new point-of-care system for HIV/AIDS CD4 monitoring in India

Becton, Dickinson and Company has now unveiled the  BD FACSPresto, a near patient CD4 monitoring system that provides absolute and percentage results of CD4 T lymphocytes and hemoglobin (Hb) concentration in whole blood samples.

The device weighs  less than 7kgs and  is capable of testing samples from a single drop of capillary or venous blood and can work for 6 hours using in-built rechargeable battery, enabling testing even in remote settings.

National AIDA Research Institute (NARI), Pune conducted a product evaluation study on the new near patient CD4 Counter system on close to 150 samples and have claimed the accuracy of the tests after conducting a systematic study.  The Institute researchers found that the accuracy and precision levels of BD FACSPresto was equivalent to the current gold standard.

CD4 testing allows HIV/AIDS patients to have access to treatment and monitoring, reducing the probability of transmitting the infection to others and providing a plan for improved long-term care. Immediate treatment for infected individuals who meet medical guidelines can dramatically quell the spread of HIV, according to the World Health Organization (WHO). This is particularly important as many new cases of HIV/AIDS are transmitted from people who are not aware they are infected.

The US concern

The US concern
With markets in the developed world becoming saturated, multinational drug companies are increasingly looking to emerging economies with large populations for sales expansion and growth.

Powerful pharma lobbies are alleging that India is running riot over intellectual property rights. They feel that a poor IP framework can impede the development of new medicines over the long term by creating an environment that all together stop the pharmaceutical industry from investing in innovation.

They feel that Section 3(d) of the Indian Patent Act undermines innovation. It disallows much of the incremental innovation done on existing treatments from being patented in India. At the same time they point out that it is incremental innovation that has delivered outstanding benefits to patients the world over—whether in the treatment of HIV/AIDS or drugs developed for malaria and other tropical diseases.

The Indian viewpoint
With calls in the US for designating India a priority foreign country (PFC), the worst downgrading of status by the US trade representative for inability to protect IPRs, the Indian government is accusing US authorities of intimidating the Union health ministry over the issue of compulsory licences.

A PFC tag can allow the US to impose unilateral sanctions against India for domestic laws which deny benefits to the US under any trade agreement. According to some officials there seems to be a two-fold agenda behind the "cacophony" emanating from the US.

While pressure is being created on India's health ministry to not consider drugs for compulsory licences , there is also a deliberate attempt to use India to scare away other developing countries like Indonesia and Brazil from introducing legislation to prevent ever-greening of drug patents, like section 3 (d) of Indian Patents Act (IPA),according to a report