ISLAMABAD: Teams of Drug Regulatory Authority of Pakistan (DRAP) and Federal Investigation Agency (FIA) conducted a joint raid at a factory in Kahuta Industrial Area where counterfeit medicine was being manufactured.
One of the drugs being produced at this factory was Sofosbuvir sold under the brand name Sovaldi, used to treat hepatitis C, which costs a patient Rs55000 for one month of treatment and six months of treatment is required. Another drug Everlong, the registration for which was cancelled by the DRAP, was also being manufactured unlawfully at the factory.
The owner of the company Everest told Dawn the allegations against him are baseless. He claimed he was manufacturing Sofosbuvir to submit samples to the DRAP, as the latter had asked him to do so in the Lahore High Court where he had applied for a license to produce the drug.
Sovaldi, which is used to treat hepatitis C, was introduced in the United States in December 2013. The medicine is approved by the United States Food and Drug Administration (FDA) and is believed to be more effective than Interferon injections in treating Hepatitis C.
In the international market, one month treatment of Sovaldi costs over Rs 3 million but as Pakistan is a third world country, the government gets the medicine for Rs 55,000. Usually, six months of treatment is required by each patient.
A Ministry of National Health Services (NHS) official, requesting anonymity, said the ministry registered the drug on February 12, 2015 and within a fortnight production of counterfeit drugs began.
“This shows how active and organised the mafia involved in manufacture of fake medicines is. One imagines that if counterfeit drugs can be manufactured right here in the federal capital, there must be numerous factories producing fake drugs in other areas, especially areas out of reach of law enforcement agencies,” he said.
“Officials of an intelligence agency informed the DRAP that a company named Everest is involved in the illegal production of medicines in the Kahuta Industrial Area. The DRAP informed the FIA and teams of both organisations reached the factory,” he said.
“The teams found the factory’s main gate closed, with a notice posted saying the factory is closed because of the death of the administrative officer’s father. The officials decided to go inside the factory and found employees working inside,” he said.
The official said that the employees admitted to producing Sofosbuvir and Everlong tablets, during initial investigation. The factory was sealed and a First Information Report (FIR) was registered against the factory owner and four employees.
“It has been learnt that Sofosbuvir was being distributed through medical clinics. It is deplorable that this manufacturer planned to sell fake medicine to someone paying Rs 55000 per month for it,” he said.
An official statement issued by the NHS Ministry stated, that the factory in the Kahuta Industrial Area has been sealed because of illegal production of medicines.
Pakistan Institute of Medical Sciences Vice Chancellor Dr Javed Akram said spurious drugs can cause complications in patients and even kill them. “It should be ensured that no manufacture of spurious drugs takes place in the country. Two years ago, a spurious drug took dozens of lives at Punjab Institute of Cardiology,” he said.
Everest Company’s owner, Muhammad Usman, told Dawn the DRAP had purposely victimised him and he is manufacturing medicines legally.
“My father died from Hepatitis C in 2003 so I have a soft corner for Hepatitis C patients. The company currently licensed to produce Sofosbuvir is selling it at Rs 55000. I submitted an application to the DRAP saying if I am allowed to manufacture the medicine, I would sell it at Rs 11, 144,” he said.
He said that the DRAP appeared reluctant to respond to his application so he approached the Lahore High Court to allow me to manufacture the medicine. The court instructed the DRAP to finalise the case within four weeks. On August 28, 2014 DRAP submitted a reply to court that the company has to fulfill the basic requirements including tablet assessment, clinical data, clinical justification etc, he said.
“So I imported 2kg material for Sofosbuvir worth USD 74,000 and started manufacturing the medicine because requirements of DRAP could not be fulfilled without manufacturing the drug,” he said.
“Just three days ago, I submitted a1000 page report on the medicine to ADC DRAP Munib Cheema. I also sent samples of the Sofosbuvir tablets to the DRAP. Instead of processing the report, the DRAP raided my factory and accused me of producing spurious drugs,” he said.
He refuted the claim that any notice was posted at the factory gates and said the gate remains locked from inside because 70 percent of the staff at the factory is female.
“The DRAP and FIA teams entered the sterlised area wearing boots and smoked cigarettes there,” he said.
When asked about Everlong tablets Mr Usman said the drug was registered on January 15, 2014 by the DRAP. “The registration was never cancelled. If it was, I never received a show case notice, no personal hearing was done in the DRAP. It was never published in the gazette of Pakistan and never advertised in the news papers which are all basic requirements for deregistration of a medicine,” he said.
“The fact is that I criticized different steps of the DRAP such as hiring building in sector G-9 due to which DRAP has been victimizing me. I will go to court against DRAP,” he said.
Published in Dawn March 1st , 2015