Health Ministry planning over India being member country to Pharmaceutical Inspection Convention (PIC) PIC/S

Union Health Ministry is seriously planning over making India a member country to Pharmaceutical Inspection Co-operation Scheme (PIC/S) initiative, to enhance the role of India in the global healthcare market. PIC and the PIC Scheme, operating together as PIC/S, provide an active and constructive co-operation in the field of GMP (Good Manufacturing Practice). The purpose of PIC/S is to facilitate the networking between participating authorities and the maintenance of mutual confidence, the exchange of information and experience in the field of GMP and related areas, and the mutual training of GMP inspectors. Currently PIC/S comprises of 46 national drug regulatory authorities around the world including Japan and US, who are competent for GMP inspections for human as well as veterinary products, whether API or finished products.

To discuss over this issue the Commerce Ministry had a meeting on 28th April, 2015 with key government officials, regulatory agencies and stakeholders to discuss with them about PIC/S. The meeting discussed about the pros and cons associated with India being a member country to PIC/S and how it will impact the exporters.

Dr. P V Appaji, Director General of Pharmexcil (Pharmaceutical Export Promotion Council of India), informed the initial reports revealed that being part of this group can bring a lot of benefits to the exporters as it will help them avoid delays due to inspection while also giving them easy and direct access to these member countries. The key concerns raised by them were on the need to come out with industry friendly schemes and they insisted that the industry should be given five to ten years time to implement these changes.