Cipla stopped making the Lopinavir syrup for under-5 kids in 2015, but government remained unaware until shortage loomed large
As many 600 children have suddenly being deprived of anti-HIV syrup Lopinavir this month, thanks to payments dispute between pharma major Cipla and the Indian government. What's more, the government was until recently unaware that Cipla stopped manufacturing the critical drug in syrup form two years ago, in 2015.
Cipla told the National AIDS Control Organisation (NACO) earlier this month that it will be unable to supply the drug.
"Mere non-payment of dues is no reason for Cipla to deny supply. It had stopped manufacturing the syrup in 2015. We had enough buffer stock and did not know that they will not be supplying further, until last week, when Cipla did not participate in tender bid," a NACO official said.
As a stop gap arrangement, NACO is procuring 3,000 bottles of 160 ml Lopinavir syrup from another pharma company, McNeil & Argus, the official said. However, the emergency purchase will meet barely more than 8 per cent of the actual demand for 36,000 bottles annually.
While NACO said on Tuesday that Lopinavir would reach the 1,600 dispensing sites nationwide within this week. Paul Lhungdim, an HIV activist with the Delhi Network of Positive People (DNP+) pointed out that paediatric tablets of Lopinavir and Retonavir, which can be used as an alternative to the syrup, are also unavailable. "Parents are being forced to break the adult dose and feed their children. This is often not done properly, putting the child's health at risk," said Lhungdim.
The issues over payment became a bone of contention after heated email exchanges between senior executives of Cipla and patient groups. While Cipla demanded that its dues be immediately cleared, patient groups expressed their helplessness in the matter.
As per its standalone balance sheet, Cipla's total trade receivables for financial year 2015-016 (FY16) were about Rs 1,899 crore.
Its claims against the government for Lopinavir stood at Rs 6 crore, or 0.3 per cent of it's total trade receivables. The Health Ministry on Tuesday released Rs 6 crore due to the pharma company for previous procurements of Lopinavir.
Incidentally, the government's dues to Cipla are less than the company's total corporate social responsibility (CSR) budget of Rs 20.5 crore for FY2016.
NACO officials said the payments would have been cleared in due time anyway. "There were some queries raised on payments by the finance division and sooner or later they would have gotten their money. Cipla was the sole large scale manufacturer of Lopinavir, and when we did not receive it's participation for the tender bid that was floated last month, we were a little alarmed. They informed us that they had stopped manufacturing the syrup all together and moved on to manufacturing pellets as an alternative," the NACO official said. Pellets are micro-tablets of the drugs Lopinavir and Retonavir that can be sprinkled over the child's food.
However, India does not yet have approvals to use the pellets in it's prescribed Anti-Retroviral Treatment (ART) regimen.
"We will gradually introduce pellets in the regimen after Cipla gets approvals for its use from Drug Controller General of India (DCGI)," the official said, adding that ART guidelines will eventually be changed to replace Lopinavir syrup with the pellets.
"There will be teething troubles as in all drug transitions," the official admitted.
Meanwhile, questions sent to Cipla over the reasons for stopping manufacturing of Lopinavir syrup remained unanswered at the time of publication.
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