Amid the ongoing coronavirus pandemic, the Ministry of Health and Family Welfare (MoHFW) has issued a directive restricting the sale and distribution of "hydroxychloroquine" declaring it as an essential drug to treat the COVID-19 patients and meet the requirements of emergency arising due to the pandemic.
The Ministry of Health and Family Welfare on Thursday made the announcement making it clear that the order "shall come into force on the date of its publication in the official Gazette".
In the order, the government declared that the Central government is "satisfied that the drug hydroxychloroquine is essential to meet the requirements 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 exercise of the powers conferred by Section 26B of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central govemment hereby directs that sale by retail of any preparation containing the drug Hydroxychloroquine shall be in accordance with the conditions for sale of drugs specified in Schedule H1 to the Drugs and Cosmetics Rules, 1945."
This would mean that any preparation containing the said drug will have a warning label of ‘only prescription sale’ and against self-medication. Additionally, chemists would need to maintain records for 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 order came at a time when the novel coronavirus claimed 17 lives and infected over 720 people across India.
The announcement regarding ban of sale and distribution of the drug was made by the government earlier but it issued an official Gazette notification on Thursday (26 March) signalling that hydroxychloroquine -- an anti-Malaria drug -- will work as a medicine for treating coronavirus infected patients as well.
Recently, the national task force for COVID-19 constituted by Indian Council for Medical Research (ICMR) has recommended hydroxy-chloroquine as a preventive medication.
What are Schedule H1 Drugs?
The regulation of India's drug and cosmetic import, manufacture, distribution and sale is done as per the Drugs and Cosmetics Act, 1940. The primary aim of the act is to ensure that the drugs and cosmetics sold in India are safe, effective and conform to state quality standards.
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:
(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: