HIV drugs now coming from US, India - Ramsammy
-cost of treating patients has quadrupled
Stabroek News
November 30, 2006

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Since May this year the Government of Guyana halted all purchases of anti-retroviral (ARVs) drugs from the New Guyana Pharmaceutical Corporation (NGPC) due to mounting pressure from the international donor community for the local drugs to come from a source that is US FDA-approved or WHO pre-qualified.

Minister of Health, Dr. Leslie Ramsammy responding to an article which appeared in yesterday's Stabroek News said that for some six months now the NGPC has not supplied the health sector's HIV treatment programme.

He said government has instead turned to suppliers in India and the United States.

Yesterday's statement was the first disclosure by the government that a decision was taken to discontinue purchases from NGPC. Ramsammy had spoken with Stabroek News back in June this year on the issue of the local ARVs having to undergo bioequivalence studies but did not say that government was no longer sourcing from the local manufacturers.

At the time the Minister had only said that Guyana was facing the possibility of no longer manufacturing its own ARVs because of the conditions set out by donors such as the Global Fund to fight AIDS and Malaria.

To date, close to US$2M has gone towards the purchase of generic drugs from outside suppliers, according to Ramsammy. He said the administration was comfortable with the quality of drugs manufactured by NGPC given the positive effects they had on patients but the decision had to be taken to sever ties.

A key element for a generic drug is establishing bioequivalence, which means that the drug when evaluated must produce essentially the same biological availability of the active substance in the body when given in the same quantity as the original.

Ramsammy noted this at his press briefing yesterday and as stated in the past, said government was not in a position to comply with this condition as it would have been too costly - around US$4M per drug.

"We did not see it as being worth the while because we did not have any plans to market the drugs. The drugs were for local patients. If the NGPC wanted to market the drugs then they could have invested in the studies." Ramsammy said.

But generic drugs manufactured from NGPC are still in use. Ramsammy said the local drugs will have to be phased out and until then will still be in circulation. On this point, he stressed the local drugs are of a high quality and were part of the HIV programme since 2001.

"The cost of treating one HIV patient locally has escalated since we started looking outside of Guyana (for drugs). The cost is now four times what it used to be but government is committed to making the purchases". The Minister said thousands of patients have reacted positively to the drugs manufactured by NGPC since they were first introduced. He said the drugs manufactured by NGPC have been tested both locally and internationally.

Referring to the article in yesterday Stabroek News which said ARVs manufactured in Brazil are approved by the US Food and Drug Administration (FDA), Ramsammy said the local NGPC drugs are the same as Brazil's. He said both drugs are of the same quality and that neither has been FDA approved.

Stabroek News has kept the issue of bioequivalence studies alive for many months now. In addition to recent articles published on the issue, an interview was carried with Minister Ramsammy and Dr. Ranjisinghi Ramroop of NGPC back in September 2005.

Then, Dr. Ramroop said the cost of getting FDA approval for the drugs was prohibitive. He said his company started producing the drugs through an agreement with its international pre-qualified collaborator, Cipla of India.

In the article published yesterday by Stabroek News, Ambassador Jimmy Kolker, Deputy US Global AIDS Coordinator and Director of Diplomatic Outreach told Stabroek News that from 2007 no drugs will be purchased with the use of US funds unless those drugs are FDA approved. (Iana Seales)