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Acitretin to be included in Schedule H, says Health Ministry

 

Clinical courses

Acitretin to be included in Schedule H

The Health Ministry says that Acitretin will be included in Schedule H after making an amendment in the Drugs Rules, 1945. Acitretin is an oral retinoid used in the treatment of severe resistant psoriasis.

Schedule H is a class of prescription drugs in India appearing as an appendix to the Drugs and Cosmetics Rules, 1945. These are drugs which cannot be purchased over the counter without the prescription of a qualified doctor. The manufacture and sales of all drugs are covered under the Drugs and Cosmetics Act and Rules.

Generally, it is used in only severe cases of psoriasis that have been unresponsive to other treatments because of the potential for problems and severe side effects.

Acitretin is highly teratogenic and known for the possibility of severe birth defects. It should not be used by pregnant women or women planning to get pregnant within 3 years following the use of acitretin.

Men and women who use it should not donate blood for three years after using it, because of the possibility that the blood might be used in a pregnant patient and cause birth defects.


Central Government proposes this amendment in exercise of the powers conferred by sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 and in consultation with the Drugs Technical Advisory Board.

Health ministry further said that objections and suggestions which may be received from any person within thirty days will be considered by the Central Government, before releasing the final draft in Gazette of India.


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