India and China Start To Regulate Antibiotics

India’s National Policy for the Containment of Antibiotic Resistance

On April 11, 2011, the Indian government released its National Policy for the Containment of Antibiotic Resistance. This is the government’s first policy that regulates the use of antibiotics in India. This policy also forms a new section to India’s 1940 Drugs and Cosmetics Bill, called Schedule HX.

Antibiotics prescribed in India are now required to have labels marked with either a ‘Schedule H’ or a ‘Schedule X’. The ‘Schedule H’ label indicates that the antibiotic drug can only be dispensed with a doctor’s prescription. The ‘Schedule X’ label indicates that the drug can only be available for use in hospitals. Following the new policy, doctors must now issue two copies of a prescription – one for the pharmacist and one for the Drug Controller General of India. In hospitals, junior doctors will also have to obtain permission from their supervisors to prescribe third and fourth generation antibiotics.


China to establish regulation against antibiotic use

In April 2011, China also announced that it will be establishing a regulation to curb the overuse of antibiotics. Once the regulation is in place later this year, the antibiotics will be divided into three categories – i) restricted antibiotics; ii) unrestricted antibiotics, and iii) antibiotics under special management.

The distribution of antibiotics to patients will come under the responsibility of the directors of medical institutions. Each medical institution will also be given varying access to antibiotics (either full or partial), depending on its institutional level.

In the meantime, the Chinese government will intensify the monitoring of antibiotics distribution. Based on official government sources, only 20% of patients in China actually need antibiotics. However, statistics indicate that 70 out of 100 Chinese inpatients are prescribed antibiotics. This is a concern for the government, as almost 700,000 cases of adverse drug reactions in 2010 were caused by medicine abuse, according to the China’s State Food and Drug Administration (SFDA).