Gerald HeddlellIssues with data integrity are not confined to Indian companies

Gerald Heddlell
Issues with data integrity are not confined to Indian companies

Gerald W Heddell, BSc CBiol MSB MRSC DMS Director of Inspection, Enforcement & Standards Medicines & Healthcare products Regulatory Agency
Gerald W Heddell, BSc CBiol MSB MRSC DMS
Director of Inspection, Enforcement & Standards
Medicines & Healthcare products Regulatory Agency

LSW:  Your views on the outcome of the meeting held in February 2016 between the Indian pharma companies and the Regulators

Gerald Heddell: The meeting provided a platform for regulators and industry to openly and frankly discuss areas concerning Indian and global pharmaceutical manufacturers.  The discussion held was very positive and the MHRA looks forward to seeing what impact the conference and IPAs work will deliver


LSW:
 Which are the areas of operation Indian pharma companies need to focus on?

GH: In general the issues facing Indian pharmaceutical manufacturers are also seen by pharmaceutical manufacturers globally.  The most serious failures in GMP that require the MHRA to take regulatory action most commonly involve:

Serious Pharmaceutical Quality System failure (including corrective and preventative actions, management oversight and resourcing, quality defect investigations and actions and operational cross-contamination cont

Issues with on-going stability programmes

Quality defects with public health impact

Data Integrity

LSW:
 Your views on the data integrity that is maintained in India

GH: Whilst the MHRA has detected data integrity concerns during some of our inspections conducted with India, issues with data integrity are not confined to Indian companies.  Data integrity issues have been identified in a number of countries in which we perform inspections.

You can keep up to date with MHRA data integrity guidance by subscribing to the MHRA Inspectorate blog – https://mhrainspectorate.blog.gov.uk/

LSW:
 Can you elaborate on the objectives of the Regulatory collaboration between MHRA and CDSCO and the current activities?

GH: The Memorandum of Understanding (MOU) was agreed between MHRA and CDSCO on . 5 October 2015. This agreement will increase collaboration between the 2 countries in the area of medicines and medical devices with the aim of further improving public safety in the 2 countries.  It provides a formal agreement between the 2 organisations, and strengthens relations between the UK and Indian governments.

The central understandings of the agreement include promotion of each other’s regulatory frameworks, requirements and processes. Significant outcomes will include the facilitation and exchange of information and opportunities for technical cooperation of mutual benefit, helping to ensure the regulators are better equipped to protect the health of their citizens.

LSW:  Details of medicines are available to the general public on the Internet and other social media are a matter of concern on safety issues. What do the Regulatory agencies say on this?

GH: The availability of unregulated medicines through the Internet and the use of social media to advertise these is a global problem. We have found the most effective method of dealing with this is to reduce demand by education and raising public awareness as to the dangers of buying medicines outside the regulated supply chain. In terms of enforcement, developing relationships with public and private bodies and executing joint proactive strategies to deal with websites and the criminals behind them is key – the Interpol Operation Pangea is an excellent example of how effective this can be.

http://www.interpol.int/Crime-areas/Pharmaceutical-crime/Operations/Operation-Pangea

https://conversation.which.co.uk/health/buy-medicines-online-illegal-safe-dangerous/

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