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Recent
Mumbai High Court Rulings on Drug Regulations
Vascular
Concepts: Approval at Central level for sale of medical devices
in Maharashtra
In
a recent order, the Bombay High Court has directed Bangalore-based
Vascular Concepts, the principal operating company of the Vascular
Concepts Group, to comply with the regulatory guidelines for the
import and manufacture of endo-vascular medical devices in India
issued by the Ministry of Health and Family Welfare ("Guidelines")
and notification in respect of medical devices to be included
as drugs - http://www.cdsco.nic.in/html/Notification/not1.pdf
) and to obtain the approval of the Drug Controller General of
India ("DCGI").
Vascular
Concepts is engaged in the design, development and manufacture
of endo-vascular medical devices dealing with the treatment of
arterial diseases. The court has directed the Food and Drugs Administration
("FDA") of Maharashtra not to pursue its case against Vascular
Concepts as the Guidelines have already been framed.
The
Guidelines for the devices, which have come into effect from March
1, 2006, include Cardiac Stents, Drug Eluting Stents, Catheters,
Intra Ocular Lenses, I.V. Cannulae, Bone cements, Heart Valves,
Scalp Vein Set, Orthopaedic Implants and Internal Prosthetic replacements.
The deadline for filing the applications for license for import
and registration of medical devices, which are currently in use
in India, has been extended to June 29, 2006. If the applications
for registration of medical device and license to import of medical
devices, which are currently in use in India is filed on or before
June 29,2006, then the import and sale of the same can continue
until August 31,2006 or until rejection of the application.
Obtaining approval for the sale of medical devices at the central
level will ensure access to the best available products in India.
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You
can direct your queries or comments to the authors
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Amway: Registration of nutraceuticals as drugs
In a recent turn of events, Amway has approached the Bombay High
Court against the decision of the Maharashtra Food and Drug Administration's
("MFDA") to seize Amway's nutraceuticals products and categorise
them as "drugs". The seized products include packs of Nutralite
- a multivitamin and mineral supplement, Nutrilite daily, folic
acid tablets for anaemia and few other products.
The
Hon'ble High Court has admitted this petition and granted an interim
stay on the order issued by MFDA to seize the alleged products
marketed by the company. Next hearing on Amway's petition is kept
on July 12, 2006.
This
litigation stems from the inherent ambiguity surrounding the regulations
that should govern "nutraceuticals". As the term suggests, it
is an amalgamation of the term "nutrition" and "pharmaceutical".
It is slotted in the dual category of "food" and "drug".
The Mumbai High Court had given the MFDA four weeks to classify
the Amway products as either "food" or "drug". The MFDA chose
the latter. The justification provided for the same is as follows:
these products contained vitamins and minerals and therefore an
overdose of the same may have adverse results on the human body.
Therefore, there is a need to duly register them as drugs under
the Drugs and Cosmetics Act, 1940 ("Act"). Section 3(b)
of the Act includes substances (other than food) intended to affect
the structure or any function of the human body, in the definition
of the expression "drug".
In
August 2005, the bill on Food and Safety Standards ("Bill")
was promulgated. Section 22 of the bill regulates the manufacture,
distribution; import and sale of novel food, genetically modified
articles of food, irradiated food, organic foods, foods for special
dietary uses, functional foods, nutraceuticals, health supplements,
proprietary foods and other notified articles of food. If this
bill is enacted, then the ambiguity surrounding nutraceuticals
and similar products will be put to rest.
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You
can direct your queries or comments to the authors
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Source:
www.pharmabiz.com
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