Public health problems today is the growing antibiotic resistance

One of the world's most pressing public health problems today is the growing antibiotic resistance due to its irrational use over the years. Confirming a bacterial infection, selecting the appropriate antibiotic for the infection and educating patients about the importance of taking therapy as prescribed by physicians are considered critical in treating infectious diseases. 

Bacteria can become resistant in several ways and all of which involve changes in their genetic material or genes. These altered genes enable the bacteria to either destroy the antibiotic or block its ability to inhibit bacterial growth. The laws of natural selection suggest that all bacteria will eventually become resistant to antibiotics at some point. Repeated and improper use of antibiotics are two main causes for increase in resistant bacteria world over. It is estimated that up to 50 per cent of antibiotic prescriptions given in the community settings are not actually needed. 

Patients too contribute to antibiotic resistance by requesting physicians to prescribe antibiotics even if they do not have a bacterial infection. Noncompliance of patients to the antibiotic treatment regimen is another contributory factor for resistance which has become a significant patient safety concern today. In India, scientific debate on antibiotic resistance has taken a serious turn in the wake of a recent controversy over a reference made in the medical journal, Lancet, regarding the superbug called New Delhi metallo-beta-lactamase 1 (NDM-1). 

The superbug is stated to be resistant to the most powerful antibiotics and the circulation of the Lancet report did hit the image of India as a destination for medical tourism and cheaper treatment facilities. Scientific community in the country did take objection to the reference of New Delhi in the name, NDM-1, as it can give a wrong impression that it originated from India. What is, however, more important now is how to bring a control on the antibiotic resistance in the country. 

And it is creditable that the Union health ministry swung into action and set up a task force to review the current situation regarding manufacture, use and misuse of antibiotics in the country and also to initiate studies documenting prescription patterns and establish a monitoring system for the same. The report has been already placed before the Drug Consultative Committee a few weeks ago. Now, DCGI decided to introduce a set of new rules to regulate the sale of antibiotics and add a separate schedule under the Schedule H of the Drugs & Cosmetics Act. 

The new Schedule, HX, is expected to be added to the D&C Act to make it compulsory for patients to carry duplicate prescriptions for buying antibiotics from the chemist shops. One copy of the prescription has to be kept by the chemists for audit up to one year. These are all highly desirable initiatives from the health ministry and not many developing countries have taken such steps to counter this new threat. What is to be seen now is how effectively and fast the health ministry and drug control machinery of the country will be enforcing these critical regulations.

Code of ethics for doctors

The Department of Pharmaceuticals seems to have abandoned its initiative to evolve a mechanism for discouraging the drug companies from bribing doctors for prescriptions. After convening some meetings last year in the wake of growing public outcry against this unethical marketing practice of pharma companies, the officials in the Department has now become virtually inactive. The DoP had last year asked the industry to evolve a common code of ethics for all pharmaceutical units as existing codes do not cover members of all the pharma industry associations. 

The OPPI was asked to take lead in this matter and compile a marketing code in consultation with all major industry associations. There were sharp differences amongst the industry associations over the proposed common marketing code. While the industry associations representing big and medium pharma companies wanted a uniform code of marketing practices but not binding on the industry, the associations representing 5000 small companies were in favour of a uniform code which should be legally binding on the companies. The stand of smaller pharma companies was based on the belief that only a legal document can ensure compliance of the code and any violation can invite punishments both in terms of money and jail term.

Subsequently, Medical Council of India, the regulatory body for the conduct of the medical profession, has been making some efforts to curb the practice amongst the doctors. It had come out with a code of ethics for doctors prohibiting them from receiving gifts, travel facilities, hospitality, monetary grants, endorsements, etc. As per this code, medical practitioners are prohibited from receiving favours from pharma or healthcare companies under any pretext. 

MCI has the powers to regulate the practice of medical professionals and take action against them. But, MCI has not been able to bring any discipline amongst the medical practitioners as yet. Now, the question is how effectively the MCI will be able to monitor the conduct of lakhs of doctors spread across the country. The practice of bribing doctors by pharmaceutical companies for generating prescriptions has been part of their marketing strategy for many years but has not been causing any serious concern. It has now grown to a major public health issue with the increased competition amongst the pharma companies to capture the market share.

 It is believed that a major part of the cost of prescription drugs is due to loading of promotional expenditure on their prices. Today, more than 80 per cent of the drugs marketed in the country are outside the purview of the DPCO as several new drugs have been allowed to be marketed in the country after the DPCO,1995. Considering this, DoP should not have given up its initiative to check this unethical practice just because there is non cooperation from some industry bodies. Such a stand from a section of the industry should be expected. Even now, DoP should take up the matter and make a serious attempt to implement the marketing code with the support of MCI.