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Current regulation of medical gases in India and future aspects Soni Navdha N*, Maheshwari Dilip G Department of Quality Assurance and Pharm. Regulatory Affairs, LJIP, Ahmedabad, Gujarat, India *Corresponding Author's E-mail: navdhasoni9@gmail.com
Online published on 17 September, 2019. Abstract Generally medical gases are administered or supplied directly to the patients. They should be manufactured and transferred with the highest quality possible as per standards and limits decided by the different regulatory authorities. In India medical gases are regulated by Ministry of Commerce and Industry and central drug standard control organization. Along with these various act are available for better regulation that are Explosives act 1884, Gas cylinder rules 2004, Drugs and Cosmetics Act and specifications of medical gases are given in Indian pharmacopoeias. Various facilities and requirements for the manufacturing and regulation of medical gases are covered. In spite of all the regulations, there are reports of problems associates with medical gas manufacturing and uses. What are steps should be taken for the solution of these problems. Top Keywords Medical gas, Regulations, Documentation, Good manufacturing practice, Standards. Top | |
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