EXCiPACT ? Advantage ChIndia

1. Introduction: Globally, there has been an increasing focus on securing supply chains, as a means to ensure quality of medicines produced. The quality of excipients too is coming under scrutiny. The International Pharmaceutical Excipients Council has come up with EXCiPACT, a third party auditing certification, which would result in a reduction of audit burden on pharmaceutical companies, and save the parties involved up to ? 30,000. Currently, 7 excipient makers have obtained the EXCiPACT certified globally, with the last 3 suppliers having been certified in the last 6 months. None of the Indian excipient makers are EXCiPACT certified yet. This whitepaper looks at the potential of EXCiPACT in the context of the Indian pharmaceutical market, which, traditionally has looked at global excipient majors for meeting its demand. The whitepaper seeks to identify how EXCiPACT certification could potentially enhance the standing of Indian excipient makers in the market 2. Main: With FDA and EMA coming up with mandates requiring the audits of excipient suppliers, a credible one-stop 3rd party audit certification that could save both time and money for the suppliers and buyers of excipients is the need of the hour, made possible by the EXCiPACT certification. The EXCiPACT? Certification Scheme was developed by IPEC-Americas, IPEC Europe and the other founding members, the UK Pharmaceutical Quality Group, the European Fine Chemicals Group and the Federation of European Chemical Distributors. 3. Recommendation: There exists a potential sourcing opportunity for pharmaceutical companies looking to cut costs ? they could choose to engage with excipient makers in the emerging markets of India and China, incentivizing them with engagement deals upon EXCiPACT certification.