The Health Ministry had notified a draft amendment to the Drugs and Cosmetics Rules, 1945 (‘DCR’) in March this year that would result in creation of Schedule H1 to the DCR.25 The draft amendment proposed that drugs which are included in the new Schedule H1 in addition of warning to retailers that the drugs should be sold only on prescription of a registered medical practitioner, would also have a warning for the consumers that there may be some harm associated with the consumption of the drug if not take in accordance with medical advice. The proposed label below is reproduced for information purposes.
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 intention behind introduction of this new schedule to the DCR was to check the continuing practice of indiscriminate use of antibiotics in India.26 This practice is resulting in development of anti- microbial resistance, that is, the pathogens are getting resistant to existing form and dosage of antibiotics. Increased anti- microbial resistance is resulting in requirement to prescribe new forms / higher dosage of antibiotics.
The draft amendment proposed to include these antibiotics and few habit- forming and anti- TB drugs which are abused, under Schedule H1 (total of 91 medicines), so that they will be sold with additional warning. It is hoped that the additional warning will make many indiscriminate users of these antibiotics refrain from using them without medical advice.
The aforementioned amendment was notified in March, 2012 without consultation with DTAB. It was eventually referred to DTAB for consultation, and the DTAB has now concurred for its validity.27 Post the concurrence of DTAB, a final amendment may be notified anytime soon.