Why recently in news?
Government of India has declared “HYDROXYCHLOROQUINE” as schedule H1 drug. On 26TH-MARCH-2020 night, the Ministry of Health through a special amendment has categorized hydroxychloroquine (HCQS) drug as a schedule H1 drug- which means 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 autoimmune disease.
In India, the cosmetic import, manufacture, distribution and sale of the drugs happen under the DRUG AND COSMETIC ACT, 1945. “Schedule H1” was introduced through “ GAZETTE NOTIFICATION GSR-588 (E)” that is dated 30-august-2013, to check the indiscriminate use of antibiotics, Anti-TB and some other drugs in the country.
The schedule H1 drugs should be recorded in a separate register. Therefore, the Ministry in the exercise of the powers conferred by Section 26B of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government has directed that sale by retail of any preparation containing the drug Hydroxychloroquine shall be in accordance with the conditions for the sale of drugs specified in Schedule H1 to the Drugs and Cosmetics Rules, 1945.
“Schedule H1 Drug-Warning:
- Under schedule H1, drugs should be labelled with the symbol “ Rx”, which shall be in RED and conspicuously displayed on the left top corner of the label.
- The drug must possess a warning label of “only prescription sale” and against self-medication.
- Also, the chemist should maintain records for the mane and address of the prescriber, the name of the patient, the name of the drug and the quantity supplied. These records must be maintained for 3 years and be open for inspection.
Recently, the ministry of health and family welfare issued a directive that restricts the sale and distribution of hydroxychloroquine. The drug has been declared as an essential drug to treat COVID-19 patients. The Central govt. has specified the sale of the drug in schedule H1 to the drug and cosmetic rules 1945.
The National Task Force for COVID-19 constituted by ICMR, recommended the usage of “HYDROXYCHLOROQUINE” to treat COVID-19 patients and restricted GOI for its export.
Classification of Drugs in India
The Drugs and Cosmetics Rules, 1945, under the Drugs and Cosmetics Act, 1940, provides for the classification of drugs into different schedules.
| Schedule | Features |
| Schedule H1 |
|
| Schedule H |
|
| Schedule X |
|
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