Is India ready for Pharmaceutical Inspection Convention (PIC) PIC/S

Membership?

The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme

(PIC/S) are two international instruments between countries and pharmaceutical inspection
authorities. The purpose of PIC/S is harmonising inspection procedures worldwide by developing
common standards in the field of GMP and by providing training opportunities to Inspectors. It also
aims at facilitating co-operation and networking between competent authorities, regional and
international organisations, thus increasing mutual confidence.

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. On January 1, 2021, Brazil has become the 54th country to join
the PIC/S. Drug regulatory bodies from across the globe including the US, the UK, China, Canada,
Japan, France, Germany, Australia, New Zealand, Italy, Mexico, South Africa, Spain, etc. are all part
of this elite group. Other countries that are currently in the PIC/S application process include
Armenia, Bulgaria, and Saudi Arabia. Established in 1995 as an extension to the Pharmaceutical
Inspection Convention (PIC) of 1970, PIC/S is open to any drug regulatory authority in the world
having a comparable GMP inspection system.

Union Health Ministry of India 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

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 affect the exporters.

Dr. P V Appaji, then Director General of Pharmexcil (Pharmaceutical Export Promotion Council of
India), informed in 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.

The PIC/S membership offers a slew of benefits including reduced duplication of inspections, cost
savings, export facilitation and enhanced market access. The member countries of PIC/S import
medicines from the manufacturing facilities of fellow member countries without duplication of
inspections on the medicines and manufacturing facilities, helping exporters significantly save cost
and time.

Unfortunately, though India is known to be the ‘pharmacy of the world’, the country is not a
member of this group so far, which would have helped India maintain global standards and enhance
global confidence in drugs coming from India. Several industry bodies, including the Indian
Pharmaceutical Alliance, have long been urging the government of India to join the PIC/S to enhance
recognition of the country as provider of quality drugs and boost drug exports.   For India, moving
from Schedule M to PIC/S standards is one step to be part of the PIC/S. The revised Schedule M of
Drugs & Cosmetics Act is on the lines of WHO-GMP guidelines. Hence, it should not be much of an
issue to join PIC/S once it is implemented in letter and spirit. After all, two-thirds of India’s exported
drugs go to PIC/S member countries. More importantly, India has over 1,400 manufacturing WHO-
GMP certified units, and over 800 are UK MHRA approved units. Apart from this, India continues to
have the highest number of US FDA approved manufacturing facilities outside the US. All these sites
qualify as PIC/S approved sites. Besides, we also have large numbers of sites that are GMP certified
from PIC/S nations. If we have to further grow and compete globally, Indian regulatory authorities
should now make a serious move to join PIC/S. This has also been a long pending wish list of the
pharmaceutical industry in the country as it will avoid multiple inspections and save on time and
money.

Speaking to Pharmabiz, Dinesh Dua, chairman, Pharmexcil, said “Brazil joining PIC/S is a huge
development. India is deeply engaged in this exercise as well.  Our country wants to become a
member of PIC/S because there is a major advantage. Although having said that inspite of the
mutual recognition of 50 odd countries, some of these nations still want their own inspections which
defeats the very purpose of PIC/S. However, getting a PIC/S approval is a great heads-up and our
country needs to definitely go for it.” Now India will need a year to come up to the PIC/S benchmark.
The DCGI department led by Dr VG Somani is working towards this and is pushing the entire CDSCO
to gear up and be in line for the PIC/S assessment, said Dua.

Reference
http://www.pharmabiz.com/NewsDetails.aspx?aid=133934&sid=1

http://pharmabiz.com/ArticleDetails.aspx?aid=135543&sid=3

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