FIA took legal action and arrested a doctor.”

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