The US Pharmacopeial Convention (USP), recently brought together national medicines control laboratory officials for a workshop in Hyderabad at its India office on improving aspects of medicines quality in the Asia-Pacific region. Kelly Willis, Senior Vice-President – Global Public Health, US Pharmacopeia shares the details in an interview with Shalini Gupta
How many national medicines control laboratory officials came for the workshop and which countries did they represent? How many times has this meeting been organised before and what have been the achievements so far?
Representatives from eight National Quality Control Laboratories from seven countries including Laos, Myanmar, Cambodia, Vietnam, Philippines, Thailand, and Indonesia attended the workshop along with Dr GN Singh, Director General, DCG(I), Director of the Central Drug Testing Laboratory of Telangana as well as representatives of the Indian Pharmacopeial Commission and Pharmexcil.
This is the second NOMCoL meeting in South East Asia. The first meeting was held in February 2013 in Siem Reap Cambodia. So far the NOMCoL initiative has led to increased capacity of the national quality control laboratories to conduct compendia testing, improved mechanisms for sharing information as well as development of a framework for collaborative testing to identify gaps in the quality assurance systems in the countries.
Which areas did you focus upon in this meeting?
At the workshop, we introduced national quality control laboratories in the region to our facility at USP-India and established mechanisms for increased collaboration between the countries in the Asia-Pacific region and USP-India. We also developed a shared framework for the collaborative testing of medicines in the region and identified priority medicines of interest for collaborative testing. Most of the laboratories in these countries have been instrumental to providing confirmatory test results to the Promoting the Quality of Medicine’s (PQM) BREMERE initiative, which investigates poor quality medicines in Southeast Asia.
Promoting the Quality of Medicines (PQM) established the Regional Expertise in Medicines Regulation, Information Sharing, Joint investigation and Enforcement (BREMERE) initiative to enhance the timely information-sharing and cooperative action on the quality of suspected, falsified, counterfeit, and substandard medicines among regulators and partners in the region, and beyond, to facilitate enforcement actions. PQM is a collaborative agreement between the US Agency for International Development (USAID) and USP.
Which laboratories in Asia Pacific in particular are doing well to promote safe medicines? What work are they doing in particular? Which countries do they represent? What have been some of the learnings?
Many countries in the region have made good progress in building a good capacity for quality control of medicines. Countries that stand out in this regard are Vietnam and Thailand. They both have attained ISO 17025 accredited laboratories and are helping to strengthen laboratory capacity in other countries in the region. These two laboratories have also achieved WHO Prequalification with the assistance of PQM.
Having attained both ISO accreditation and World Health Organisation (WHO) prequalification status, these NQCLs can serve as a reference for pharmaceutical manufacturers in the region that are seeking to supply bulk medicines to procurement agencies but must first obtain WHO product prequalification to ensure that their products meet acceptable standards of quality, safety and efficacy.
How would you rate the quality of medicines in the Asia Pacific? Which countries stand apart and why?
Significant improvements have occurred in medicine quality in Asia. While the problem of substandard and counterfeit medicines still persists, it has improved. For example, in 2003, Cambodia had an alarming rate of upto 40 per cent for substandard and counterfeit medicines, but today, given these improvements, that number is much smaller.
What have been some of the newer methods for analysing the quality of drug samples and increase laboratory performance that you aim to bring to India with this workshop?
The methods of analysis are not so much what are new; what is new, and smarter, it is how we are applying existing technologies. We are applying current known technologies in smarter ways to better solve the problems of counterfeit and substandard medicines. For example, we are promoting the use of field based screening technologies such as Raman spectrometry to quickly screen medicines in the field especially in remote parts of a given country so that poor quality medicines can be quickly removed from the supply chain.
What are some of the novel strategies and tools for increased data transparency and information sharing with laboratories?
These include increased collaboration, coordination, communication and sharing of test results and other relevant information on specific cases of suspected products found in the region. They are discussing plans to develop an online information and data sharing platform for the NOMCoL Asia Pacific lab members. All countries represented at this workshop have functional quality control laboratories and are all in the front line of their countries to control the quality of medicines in the respective countries. At the workshop, USP experts shared current approaches for conducting quality control and stressed the need for proper quality management systems to ensure data integrity and reliability.
How do you think regulatory authorities can partner better with USP to achieve a standardisation of laboratory practices and better sharing of best practices?
Regulatory authorities play a central role in ensuring that quality standards are adhered to. In general standards are not embraced without regulatory oversight, hence regulatory authorities play a principal role in ensuring compliance. USP seeks partnership with regulators in a number of ways including working through NOMCOL where USP shares best practices in quality control, through our RSAP (Reference Standard Assistance Program) where we make primary reference standards and documentary standards available to countries at reduced or no cost to allow them to use high quality and reliable reference materials. Through these programmes, USP hopes to foster strong quality management culture in the quality control Laboratories so that results produced are reliable and trustworthy. We also support exchange programmes through
visiting scientist programmes and international technical assistance programme at USP-US in the US to share learnings and best practices.