| INDIA CAN BE A LEADER IN PROVIDING PEDIATRIC HIV MEDICINES GLOBALLY, Says WHO |
| By : Puneet | Previous | Next |
| Posted on : 13 Feb, 2006 | Total Views : 323 |
India has all the prerequisites to become the leading supplier of the much-needed fixed dose combinations suitable for treating HIV-infected children. This was stated by Dr. Hans Hogerzeil, Director of Geneva-based Department of Medicines Policy and Standards at the World Health Organization, who was recently in Delhi on a three-day visit to India.
Talking to the media at a press conference organized by the Delhi Society for Promotion of Rational Use of Drugs (DSPRUD), Dr. Hogerzeil said, “Children with HIV/AIDS, especially in many African countries, are dying unnecessarily because of a lack of access to antiretroviral (ARV) treatment. The problems arise mainly from a lack of cheap feasible diagnostic tests for children under 18 months, lack of trained health personnel and the affordable child-friendly ARV drugs. Despite WHO simplified treatment guidelines that specify which drugs to use in children, countries have difficulty in getting simple and affordable combinations of the drugs.”
Elaborating on the probable reasons for the short supply of medicines for HIV-infected children, DSPRUD President, Mr. R. Paramsewar said, “The global market for paediatric AIDS drug formulations is not attractive for originator or generic companies. One reason is that in wealthy countries very few children are being born with HIV. A second deterrent is that, whereas the cost of treating one child is often as much as six times more than an adult, the national and or international regulatory and prequalification procedures in originator countries tend to discourage the production of specific pediatric ARV formulations.”
Precisely this, according to Dr. Hogerzeil, may spell a big market opportunity for Indian pharmaceutical companies. “Where the drug regulations in developed countries generally discourage pharma players from developing drug combinations, Indian laws presently do not deter the companies from developing cheaper mass-scale fixed dose combinations. In children, it is generally easier to administer a combination of two or three medicines in one dose rather than giving three different medicines,” said Dr. Hogerzeil.
Another major opportunity that India may tap on, according to the WHO Director, who has spent several years in India in his early career as a missionary doctor, is that of developing second-line ARV drugs. Says Dr. Hogerzeil, there have been reports that about 10-15% of the populations being treated for HIV/AIDS are developing resistance to first-line treatment regimen. This calls for an emergent need for second-line ARV drugs, of which unfortunately there are frighteningly few available. One reason why countries in dire need of second-line HIV drugs still do not buy them is that there aren’t many options available in the WHO’s prequalification list.”
Explaining the concept of prequalification, Dr. Ranjit Roy Chaudhary, Patron, DSPRUD, says, “WHO’s Prequalification project, set up in 2001, aims to facilitate access to medicines that meet unified standards of quality, safety and efficacy for HIV/AIDS, malaria and tuberculosis. The project is supported by UNAIDS, UNICEF, UNFPA and the World Bank as a concrete contribution to the United Nations priority goal of addressing widespread diseases in countries with limited access to quality medicines. It provides governments and pharmaceutical manufacturers with the means to establish and maintain mechanisms which ensure the quality, safety, efficacy and rational use of pharmaceutical products. The “prequalified” list is used when United Nations organizations want to purchase products. Manufacturers listed on the prequalified list are invited to submit offers to the procurement agency for the listed products when these are to be purchased.” So far, a total of 98 pharmaceutical products have been prequalified by WHO, of which 88 are for HIV/AIDS, eight for tuberculosis and two for malaria, added Dr. Chaudhary.
Ever since its inception, the Prequalification Project has gained immense popularity among the macro-level buying agencies and countries. In April 2005, the Global Fund (the single largest aid funder of medicines for AIDS, tuberculosis and malaria) decided to only fund medicines approved either by the WHO prequalification project or by "a stringent drug regulatory authority". Dr. Hogerzeil expressed hope that India will continue to play a crucial role in the prequalification list, citing that already, the largest number of medicines approved in the prequalified list are being manufactured by Indian companies. Dr. Hogerzeil however also cautioned on the emerging competition from Chinese companies, saying, “Whereas presently, Chinese companies have been prequalified only for supplying raw materials for medicines, I trust that in another 2-3 years, China will also have upgraded its manufacturing facilities and processes to meet the Prequalification criteria for medicines as well.”
Snubbing the allegations that WHO is budging under pressure from Pharma lobby of developed countries to stop expansion of the Prequalification Program, Dr. Hogerzeil said, “Based on a need-assessment study conducted by McKinsey Consultants on our behalf, I’ve already written to the WHO’s Director-General seeking a hike in the budgetary allocation for the project from the present $3 million to $12 million. Keeping in view the growing demands on the Prequalification project, we are now also seeking support of some external funding agencies. The Gates Foundation and countries including Germany, France, Ireland and Luxembourg have offered to support us in this project.”
Written By : Puneet
