Context: Recently, anti-malarial drug hydroxychloroquine has been notified under Schedule-H1 by the government. This was done in exercise of its powers conferred by Section 26B of the Drugs and Cosmetics Act, 1940 (23 of 1940).
About 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 and display.
• It 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 3 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, and shall also be labelled with the following words in a box with a red border.

Implications of the classification of the malaria drug as Scheduled-H1

• It restricts its sale only based on prescription. The sale of the drug from now on should be in accordance with the conditions for sale of drugs as 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 3 years and be open for inspection.

Classification of drugs in India based on their approval status are as follows

• Drugs approved in India for more than 4 years except for modified release dosage form [old drugs*]. (*Drugs that are official in the Indian pharmacopeia are also considered as old drugs with the exception for modified release formulations.)
• New Drugs approved in India for a period of more than 1 year but less than 4 years.
• Drug products in modified release form irrespective of their approval status
• New drugs approved in India within a period of one year.
• New molecule not approved in India but approved in other countries.
• It should be noted that one cannot perform bio study in India on Indian population for a drug not marketed/approved anywhere in the world.