Government announces national policy for containment of antimicrobial resistance

The widespread irrational use of antimicrobials in the Indian health care system and its contribution to emerging drug resistance has
often been voiced as a major cause of concern. Several reasons have been cited for this malaise that plagues human, veterinary and agriculture sectors in India. Some of these include regulatory gaps, inability to enforce the existing regulations, over the counter availability of antimicrobials, lack of awareness amongst prescribers and clients, lack of quality assured laboratory testing facilities to support evidence based antimicrobial prescriptions etc. However,
one overarching gap has been the absence of comprehensive
national antimicrobial use policy to guide various control efforts. This void came to renewed prominence during discussions that followed the recent reports on isolation of bacteria containing NDM-1 gene in patients, carriers and environment in select cities in India. This gene confers resistance to carbapenamases (the most advanced and potent antibiotics to treat resistant infections) as well to host of other antibiotics, thus leaving very little choice for treating patients with this infection.

Government of India formed a National Task Force in August 2010 to recommend a National Antibiotic Policy. Through several deliberations of the task force, a National policy for containment of antimicrobial resistance in India 2011 was formulated and announced in May 2011.

The policy recognizes that “there are definite policies / guidelines for appropriate use of antimicrobials at national level in specific national health programmes being run in the country e.g. RNTCP, National AIDS control programme, etc. For other diseases of public health importance like enteric fever, diarrhoeal disease, respiratory infections, etc. the individual hospitals follow their own antimicrobial policies and hospital infection control guidelines. To monitor antimicrobial resistance it is necessary to have regulations for use and misuse of antibiotics in the country, creation of national surveillance system for antibiotic resistance, mechanism of monitoring prescription audits, regulatory provision for monitoring use of antibiotics in human, veterinary & industrial sectors and identification of specific intervention measures for rational use of antibiotics.”

While the draft policy is good first step towards a more systematic approach to control the spectre of drug resistance, there are issues which the policy needs to be cognizant of before it is able to guide any significant changes.

To highlight a few, the policy is overly regulation focused in an environment where there is little regulatory capacity. Moreover, involvement of concerned stakeholders in the review process is missing completely; this is likely to increase the probability of increasing the number of regulations that are not implemented/ not implementable e.g. ICAR is specifically mentioned; not ICMR. The implementation of policy recommendations will greatly benefit from systematic process of evidence generation for better understanding of compliance to existing regulations and identification of gaps in their implementation; mapping the extent and scope of illegal practices.

Great amount of work has been done by earlier expert group to identify key systemic and regulatory issues with specific recommendations to address them. These include e.g. several national and international experts, including D Srivasta (2008), Mashelkar Committee report (2003) and Draft National Pharmaceutical Policy (2006). The policy in its current form has failed to synthesize and build upon the existing efforts.

The larger issues of risk drivers (market incentives, public health concerns of industry regulations), systemic factors (like capacity to enforce regulations) do not appear to be addressed directly. While there is talk of inter-ministry coordination to put together evidence, no action has been suggested on means of increasing the influence of public health concerns in pharmaceutical policy making.

The draft policy is in the public domain. In order to ensure its effectiveness, it is imperative that the document is critically reviewed and appraised through open and transparent process of incorporating comments and suggestions.

  • National policy for containment of antimicrobial resistance in India, 2011. (accessed May 2011)
  • Srivastava D (2008). A country level report on the pharmaceutical sector in India Part One: Institutions involved in pharmaceutical regulation. DFID, UK
  • Government Expert Committee (2003). A report of the Expert Committee on 'A comprehensive examination of drug regulatory issues, including the problem of spurious drugs'. Ministry of Health & Family Welfare., Government of India
  • Department of Chemicals and Petrochemicals (2006), Draft National Pharmaceutical policy. Department of Chemicals and Petrochemicals, Government of India