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Fees For GMP Certification, Hike Of all Other Fees Likely
Once CDAI Starts Operations
Setting up of the Central Drug Authority of India may prove 'too heavy' for
the pharmaceutical industry in the country with the proposal to have a flat
increase in the present fee structure and introduction of a new fee for GMP
certification inspection. These are the two key proposals to raise funds for
running the Authority.
With no grant-in-aid being proposed to run the new CDAI and to meet the
additional expenses including those required for creation and maintenance of new
posts, the additional cost burden of CDAI is thus going to be directly passed on
to the industry, it is learnt.
"The CDSCO earns revenues through import registration fees, new drug
registration, licence fees etc. But it has the grant-in-aid funds too. Once the
CDAI becomes functional, it is proposed to add new fees for GMP certification
inspection and to increase the rate of present fees for import registration
(started in 2002), new drug registration, licence for manufacturing / inspection
/ products (last revised in 2001) and clinical trials," sources said.
Except for new drug registration and licence fees, there would be a yearly
increase of 5 percent of fees in all other categories. In the first two
categories, increase would not be on yearly basis. And the rate of increase
proposed in all the categories would be clear only when the CDAI comes into
force.
Interestingly, the Finance Ministry and the Planning Commission had already
made clear to the Health Ministry that there would not be any budgetary or Plan
support for the new authority. The Health Ministry is planning to mobilize the
resources for operational and administrative costs and additional burdens of the
CDAI fully through fees and other charges.
(Ref: The Chronicle Pharmabiz dated 20, December 2008)
Health Minister Releases Indian Pharmacopoeia 2007
The Indian Pharmacopoeia (IP) 2007, having many new features to match with
its counterparts in developed countries and encompassing over 1500 monographs,
was today released here. The new monographs would be made effective from April
2008.
Union health minister Dr Ambumani Ramadoss released the massive document,
prepared by the Indian Pharmacopoeia Commission. The function at the Central
Indian Pharmacopoeia Laboratory at Ghaziabad near here, was attended by his
deputy in the cabinet Panabaka Lakshmi, senior officials, scientists and
industry representatives.
The new edition comes out in 3 volumes with 300 additional monographs has
many new features. Besides, the 175 new monographs of chemicals and dosage
forms, it has monographs on vaccines, immunosera, herbs, herbal products, blood
and blood related products, biotechnology and veterinary products.
"The standards of this pharmacopoeia are authoritative, legally enforceable
and intended to help in the inspection and licensing of manufacturing and
distribution of drugs and pharmaceuticals," officials behind the effort said.
The fifth edition of the standard-setting document has been prepared in
accordance with the principles and designed plan decided by the Scientific Body
of the India Pharmacopoeia Commission. In addition to the past practices of
requesting for comments, the contents of revised appendices and monographs have
been publicized on the website of the Indian Pharmacopoeia Commission, for
collecting comments widely from various institutions and organizations.
(Ref: The Chronicle Pharmabiz dated 20, December 2008)
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