27 September 2013
The Indian government has tightened regulation of sales of over the counter (OTC) antibiotics following widespread domestic and global concern over growing antibiotic resistance in the country.
In late August this year the Indian Ministry of Health and Family Welfare, through an official notification, brought 24 antibiotics under a new ‘Schedule H1’ category of drugs, whose sale without a doctor’s prescription could attract significant penalties. Pharmacists now have to document details of the patient, the actual drug and the prescriber in a separate register, subject to regular inspections by drug control officials.
The drugs specified in Schedule H1, will be labelled with symbol ‘Rx’ and prominently displayed on the packaging in bold red colour with following warning: “Schedule H1 Drug-Warning -It is dangerous to take this preparation except in accordance with the medical advice. Not to be sold by retail without the prescription of a Registered Medical Practitioner”. The new rules will come in force in early March 2014.
In India, the issue of infections caused by multi-drug resistant bacteria came to the spotlight with the discovery of the highly resistant New Delhi Metallo beta lactamase-1 or NDM-1, which was found on European patient who had been to India in 2009. While the Indian government initially objected to the resistant bacteria being named after ‘New Delhi’ the controversy also spurred the government to frame a new antibiotic policy.
One of the recommendations of the committee set up to frame this poicy was to regulate the sale of antibiotics by introducing “Schedule H1” under the Drugs and Cosmetics rules, to regulate sale of antibiotics.
The official notification of the list of drugs in Schedule H1 was however held up over the last couple of years due to protests by the All India Organization of Chemists and Druggists (AIOCD), which has pointed out that in many rural areas, licenced doctors are scarce or unavailable, making many drugs inaccessible to rural populations. Others fear that new regulations will make life-saving drugs scarce, and lead to increased costs as they will be routed through the gray market.
Another problem with regulation of antibiotics sales is that of poor implementation. Antibiotics are already listed under Schedule H of the Indian Drug Control Act, which includes over 536 drugs that cannot be sold without prescription, but this has had little regulatory effect so far.
According to the Chennai Declaration, a significant policy statement made in 2012 by prominent medical professionals and their associations in India, the problems that India faces in tackling anti-microbial resistance are multi-factorial. The health infrastructure is very diverse with uneven standards of hospital infection control or antibiotic use and across such a diverse country uniform implementation of restriction of antibiotic sales is a difficult task. In many rural and remote areas with inaccessible medical facilities, there is hardly any qualified doctor available to make “prescription only” policy for sale of antibiotics. Due to the lack of laboratory infrastructure, collecting and monitoring national data on antimicrobial resistance is a challenging task.
Keeping these issues in mind the Chennai Declaration had suggested a practical approach to regulating antibiotic sales that would be implementable and not just remain on paper. According to it one of the strategies that the government should consider is to formulate a list of key antibiotics with strict monitoring on the dispensing of these drugs. Once the success of the first stage is ensured step- by- step introduction of other drugs to the restricted list could be tried.
The lastest government notification putting a list of selected antibiotics for greater regulation seems to have taken up this recommendation of the Declaration and the next move in this context will be determined by how well this new approach works in practice.
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