IPEC Federation is a global organization that promotes quality in pharmaceutical excipients. IPEC currently is a federation of five independent regional Industry Associations headquartered in the United States (IPEC-Americas), Europe (IPEC-Europe), Japan (JPEC-Japan), China (IPEC-China) and India (IPEC-India) – provides a unified voice to promote the best use of excipients in medicines as a means of improving patient treatment and safety.
International Pharmaceutical Excipients Council of India (IPEC India)
IPEC India was registered in the year 2014 in India and is a not-for-profit organization.
Key objectives for the Federation are Harmonization of Standards, Promoting Supply Chain Security, and the further development of Third-party Certification, as well as providing a source of Advice and Expertise for other stakeholders on excipients.
Excipients play a critical role in the manufacture of medicines by helping to preserve the efficacy, safety, and stability of active pharmaceutical ingredients (APIs), and helping to ensure that they deliver their promised benefits to patients. Optimal use of excipients provides pharmaceutical manufacturers with drug development cost savings, enhanced functionality, capability and can also assist in drug formulation innovation.
Developing to be a well-recognized independent association effectively creating awareness in GMP, GLP among excipient users and manufacturers;
Bridging the gaps between government and non-government; existing regulation and the next one to go for improvement, harmonizing the gaps of standards and regulations between local and global.
Aims & Objectives
- To develop and promote voluntary guidance and other programs for the global pharmaceutical industry that are designed to ensure continued availability of excipients and related components for finished products that meet the highest appropriate standards for quality, safety and functionality throughout their manufacturing process and supply chain
- To encourage the pharmaceutical industry, the Indian regulatory authority (CDSCO), the Indian Pharmacopoeia Commission (IPC), and other public health and compendial standards for pharmaceutical excipients
- To educate and cooperate with regulatory authorities, industry organizations and scientific bodies working to advance public health on matters relating to the manufacture, distribution, use, and functionality of excipients
- To maintain and develop external collaborative relationships and establish new ones as appropriate to meet member’s objectives
- To develop a promotion and communication program by means of seminars, webinars, workshops, participation in symposiums, exhibitions to inform government, industry, media and the public about excipients issues and accomplishments.
- To create awareness among excipient manufacturers, distributors and users about the various IPEC Guidelines for the industry.
- To initiate timely actions those are likely to improve the regulatory climate, the reputation of the industry and consumer confidence in the industry and its products
- To create standards and procedures towards self-regulation to assure quality, safety and integrity of natural pharmaceutical foods, products, services, and labelling information. The key concept for IPEC India is to project a neutral industry association which can independently make regulators and excipient users and producers work together.