000			a
999			_c23002 _d23002
003			OSt
005			20250620094437.0
008			250620b xxu||||| |||| 00| 0 eng d
040			_aAIKTC-KRRC _cAIKTC-KRRC
100			_926509 _aPathak, Rahul
245			_aUnlocking the benefits of Drug Master File filing in the Indian pharmaceutical industries
250			_aVol.56(5), Sep-Oct
260			_aNew Delhi _bWolter Kluwer _c2024
300			_a342-347p.
520			_aEnsuring the safety and quality of drugs is a crucial component for the development of any pharmaceutical industry. This requires stringent regulation in the process of drug manufacturing and marketing. A Drug Master File (DMF) serves as a comprehensive document containing information about the quality, safety, and manufacturing procedure/facility of a drug or drug substance. Many countries with highly regulated markets use the DMF system extensively to protect their intellectual property rights while providing accurate and detailed information about their products to regulatory bodies. In India, the regulatory body, the Central Drug Standard Control Organization, does not currently mandate the submission of a DMF. However, adopting a DMF system may have immense benefits to regulatory bodies, pharmaceutical industries, as well as to patients. This review aims to provide a comprehensive overview of DMF and highlight the significance of its adoption in India.
650		0	_94774 _aPHARMACOLOGY
700			_926510 _aSingal, Rajat
773	0		_tIndian Journal of Pharmacology _dAndheri - Mumbai Wolters Kluwer India Private Limited _x0253-7613
856			_uhttps://journals.lww.com/iphr/fulltext/2024/09000/unlocking_the_benefits_of_drug_master_file_filing.7.aspx _yClick here
942			_2ddc _cAR