The Delhi-headquartered regulator issued a guidance note today, explaining it aims to "contain microbial resistance" by reminding pharmacies and patients of the problems associated with taking antibiotics that have not been prescribed.
"To contain anti-microbial resistance, the office has been advising the supply chain system in India to follow strict requirements of Schedule H and H1 for the sale of medicines."
Under Indian law Schedule H medicines must be labelled with “Rx” and information making clear the drug is only available on prescription.
Schedule H1 drugs carry the same information and a warning that “it is dangerous to take the preparation except in accordance with the medical advice.”
The Central Drugs Standard Control Organization (CDSCO) said the note was prompted by reports that “antimicrobial resistance has resulted in the death of a patient in India” but did not provide additional information.
US death
The CDSCO note comes days after the Centers for Disease Control and prevention (CDC) reported the detection of an untreatable superbug in samples from a woman who died last September after returning to the US from India.
According to the agency the deceased woman returned to the US and was admitted to hospital in Reno, Nevada in August after an extended visit to India during which she was hospitalized on several occasions after fracturing her right femur.
Subsequent testing of isolates from the deceased woman identified a strain of Klebsiella pneumoniae that is resistant to all antibiotics available in the US.
Collaboration
Publication of the note coincides with the start of an antibiotics-focused research projects by India's Department of Biotechnology and the Swedish Governmental Agency for Innovation Systems (VINNOVA).
The wide ranging project is designed to foster development of research and innovation in a number of scientific areas, including antimicrobial resistance.