Union health ministry is seriously prodding over making India a member country to WHO's Pharmaceutical Inspection Co-operation Scheme (PIC/S) initiative, to enhance the role of India in the global healthcare market. Taking a lead in this process and, keeping in mind the larger interest of the exporters, the commerce ministry yesterday had a meeting with key government officials, regulatory agencies and stakeholders to sensitise them about the WHO's PIC/S.
It is understood that the country member to the PIC/S will not have to undergo the process of repeated inspections to get export approval to the other member countries. However, it requires that all the member countries will have to strictly undergo all the stringent good manufacturing practices (GMP) as required under the scheme, which includes up-gradation of the GMP standards.
Currently PIC/S comprises of 46 national drug regulatory authorities around the world, who are competent for GMP inspections for human as well as veterinary products, whether API or finished products. The meeting discussed about the pros and cons associated with India being a member country to the same and how it will impact the exporters. Based on the direction by the commerce ministry, Pharmexcil had asked IMS to conduct a study on the same, a preliminary report of which was submitted and deliberated in the meeting.
Dr P V Appaji, director general of Pharmexcil, informed that 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. Moreover, the study also pointed out that in the recent times, since most of the government agencies have shown inclination towards getting medicines under the government procurement through PIC/s members, it would give an extra edge to the Indian exporters to be part of the organisation in the long run.
Though this move was generally perceived to be useful for the country in the long-term perspective, Dr Appaji informed that the industry members did strongly caution the Centre against taking any hasty decision on this matter. They stressed that whatever decision has to be taken in this issue should be taken only after addressing the relevant problems associated with the same.
The key concerns raised by them were on the need to come out with industry friendly schemes and getting financial assistance from the government especially to small-scale manufacturers to meet the GMP requirements specifically for upgrading their facilities etc. Most importantly they insisted that the industry should be given five to ten years time to implement these changes.
Dr Appaji said that the commerce ministry had showed positive inclination towards addressing their issues and has assured them to duly note their concerns in the consecutive meetings. It is understood that the commerce ministry will give their suggestions on this matter to the health ministry after getting IMS's final report on this. Health ministry will be the ultimate authority to take a final decision on whether to be a member country to PIC/S or not.