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Plan to ban Over-The-Counter (OTC) sale of antibiotics put off

NEW DELHI: The government’s bold decision to clamp down on over-the-counter sale of third generation antibiotics has been shelved for the time being.

Just days before the drug controller general of India was to notify Schedule H1, the health ministry decided that a “broader consensus was required” and withheld its notification. As many as 90 antibiotics would have been brought under the new schedule. There would have been strict curbs on the sale of these antibiotics.

Union health minister Ghulam Nabi Azad said, “We need to debate the feasibility of a separate Schedule H1 to rationalize and regulate antibiotics in the market, keeping in view the ground realities, particularly the rural India.” Azad added that although resistance was a problem shared by developing and developed countries, “our solutions must be local and sensitive to constraints of respective health systems”.

Speaking to TOI, ICMR director general Dr V M Katoch said, “Several parts of rural India do not even have doctors to prescribe an antibiotic. At present, people go to shops and purchase the antibiotics needed to cure their illnesses. Bringing in this schedule would mean that shops wouldn’t have the drugs. We need to find a solution that helps both urban and rural India.”

According to Prof Ranjit Roychoudhury, “While urban India faces the problem of over-prescription of antibiotics and irrational use, rural India faces under-prescription. Hence, this schedule should be introduced in urban India first.”

Azad said, “In India where a significant fraction lacks access to basic healthcare and antibiotics, we have an urgent need to protect the effectiveness of our most affordable drugs. We have created an antibiotics policy that will restrict access to new generation antibiotics over the counter, restrict use for sub-therapeutic purposes in the animal feed sector and will focus on various measures to reduce the need for antibiotics. However it will need a broader debate.”

India was planning to ban the availability and OTC sale of the latest generation of antibiotics from general pharmacies in a bid to end the country’s obsession with popping pills.

Drug resistance due to irrational use of antibiotics will increase in the future, director of Centres for Disease Control and Prevention (CDC), Atlanta, Dr Thomas R Frieden has warned.

In an interview to TOI, Dr Frieden said it was very important that India came out with a policy to control irrational use of antibiotics. “There will be increasing drug resistance in the future. Superbugs like NDM1 and drug resistance are definitely major threats,” Dr Frieden said.

The schedule, however, would have had two parts — Part A having 16 drugs and antibiotics that would be sold directly by drug manufacturers to the tertiary care hospitals. These drugs will have a label with a red box and would be marked as for use in tertiary care hospitals only. Part B had 74 drugs and formulations that would carry the warning, “It is dangerous to take this preparation except in accordance with the medical advise”, and “Not to be sold by retail without the prescription of the doctor”.

Part A included drugs like Moxifloxacin, Meropenem, Imipenem, Ertapenem, Doripenem, Colistin, Linezolid and Cefpirome. Part B included drugs like Gentamicin, Amikacin, Pencillin, Oxacilin, Zolpidem, Cefalexin, Norfloxacin, Cefaclor and Cefdinir.

Even the World Health Organisation (WHO) has warned that the world is staring at a post-antibiotic era, when common infections will no longer have a cure. WHO director general Dr Margaret Chan said when antibiotics were first introduced in the 1940s, they were hailed as wonder drugs. “Widespread infections that killed millions could be cured. Major diseases, like syphilis, gonorrhoea, leprosy and tuberculosis lost much of their sting. However today, the message is clear — the world is on the brink of losing these miracle cures,” Dr Chan said. … Read More

via Plan to ban Over-The-Counter (OTC) sale of antibiotics put off

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