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Medical Devices Bill : Before Parliament Soon
The draft Bill seeking to introduce a regulatory system for
medical devices used in clinical applications will be introduced in the
parliament soon. The Bill with certain key provisions, was discussed by the Drug
Technical Advisory Board and is forwarded by the DCC subcommittee.
The Bill is learnt to have included standards and approval
procedures for more than 1000 products available in the healthcare market.
The Bill is expected to be part of the Drugs & Cosmetic Act
by including a specific definition for "medical devices". It has also
proposed a separate Medical Device Division in the office of Central Drug
Standard Control Organization (CDSCO) and the setting up of appropriate
regulatory mechanism for certification, quality assurance and post marketing
surveillance of imported as well as locally made medical devices.
Broadly, the products included in the draft Bill are electronic
as well as mechanical devices made of plastic and metals, which are used within
the body and externally for medical and therapeutic applications. Though there
are standards set by the Bureau of Indian Standards (BIS) for almost all theses
products to ensure the manufacturing quality, the sources close to the technical
committee, confirmed that since these devices are used in the clinical
applications, the safety and therapeutic accuracy have to be tested and approved
exclusively as it is followed in case of drugs.
"A lot of other factors have also to be considered and
incorporated in the regulatory framework as the engineering (mechanical,
electronic) and other scientific aspects are also to be looked after before
evaluating the safety and manufacturing standards for these devices to be
granted license for manufacturing and marketing," the official said.
Currently, there are no regulations for the manufacture, imports
and marketing of these products in the country. The proposed regulatory
framework will put all the medical devices including hearing, aids, patches,
straps, electronic massaging devices, inhalers, etc used for healing under
regulatory mechanism. And none of these products are currently under regulatory
monitoring for certification, quality assurance and post marketing surveillance.
Also, many of these devices are sterilized using various techniques, efficiency
of which need to be validated. In view of the emerging regulatory code for
medical devices, the CDSCO has already initiated measures to build up capacities
to have a separate division to deal with the new area, it is learnt.
(Ref : CHRONICLE PHARMABIZ
Dated January 20, 2005)
Pharma Packaging : Bilcare's Expansion plan for
Exports
Fitch Ratings India has assigned an 'A-(ind)' rating to Bilcare's Rs. 400-m
long-term debt programme. The rating outlook is stable. The rating reflects the
company's established position in the blister-packaging segment in the country,
research and development (R&D) capabilities and a track record of steady
growth in revenues and net cash accruals over the past few years. The company's
business model is based on providing integrated solutions to its clients; from
advising on the right packaging material for a particular drug to importing,
processing and printing the material for the client, rather than just supplying
the ordered material.
Bilcare is a leading player in the domestic solid pharmaceutical packaging
market. It provides comprehensive packaging solutions to the pharmaceutical
sector. The company's manufacturing facility is near Pune (Maharashtra). During
H1 '05, it recorded revenues of Rs 724m with a net income of Rs 120m.
Bilcare has state of the art manufacturing and R&D facilities at
Shiroli near Pune. In this facility the manufacturing of packaging solutions is
done in a totally dust-proof and temperature and humidity controlled atmosphere
conforming to cGMP norms. Being the first pharma packaging company to comply
with cGMP norms in the country, Bilcare now manufactures multilayered laminates
for pharmaceutical packaging, featuring exclusive entries for personel and
material through a dedicated air lock system having circulatory air shower
systems fitted with 1 5-micron filter abrasion resistant seamless epoxy coated
flooring and a high efficiency exhaust system. "Microbial count in the area
is zero and area particle count is less than 40,000 particles of below 0.5
microns. Bilcare also has an advanced coating facility, the only one of its kind
in Asia," says Praful Naik, president, Bilcare.
According to Naik, all processes in the facility are completely validated and
encompass critical quality checks at each stage. "Quality materials inputs
procured from the world's leading manufacturers, complying to stringent USFDA/
EU/ Japanese & ISO 9002 requirements, coupled with the validated process,
excellent systems and infrastructure ensure world-class products that meet all
regulatory and quality requirements globally," he informed.
Adding that the concepts of specific quality and drug stable pharma packaging
are yet to be fully emerged among the Indian pharmaceutical industry, Naik said
that Bilcare blister films were the most cost effective and novelly designed
pharmaceutical packaging systems excelling international quality standards.
(Ref : Economic Times Dated January 4, 2005)
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