Two months after reports came of a superbug originating in South Asia that was resistant to most antibiotics, the Union Health Ministry is planning to strictly enforce the requirement that these drugs be sold only on the prescription of a registered medical practioner.
While antibiotics can’t be sold even now without a prescription, under Schedule H of the Drugs and Cosmetics Act and Rules, this is hardly implemented. Now the Ministry is planning to place antibiotics under a separate Schedule, H 1.
According to a senior Health Ministry official, there are about 500 “prescription” drugs already under Schedule H, including antibiotics. “Having a sub-regulation was discussed to make the enforcement stringent. If H1 is given a go-ahead, there will be separate regulatory riders for violators.” About 70-odd antibiotics are currently available in the market.
Drug Controller General of India (DCGI) Dr Surinder Singh will take a final call on a separate schedule following a drug consultative meeting to be held this Thursday.
At a meeting last week presided over by Director General of Health Services (DGHS) Dr R K Srivastava and attended by experts from the All India Institute of Medical Sciences (AIIMS), National Centre for Communicable Diseases (NCDC), Hinduja Hospital, Mumbai, and other institutes, a range of measures were discussed to regulate the use of antibiotics in the country.
Among other steps, the Health Ministry is considering a separate colour code for high-end antibiotics needed only in tertiary care. “This will make it easy to identify the high-end antibiotics,” said the health official.
The experts have also proposed making it mandatory for hospitals to constitute “drug control committees” and “infection control committees”. While the drug control committee will approve the high-end antibiotics, the infection control committee will keep a tab on the infection rate and do analysis.
“High-end antibiotics like carbapenem, imipenem, meropenem will only be prescribed after the committee of experts gives their go-ahead. At present there is no such rule,” said the official.
To start with, the final guidelines may be implemented in government hospitals.
The ministry is also planning to set up an expert group to carry out “prescription audit”. This will involve drug inspectors keeping a tab on the commonly prescribed antibiotics, and the disease/problem these are used for. “The experts will co-relate this data further to know if people are developing antibiotic resistance,” another official said.
Experts have also recommended separate sets of antibiotics depending on the disease — meaning mild ones for out-patient and emergency patients and strong and high-end antibiotics for those under intensive care.
The guidelines, it is hoped, will make sure that antibiotics are used judiciously so that resistance to commonly used antibiotics does not develop rapidly, and that the medicines are available for critically ill patients.
As per law, drugs under Schedule H can be sold only on the prescription of a registered medical practitioner. Medicines containing such drugs are labelled with the symbol Rx.