Renu Arya
Central Research Institute of Homoeopathy Noida, India
Title: Indian Regulatory Standards & Quality Control of Drugs Used in Homoeopathy
Biography
Biography: Renu Arya
Abstract
India has its own unique health care delivery system. There is a provision of multiple systems of medicines for the promotion of health and prevention/cure of diseases. Integration of different philosophies in the delivery of health services is challenging but viable. Quality control is always been a challenge to every path of treatment which is directly dealing with the use of medicines derived from different sources and techniques. When it comes to homeopathic drugs which works on the principle of high dilutions of potentially active molecules retain a memory of the original substance it becomes even more important that the amount and quality of starting material depends on the method of preparation which should be standardized and controlled. The quality of source materials and of the excipients used in the manufacture of homeopathic medicines also leads to production of safe and effective drugs. Success in homoeopathic prescribing is based upon the purity and quality of drugs. A sub-standard drug will not produce desired therapeutic results. Standardization is essential to ensure purity, safety and efficacy of homoeopathic drugs. It is one of most fundamental prerequisites study for introduction of drug or formulation in clinical practice. Drug standardization study plays major role to ensure genuineness/authenticity, purity, quality, safety and efficacy of raw drugs as well as finished products used in homoeopathy. Every person engaged directly or indirectly in manufacturing, import, distribution should meet the relevant requirements as laid down in Good Manufacturing Practices (GMP) described in Sub rule (2) of Rule 85E of D&C Rules 1945 with conditions specified in Schedule M-1 which includes effective process controls, quality check on source materials, validated analytical methods, adequate buildings, good storage and sanitary conditions. It is high time that the available drugs should be of utmost quality and safe to consume.