Monday, October 03, 2011

India Puts Antibiotic Regulations On Hold

 

image

Inoculated MacConkey agar culture plate cultivated colonial growth of Gram-negative, small rod-shaped and facultatively anaerobic Klebsiella pneumoniae bacteria. – CDC PHIL.

 

# 5877

 

 

In August of 2010 a research article was published in The Lancet on the emergence on the Indian sub-continent (and its recent importation into the UK, US, and other countries) of a particularly worrisome enzyme that confers antibiotic resistance to common bacteria (see NDM-1: A New Acronym To Memorize).

 

This enzyme was dubbed NMD-1 or New Delhi metallo-ß-lactamase-1, using a long-standing convention for naming pathogens that often incorporates its place of discovery or emergence.

 

The reaction from officials out of India was both swift and disappointing. 

 

Rather than taking steps against a growing public health threat, they condemned of the use of `New Delhi’ in the naming of this enzyme, dismissed the findings, and called the paper a `conspiracy theory’.

 

The first `action’ that many scientists hoped the Indian government would take would be to end the unrestricted sale of antibiotics at local pharmacies. 

 

Over the following two months a chorus of international calls for action, along with highly critical Indian press coverage, finally resulted in a grudging agreement to regulate the sale of dozens of common antibiotics.

 

In NDM-1 Updates From India, I carried the following news report from the Indian news service DNA (Daily News & Analysis).

 

Superbug fallout: Antibiotics ‘on counter sale’ ceased

Published: Saturday, Oct 30, 2010, 9:00 IST


By Akanksha Bafna | Place: Mumbai | Agency: DNA

The drug controller general of India (DCGI) on Friday introduced new rules to buy antibiotics. According to the revised rules, a patient will need two copies of a prescription - one which will be in the chemist's custody.

(Continue . . .)

 

 

While this headline made these rules look like a fait accompli, in fact, they were not immediately enforced.

 

Over the next 10 months we saw a long list of reports out of India on the detection of NDM-1 and other resistant bacteria, yet as of mid-August of 2011 (see NDM-1: One Year Later) these new restrictions on the sale of antibiotics were still to be enforced.

 

Today, we’ve news that India’s Health Ministry continues to consider the impact of such regulations, and has not decided whether, and how, they will enforce them.

 

First stop, a press release from the Government of India’s Press Information Bureau on a forum being held in New Delhi on bacterial resistance.

 

 

Antimicrobial Resistance A Global Problem – Our Solutions Need to be Sensitive to Local Constraints: Azad

The Union Minister for Health & Family Welfare, Shri Ghulam Nabi Azad inaugurated today the “1st Global Forum on Bacterial Infections: Balancing Treatment, Access and Antibiotic Resistance” organized in New Delhi.

 

Speaking on the occasion, Shri Azad said “Antimicrobial Resistance poses a growing threat to the treatment and control of infectious diseases. It is now time to look into this problem more holistically. Resistance to micro-organisms leads to loss of lives, productivity and earnings, and also threatens to undermine the effectiveness of health delivery programmes in all Member States”. He said there is an urgent need to formulate and implement effective strategies to prevent and contain antimicrobial resistance and preserve the efficacy of antimicrobial drugs.

 

The Minister noted that “For a large country like India where a significant fraction lacks access to basic healthcare and antibiotics, we have an urgent need to protect the effectiveness of our most affordable drugs”. He informed that India has created an antibiotics policy that will restrict access to new generation antibiotics over the counter, restrict use for sub-therapeutic purposes in the animal feed sector and will focus on various measures to reduce the need for antibiotics.

 

Shri Azad asked the forum to debate the feasibility of a separate schedule H1 under the Drugs and Cosmetics Rules to rationalize and regulate antibiotics in the market, keeping in view the ground realities of particularly the rural India. The Minister acknowledged that the Ministry of Health and Family Welfare has received representations from various stakeholders and a balanced view in the matter would be taken. Shri Azad said “although resistance is global problem, shared by developing and developed countries, our solutions must be local and sensitive to constraints of respective health systems”.

 

Not explicitly stated in this press release is that while `India has created an antibiotics policy that will restrict access to new generation antibiotics over the counter’ . . . these regulations are not being enforced.

 

From DNA (Daily News & Analysis) we get a bit more clarification, with this report:

 

Govt holds antibiotic policy, not to restrict access to drugs

Published: Monday, Oct 3, 2011, 

 

 

The DNA report states that the government has put enforcement of their new antibiotics policy on hold until a way can be found to provide access to antibiotics for rural populations who may not have access to doctors.

 

And this is, no doubt, a legitimate concern. Access to doctors, and the ability to pay to see one, often elude the rural poor in India.

 

One proposal being considered involves training chemists and non-physician healthcare providers in rural areas so that they can prescribe antibiotics.

 

But lobbying and protests by pharmaceutical companies, drugstore retailers, online pharmacies, and agricultural interests also appear to be part of the delay.

 

For now, massive amounts of antibiotics continue to be sold freely over the counter across India, and we’ve no word of when these issues are expected to be resolved.

 

 

 

While the end of the antibiotic era is not yet at hand, many experts fear we may be drawing closer to that day.

 

In April of this year, Margaret Chan – Director General of the World Health Organizationin a speech for World Health Day 2011, issued this stark warning:

 

In the absence of urgent corrective and protective actions, the world is heading towards a post-antibiotic era, in which many common infections will no longer have a cure and, once again, kill unabated.

 

The implications go beyond a resurgence of deadly infections to threaten many other life-saving and life-prolonging interventions, like cancer treatments, sophisticated surgical operations, and organ transplantations. With hospitals now the hotbeds for highly-resistant pathogens, such procedures become hazardous.

 

While there are legitimate concerns over the impact that enforcing India’s new antibiotic rules might have, we are literally in a race against a rising tide of rising antibiotic resistance, and delays in curbing inappropriate antibiotic use endangers all of us. 

 

For a far more complete (and eye-opening) discussion of antimicrobial resistance issues, I can think of no better primer than Maryn McKenna’s book SUPERBUG: The Fatal Menace of MRSA.

 

And Maryn’s SUPERBUG Blog, now part of Wired Science Blogs, continues to provide the best day-to-day coverage of these issues.