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Section H1

Section H1 Drugs and Cosmetics Rules

In September 2013, the Drugs and Cosmetics Rules 1945 was modified. A section H1 was added to specify certain 3rd and 4th generation antibiotics in addition to some anti-TB drugs and addictive drugs.

For the drugs under Schedule H1, pharmacies are required to retain a copy of the prescription and maintain a separate register with the name of the prescriber and the patient, among other details.

This is a measure to curb the rampant (ab)use of antibiotics in India which has led to antibiotic-resistant bacteria e.g TB bacteria.

Initially, 91 drugs were to be included in the list. But based on feedback from the industry, only 48 have been added in the first phase. A complete list of these drugs can be found at http://www.cdsco.nic.in/writereaddata/MinutesDTAB%2062nd.pdf

There already exists a Section X (containing 110 drugs; mostly narcotic and psychotropic) which are similarly controlled and have stringent controls on dispensing and record-keeping.

It is estimated that there are about 6 lakh retail pharmacies in India. As seen in a previous blog entry, this measure has been met with resistance from chemists associations who complain that the Indian pharma industry currently does not have the infrastructure to maintain such records. Nor do they have enough qualified chemists.

However the danger of antibiotic-resistant superbugs is real and important enough to justify public health policy makers to work on this problem.