MRP of stents, valves must be declared

Medical devices which are declared as `drugs' such as stents, valves,
orthopaedic implants, syringes and tools for operations will now have
to declare their maximum retail price (MRP) and other details including
that of manufacturer and importer. These also need to mention the consumer
 helpline number of lodging any complaint. The new rules, which come to
 effect from January 1also makes it mandatory for ecommerce firms to
 mention MRP of products, which is aimed at ending any ambiguity whether
the online firms are actually giving huge discounts that they claim in their
advertisements. ―Even after capping of prices of medical devices many
companies were not displaying (the rates). The new rules will be of great
 help to consumers at large and particularly the poor. The companies have
 to follow these norms under the legal Metrology Rules,― consumer affairs
minister Ram Vilas Paswan told TOI. These norms will come into effect from
January 1. Earlier, all medical devices were covered under the Legal Metrology
(Packaged) Commodities Rules. But in 1995, some of them were declared
as drugs and so they stopped mentioning MRP. A sub-committee set up to
 propose changes in the Rules had recommended bringing them back under
MRP regime. A consumer affairs ministry official said that the application of
Legal Metrology Rules will provide another layer to protect consumers' rights.
Non-application of MRP led to a crisis where consumers were charged
arbitrarily by hospitals for medical devices and the health ministry had to cap
the prices of stents. On March 6, TOI had first reported how government was
bringing such devices and the entire e-commerce sector under MRP regime.

Source: The Times of India

The enemy of my enemy

A new antibiotic for drug-resistant tuberculosis

 

TUBERCULOSIS has plagued humanity for thousands of years. The discovery in the 19th

century of its cause, a bacterium (pictured above) called Mycobacterium tuberculosis, and the

consequent development of better hygiene, helped bring that plague under control. Then, in

the mid-20th century, what many hoped would be the final nail in its coffin appeared:

antibiotic drugs.

Unfortunately, TB is back. After a few decades in which antibiotics did indeed seem to be

working miracles, some strains of M. tuberculosis have evolved resistance to them. In 2015

5% of the world’s 10m cases failed to respond to treatment with isoniazid and rifampicin, the

drugs of first resort. Half of those non-responders were infected by strains of the bacterium

immune to second-line treatments as well. Most microbiologists regard these numbers as

portents of worse to come. That is driving a search for new antibiotics against which M.

tuberculosis has evolved no resistance.

Eshwar Mahenthiralingam of Cardiff University and Greg Challis of the University of

Warwick, both in Britain, think they have found one. As they and their colleagues describe in

the Journal of the American Chemical Society, they have discovered a compound, produced

by another bacterial pathogen, that kills resistant strains of M. tuberculosis.

This compound, which they call gladiolin, is created by Burkholderia gladioli—a bacterium,

generally rare, that thrives in the lungs of those suffering from cystic fibrosis. It is able to

gain a foothold there because the respiratory tracts of such patients are clogged with mucus

that inhibits the actions of immune-system cells which would otherwise destroy the invaders.

What interested Dr Mahenthiralingam and Dr Challis about B. gladioli was that, once

established in a patient’s lungs, it seems able to keep rival bacteria such as M. tuberculosis at

bay. This suggests it is engaging in chemical warfare.

To isolate the agent that inhibits B. gladioli’s competitors, the researchers cultivated samples

from a patient with cystic fibrosis and analysed the chemicals secreted by bacteria therein. It

was thus they discovered gladiolin, which shuts down bacterial versions of the gene for an

enzyme called RNA polymerase that is crucial for life.

This was interesting. But it was also reminiscent of a false dawn involving another substance,

etnangien, which was discovered in 2007 and which also inhibits RNA polymerase.

Unfortunately, etnangien proved chemically unstable and thus impossible to use as a drug.

The first task Dr Mahenthiralingam and Dr Challis undertook was therefore a detailed

comparison of the two. They established that the parts of etnangien molecules which cause

their instability are not shared by gladiolin. That suggested gladiolin might indeed be robust

enough for use against tuberculosis, and encouraged them to test it further.

The new substance performed reasonably well against a strain of tuberculosis that had no

resistance to antibiotics. A solution of 400 nanograms (billionths of a gram) per millilitre was

enough to inhibit the growth of such bacteria. But isoniazid and rifampicin performed better.

They needed only 40 nanograms and 1 nanogram per millilitre of solution respectively to

keep the non-resistant bugs under control. Where gladiolin did shine, though, was against a

strain of tuberculosis known for its resistance to isoniazid and rifampicin. Even 10,000

nanograms per millilitre of either of those two drugs was insufficient to harm it. However, a

mere 1,700 nanograms per millilitre of gladiolin proved enough to knock it out.

Whether gladiolin can be taken out of the Petri dish and made into a useful drug will require

many clinical trials to discover. But, in a world crying out for new antibiotics, it seems a

useful lead.

Source: The Indian Express

WHO for use of devices to test multiple diseases

A single device can diagnose Tuberculosis, HIV and Hepatitis

The World Health Organization (WHO) on Tuesday released new advice to countries,

recommending the use of multi-disease testing devices for Tuberculosis, HIV and Hepatitis.

A single device called the GeneXpert can be used to diagnose TB and HIV infections, and

quantitatively measure HIV and hepatitis C viral loads. India recently procured 600

GeneXpert machines for the National Tuberculosis programme.

The WHO is recommending use of these state-of-the-art portable machines the size of a

microwave oven, which can run molecular tests. However, most countries do not use them

for multi-disease testing.

“Any good health system must have the capacity to do several tests that are of importance.

Currently, we are mostly investing in single disease testing technologies, while there is great

potential to use the same platform for multiple conditions.” said Prof Madhukar Pai, Canada

Research Chair in Epidemiology & Global Health.

Single platform

“With the power and adaptability of molecular technologies, we are in an era of great

advancement for the rapid diagnosis of many diseases using single platforms,” said Dr Mario

Raviglione, Director of WHO’s Global TB Programme. “These platforms offer technical and

financial efficiencies to countries in their disease control efforts, while expanding access to

care.”

GeneXpert machines — initially procured by countries for the detection of TB and rifampicin

resistance, following an initial WHO recommendation in December 2010 — were

subsequently expanded for use in early infant diagnosis of HIV and viral load testing using

relevant cartridges in the same device.

“We encourage countries to use multi-disease platforms for testing of HIV, TB and hepatitis

as much as possible and feasible,” said Dr Gottfried Hirnschall, Director of WHO’s

Department of HIV and Global Hepatitis Programme.

“Multi-disease devices can increase system efficiencies and improve access to testing for

patients in need. Such devices can also help overcome specific challenges in diagnosis and

treatment, such as HIV early infant diagnosis and viral load monitoring for both HIV and

hepatitis,” he said.

Source: The Hindu