Navdha et al. International Journal of Drug Regulatory Affairs; 2018, 6(1), 35-40 ISSN: 2321 - 6794 © 2018 IJDRA Publishing Group, All rights reserved Page 35 CURRENT REGULATION OF MEDICAL GASES IN INDIA AND FUTURE ASPECTS Available online at www.ijdra.com REVIEW ARTICLE 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 DOI: https://doi.org/10.22270/ijdra.v6i1.226 INTRODUCTION Under the Drug and Cosmetics Act, the regulation of manufacture, sale and distribution of Drugs is primarily the concern of the State authorities while the Central Authorities are responsible for endorsement of New Drugs, Clinical Trials in the country, setting down the standards for Drugs, control over the quality of imported Drugs, coordination of the activities of State Drug Control Organizations and providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act. Drug Controller General of India is responsible for approval of licenses of specified categories of Drugs. The Central Government in exercise of power under Section 5 & 7 of the said Act had proclaimed the rules namely Gas Cylinder Rules, 2004 to regulate filling, ownership, transport and import of such gases. The goal of these Rules is to ensure safety of the general population occupied with the activity of filling, ownership, transport and import of such gases. (1) Manufacturing practice for Medical Gases (1-3) The organization must be manufacturer of Medical Gases i.e. Medical oxygen IP, Nitrous oxide IP, Medical carbon dioxide, IP and should be have valid manufacturing license issued from the state Drug controller as per the provisions of the Drug and Cosmetic Act 1940 and rules there under. General requirements Location and surroundings: The facility for the manufacture of medical gases shall be so situated and shall have such measures as to avoid risk of contamination. Personnel: The manufacturing shall be conducted under the direct supervision of competent technical staff with prescribed qualifications and practical experience in the relevant areas. Buildings and premises: Facility shall be designed, constructed, adapted and maintained to suit the manufacturing operations so as to permit production of drugs under hygienic conditions. They shall conform to the conditions provided in the Factories Act, 1948. Production area: The production area shall be designed to allow the production preferably in uniflow and with logical sequence of operations. 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. Keywords: Medical gas, Regulations, Documentation, Good manufacturing practice, Standards.