According to the revised rules, a patient will need two copies of a prescription - one which will be in the chemist's custody.
The drug controller general of India (DCGI) on Friday introduced new rules to buy antibiotics. According to the revised rules, a patient will need two copies of a prescription - one which will be in the chemist's custody.
"Doctors prescribing powerful antibiotics for common ailments will know that they can be pulled up because a copy of the prescription will be given to the chemist who will have to keep it for a year, and will be used for audits," IBNLive quoted Surinder Singh, Drug Controller General of India, as saying.
The DCGI's decision comes in the wake of the Superbug scare - after the NDM1 (New Delhi metallo-beta-lactamase 1) was found to be resistant to even the most powerful antibiotics, and is aimed at nipping the problem of antibiotic abuse in the bud.
Antibiotics are substances that kill or cease the growth of harmful-disease-causing bacteria. In the UK they are only prescribed to patients after various antibody screening tests based on the sensitivity and resistance profile, which differs for every individual.
An over-or-wrong use can lead to lasting drug-resistance in patients, which would in turn, make them more susceptible to infections.
Antibiotics can cause side effects too. Under allergic conditions a person can develop an anaphylactic reaction, go into shock and die. Other antibiotic side effects include nausea and diarrhoea, abdominal pain, liver toxicity, brain and kidney damage or even pseudomembranous colitis. Thus, a judicious and controlled use of antibiotics was the prime agenda before the DCGI.
While antibiotics were not allowed to be sold over-the-counter before, without a prescription, under Schedule H of the Drugs and Cosmetics Act and Rules, this was hardly implemented. Now, the Union ministry of health placed antibiotics under a separate schedule, H1.
Further, a new schedule called HX will soon be added to the drugs and cosmetics act to keep a check on antibiotics and habit-forming drugs. This will include -antibiotics, anti-TB drugs, habit-forming drugs like Corex and Phensedyl cough syrups, sedatives and anti-anxiety drugs such as Diazepam and Alprax.
About 70 drugs including antibiotics will come under the new Schedule HX. Violators will be punished with a fine of Rs20,000 or upto two years imprisonment.
According to a senior health ministry official, there are about 500 'prescription'drugs under Schedule H, including antibiotics. Having a sub-regulation was discussed to make the enforcement stringent. The proposal has now been sent to the Union health ministry for approval.
Government is also likely to come out with a comprehensive policy by next month on the use of antibiotics which include setting up of a task force and involvement of NGOs for enforcement of regulations.
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.
At a meeting last week, presided over by director general of health services (DGHS), Dr RK 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.
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 idea behind the drug controller general of India's latest move is to curb overuse of antibiotics.
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