India removes price caps on foreign-made drugs to treat rare diseases

In a controversial move intended to help patients gain access to new drugs, India has exempted from price controls foreign-made pharmaceuticals for treating rare diseases such as cystic fibrosis and muscular dystrophies. Drugs to treat such diseases are sometimes called orphan drugs in India. The exemption lasts for five years and applies to medicines patented in India and produced anywhere abroad. Previously, price-cap exemptions applied only to new drugs developed through R&D in India and produced there. India’s Department of Pharmaceuticals expanded the price-cap exemption despite the concerns of Secretary of Health and Family Welfare Preeti Sudan, who wrote to Secretary of Pharmaceuticals Jai Priye Prakash in November 2018 asking for increased price controls. Other critics of the expanded exemption include domestic drug makers and public-health advocates. The decision was “hasty and ill-conceived,” will reduce access to high-priced drugs, and will constrain the government’s ability to act in the interest of public health, says Malini Aisola of the All-India Drug Action Network, which advocates for increased access to essential medicines. India’s Ministry of Health & Family Welfare determines which diseases qualify as rare.