ISLAMABAD: The Ministry of National Health Services said on Sunday that five of its officers issued a fake registration letter to a pharmaceutical company.

The ministry has suspended the five officers and decided to get the Federal Investigation Agency (FIA) involved in the case and take action against the accused under the Efficiency and Discipline Rules.

A statement issued by the ministry on Sunday said the fake registration letter was issued to Everest Company for Everlong, a 60mg tablet, used to enhance male potency without going through the proper process and standard procedures.

The fake letter was withheld and that Secretary Ministry of Health Ayub Sheikh formed a three-member inquiry committee, comprising Senior Joint Secretary Dr Amer Sheikh, Deputy Secretary Sanaul Islam and Director Administration Drug Regulatory Authority of Pakistan (Drap) Dr Raja Mustafa Hyder to look into the matter and “fix responsibility for the alleged lapse or forgery.”

The statement added: “The inquiry committee has held the five officers of Drap directly responsible for the act of omission and commission in the case and recommended that they be proceeded against under Efficiency and Discipline Rules leading to the award of a major penalty of dismissal from service.”

Ministry to involve FIA, proceed against accused over ‘fake’ registration for pharma firm

The ministry said the five officials were: Deputy DG Registration Tariq Siddique, Deputy Drug Control Faisal Shahzad, Statistical Officer Bashir Ahmed Bhatti, assistant Pricing Section Khurshid Ahmad and stenotypist Mohammad Changez.

The Drug Regulatory Authority of Pakistan (Drap) and the FIA had together raided one of Everest Company’s factories in the Kahuta Industrial Area in Islamabad on February 27.

The factory produced Sofosbuvir, a medicine for treating Hepatitis C and Everlong. Some of the Everlong was confiscated by the teams while Sofosbuvir was not found on the factory premises. The teams also arrested two employees.

During a hearing about the matter in the drug court, the Everest Company produced a letter of registration for the Everlong tablet.

The owner of the pharmaceutical company, Mohammad Usman, claimed that he had sent the samples of the medicine to Drap because doing so was a requirement for getting the drug registered. Instead, he said, Drap raided the factory.

Mohammad Usman told Dawn that Everlong was an anti-depressant and not for enhancing male potency as was claimed in the ministry’s statement.

He said: “I applied to register [the drug] in 2009 and the file was forwarded to the price committee which approved a price in November 2013 and in January 2014 a registration letter was issued.”

He added, “My factory was raided on February 27 but at a meeting of the registration board held in March, another medicine produced by a different company, but using the same formula, was approved by Drap. Why did they approve the medicine if the formula was wrong and illegal?”

Mr Usman said he had provided the drug court with all the documents and registration papers because of which his employees were granted bail.

The owner of the company then proceeded to file a petition with the Islamabad High Court against the FIR registered against his company.

Talking to Dawn, Minister for Health Saira Afzal Tarar said the ministry had examined the papers when they were presented in the court and had found them fake.

She said: “I have no personal enmity with the owner of the company. My interest is ensuring that quality medicines are produced and that there is no corruption in Drap.”

The minister said other companies would now be asked to bring in their registration letters to be verified from Drap because, she said, “there is a possibility that others might also have fake letters.”

Ms Tarar said she was also thinking about computerising all the records which would cost around Rs20 million. She said the registration board would be revisited and the companies which imported less than two kilogramems of chemicals for making medicines would not be allowed to operate because the quality of such material cannot be verified.

The three-member inquiry also recommended that a commercial audit be conducted for the molecules registered and the prices fixed for them by the registration, costing and pricing section of Drap over the last five years. Since records of the fake registration are missing, the inquiry suggested that the CEO of Drap should register an FIR for retrieval of all the records that were missing or had been stolen from the department.

Published in Dawn, November 9th, 2015

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