Question: Consider the following statements:
(1) Ministry of Health through a special amendment has categorized hydroxychloroquine (HCQS) drug as a schedule H1 drug.
(2) The supply of a drug specified in Schedule H1 shall be recorded in a separate register at the time of the supply giving.
Choose the correct:
(a) Only(1)
(b) Only(2)
(c) Both (1) and (2)
(d) None of the above
Answer:(c)
Related facts:
- On March 26, 2020, the Ministry of Health through a special amendment has categorized hydroxychloroquine (HCQS) drug as a schedule H1 drug-
- It means that it cannot be sold over the counter.
- The move comes as reports emerged of hoarding and shortage of this drug due to the national lockdown, this drug is prescribed as a chronic therapy for patients suffering from Lupus and Rheumatoid Arthritis, an auto immune disease.
Schedule H1 Drug:
- The Drugs and Cosmetics Rules, 1945, are the set of rules under The Drugs and Cosmetics Act, 1940, which has provisions for classification of drugs into different schedules and also guidelines for storage, sale, display.
- Schedule H1 has been introduced through Gazette notification GSR 588 (E) dated 30-08-2013 to check the indiscriminate use of antibiotics, anti-TB and some other drugs in the country.
- The schedule contains certain 3rd and 4th generation antibiotics, certain habit forming drugs and anti-TB drugs.
- As per government notification, these drugs are required to be sold in the country with the following conditions:
- The supply of a drug specified in Schedule H1 shall be recorded in a separate register at the time of the supply 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 in Schedule H1 shall be labelled with the symbol Rx which shall be in red and conspicuously displayed on the left top corner of the label.
Links: https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/hydroxychloroquine-becomes-a-schedule-h1-drug-as-hoarding-leads-to-shortage/articleshow/74842650.cms?from=mdr http://vbch.dnh.nic.in/pdf/Rules%20and%20regulations%20of%20Drug%20and%20Cosmetics%20act.pdf