ISLAMABAD: Following the suo motu notice of the Supreme Court, the Drug Regulatory Authority of Pakistan (Drap) finally called a meeting to discuss the pricing of hepatitis medication on Thursday. However, seven out of 16 companies have been ignored.

Representatives of the companies that have been left out claimed they were ignored because they quoted lower prices and the Ministry of National Health Services (NHS) wanted to set higher prices for the medication. They demanded that the price not exceed the minimum price rate submitted in the Supreme Court.

However, NHS minister Saira Afzal Tarar claimed that the seven companies were ignored after physical inspections revealed that they did not have the capacity to manufacture quality medication.

A new drug, Sofosbuvir, which is used to treat hepatitis C, was introduced in the United States in December 2013. The medication was approved by the US Food and Drug Administration (FDA), and has higher cure rates than Interferon injections, with minimal side effects. Overall, six months of treatment are required for each patient.

Although the price of one month of treatment, or 28 tablets, is $26,600 per bottle (Rs2.6 million) in the US, the company has provided the medication for almost Rs30,000 in Pakistan for the same number of tablets. However, it has been suggested that the drug should be manufactured in Pakistan to further decrease its cost, since there are over 10 million hepatitis patients in the country.

The technical advisory group (TAG) for the prevention and control of viral hepatitis also recommended that the drug’s registration be expedited.

A number of companies have shown an interest in manufacturing the drug in Pakistan, due to which Drap registered 16 companies. However, Drap did not fix the price, so the companies were not able to manufacture the medication.

In November, the Supreme Court took suo motu notice of the issue, and a three member bench comprising justices Ejaz Afzal, Qazi Faiz Essa and Faisal Arab, began hearing the case.

The last hearing was held on Dec 22, and the next hearing will be held in Jan.

A number of companies have also submitted prices to the Supreme Court and have given assurances that they will manufacture the medication at the same price.

According to a notice posted to the Drap website, a meeting of the Drug Pricing Committee will be held on Thursday to fix prices of hepatitis medications. The names of nine companies, and their quoted prices, have been mentioned. However, a company which offered Rs3,248 for one month’s treatment and Rs19,000 for six month’s treatment has been ignored.

Ms Tarar told Dawn that the seven companies left off the list were done so because they were found to be incapable of manufacturing the medicine.

“Our teams visited the companies, and found that they were not able to make the medicine. Moreover, one company submitted a fake stability of medicine report, due to which they have been ignored,” she said.

“We have deferred their cases, and they will be allowed to manufacture the medicine if they remove all the deficiencies” she added.

However, Mohammad Usman, the representative of a company that was ignored by Drap, claimed this was because the ministry wants to fix a higher price for the medication in question.

“A few officials in Drap are trying to block low cost medicine for hepatitis C for a bribe of a few rupees. The rest is all a concocted story, and deceiving apex and higher judiciary and nation at large. I do not mind if Drap refuses the registration of any company, but the price must not be more than the lowest price which has been submitted in the [Supreme Court]: Rs46 for Daclatasvir and Rs116 for Sofosbuvir per tablet,” he said.

He alleged that the authority only asked his company for clinical trials, claiming this showed clear “mala fide”, while the other companies were awarded registration without clinical trials.

Published in Dawn, December 31st, 2015