|
India mulls over being member country to WHO's PIC/S
|
|
Suja Nair Shirodkar
April 29 , 2015
|
|
|
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.
|
|
|
|
|
|
|
|
TOPICS
|
That foods might provide therapeutic benefits is clearly not a new concept. ...
|
|
|
|
|