Drug Regulation Others

Plain Apathy or Sheer Incompetence? Govt. Sets New Lows by Running Out of Child Anti-HIV Drugs


Roughly two years back, Kartik had brought up the role of non-IP factors, specifically government apathy, in impeding “access to medicines”. 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. What is even more stunning is the solution proposed by the NACO to the problem-it has suggested that parents of children suffering from HIV and AIDS physically break the tablets meant for adults into eight parts so as to fit the dosage for 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 realises that there was no shortage of notice for the administrators of the looming crisis and no tangible steps were taken to avoid it. In fact, the article referred to above, had reported about the possibility of stock out of the exact same drug- lopinavir and the stop gap measure the government put in place to combat the problem.

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. Both Hindu and Scroll have exhaustively mapped the events leading up to the present crisis although with slight variations. While 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. Be that may, the pellet version got its approval by the US Food and Drugs Administration in 2015 but is yet to get approval in India. Also, the larger point here is that even after having notice for more than two years, the government failed to expedite the approval process and did not come up with a viable solution to stem the tide.

State’s repeated failure in ensuring access to life saving drugs

While government has often tried to shrug away the issue of access to medicines with the retort of resource constraint, the Indian courts have of late held up the government for shirking off its responsibilities. Notably, the decision of Delhi High Court in Mohd. Ahmed (Minor) v. Union of India (see here and here for two excellent pieces on this case), made in the context of government’s responsibility to provide expensive treatment for a rare disease, had made it clear that even when resource-constrained, the government is under a duty to fulfil its core obligations like ensuring access to life saving drugs. Paragraphs 64-69 of the decision (of the version cited above) capture the non-derogable duty cast upon the government to ensure access to medicines and in Court’s words:

68. In the opinion of this Court, Article 21 of the Constitution clearly imposes a duty on the
Government to take whatever steps are necessary to ensure that everyone has access to health
facilities, goods and services so that they can enjoy, as soon as possible, the highest attainable
standard of physical and mental health. By virtue of Article 21 of the Constitution, the State is under
a legal obligation to ensure access to life saving drugs to patients. […]”

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 discussion would be incomplete without a reference to the duty of the pharmaceutical manufacturers while resorting to a measure as drastic as terminating the production of a drug. 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. While I am not entirely sure whether the same requirements would apply even in the case of a switch to an alternate form of the drug, as is the present case, given the situation we find ourselves in, it is only reasonable that the rule be read to include even a switch to an alternate form of the drug. More than the technical rules that bind the pharma manufacturers, one needs 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?

A follow up report by the Hindu states that 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.

But, to my mind, what should worry all of us is not what lies ahead but what lies behind us? 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? As I asked in the beginning, is it sheer apathy or a lack of competence to respond when required? Is the government going to sit still every time till the crisis has reached a tipping point? In 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 citizens.

Image from here.

Balu Nair

Balu Nair

Balu is a graduate of the WB National University of Juridical Sciences and is currently practising law at the Madras High Court. He can be reached at [email protected]

2 comments.

  1. Anonymous

    Dear Balu:

    Coming from the industry, I can tell you the issue of non-payment of dues from Naco or any other Govt body is a big pain. On top of it, getting the dues cleared requires a lot of ‘persuasion’ with various departments.
    What Cipla has done is not wrong – per my contacts- they tried for 2+ years to get their dues cleared (as noted in your post) but the Govt. was absolutely NOT listening since they had already received the drugs. Even now, as you point out, it still has paid only a part of the dues. Not one Govt officer / dept. has come out to explain why dues were not cleared.
    The department heads in the payments function and at Naco need to hauled in public for their complete irresponsibility.

    Freq. Anon.

    Reply
  2. ZRS

    Dear Balu:

    Coming from the industry, I can tell you the issue of non-payment of dues from Naco or any other Govt body is a big pain. On top of it, getting the dues cleared requires a lot of ‘persuasion’ with various departments.
    What Cipla has done is not wrong – per my contacts- they tried for 2+ years to get their dues cleared (as noted in your post) but the Govt. was absolutely NOT listening since they had already received the drugs. Even now, as you point out, it still has paid only a part of the dues. Not one Govt officer / dept. has come out to explain why dues were not cleared.
    The department heads in the payments function and at Naco need to hauled in public for their complete irresponsibility.

    Freq. Anon.

    Reply

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