LAHORE: The Drug Regulatory Authority Pakistan (DRAP) has deferred applications of 37 pharmaceutical companies for the registration of ‘miracle’ hepatitis-C drug that was marketed by a US-based company in the developing and low-income countries on discounted rates.

However, it allowed only M/s Ferozsons Laboratories Limited to ‘import’ the drug on the basis of the personal use at a discounted rate of US$20 per tablet only which was presently available in America at US$1000 per pill.

The decision was taken by the Central Drug Registration Board of the DRAP in its meeting held on July 23 drawing ‘serious objections’, an official who is close to the information told Dawn.

Arshad Khan, the Chief Executive Officer (CEO) of the DRA who is looking after the matters of the authority on day to day basis, confirmed that the board had deferred applications of the firms for registration saying that the companies were asked to fulfill laid-down criteria first to qualify for getting rights to introduce the drug.

The companies which were denied registration termed the objections “ridiculous and another attempt to further delay the registration” of the drug, the official said.

The owners of the firms said the DRA should immediately register the drug to make it available in every medical store or pharmacy of the country rather than to give ‘short relief’ to a certain number of patients only.

They were of the view that several other medicines were also being imported on the prescriptions of the doctors but it was not a permanent solution to the issue, quoting the owners of the companies, the official said.

Approved by the US Food and Drug Administration (FDA), ‘sofosbuvir’ (brand name Sovaldi), the drug was manufactured in oral form (tablet) as an alternate to the interferon for the first time by a leading multinational pharmaceutical company of America.

The official said the drug was available in India, China and other neighboring countries but a year delay in its registration in Pakistan had already put health of millions of hepatitis-C patients at grave risk.

He said the Central Drug Registration Board meeting which was chaired by Ghulam Rasool Duttani deferred applications asking the firms to present first evidences of the drug manufacturing and renewal licenses, technical staff, stability and clinical data of the drug.

He said that owners of pharmaceutical firms who had applied for the registration of the hepatitis-C drug with affordable prices were shocked to learn about the ‘strange demands’ placed in the board meeting.

Quoting some of them, the official said they were of the view that the Sofosbuvir drug was the FDA approved and there was no need to raise such objections.

Gilead Sciences, a US company, had hit a breakthrough last year by discovering the life-saving interferon-free oral drug. It is now available in the international market in the form of a 400mg pill.

The drug is considered by many a revolutionary treatment for hepatitis-C and is said to effectively cure hepatitis in 90pc of the patients in combination with other therapies.

After successful launching in the European states, the company had marketed the drug in developing countries, including India and Pakistan, on discounted rates as one pill of Sovaldi is being sold in America for $1,000.

The official said, initially, three pharmaceutical firms had applied for the registration of the drug and offered various prices.

Later, more companies came forward and the cases of 37 firms were placed in the meeting of the Drug Registration Board for consideration.

He said the DRAP continued to receive applications from more pharmaceutical firms even during and after the central board meeting and the total number of pending applications for the registration of ‘sofosbuvir’ drug has now reached 70. M/s Everest Pharmaceuticals, Islamabad, has offered the lowest price of Rs398 per tablet. Its therapy for treatment of patients with genotypes 1, 2 and 4 would cost Rs33,432 and with genotype 3 for Rs66,864 which is also affordable compared to the interferon-related treatment.

When contact Ghulam Rasool Duttani did not attend calls. Arshad Akan told Dawn the in question drug was absolutely a new one and was not declared so far pharmacopoeia drug.

He endorsed the decision of the Board meeting of differing applications of the 37 firms saying that companies which applied for the registration of the drug required laid down criteria to ensure efficacy, stability, and standard of the drug.

“The companies have been asked first to develop and certify the method to ensure quality control of the drug for which they had applied”, Mr Khan said adding that the DRA did not want to put health of the patients at risk by registering newly manufactured drug without following laid down rules and regulations of the land.

“We have allowed import of the drug on non-commercial basis and for personal use on the prescription of the doctors”, he said. He said the M/s Ferozsons had entered into an agreement with US-based company, Gilead Sciences, to be its exclusive branded medicines business partner for Pakistan.

He said under the agreement, Gilead had given rights to Ferozsons to market its medicines for the treatment of chronic Hepatitis-C; HIV and chronic Hepatitis-B virus (HBV) infection in Pakistan.

The Ferozsons had applied to the DRA for permission to import the drug some four months ago and the Authority has granted approval a couple of days ago.

To a question, Arshad Khan said the approval was granted under Drugs rule 13 (import and export) 1976 for personal use.

Earlier, the Ministry of National Health Services in a press release issued on July 23 had claimed that the drug registration board had unanimously decided to register the hepatitis C medicine developed in the United States recently.

It said, however, the local manufacturers will have to fulfill certain regulatory requirements before introducing the medicine in Pakistan.

According to the press release, the decision to register medicine was taken at a meeting attended by experts from medical and pharmaceutical fields and directors from Drug Regulatory Authority of Pakistan.

Published in Dawn, July 26th, 2014