India’s HIV/AIDS program that distributes free critical drugs might have a shortage in three weeks. According to a senior government official, the program is set to run out of drugs due to bureaucratic bungling and will leave more than 150,000 patients untreated for roughly one month.
Drugs in the open market are expensive. In India, more than one-third of the 2.1 million people infected with HIV/AIDS get free antiretroviral drugs from the government with free antiretroviral drugs that are procured from pharmaceutical companies via a tender process.
A delay in approving such tenders has left the National AIDS Control Organization (NACO) scrambling to secure supplies of tenofovir/lamivudine tablets which are given to patients during the initial stages of treatment.
“We are also fed up. What to do? There are so many bureaucratic hurdles. The file goes to so many comments,” NACO Deputy Director General A.S. Rathore told Reuters. NACO had raised the demand in January, Rathore said.
According to Reuters, a tender for medicine appeared to have been approved last week. Since it takes about 60 days to get the drugs to the patients, patients will not have proper treatment for about a month.
Missed dosages for long durations can increase patients’ drug resistance and result in faster spread of the virus, while changes in medication regimens expose patients to side effects.
Patients and activists complained of shortages of several HIV drugs in September, forcing one group to send a legal notice to India’s health secretary, Lov Verma. Verma directed NACO to take stock of the program and told Reuters on Sept. 4 that the situation was not as grave as activists described.
However, Rathore said that the program had only 1.6 months of tenofovir/lamivudine tablets in stock on Sept. 4. That means, supplies will run out in about 20 days from now.
As of Sept. 24, 10 Indian states had less than a month of stocks of such tablets, data available on NACO’s website showed.
NACO is now leaning on companies – including Aurobindo Pharma, one of the manufacturers that have been awarded the contract – to help avert a crisis.
India had the third-largest number of people living with HIV in the world at the end of 2013, according to the U.N. In 2012, 140,000 people died in India because of AIDS.
The government has been providing free antiretroviral drugs for HIV treatment since 2004, but only 50 percent of those eligible for the treatment were getting it in 2012, according to a report by the World Health Organization.
‘WORKING AGAINST TIME’
Other than bureaucratic delays, Rathore said poor coordination between NACO and the state centers that dispense the medicines had made it difficult to collate data on the real supply-demand situation.
Documents reviewed by Reuters showed the government officials referring to the situation as a “crisis” several times in September and were seeking emergency donations to fill the gap.
“In the long run it (the tender approval) is going to help, but in the immediate term, it’s already too late,” said Loon Gangte of the International Treatment Preparedness Coalition, South Asia, who has been tracking the nation’s HIV/AIDS drug status.
While NACO is confident it will be able to secure supplies before stocks go dry, companies are not committing.
Aurobindo Pharma: A senior executive at Aurobindo Pharma confirmed on Tuesday that his company had received the approval five days earlier, but said the manufacturing process – which usually takes a minimum of 60 days – would only begin on Wednesday or Thursday.
“As per the books we can only supply by November-end, but we are trying to do something by which we can supply earlier to meet the urgent demand,” the official, who had direct knowledge of the matter, said on condition of anonymity.
“We are trying to work against time.”
Hetero Drugs: A senior company executive at Hetero Drugs, another company that has been awarded the contract to supply tenofovir/lamivudine tablets under the latest tender, blamed NACO for a lack of planning and delaying the approval process.
“I have all the respect for our ministries, but when you’re looking at HIV patients, who can’t be deprived even for a single day, this is not an effective way of handling the system,” said the executive, who declined to be identified because of the sensitivity of the matter.