Formation of separate ministry for pharma and medical device under consideration

Medical devices in India are currently governed by the Drugs and Cosmetics Act of 1940

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Union government is considering to make medtech (medical devices) as a seperate ministry excluding from pharmaceutical industry. The device industry also is asking the government to recognize local regulatory certifications, in addition to the currently accepted FDA approval from the U.S.

Medical devices in India are currently governed by the Drugs and Cosmetics Act of 1940, which was written primarily to govern pharmaceuticals. By splitting medtech from pharma, the Indian government is hoping that the industry can chart its own course moving forward, spurring growth for the industry. India's Health Ministry recently introduced a new regulatory document, Medical Device Rules 2017, which is specific to medical devices.

Medical devices currently are governed by the ministry of chemicals and fertilizer, but this may also soon change, stated Ananth Kumar, union minister for chemicals and fertilizers in a conference at Bangalore recently. He said India accounts for 20% of the world's generic medicine supply chain, exporting to over 250 countries.

The Union minister also said that his ministry, in collaboration with the Karnataka government, will establish a Pharma and Med Tech Zone in Bangalore to promote domestic manufacture of pharmaceuticals and medical devices under the Make in India mission.

India's medical device industry is growing at about 15 percent per year and is projected to reach $25 billion to $30 billion by 2025.

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