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LATEST NEWS UPDATES | Curb on over-the-counter sale of 92 antibiotics soon -Kounteya Sinha

Curb on over-the-counter sale of 92 antibiotics soon -Kounteya Sinha

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published Published on Sep 4, 2012   modified Modified on Sep 4, 2012
-The Times of India

Over-the-counter sale of around 92 antibiotic and anti-tuberculosis drugs in India will be restricted soon. Drug Controller General of India G N Singh has written to the Union health minister to notify a new schedule, H1, in the Drugs and Cosmetics Rules.

Once notified, following clearance from the law ministry, these drugs cannot be sold without prescription.

The drugs will also have to carry a prominent label in red colour on the left corner with the following warning: "It is dangerous to take this prescription except in accordance with medical advice and not to be sold by retail without the prescription of the registered medical practitioner."

Dr Singh said important drugs that Indians are becoming resistant to or can become resistant to are being put under schedule H1.

He added, "These drugs will only be sold against a prescription that the chemist will have to retain. The label of these drugs will have to carry a special warning. I am instructing the state drug controller generals to be ready to conduct surprise check on compliance of retailers once H1 is notified."

A Union health ministry official said, "The draft rules to amend the Drugs and Cosmetic Rules were earlier published. We will look at the public feedbacks as soon as the monsoon session in Parliament is over. We intend to notify H1 after the law ministry clears it."

Resistance to antibiotics is becoming a serious threat for India because of popular habit to pop pills at will.

Even the World Health Organization (WHO) recently 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 had said, "The world is on the brink of losing these miracle cures."

Even director of Centres for Disease Control Atlanta chief Dr Thomas R Frieden, who was in India, told the TOI that drug resistance due to irrational use of antibiotics will increase in the future.

"It is very important that India came out with a policy to control irrational use of antibiotics. Superbugs like NDM1 and drug resistance are definitely major threats," Dr Frieden had said.

A recent study by the Centre for Disease Dynamics, Economics and Policy, Washington DC, said there has been a six-fold increase in the number of antibiotics being popped by Indians.

This includes the retail sale of Carbapenems — a powerful class IV antibiotics, typically used as a "last resort" to treat serious infections caused by multi-drug resistant, gram-negative pathogens.

The CDDEP study said that retail sale of carbapenems increased six times — from 0.21 units per million in 2005 to 1.23 in 2010 — raising serious fears of resistance to these drugs.

The Centre said that based on pharmaceutical audit data from IMS Health's Multinational Integrated Data Analysis System (MIDAS), the size of the carbapenem retail market in India was $27.4 million (Rs 119.4 crore) in 2010.

The drugs to come under H1 includes Moxifloxacin, Meropenem, Imipenem, Ertapenem, Doripenem, Colistin, Linezolid, Cefpirome, Gentamicin, Amikacin, Pencillin, Oxacilin, Zolpidem, Cefalexin, Norfloxacin, Cefaclor, Cefdinir, Tigecycline, Tobramycin, Tramadol and Vancomycin.

CDDEP says the highly competitive domestic pharmaceutical industry in India could play a role in the rapid growth of carbapenem overuse. Based on search of the CIMS, there are over 55 brand names of carbapenem antibiotics retailed on the Indian market.

""This is a lot, considering carbapenems are a relatively new antibiotic class with only four drugs: meropenem (most popular in India), imipenem/cilastatin, ertapenem and doripenem (the newest and most expensive one). By comparison, there were only six product names in Pakistan and five in the US," the study said.

According to Chan, 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, gonorrhea, leprosy and tuberculosis lost much of their sting," she added.

The Times of India, 4 September, 2012, http://timesofindia.indiatimes.com/india/Curb-on-over-the-counter-sale-of-92-antibiotics-soon/articleshow/16241650.cms


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