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Home Government and Policy Coronavirus: Govt orders sale of Hydroxychloroquine strictly as per Schedule H1 norms, read what...

Coronavirus: Govt orders sale of Hydroxychloroquine strictly as per Schedule H1 norms, read what it means

The ICMR had recently prescribed the use of Hydroxychloroquine as a preventive measure in high-risk cases, like healthcare workers who are exposed to COVID-19 patients. Thereafter the government had also banned the export of the drug and its formulations.

As the coronavirus pandemic ravages through the world, nations worldwide are taking steps to battle the spread of the viral infection. The anti-malaria drug Hydroxychloroquine has reportedly shown promising results in the treatment of the COVID-19.

The ICMR had recently prescribed the use of Hydroxychloroquine as a preventive measure in high-risk cases, like healthcare workers who are exposed to confirmed COVID-19 patients. Thereafter the government had also banned the export of the drug and its formulations.

Now, the central government’s ministry of health and family welfare has ordered that the retail sale of the anti-malaria drug in any preparation containing it has to strictly be in accordance to the Schedule H1 of the Drugs and Cosmetics Rules, 1945.

The notification dated 26 March 2020 reads “Whereas the central government is satisfied that the drug Hydroxychloroquine is essential to meet the requirement of emergency arising due to pandemic COVID-19, and in the public interest, it is necessary and expedient to regulate and restrict the sale and distribution of the drug Hydroxychloroquine and preparation based thereon for preventing their misuse.

Now, therefore, in the exercise of the powers conferred by the Section 26B of the Drugs and Cosmetics Act, 1940 the central government hereby directs that the sale by retail of any preparation containing the drug Hydroxychloroquine shall be in accordance with the conditions for the sale of drugs under the Schedule H1 to the Drugs and Cosmetics rule 1945.”

The Schedule H1 of the Drugs and Cosmetics rule 1945 was added in 2013 and contained certain 3rd and 4th generation antibiotics, anti-TB drugs, and certain habit-forming drugs. These drugs are required to be sold under the following conditions:

  1. 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.

2. 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, and shall also be 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.”

The ministry’s order is to prevent self-medication, panic buying and OTC selling of the drug

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