Indian pharmaceutical exporters have recently stumbled upon another non-tariff trade barrier from strong markets like Ukraine, Malaysia and Mauritius creating roadblocks for Indian products on the ground that India is a non-PIC/S (Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme) country.
Ukraine authorities have notified that products of those countries which are members of PICS will be registered automatically. In case of non-PICS countries, registration would be granted only after inspection and analysis of imported products on consignment-wise by the authorities, citing the reasons of quality.
Likewise, it is learnt that countries like Mauritius and Malaysia have also refused registration of Indian products on the same ground and communications were also sent from their respective embassies to the industry in the country.
The issue also has triggered a debate whether India should join the PICS or not. While Ministry of Commerce suggested joining the forum, the industry representatives have already raised objections because of the hardships it can cause to them. IDMA discussed the issue long back and did not approve it, sources said.
PIC/S is a private international organization established with a mission to develop, implement and maintain harmonized GMP standards with the regulatory authorities are the members. Currently, 40 FDS, mostly European Union Countries along with US FDA, South African MCC, and Australian TGA are the members. PIC and PIC Scheme, operating together as PIC/S, is a cooperative arrangement between health authorities, instead of having a legal binding.
“We have taken up the matter with the Commerce Ministry. There can be unfavourable reactions from the industry due to huge requirement of investments. DCGI is the right authority which has to write to the PIC/S and join. A better option now is if DCGI can write to them on the possibilities of issuing company specific-members, on the lines of WHO GMP, instead of the country joining it,” commented Pharmexcil SME panel chief Nipun Jain.
It is also learnt that moves are afoot to hold a detailed study on the pros and cons of India joining PIC/S and based on the recommendations of the study, the matter could be taken up formally with the Health Ministry. The Department of Pharmaceuticals (DoP) is being requested to fund this proposed study, sources said.