When responsibility is fixed and systems are in place, how do you explain a scarcity of life-saving anti-tuberculosis drugs? You don't.

Coughing up funds for TB - Why are there drug shortages

While we were busy, and rightly so, with the Uttarakhand floods and the extensive damage it had caused, a public health emergency crept up on us in the dead of the night. Well, not exactly the dead of the night, because, certainly a few people saw it coming.

Suddenly, it seemed the country had run out of stocks of crucial anti–tuberculosis drugs. Two key drugs in the anti-tuberculosis cocktail: Streptomycin and Rifampicin, were in short supply. Alarmingly so. For the health of not only the patients, but also the community. But, we’ll come to that, in just a bit.

Citizens and activists took up a campaign both online and offline, building a people’s movement, urging the government to act. Online, they called for signatures on the petition:

“We urge you to take immediate steps to address India’s repeated shortages of tuberculosis medicines. Despite clear warnings about impending drug stock-outs, the Ministry of Health and Revised National Tuberculosis Control Programme are failing to act with the urgency and transparency needed to address the crisis. As a result, health centres may run out of first line, second line, and pediatric tuberculosis medicines. We urge you to intervene so that immediate measures are taken to restore supplies of these life-saving drugs.” This group, which held a public rally in Delhi last Wednesday to gather more grist for their mill, also debunked the Health Minister’s claim that there was no shortage:

“ It is totally untrue because we know children are not getting drugs, 1st and 2nd line drugs are also in danger of running out shortly.”

They also made mince meat of the WHO India head’s statement that there was only a “dip” in the supply of these drugs:

“… is a statement that is not true. Just the day before we received a mail from WHO India giving us a clear picture. She[WHO India head] and Dr. Mario Raviglione were CCed on that mail which said,

“There is stock out of pediatric TB drugs, rifampicin 150 and streptomycin.

No stock out of first line drugs, but the existing stock will dry out in 3-4 months

2nd line –There is no stock out.”

The bulk of the TB treatment programme in the country is run via the public healthcare delivery systems, primarily routed through the Revised National Tuberculosis Programme. The RNTCP, swearing by the Directly Observed Treatment Short Course (DOTS) therapy, dispenses boxes of potent drug cocktails of varying protocols for patients at various stages of TB infection and treatment.

Ergo, the bulk of all anti tubercular drugs procurement in India is in the public sector, and by a single agency - the Central TB Division (CTD). Drugs thus procured are then distributed to the different states, and thereon to the providers, from where it is passed on to the patients. RNTCP even has a detailed manual on Drug Procurment, Distribution and Storage for the country.

These drugs are life-saving, definitely, when taken according to the prescribed regimen. Deadly, literally. However, that is not all. If not taken in adherence to the protocols specified by the medical practitioner, they do not merely impede cure, but also facilitate the creation of strains of bacteria that are resistant to known drugs. These resistant strains of bacteria infect others who then have to negotiate a more deadly form of the Tubercule bacillus right from the beginning, making their course of treatment not only longer, but also more complex. Drug resistant conditions are famous for frustrating attempts at cure, and increasing mortality rates.

But here we go: One central procurement agency . From the point of view of maintaining uniform standards across the country, it works. Beautifully. But, there in is the inherent loophole: once procurement goes wrong or is delayed, there is the gaping possibility that the entire programme can go off the rails. And now, not merely a possibility, but also the eventuality.

You might have heard this if you have your ear to the wall; We only got this way because the CRD did not quite pay attention to procurement of drugs/placing orders. Experts say sometimes the process of procurement and distribution can take as many as 12-16 months.

Experts have been hinting to the government for a while now that the procurement system needed a serious dekho. And, while we waited for some one to do something about this, the shortage was up on us already. Surprise. Surprise.

So you have to take your drugs without a break, in the dosage recommended. Only, there are no drugs.

But that was not the only kind of shortage in the market this time around. There was also a genuine shortage of drugs, because of problems in the manufacturing process itself, going by market gossip. Apparently, there was a hitch in sourcing some raw material from Japan after the earthquake and tsunami.

Supply Chain Management

Drugs, after all, do have an expiry date, and hoarding for a rainy day is never quite the wise thing to do. However, it is possible to look at diminishing stocks, especially when the empty shelves are not filled up with drug boxes soon enough. It is possible to use simple SCM applications to manage drug positions and stocks and engineer the software to trigger an alert when dangerously low margins are reached. All kinds and manner of logistics and warehousing companies use them everyday, managing stock positions on the mobile phone.

It’s nice to be on the grid, but when the grid has failed, it pays to have a Plan B, and a Plan C. Something that the Tamil Nadu government reportedly did, not app wise, but offline. To surmount the problem of a deficient supply, they went in for local purchase of the drugs. They also used the loose drugs that were being scraped together and sent down by the Centre, cobbling together the recommended dosage individually for each patient. In anticipation of an impending shortage of paediatric drugs, State TB officials have prepped themselves with standing instructions to buy locally in the market the moment they sense a shortage around the corner.

Despite several years of running the RNTCP, it is annoying that the CTD, whose only raison d’etre is to fight TB in this country, is not coughing up right. To cover a deficiency with denials is like shooting yourself, with a pistol in the mouth. Who are you fooling? The most wily Mycobacterium tuberculosis?