Had it not been for the scare caused by super bug New Delhi Mettalo beta lactamase 1(NDM1), the Union Health Ministry would have still dragged its feet on framing an effective national antibiotic policy.
The Centre swung into action after the controversy over superbug, which is said to be resistant to even the most powerful antibiotics, dented country’s image as a medical tourism destination. It directed the Drugs Controller General of India (DCGI) to set a committee to frame the draft antibiotic policy.
The draft policy is currently being vetted by the Union Law Ministry and will be subsequently forwarded to Drugs Technical Advisory Board (DATB) for consent.
The policy seeks to insert a new Schedule HX under the Drugs and Cosmetics Act to check the misuse of about 70 antibiotics. Currently these antibiotics are under Schedule H of the Act.
The antibiotics will be categorised as non- restricted, restricted and very restricted once the antibiotic policy comes into being. According to officials, steps would be taken to ensure that each category of antibiotics had a separate colour code for the convenience of the people.
Besides, the policy would also come out with a list of antibiotics for which doctors’ prescription would be mandatory. There will be strict curbs on doctors to ensure that they do not prescribe antibiotics out of the said list. This would also help in preventing the misuse and bulk use of third and fourth generation antibiotics.
There is also a move to restrict the prescription of 16 third generation antibiotics to tertiary hospitals. According to experts, 16 drugs including Doripenem, Colistin, Moxifloxacin, Linezolid, Cefpirome Meropenem, Imipenem and Ertapenem would be dispensed only from tertiary hospital.
On the other hand as many as 75 drugs including Pencillin, Oxacilin, Norfloxacin, Cefaclor, Cefdinir, Gentamicin, and Cefalexin will be sold strictly against prescriptions.
As per the amendment, the doctors will have to make double prescriptions for the sale of antibiotics, one for the patients and other for the chemists. It will be mandatory for the chemists to keep the record of these prescriptions for at least two years.
Officials from the Drugs Controller General of India (DCGI) or state drugs controller’s office will audit these prescriptions at any time. Violations under the new schedule will make a person liable for a fine of 20,000 rupees or up to two years imprisonment.
Antibiotic arsenal growing
Eighty three years after Scottish scientist Alexander Fleming discovered Pencillin, the need for new antibiotics has only grown by the day.
Medical experts say at the moment there are more than 130 antibiotics classified under different generations. But there is still need for new antibiotics to check the resistance developed by bacteria.
Experts say the standard dosage of antibiotics has increased fourfold because of bacteria resistance.Along with the long list, the prices too have grown manifold.
The price of antibiotics available in the market today ranges from Rs 2 for Septran to Rs 6,000 for carbapenemes and even more.
“The first rule of antibiotics is try not to use them. And the second rule is try not to use too many of them,” says Paul L. Marino in The ICU Book.
(Henan Kangtai Pharmaceutical Group Corporation is the largest norfloxacin USP & norfloxacin hcl|norfloxacin nicotinate|norfloxacin lactate producer.)
*New Delhi metallo-beta-lactamase-1 (NDM-1) is an enzyme that makes bacteria resistant to a broad range of antibiotics.
*NDM-1 was first detected in a Klebsiella pneumoniae isolate from a Swedish patient of Indian origin in 2008.
*It was later detected in bacteria in India, Pakistan, the United Kingdom, the United States,Canada, Japan and Brazil.
*The bug was named after New Delhi as it was first identified in a Swedish national, who fell ill with an antibiotic-resistant bacterial infection that he acquired in India.
*Bacteria with the NDM-1 gene was found in drinking water and seepage samples in New Delhi, says study.
*The Indian health ministry has disputed the conclusion that the gene originated in India, describing this conclusion as “unfair” and stating that Indian hospitals are perfectly safe.
*Journal of Association of Physicians of India blamed the emergence of this gene on the widespread misuse of antibiotics