Regulatory Aspects of Pharmaceutical Excipients in India and their Qualification to Use in Pharmaceuticals
Kambham Venkateswarlu1*, B. Siva Sai Kiran2
*1Department of Pharmacoinformatics, National Institute of Pharmaceutical Education and Research (NIPER), Hajipur, Vaishali-844102, Bihar, India.
2Department of pharmaceutical Analysis and Regulatory Affairs, JNTUA Oil Technological and Pharmaceutical Research Institute, Jawaharlal Technological University Anantapur, Ananthapuramu-515001, Andhra Pradesh, India.
Excipients are an inactive substances formulated along with the active pharmaceutical ingredient(s) (APIs) of medication for bulking up of formulations or to give a therapeutic enhancement of API in the final dosage form. Almost of all the marketed products contain excipients thereby the excipients play a crucial role in the manufacture of medications by helping to preserve the efficacy, safety and functionality of the APIs. Excipients categorized as compendial excipients (official in pharmacopoeia) and non compendial excipients (non official in pharmacopoeia). The main objective of excipient in formulation is, they can deliver a drug from its dosage form in desired path. This paper deals with the challenges, regulatory aspects of excipients and role of International Pharmaceutical Excipients Council (IPEC) in regulating the quality of excipients.
Key words: Regulatory affairs, Excipients, IPEC, Challenges, Qualification.