Changing Pharmaceutical Regulation in India to Promote Rational Use of Antimicrobials

The discovery of antimicrobials has reduced the mortality and morbidity throughout the world, but the infectious diseases continue to be the major causes of mortality and morbidity in India. The use of antimicrobials has increased over the years and study has proved that many of them have not been used inappropriately. The inappropriate use of antimicrobials increases the chance of developing resistance and treating resistant organism becomes cost prohibitive. The reported emergence of superbug, NDM-1, awakened the Government of India. The Government of India initiated regulatory measure by including new Schedule H1 covering higher antimicrobials to reduce the free sale or availability. Though the Government initially proposed a stringent rule similar to Narcotics and Psychotropic Substances, the rule has been diluted to the form of H drugs. The proposed Schedule H1 intends to prevent their selling without doctor’s prescription. This raises many concerns like its impact on non-availability of these medicines in rural areas especially where physicians are not available. The lack of proper guidelines for rational use of these medicines and ineffective implementation of the rules have further raised the concern whether insertion of this new Schedule H1 would improve the use of antimicrobials and reduce or delay development of resistance