It is said that we live in a "post-truth" era – a
time, when truth is considered largely irrelevant. In March 2016, The
Union Government of India imposed a ban on 344 fixed-dose combination
(FDC) drugs. The ban was based on a report by the Kokate Committee which
had compiled a list of FDC’s, which they considered as irrational. The
ban impacted over 6000 brands, and pharmaceutical companies were quick
to react by filing a total of 453 separate petitions challenging the
validity of the ban. The Government had defended its decision, saying
these medicines are potential health and safety hazards. The companies,
on the other hand, had contended that no enquiry was made from them or
show cause notice issued prior to the notification.
On December 1, 2016, the Delhi High Court revoked the
ban saying that the Centre had acted in a haphazard manner, and did not
take the advice of the statutory bodies under the Drugs and Cosmetics
Act before issuing the March 10 notification. Noting that the power
cannot be exercised in public interest for any reason other than the
drug being risky or not having any therapeutic value, the Bench said
that the same had to be decided based on scientific technical reasons on
the advice of the Drugs Technical Advisory Body (DTAB) and the Drugs
Consultative Committee (DCC) constituted under the Drugs Act.
The story is similar to the 294 FDC’s, which were
banned by the Drug Controller General of India (DCGI) in 2007. Then too,
important issues of patients’ health, safety and economical interest
were lost in legal loopholes. Consequently, those 294 irrational FDCs,
banned by the Union Ministry of Health on health and safety grounds,
continued to be promoted, prescribed and sold to patients across India,
without any hindrance. A sense of confusion and bewilderment prevails. (The
Hindu 2 December 2016)
HIV Self Testing
The first step towards change is awareness. Echoing
this, the WHO has released new guidelines on HIV self testing to improve
rates of diagnosis and therapy. According to the report 18 million
people, ie 40% of all persons infected with HIV are unaware of
their status. However between 2005 and 2015, the percentage of people
who knew of their infection rose from 12% to 60%. This increase in
testing meant that now 80% of the people diagnosed with HIV are on
therapy. Increased diagnosis means more chances of being on treatment
and less transmission. However at the current rates of detection, it
will take 25 years to pick up 90% of patients living with HIV.
In India, incidence of new HIV cases has been
plummeting. Rates in 2015 were 66% lower than in 2000. It is estimated
that in India 2.1 million people are infected with HIV. Of them 1.5
million have been detected and tested in the integrated diagnosis and
testing centers. India is also considering the options of self testing.
Community-based testing has been approved in principle. The WHO also
wants to encourage people to inform their partners and help them find
out their infection status.
Self testing is based on detecting antibodies in
saliva or blood. One of the WHO approved kits is called OraQuick.
Sensitivity (96.2-100%) and specificity (99.5-100%) is higher for the
blood-based test as compared to the oral fluid (80-100% and 95.1-100).
Counseling support over hotlines will also need to be established to
prevent self harm. Currently, 23 countries have policies which support
self testing. Self testing will substantially reduce the barriers and
stigma attached to hospital based testing, and reduce transmission
rates. (The Hindu 2 December 2016)
The New Superbug – Candida Auris
Candia auris is emerging globally as a serious
and potentially fatal fungal infection. In June 2016, the CDC issued a
clinical alert about this deadly fungus, and in November 2016 published
a detailed report of the first 13 cases in the US. The first report of
its isolation was from the external ear of a patient in Japan. This
pathogen is now reported from several countries, including India, and is
recognized as emerging multidrug-resistant (MDR) yeast that can cause a
wide spectrum of infections, ranging from fungemia to deep-seated
infections, especially in intensive care settings such as neonatal
intensive care units. Studies from tertiary care hospitals in New Delhi
and Kochi showed that the fungus is uniformly resistant to fluconazole,
and 37 % showed elevated minimum inhibitor concentration (MICs) against
caspofungin.
Scientists from The Indian Institute of Science,
Bangalore have completed the genotype sequencing of this fungus, and
this is now the reference sequence around the globe. They have also
developed a polymerase chain reaction based test for this fungus as it
is often misdiagnosed as Candida haemulnii in routine laboratory
tests. They found that one of the reasons for the high drug resistance
is a higher drug efflux pumps compared to other species.
Although no established MIC breakpoints exist for C. auris,
resistance testing of an international collection of isolates conducted
by CDC demonstrated that nearly all isolates are highly resistant to
fluconazole. More than half of C. auris isolates were resistant
to voriconazole, one-third were resistant to amphotericin B (MIC e"2),
and a few were resistant to echinocandins. Some isolates have
demonstrated elevated MICs to all three major antifungal classes,
including azoles, echinocandins, and polyenes, indicating that treatment
options would be limited.(http://www.cdc.gov/fungal/diseases/candidiasis/candida-auris-alert.html,
The Hindu 27 November 2016).