Ministry of health has notified hydroxychloroquine, which may have some preventive role in COVID 2019, as a Schedule H1 Drug
Hydroxycholoroquine, a drug used in the treatment of autoimmune disorders such as rheumatoid arthritis, has been put under Schedule H1 of the Drugs and Cosmetics Act. This was necessitated by raid depletion of stocks in stores after the Indian Council of Medical Research said it could be used to post exposure prophylaxis (prevention after contact) in healthcare workers and caregivers at home with exposure to a confirmed COVID 2019 patient.
Drugs in this category cannot be self without the prescription of a registered medical practitioner. The supply of a drug specified in Schedule H1 needs to be recorded in a separate register by chemists at the time of the sale, giving the name and address of the prescriber, the name of the patient, the name of the drug and the quantity supplied and such records shall be maintained for three years and be open for inspection.
The drug specified is labelled with the symbol Rx which is in red and conspicuously displayed on the left top corner of the label, and is also labelled with the following words in a box with a red border:
| “Schedule H1 Drug-Warning:
-It is dangerous to take this preparation except in accordance with the medical advice. -Not to be sold by retail without the prescription of a Registered Medical Practitioner.” |
This is to ensure there is no misuse of the drug. Health officials say the reason why these precautions are being taken is because efficacy of the drug for the purpose of post exposure prophylaxis, is not clinically proven. During a briefing on Thursday, health ministry joint secretary Lav Agarwal said: “This is an experimental drug (use).” HCQ has been in use for many years but whether it works in the Novel Coronavirus Disease (COVUD 2019) is not known because this is a “novel” virus.
Dr Balram Bhargava, secretary, department of health research, had said earlier this week that they were recommending hydroxychloroquine for preventive use in only health workers or people at home caring for COVID-19 patients.