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Fix trade margin to be on orphan drugs, basically orphan drugs are synthetic pharmaceutical which are very specifically developed for the treatment of rare medical conditions, such conditions which are itself known as an orphan disease. As per the health ministry official said assuring relief on the patients burdened with exorbitant treatment costs. If, this move gets successful then it may affect many multinational pharmaceutical companies like Pfizer, Sanofi Genzyme & Shire USA, who makes orphan drugs.
Till now the health ministry has identified drugs to treat 21 rare diseases & 39 cancer drugs. The department of Pharmaceuticals (DoP) has been asked to examine the possibility of fixing the trade margins.
“The DoP had asked to shortlist the drugs on which trade margins can be applied. The list has been sent to them. Now, the DoP will have to examine the individual drugs and take a call," the official cited above said.
Some of the diseases mentioned in the health ministry communications to the DoP are Type 2 cerliponase, Lysosomal acid lipase deficiency, Hunter Syndrome, Fabry Disease, Gaucher Disease, Pompe Disease, Duchenne muscular dystrophy, cystic fibrosis etc.
The issue regarding the cost of such drugs were always a concern for the health ministry & they have been raising the concerns about the over pricing of such life saving drugs for a long while. On 29 November, health secretary Preeti Sudan wrote to DoP secretary Jai Priye Prakash “to explore the feasibility of capping the prices of drugs used for treatment of rare diseases so that their prices become responsible and affordable to the patients."
Malini Aisola, co-convenor of All India Drugs Action Network (AIDAN) said that “The discussion of trade margin capping for cancer and rare diseases is to distract from the disastrous amendments to DPCO recently notified. Margin caps of these medicines is misconceived, will not address the root of the high prices and will not increase affordability".
