The pharmaceutical exporters, who are looking to export their products to less explored countries like Cambodia, Myanmar, Vietnam, Laos, etc, have asked the Department of Pharmaceuticals (DoP) to initiate measures to make India a member country of Pharmaceutical Inspection Cooperation Scheme (PICS) to overcome the export hurdles to these countries.

According to the exporters, exporting to these countries have become well nigh impossible as the product registration approval timeline in most of these countries has been increased from one year to two years as the Ministry of Health in countries like Cambodia does not have enough staff to evaluate the ACTD dossiers. Similar is the case in Myanmar also as the FDA there, which has been moved to the new capital city does not have enough staff to evaluate the ACTD dossiers. If India becomes part of the PICS, Indian exporters will get the benefit as the Myanmar FDA gives preference to the PICS approved manufacturing facilities, exporters said.

Exporters further rued that the situation in Vietnam is also not different as it encourages the local manufacturers and is also getting influenced by multinational companies. The country is putting a lot of restrictions on Indian companies to prevent them to enter Vietnam pharma market. It is also delaying the registration approval of the products to unlimited timeline. All these export hurdles can be overcome if India becomes a PICS member, as these countries prefer PICS approved manufacturing facilities.

The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (jointly referred to as PIC/S) are two international instruments between countries and pharmaceutical inspection authorities, which provide together an active and constructive co-operation in the field of GMP.

PIC/S' mission is "to lead the international development, implementation and maintenance of harmonised Good Manufacturing Practice (GMP) standards and quality systems of inspectorates in the field of medicinal products."

This is to be achieved by developing and promoting harmonised GMP standards and guidance documents; training competent authorities, in particular inspectors; assessing (and reassessing) inspectorates; and facilitating the co-operation and networking for competent authorities and international organisations.

There are currently 44 Participating Authorities in PIC/S (Convention and Scheme taken together).