NOMCoL urge for collaboration between the pharmacopeias and drug regulatory bodies

28 May 2015 | News | By BioSpectrum Bureau

NOMCoL urge for collaboration between the pharmacopeias and drug regulatory bodies

US Pharmacopeia (USP) organized a three-day workshop for the Asia chapter of the Network of Official Medicines Control Laboratories (NOMCoL) from May 26-28, 2015. Members of NOMCoL's Asia-Pacific chapter met on day one to discuss the need for harmonization and collaboration between the pharmacopeias and drug regulatory bodies to ensure quality, safety and efficacy of drugs.

The NOMCoL Hyderabad workshop was also attended by representatives of the Central Drugs Standard Control Organization and drug and quality control officials from countries like Vietnam, Philippines, Indonesia and Laos. Discussions focused on current issues faced by the laboratories related to dissolution and HPLC (high performance liquid chromatography), Inter Laboratory Testing (ILT) results from 2014, selection of ILT sample for 2015 and proper ways to test samples from receipt to storage. The discussion also touched upon NOMCoL Asia Pacific's future sustainability plan and the strategy to enhance network operations.

"Borders are porous for poor quality medicines, which present a real threat to public health. Communications across regions and a cooperative response are imperative. USP sees an opportunity to support India in a leadership role in the Asia Pacific region: helping to build laboratory capacity among other neighboring countries, enabling stronger regulatory systems, and protecting millions of patients from harm ," said Kelly Willis, Senior Vice-President - Global Public Health, US Pharmacopeia

"We appreciate US Pharmacopeia's work initiated through NOMCoL and congratulate them for organizing this meeting of regulators from South-east Asia that enables collaboration with them. US Pharmacopeia's presence in India has boosted the confidence of the Indian drug manufacturers who export their medicines and vaccines and we want USP to work with us in the national quality control program. We are planning to introduce international alert and mobile testing units to maintain the quality of medicines and keep a check," said Dr. GN Singh, Drugs Controller General of India.

"NOMCoL offers unique inter-laboratory testing activities for participating labs to improve laboratory performance as well as harmonize their drug analysis methodologies and help in the quality control of essential medicines, detect substandard and counterfeit drugs. As a standard setting organization and Global Public Health as our mission, we would like to promote good quality medicines across the world. NOMCol is one such initiative," said Dr. K V Surendranath, Senior Vice President, International Site Operations; Senior Vice President, USP-India

NOMCoL networks have been established to provide a forum for sharing best practices and address issues surrounding quality of medicines at regional and national levels. These networks offer unique inter-laboratory testing activities for participating labs to improve laboratory performance as well as harmonize their drug analysis methodologies.

There are currently four OMCL networks: The External Quality Control Programs (EQCP) network, created in collaboration with the Pan American Health Organization (PAHO) and OMCLs from Latin American and Caribbean countries (2001); and the Networks of Official Medicines Control Laboratories (NOMCoL) in Africa (2009), Middle East/North Africa (MENA) (2010), and Asia Pacific (2013).

NOMCol-Asia Pacific was established in the region with the aim of strengthening the technical and procedural capacity of members to achieve and maintain international medicines control laboratory standards.

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