[Ip-health] India: Shortage of key TB drug stress patients; activists urge govt to issue compulsory license

leena menghaney leenamenghaney at gmail.com
Tue Oct 19 04:27:02 PDT 2021

 Shortage of key TB drug stress patients; activists urge govt to issue
compulsory license

Source: TimeOfIndia


MUMBAI: Stockouts are being reported across the country of a key patented
drug, Delaminid, used in drug-resistant tuberculosis (DR-TB), hampering the
government’s goal of TB elimination and causing hardship to patients.

Much worse, the procurement of the drug in still pending as negotiations
with the Japanese patent holder Otuska are stuck due to the high price,
health activists told TOI.

India has the highest burden of DR-TB, accounting for about one-fourth of
the global burden. Among them are the most difficult to treat. XDR-TB
(extensively Durg-resistant TB) cases.

The proposal to supply Delamanid at $1275 (approximately a lakh) per course
is yet to be cleared, even though it is already Q3 of the year, health
activists and TB-affected communities pointed out in a letter (click here
to read more)
the Union Health Minister recently.

Ironically, the shortages are being reported, even as the government
assured the Bombay High Court of sufficient supplies of the drug that is
critical for an effective TB treatment.

Children with DR-TB and adult patients with XDR-TB need inclusion of both
the new TB drugs, Otsuka’s Delaminid and Johnson & Johnson’s Bedaquiline to
ensure an injection free, less toxic and effective regimen.

In the case filed by patients groups in March, theCentre rejected
compulsory licensing for the generic supply of Delamanid, citing “available
stock is sufficient to meet the requirements for the next nine months.”

The negotiations for a lower price of Delamanid with the patentee have
failed and now the countrywide stock-out of Delamanid is life threatening
for adult and pediatric patients with drug-resistant TB who need access to
ensure a regimen that is effective. The programmatic management of
drug-resistant TB (PMDT) is suffering a setback due to shortages of
GeneXpert kits and Delamanid even as it had started to recover after the
second wave of the pandemic. Immediate steps to ensure supplies and
encourage generic competition are the need of the hour to ensure that all
patients have a chance of an effective cure for DR-TB,” Leena Menghaney,
lawyer working on IP and access to medicines told TOI.

The situation has become worse since May with shortages reported of
essential TB drugs at several DOTS centres across the country, with
hotspots like Mumbai and Delhi suffering the most. Stocks are also running
thin in states like Karnataka and Uttar Pradesh, a TB activist said.

This comes in the midst of an overall worsening situations of TB globally,
according to the Global Tuberculosis Report, with TB deaths in 2020 having
increased for the first time in over a decade.

Delamanid is part of the WHO Essential Medicines List for the treatment of
DR-TB for adults and children, and is included in India’s NTEP (National
Tuberculosis Elimination Programme) guidelines on PMDT. It was recently
added in the draft NLEM (National List of Essential Medicines).

A compulsory license on Delamind would allow domestic companies to offer
affordable generic versions to the NTEP, helping in the scale-up of
treatment, experts added.

“We also urge you to encourage generic suppliers to register the adult and
child formulations of delamanid with the CDSCO so that in 2022 a similar
situation of high pricing failed negotiations with the patentee, leading to
stockout, can be avoided. In the circumstances, a government authorisation
or a compulsory license must be issued to allow generic companies to supply
delamanid to NTEP,” The letter adds.

Leena Menghaney
Mobile: 9811365412

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