The discussion came up in the context of National AIDS Control Programme (NACO) facing reverses due to the dwindling of stocks of anti-retroviral medication. Two years hence, the government and its bureaucracy, in a shocking display of indifference towards the children living with HIV, have turned a blind eye towards the running out of stocks of syrup containing the anti-retroviral drugs- lopinavir and ritonavir, administered to children. While one might shrug it off as a short term solution to combat the situation at hand, the audacity of it all will be clear when one realizes that there was no shortage of notice for the administrators of the looming crisis and no tangible steps were taken to avoid it.

How the crisis panned out

‘Lopinavir’, in its syrup form, is NACO’s prescribed drug for children and was manufactured and supplied to NACO by Cipla. Cipla stopped production of the drug in its syrup form in 2014. The reason of this seems to be the non-payment of dues by the government of the stocks NACO had procured. The last batch of the syrup was procured in 2015 and NACO ran out of stock earlier this year.Hindu has reported that Cipla decided to put an end to its production after multiple defaults by the government in its payment and in fact stopped participating in government tenders afterwards; Scroll does not cite this as the reason for Cipla putting an end to the production of Lopinavir. As per Scroll’s account, the high content of alcohol in the syrup version was making it difficult to administer it to children and once they came up with an improved version in the form of a pellet, syrup form was dropped.
State’s repeated failure in ensuring access to life saving drugs
In light of the clear finding of the court, one can be absolutely certain that the present fact situation is yet another instance of the government abdicating its constitutional obligation with impunity. Even its explanation that the approval process for registration of lopinavir pellets shall be expedited comes too late in the day given that it had sufficient notice of what was about to happen.
The legal responsibility cast upon manufacturers may be traced back to paragraph 21(2) of the Drug Price Control Order, 2013, which mandates that a manufacturer intending to discontinue a scheduled drug formulation shall issue a public notice as well as intimate the government at least 6 months in advance of the proposed date of such termination. Government is empowered to direct the manufacturer to continue the production for a maximum of one year from the date of proposed discontinuation if public interest demands so.
More than the technical rules that binds the pharma manufacturers, one need to examine the moral responsibility of manufacturers like Cipla who have been the flag bearers of access to medicines and have played a significant role in making India the pharmacy of the world. While it might not be the wisest idea to solely rely on private corporations to ensure supply of drugs at any cost, even when dues are being not paid, the economic strength and operational size of the twenty first century corporations should be factored in while determining responsibility in instances such as these.

What lies ahead?

The government is considering the possibility of procuring the drug from Global Fund for AIDS, Tuberculosis and Malaria (GFATM). Moreover, the government also has given the first installment of the pending dues to Cipla along with the announcement that an expedited approval for the pellet form is being actively considered. Also, a small order has been placed with another manufacturer, who produces the drug on demand.

A short answer to this is in fact simple- a gargantuan mess. With all alarm bells blaring loudly at the same time, how did the government manage to mess this up? n the present case, the crisis has reached and may have even gone beyond the tipping point. Given the nature of the HIV, any lapse in the medication can have the effect of developing drug resistance in children. Thus, such instances should not be seen just as another case of routine government apathy but as a crime against its citizen.