DCGI Office Confuses Exporters Over
Issuance Of WHO-GMP Certificate
Utter confusion and lack of coordination seem to prevail in
the office of DCGI over the issuance of WHO-GMP certificates for the exporters.
While DCGI Dr Surinder Singh categorically stated some days ago that there is no
move to withdraw WHO-GMP certification or replacing it with certificate of
pharmaceutical products (COPP), his North Zone office issued a circular asking
the state drugs controllers of North Zone to withdraw the WHO-GMP Certificate
issued by them.
In the letter issued to the North Zone drug controllers,
deputy drugs controller, North Zone, Dr R Ramakrishna wrote: "It has been
observed by this office that WHO-GMP Certificate has been issued to many firms
by State Licensing & Controlling Authority. Copies of such certificates issued
are enclosed for ready reference. It may please be noted that neither your
office nor this office is having any authority to issue WHO GMP Certificate
(which can only be issued by WHO, Geneva after pre-qualification assessment of
the manufacturing site). As per WHO Certification Scheme, we are only authorized
to issue COPP's for marketing in International Commerce. In view of above, you
are hereby requested to withdraw all the above type of WHO-GMP Certificate
issued in your state, if any, by your State Licensing Authority".
The letter is undated, but sources said it was issued on
January 7 this year. Sources also said that in view of the letter, the North
Zone state drug controllers are not issuing WHO-GMP Certificates to the
Incidentally, no such letter was issued by deputy drug
controllers (DDCs) of other three zones in the country. Sources said that the
other DDCs beat a hasty retreat and just stopped short of issuing such letters
on oral instructions from the DCGI due to the hue and cry created by the
industry over a news report stating that the DCGI office is going to withdraw
the issuance of WHO-GMP Certificate.
WHO-GMP Certificate is a basic document required by the
exporters to export their products to the countries where there is no regulatory
system of their own. While the US, European Union countries, Canada, Australia
and other developed countries have their own regulatory system and they import
drugs from the plants inspected and approved by their own agencies like the US
FDA, countries in Latin America, Africa, CIS countries and other developing
countries accept WHO-GMP certificate as the proof of quality of the
manufacturing plant and COPP as the quality of the product.
(Ref : Chronicle Pharmabiz dated March 26, 2009)
Centre Clears DBT's Proposal To Set Up
National Institute Of Biomedical Genomics
The Centre has approved the Department of Biotechnology (DBT)'s
proposal to establish a National Institute of Biomedical Genomics (NIBMG) at
Kalyani near Kolkata in West Bengal. Conceived under the National Biotechnology
Development Strategy, the institute will provide basic research evidence using
biomedical genomic approaches for betterment of public health programmes and
services. The Institute will be an autonomous body under the administrative
control of the DBT.
According to DBT sources, the main objective of establishing
the institute is to have a state-of-the-art infrastructure for genomic and
proteomic analyses, with the explicit goal of improving public health in India
through use of genomic knowledge and technologies.
The research programme of the institute will focus on large
scale genetic epidemiological studies on diseases of relevance to India, which
will include mapping genes for diseases and disease-susceptibilities, estimating
gene-environment interactions, evaluating mutational spectra, host-pathogen
interactions, mechanisms of disease precipitation, etc.
Other objectives of the institute include: to seed research,
education, translation and service networks among clinicians and researchers
from different disciplines for promotion of better public health through the
establishment of genomics infrastructure in hospitals and medical colleges; to
anchor young talent on the national soil and build capacity in biomedical
genomics, through organizing specialized post graduate courses, specialized
training programmes and PhD courses in medical biotechnology, human genetics,
molecular & genetic epidemiology and to facilitate their early participation in
research, translation and services for promotion of genetics-based healthcare;
to have academic affiliation with a University / Deemed University or seeking a
Deemed University status for award of degrees; and to enable better
understanding of new medical biotechnologies to permit faster but more
discriminating uptake by health care providers.
DBT sources said that the emerging discipline of genomics is
fast becoming an integral part of medicine. It has tremendous potential to
address health problems in developing countries. Understanding genomic
underpinnings of diseases results in early and more precise risk-prediction,
that opens up the possibilities of prevention and therapy. India has a multitude
of genetically diverse, unadmixed and isolated population groups, large
population and family sizes. There have been phenomenal improvements in India
within the past decade in the availability of medical technologies for diagnosis
and clinical evaluation. These facts make India a fertile ground for
gene-hunting, and validation of results from genome-wise association and linkage
studies obtained elsewhere.
(Ref : Chronicle Pharmabiz dated April 07, 2009)