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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 manufacturers.

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)

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