India proposes banning 73 antibiotics from sale over the counterBMJ 2012; 345 doi: http://dx.doi.org/10.1136/bmj.e8290 (Published 04 December 2012) Cite this as: BMJ 2012;345:e8290
India has announced plans to ban 91 drugs from sale over the counter to reduce their misuse. The drugs include 73 antibiotics, 13 potentially addictive drugs, and four drugs to treat tuberculosis.
The minister for health and family welfare, Ghulam Nabi Azad, said, “The government has taken note of irrational use of antibiotics across the country and published draft rules for amending the Drugs and Cosmetics Rules 1945 for insertion of a new schedule H1 containing 91 drugs, including 73 antibiotics.”
He added, “Such an amendment in the rules would help enforcement in a more focused manner and restrict the indiscriminate use of antibiotics.”
Under this new provision the drugs included in the new schedule could not be sold without a prescription from a registered medical practitioner, he added.
In March this year the health ministry published a draft amendment to the Drugs and Cosmetics Rules 1945 (www.cdsco.nic.in/G.S.R%20228.pdf). This proposed that, as well as requiring a prescription, drugs that were included in the new schedule H1 would also carry a warning that they may cause harm if not taken in accordance with medical advice.
However, the government made this amendment without consulting the Drug Technical Advisory Board. The amendment was eventually referred to the board for consultation, and in July it agreed with the proposed amendment. The final amendment is yet to be notified.
Irrational use of antibiotics is a major public health concern in India. The burden of bacterial disease in India is among the highest in the world.1 Between 2005 and 2009 the number of units of antibiotics sold rose by about 40%.
It is hoped that the additional warning will deter indiscriminate users from taking antibiotics without medical advice.
In a separate move India’s drug controller general, G N Singh, has sent an urgent letter to all the states’ drug controllers reminding them to make warnings about drugs visible to consumers to reduce the chances of misuse.
The letter says, “In many cases the caution does not appear in a conspicuous manner on the innermost label of these drugs and is overlooked by consumers as well as persons handling the drug. This leads to unethical use.”
Cite this as: BMJ 2012;345:e8290