India’s AIDS control programme has run out of kits to measure the intensity of infection even as the government negotiates the right price for these kits and suggests that treatment be based on clinical symptoms against actual tests.

The viral load kits are used to determine the severity of an infection before deciding the treatment regimen. The tests are conducted regularly to ensure the treatment is appropriate to the level of infection.

These kits are different from the ones used to test whether a person has AIDS or not (commonly called AIDS testing kits). Mint first reported on 26 November 2013 that the National Aids Control Organization (Naco) was running out of these kits.

Roche Diagnostics, which is the only supplier of viral load kits to Naco, had increased the price per kit, which the government is not willing to pay. According to people familiar with the matter, the company has demanded nearly 1,400 (nearly $22) per viral load test for 2013-2014 and an additional “escalation cost" of 15% for the next financial year.

A spokesperson of Roche Diagnostics said the company is in dialogue with the health ministry. “In respect of our commercial agreements, we do not release specific commercial details, including information on pricing while we are still in dialogue with the government. What we can say is that our aim is to provide the best solution to further increase access to quality testing for people living with HIV."

Interestingly, Dr Naresh Goel, deputy director general, Lab Services, Naco, said: “We have already placed order to Roche and it will be supplying soon".

In contrast, South Africa has negotiated a price of $9.40 ( 600) for the same kits.

“The terms set by the company are unreasonable, especially when it is supplying to other countries at cheaper rates. It wants us to guarantee them ‘X’ number of kits will be purchased; it wants us to upgrade to automated platforms even though our current testing platforms are not obsolete. We have had five or six rounds of negotiations with the company which have not been successful. The company knows it has a monopoly on the product and is holding the programme hostage," a senior official at India’s department of AIDS control said, speaking on condition of anonymity.

The health ministry, in a memo sent on May 2014, approved switching treatment regimens for HIV patients (from first-line drugs to second-line, etc.) based on clinical symptoms, against the regular practice of testing the viral load before deciding treatment regimen.

For an HIV patient, the routine viral load monitoring measures the level of HIV virus in the blood and rapidly identifies those people who need to be switched to second- or third-line treatment regime, if their existing treatment is failing.

“It is the best way to monitor whether treatment is working," said Leena Menghaney of the non-governmental organization MSF Access Campaign. “The high price that Roche has been demanding from the Indian government has held up the procurement of the viral load monitoring tool for months. Patients who have been failing first-line treatment have been waiting for access for months. The government urgently needs to introduce competition into the market by introducing viral load tests from companies such as Abbott and bioMérieux. The health ministry and Naco need to break Roche’s monopoly over the public sector market in India," she added.

With no solution in sight, and little information available in the public domain, patient advocacy groups are threatening to file a public interest litigation (PIL) in the Supreme Court as diagnostic kits run out. India’s AIDS programme provides free treatment to more than one-third of the country’s 2.1 million HIV/AIDS patients and is the largest in the world. With drug and diagnostic kits running short of supply, patient advocacy groups maintain there that as many as 150,000 HIV/AIDS patients have been left without recourse.

“In the past year, there have been stocks of first-line treatment drugs, then the second-line treatment drugs ran out. Now, people are kept waiting for second-line assessment and diagnostic kits have run out. We are getting ready to file a PIL as the problem with ministry’s procurement policy is much larger. This time, they will find a quick-fix for viral load and in a few months something else will run out again. People’s lives are at stake here," said Vikas Ahuja of the Delhi Network of Positive (DNP+) Persons.

Between May and September 2014, massive stockouts of Tenivur and Lamivudine tablets, used during the initial stages of treatment, were reported across the country. In November, second-line treatment drugs ran out and the Naco website showed that 10 Indian states had less than a month’s supplies of these tablets left.