The World Health Organization (WHO) International Medical Products Anti-Counterfeiting Taskforce (IMPACT) has a five pronged strategy to combat counterfeit and substandard medicines.
IMPACT which was formed in Rome in 2006 has 193 members and five working groups focusing on national and international initiatives in legislative and regulatory infrastructure, regulatory implementation, enforcement, technology and communication.
At the IPC-USP 8th Annual Scientific Meeting held in Hyderabad, experts addressed the key issues under the topic 'India Explores Important Public Health Topics'. It was here Dr Valerio Reggie, executive secretary, IMPACT recommended for the revision of Good Distribution Practices with emphasis on counterfeit medical products. IMPACT's modern testing technologies will help to combat counterfeiting and adulteration, he added.
Nearly 250 participants from over 90 companies in India attended the event which also featured exhibits and poster presentations.
There was a special session on metal impurities and a series of track sessions on which covered topics ranging from drug substances-adulterants and impurities. It also included drug product manufacturing and control, microbiology, biologics and biotechnology. Under the Special Tracks, speakers brought out the importance of reference standards and metal impurities.
The experts included Dr G N Singh, secretary and scientific director, Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare; Dr Jayashree Gupta, chairperson and managing director, IDPL, Ministry of Chemicals and Fertilizers, Dr Valerio Reggie, executive secretary, IMPACT, World Health Organization, and Dr Roger Williams, chief executive officer of the United States Pharmacopoeial Convention (USP).
The key issues addressed included drug substances like adulterants and contaminants track covered the Heparin and Glycerin cases. Emerging technologies like libraries of spectra would help identify counterfeits and substandard medicines. The experts also talked about residual solvents, metal impurities, and genotoxic impurities that may be present in a compendial article, closing with quality assurance and regulatory authorities to assure that impurities have suitable assessment methods and are appropriately managed in pharmaceuticals.
Under the track discussions for Drug Products focused on manufacturing of dosage forms and adherence to the International Conference on Harmonization (ICH) guidelines, performance verification and ways to consider equivalent or better procedures. The acetonitrile shortage was discussed and the prospect of upgrading some USP methods was also indicated.
The Biology and Biotechnology track focused on new cell-based bioassays, which may offer new ways to move from long-standing animal-based bioassay. Manufacturers also indicated they would like to see B&B monographs seven years before patent expiry.
Reference materials were discussed as key to successful use of documentary standards. Participants discussed how India is rapidly growing into a global leader in conduction of clinical trials, requiring availability of good reference standards and products.
In its closing session, USP encouraged industry, government, and academic representatives to apply to be candidates for the 2010-2015 Council of Experts.
Dr K V Surendra Nath, USP vice president, India, called for the collaboration with the Indian Pharmacopoeia Commission for drugs and dietary supplements.