Workshop was attended by representatives of the CDSCO and drug and quality control officials from countries like Vietnam, Philippines, Indonesia and Laos
US Pharmacopeia (USP) recently organised a three-day workshop for the Asia chapter of the Network of Official Medicines Control Laboratories (NOMCoL). Members of NOMCoL’s Asia-Pacific chapter met on day one to discuss the need for harmonisation 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 neighbouring 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 organising 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 programme. 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 (India).
Speaking more about mobile testing units, Singh said, “We have already launched a pilot mobile testing unit in Gujarat. We will look at its success and make the required changes. We plan to introduce atleast 20 mobile testing vehicles over the period of next one year. Approximate investment per mobile unit is around one crore. Currently, we are in the process of studying the instruments that will be used insides the mobile vehicles. These instruments are going to be of special quality and dimensions as they will be used inside the mobile vehicles.”
“NOMCoL offers unique inter-laboratory testing activities for participating labs to improve laboratory performance as well as harmonise their drug analysis methodologies and help in the quality control of essential medicines, detect substandard and counterfeit drugs. As a standard setting organisation 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 KV 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 harmonise 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.
NOMCoL network objectives include:
- Strengthening the performance and technical skills of staff
- Promoting communication and the exchange of information
- Harmonising methodologies to facilitate acceptance/recognition
- Ensuring compliance with Good Laboratory Practices (GLP)
- Eliminating substandard and counterfeit drugs