What is PIC/S? Is India part of PIC/S?
What is PIC/S?
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is a non-binding, informal co-operative arrangement between Regulatory Authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use.
Pharmaceutical Inspection Co-operation Scheme (PIC/S) is the international instruments between countries and pharmaceutical inspection authorities, i.e regulatory bodies. The PIC/S is meant as an instrument to improve co-operation in the field of Good Manufacturing Practices between regulatory authorities and the pharmaceutical industry.
Is India part of PIC/S?
As on date, India is not part of PIC/S.
Which are the countries are presently member of PIC/S?
- Argentina
- Austria
- Australia
- Belgium
- Canada
- Switzerland
- Cyprus
- Czech Republic
- Germany
- Denmark
- Estonia
- Spain
- Finland
- France
- United Kingdom
- Greenland
- Greece
- Hong Kong
- Croatia
- Hungary
- Indonesia
- Ireland
- Israel
- Iceland
- Italy
- Japan
- South Korea
- Liechtenstein
- Lithuania
- Latvia
- Malta
- Malaysia
- Netherlands
- Norway
- New Zealand
- Poland
- Portugal
- Romania Sweden
- Singapore
- Slovenia
- Slovakia
- Thailand
What are the advantage to become part of PIC/S?
- Major advantage for countries to being part of PIC/S is International GMP harmonisation. By taking part in the meetings of the PIC/S Committee, PIC/S Participating Authorities are involved in the development and harmonisation of international GMP guides and guidelines. The PIC/S Committee also actively promotes the uniform interpretation of GMP and Quality Systems for GMP Inspectorates.
- Membership in PIC/S may also facilitate the conclusion of other agreements, e.g. Mutual Recognition Agreements, between Members at various levels (e.g. Australia-Canada MRA, EU-Switzerland MRA, etc.). During the recently concluded initial negotiation on ASEAN MRA on GMP Inspection, PIC/S Membership accession was accepted as one of the essential criteria for MRA.
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There are also indirect benefits to industry when their relevant Regulatory Authority becomes a Member of PIC/S. These benefits may include the following:
- Reduced duplication of inspections
- Cost savings
- Export facilitation
- Enhanced market access
Although PIC/S is not a trade agreement, Membership in PIC/S may facilitate the export of pharmaceuticals. Some non-PIC/S Authorities accept GMP Certificates from PIC/S Participating Authorities. This means that non-PIC/S Authorities and organisations have a greater confidence in medicines manufactured in countries where the Regulatory Authority is a PIC/S Participating Authority. Consequently, the pharmaceutical industry located in these countries indirectly benefits from PIC/S Membership.
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