New GPC producing anti-HIV/AIDS drugs By Shirley Thomas
Guyana Chronicle
December 6, 2001

The Anti-retroviral drugs will be of a standard quality equal to that of any first world manufacturer, but will not carry the burden of their heavy price, placing them within the access of infected Guyanese.
--Dr R.Ramroop

FOUR days after the observance of World AIDS Awareness Day 2001, the executives of the New Guyana Pharmaceutical Corporation have announced that Guyana is now making its own anti-retroviral drugs to be used by persons living with HIV/AIDS.

Minister of Health, Dr. Leslie Ramsammy confirmed this announcement during a press conference held at his Brickdam office yesterday afternoon.

The Minister however, cautioned that such drugs should not be used indiscriminately, since the virus could develop resistance to them. He warned, too, that the Ministry of Health will be setting strict guidelines for the use of these medications.

The release from the drug manufacturing facility stated: "The New GPC is pleased to announce that, in recognition of its role as a partner in the fight against HIV/AIDS, and its responsibility to the people of Guyana, it has commenced the manufacture of Anti-HIV/AIDS drugs.

Dr. R. Ramroop, Executive Chairman of the New GPC assured: "The Anti-retroviral drugs will be of a standard and quality equal to that of any first world manufacturer, but will not carry the burden of their heavy price, placing them within the access of infected Guyanese."

The raw materials and technical assistance necessary for the manufacture of the drugs were obtained from an international pharmaceutical company based in India.

According to Dr. Ramsammy, the company has been contracted on a long-term basis, and the experts tasked with setting up the facilities and manufacturing the initial batch of the drugs includes one Guyanese doctor, who has been working in Canada. The others are Indian doctors, he said.

Minister Ramsammy disclosed that at present, Guyana is manufacturing both single drugs and combination therapy, utilising technology obtained from India. He explained that for effective therapy, one needs a combination of drugs.

Ramsammy added that the Ministry of Health has developed a 'minimum treatment package' for patients living with HIV/AIDS, and this involves the use of Anti-retroviral drugs.

Noting that the Ministry is aware that patients could develop resistance to the drug, he said it should be strictly monitored and only dispensed by doctors specially trained in the dispensing of these. And even though the drugs will be made available to both the public and private sectors, systems will be put in place to ensure there are no lapses as regards the dispensing and use of the drugs, which the Minister described as highly potent.

Ramsammy reiterated: "The Ministry of Health would be setting strict guidelines for the use of these drugs. We do not want indiscriminate use of the drugs, especially since the virus could develop resistance to the drugs."

He said that the Ministry of Health is ensuring that whoever uses the drugs in the private sector, will do so under the guidance of the Ministry of Health.

And commenting on the question of the quality of the drugs, he stated Guyana has had a long history of obtaining 'quality' drugs from India and other countries outside of the first world. The country also has a long history of manufacturing its own drugs.

The Health Minister recalled that from the 1970s to the 1990s, GPC has manufactured many drugs under licence, and these were used in the public and private sectors with a very good record.

Notwithstanding this, Ramsammy said, when the company approached him several months ago and said that it was in a position to manufacture the drugs, he did indicate to them that Guyana would have to be convinced of the fact that they have in place - mechanisms to ensure 'high quality products', given the life and death circumstances that were involved.

"They assured me then, and I have visited the plant, and am convinced that they have put in place enhanced mechanisms to deal with the quality issue," Ramsammy said. He noted that the local pharmaceutical company has purchased new laboratory equipment and hired international staff so as to strengthen its resources.

The Minister gave the assurance that the raw materials that are to be utilised are of the highest quality, and that they were tested before being used. "I want it to be assured that the end product to be utilised by the consumer would be tested in terms of quality," he affirmed.

Ramsammy said that in addition to testing at the New GPC, the Ministry of Health will also have its own testing done to satisfy itself about the quality.

"We will not only be treating patients, but we are also going to be monitoring them very, very carefully to ensure the efficacy of the drugs... We will be monitoring the patients to ensure that they respond positively to the treatment, he stated.

Noting that there are some 20,000 Guyanese infected with the virus, Ramsammy said that at the moment the Ministry of Health is only equipped to treat 1,000 patients within its present budgetary allocations. He said that it is anticipated that the total cost to the Government for treating HIV/AIDS patients would be in the vicinity of $2 Billion per annum.

For this reason, Government will only be treating public sector patients, and it is expected that the private sector patients will continue to pay their own bills, especially since the drugs are now affordable.

He also mentioned that based on the criteria established by the Ministry for treating patients, it has been determined that all the patients need not be treated at the same time. One consideration is that of avoiding over-use of the drugs.

Cautioning that now that the drugs are in place there may be a tendency for more persons to come forward to be tested, the Minister said that the question will be how to deal with numbers exceeding the 1,000 budgeted for. "And so I am still hoping that a number of persons will continue to use the private sector."

The Minister said he is hopeful that through the Global Fund and other programmes Guyana may be able to access additional funds.

Commending the New GPC on its initiative, Ramsammy said that the company is the first pharmaceutical company in the region to have undertaken the manufacture of the Anti-retroviral drugs. This also represents yet another first for the pharmaceutical leader, and Guyana as a whole.