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US FDA To Join PIC/S To Help In Harmonisation of GMPs
The United States Food and Drug Administration (FDA) have applied for a
membership with the Pharmaceutical Inspection Cooperation Scheme (PIC/S), an
international initiative to harmonise GMP standards. This is part of FDA's 21st
Century Drug cGMP initiative with global harmonization, said Dr Ludwig Huber,
Compliance and Validation expert, Agilent Technologies.
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 organizations, he added.
Currently PIC/S has 29 members with the authority from Poland being the most
recent addition in January 2006. Most of the regulatory authority members are
from Europe. Non-EU member countries include Switzerland, Canada, Australia,
Singapore and Malaysia.
According to Dr Ludwig Huber, PIC/S provides for GMP inspection reports and GMP
certificates to be exchanged. However, being a member of PIC/S does not mean
that GMP certificates are automatically accepted within all member countries.
The big benefit for the industry are more harmonized and thus more predictable
inspections which are achieved through good practices guides, inspection guides
and a structured training programme.
Harmonized inspections are also achieved through the 'Joint Visits Program'.
Within this program inspectors from countries are teamed up to observe typical
GMP inspections in each country and deviations from expectations are reported.
(Ref : Chronicle Pharmabiz dated August 17, 2006)
SonoSite To Expand Hand-Carried Ultrasound Systems Market
In India
The US based SonoSite, Inc., one of the world leader in hand carried
ultrasound, is keen to tap the Indian healthcare market. It has initiated talks
with Government, Private, Army and Navy Hospitals in the country. India is
gradually transforming as a value driven market, Pavan Behl, country manager,
SonoSite India, said.
SonoSite ultrasound systems are increasingly being used for procedures, where
physicians need non-radiating imaging in diverse applications such as real-time
trauma assessment in emergency situations, guiding interventional procedures
such as biopsies, nerve blocks and surgery, and in the imaging lab for full
diagnostic examinations.
The company's latest brand MicroMaxx is the next generation of hand carried
ultrasound system that produces high resolution image quality and weighs 3.8 kg.
It offers optional SonoCalc software that enables clinicians to quickly measure
intima-media thickness of the carotid artery for assessment of arterial wall
disease progression and cardiovascular risk. MicroMaxx was introduced last year
worldwide, which accounted for about 50 per cent of the company's global
revenues. The global hand carried ultrasound systems market is growing at a rate
of over 20 per cent.
Pavan Behl, said, "The company has brought a transformational change in
clinical practice by providing point-of-care ultrasound at the patients beside
or physician's examination table. The system's mobility eliminates delays, which
are associated with the outpatient referral process or moving heavy, cart-based
systems across hospital departments to scan patients. The system will
potentially reduce healthcare costs through early and rapid diagnosis of disease
and conditions."
The company opened its liaison office in Gurgaon in October 2005 to support
its exclusive distributor United Medical Instruments (UMI). The company has sold
100 systems so far in India and is spreading its presence across India, aiming
to achieve a turnover of US$3 million by the end of current fiscal. The company
has introduced the concept of ultrasound imaging to regional anesthesia and is
organising a series of knowledge seminars across the country. Three such
seminars are lined up in Hyderabad, Pondicherry and Vellore in the near future.
The company launched its first hand-carried ultrasound system in 1999 in the
US and since then, radiologists and clinicians across various medical
specialties all over the world have been using the system. The company's
products are designed for imaging in traditional applications such as radiology,
cardiology, vascular medicine and obstetrics and gynecology as well as in
applications where ultrasound has not typically been used such as emergency
medicine, surgery, critical care, internal medicine and vascular access
procedures, he explained.
SonoSite has an installed base of more than 25,000 systems. The company
headquartered near Seattle, Washington is represented by eight subsidiaries and
a global distribution network in over 75 countries, achieving global revenues
upto USD148 million. The company is hoping to achieve revenues upto USD 200
million this fiscal. The company's small, lightweight systems are expanding the
use of ultrasound across the clinical spectrum by cost effectively bringing high
performance ultrasound to the point of patient care.
Global medical imaging industry is about US$18 billion globally, of which the
ultrasound systems market accounts for about US$3.8 billion. Hand-carried
ultrasound systems are estimated to have a market of US$300 million, which are
expected to touch US$1 billion by 2010, according to Frost & Sullivan.
(Ref : Chronicle Pharmabiz dated August 24, 2006).
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