28 October 2010
By Teena Thacker
New Delhi, India
The decision, made by the Drug Controller General of India (DCGI), India's national drug regulator, is aimed at preventing the widespread misuse and overuse of antibiotics, whichwasrecentlyblamedfortheevolutionof the new `superbug' NDM–1, resistant to even the most powerful group of antibiotics.
The DCGI also decided to create a separate schedule for antibiotic drugs under the Drugs and Cosmetics Act to effectively enforce this decision.
The Indian Express had reported on Wednesday that the Health Ministry was planning to put antibiotics under a separate schedule, and make it mandatory for them to be sold only against prescriptions.
"These steps are expected to act as deterrents for doctors and chemists who prescribe antibiotics unabated," Dr Surinder Singh, DCGI, told The Indian Express today.
Violations will be punished by a fine of at least Rs 20,000 and imprisonment of a year, which may be extended to two years. "Drug inspectors can go and check chemist shops. Violators can then be taken to court," Dr Singh said.
At the Drug Consultative Committee meeting with drug inspectors, a consensus was reached on placing antibiotics under a new schedule called HX. Some 50–60 antibiotics will be placed under Schedule HX, along with 15–20 anti–TB drugs and 10–15 habit–forming drugs like cough syrups that contain codeine.
"TB resistance is becoming quite common, that is why it was decided to keep an eye.
Duplicate prescriptions will also be needed for all cough syrups containing codeine, and anti–anxiety drugs too," Dr Singh said.
Prescriptions in duplicate are currently needed only for drugs under Schedule X of the Drugs and Cosmetics Act and Rules. The most commonly known drug under Schedule X is Oseltamivir Phosphate or Ta miflu, prescriptions for which are supposed to be re tained for two years by chemists.
"The new Schedule HX will be a little relaxed than the existing Schedule X, but it will be stricter than Schedule H," said an official.
The recommendations of the Consultative Committee meeting will now be sent for notification to the Union Health Ministry, which will then have to be ratified by the Drugs Te chnical Advisory Board (DTAB) within a period of six months.
A task force constituted by the Ministry under Director General of Health Services (DGHS) Dr R K Srivastava, which includes experts from India’s top medical institutes, is likely to meet soon to decide on a range of other measures for regulate the use of antibiotics in the country.
The experts have already proposed that hospitals should mandatorily set up a "drug control committee" to approve high–end antibiotics and an "infection control committee" to track and analyse infections.
"High–end antibiotics like carbapenem, imipenem and meropenem should be prescribed only after the committee gives the go–ahead," said a senior Health Ministry official.