India needs new prevention technologies for HIV, other STIs and unwanted pregnancies

Bobby Ramakant *

"India needs the [new prevention] technologies for meeting all the three important [sexual and reproductive health] needs of an individual as well as for the country – i.e. prevention of unwanted pregnancies, prevention of non-HIV sexually transmitted infections (STIs) as well as HIV" said the Dr Badri N Saxena, President-elect of Microbicides Society of India (MSI).

The Microbicides refers to a new type of product being developed that people could use vaginally or rectally to protect themselves from HIV and possibly other sexually transmitted infections. A microbicide could be produced in many forms, including gels, creams, suppositories, films, or as a sponge or ring that releases the active ingredient over time. They are still being researched upon around the world and not available over the counter (for more information on microbicides, go to: www.global-campaign.org).

"According to the National AIDS Control Organization (NACO) in India, unsafe sex is the highest risk factor for HIV transmission in the country. About 86 percent HIV incidence in the country is from unprotected sex. Globally too, unsafe sex is recognized as one of the highest risk factors for disability and deaths worldwide.

More people acquire curable sexually transmitted infections (STIs) other than HIV, than HIV globally. The data is shocking: every year, about 34 crore people (340 million) get infected with at least one of the four primary curable STIs: Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT), Trichomonas vaginalis (TV), and syphilis, and just under 30 lakhs (3 million) become infected with the human immunodeficiency virus (HIV).

It is evident from clinical experiences in India, that a large number of people acquire chronic infections with pathogens such as the herpes simplex virus (HSV), a cause of genital ulcers, and the human papilloma virus (HPV), responsible for cervical cancer. According to the United Nations Population Fund (UNFPA) recent research estimates of 2005, over 200 million women in developing countries have an unmet need for effective contraception. Every life is invaluable so we need to advocate for prevention of HIV, non-HIV STIs, and effective contraception as well" further explains Dr Badri N Saxena.

Dr Saxena is an internationally acclaimed medical doctor in the field of reproductive health research. He has worked in India with the Indian Council of Medical Research (ICMR) for 21 years. Dr. Saxena had been primarily responsible for developing multi-faceted national programmes for research in human reproduction and nutrition and introduced the concept of Task Force Approach in India for biomedical research activities.

To reduce the regional imbalances in a diverse country like India for the national research efforts, Dr. Saxena established a network of collaborating centres in the medical colleges in the different parts of the country - called as Human Reproduction Research Centres (HRRCs).

"Despite considerable evidence of causal relationship between HIV and other STIs, there is – no oral or topical HIV prevention product, at present, which has yet produced clinical evidence of efficacy against non-HIV STIs, nor any new products under investigations which are highly HIV-specific, are expected to do so.

Except for physical barrier methods like male or female condoms, which provide dual protection i.e. certain degrees of pregnancy protection besides HIV and non-HIV STIs protection when used correctly and consistently, none of the chemical microbicides investigated so far have shown any degree of acceptable pregnancy protection" says Dr Saxena.

"India needs the technologies for meeting all the three important needs of an individual as well as for the country – i.e. prevention of unwanted pregnancies, prevention of non-HIV STIs as well as HIV. It may be scientifically difficult to have one single product possessing all the pharmacological properties to meet the requirements effectively, for all the three preventive needs.

However, it may be possible to develop combination products having only two of the preventive properties and use newer drug delivery systems to combine the remaining third preventive pharmacological product, so that all these different products could be delivered concurrently, at the same time.

The Microbicides Society of India (MSI) would make efforts with the national and international agencies to focus their efforts and provide the required funds as well to develop interactive/ collaborative programs with the Indian scientists. If required, the MSI would develop the facilitatory mechanisms/ promote networking between the national and international scientists/ institutions" said Dr Saxena.

"The Microbicides Society of India (MSI) would advocate for the development of multipurpose technologies which would protect the individual from several or all of the health risks i.e. unwanted pregnancy, non-HIV STIs/ RTIs and HIV. The availability of such a product would be both user friendly as well as provider friendly, with improved accessibility" explains Dr Saxena.

Dr Badri Saxena has immensely contributed to the field of microbicides research over the past years. He has used his earlier reproductive health research experiences – both national and international ones, to promote the research in the field of microbicides in India as well as initiate international collaborative activities.

The Indian Council of Medical Research (ICMR) has now got an Expert's Group on the Microbicides Research and Development (R & D) programmes, as well as the ICMR-CONRAD MoU for Microbicides Research. There is also a joint ICMR – Department of Bio-Technology (DBT) Programme as well as DBT-CONRAD MoU for Microbicides/ Reproductive Health Research.

Speaking about some possible challenges he foresees in coming years as microbicides research goes ahead, Dr Badri Saxena says "there would be regulatory challenges for the multipurpose technologies for providing the dual protection. Which means good basic science researches which would include better insights for vaginal and rectal physiologies, better biomarkers and in-vivo/ in-vitro testing methods as well as animal models.

Better clinical trials would need to be designed to provide the answers rapidly and reliably. We must also realize that these technologies will not by themselves, achieve all the desired goals. It would be essential that these newer technologies need to be introduced with due care, and backed up by well-designed educational programs as well as community involvement with their grass roots leaderships."

Suggesting some ways to address the foreseeable challenges in microbicides research and advocacy in India, Dr Saxena opines "apart from promoting the basic and clinical researches as mentioned above, public health and socio-behavioural researches would be other areas for the MSI to be promoted equally well."

NEED FOR INTEGRATION OF SRH and HIV SERVICES

"Despite the recent efforts by the Government of India and their respective state counterparts, sexual and reproductive health (SRH) services and HIV/AIDS services are still functioning independently, in most of places. The need for service integration remains an important programmatic challenge for sexual and reproductive health and HIV care services.

Eventually, new multi-purpose technologies will need to be delivered under the existing primary health care delivery system. Therefore, it would be necessary to use the multiple marketing and distribution channels from both public and private sectors, for existing and new methods. The innovative social science and market researches on optimal introduction and development of appropriate strategies for the positioning of the microbicidal products would be the important areas for the R & D activities, in India" says Dr Saxena.