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CII Concerned About Misleading Reports
Portraying Indian Drugs And Devices Regulators In Poor Light
The Confederation of Indian Industry (CII) Medical Technology
division, Chairman, Pavan Choudary on Monday expressed concern about the recent
misleading reports in certain sections of the media portraying Indian Drugs and
Devices Regulators in poor light.
“We believe that the Indian Drugs and Devices regulatory
agencies are truly doing a commendable job by effectively monitoring the quality
of medical devices and in-vitro diagnostics products which are quiet
different from drugs, imported into, or manufactured and sold in India”, said Choudary.
The Chairman stated that in fact today both the executive arm
of the Government as well as the legislature are fully cognizant of the fact
that Medical devices need to be disaggregated from Drugs for their effective
regulation and this awareness is reflected in their decisions which are
sensitive to the difference between Drugs (Chemical units) and Devices
(Mechanical entities) without compromising patient interest.
Choudary added that the Indian drugs and medical devices
regulatory agencies have ensured that the medical devices and invitro diagnostic
products which are manufactured or imported in to the country, stay continuously
available to the patients who need them and are used in the most appropriate,
effective and safe way.
Choudary expressed that it has been proven also by the fact
that the quality of Healthcare outcomes in India is at par with global best,
which is attracting patients from many foreign countries to India as well as
saving precious foreign exchange which was in the pre reform period spent on
medical treatment of Indian citizens abroad. Another proof of the quality of
medical devices manufactured in India is their growing acceptance world-wide.
“We continue to look forward to working in close
collaboration with our regulatory agencies for driving safety and better
treatment of Indian patients,” Choudary added.
(Ref:
http://www.business-standard.com/article/news-ani/cii-concerned-aboutmisleading-reports-portraying-indiandrugs-and-devices-regulators-in-poorlight-114040701156_1.html
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Gujarat FDCA Proposes To Share Its XLN
Software With CDSCO
The Gujarat Food and Drug Control Administration (Guj FDCA)
recently made a proposal to the Drug Controller General of India (DCGI) urging
him to consider entering into a tri-party agreement between the state regulatory
body, DCGI and Gujarat National Informatics Centre (NIC) for sharing its
self-licensing software Extended Licensing and Laboratory Note (XLN) with
interested parties. Through this initiative, which will put this unique software
into public domain, Guj FDCA hopes to share its benefit with other drug
regulators for ensuring good governance across country through the use of IT.
This software, an integral part of the egovernance programme
adopted by the Gujarat drug authority was developed by NIC, to help the
regulators perform their duties more effectively. This software enables speedy
disposal of various applications while bringing in transparency to the system.
Dr H G Koshia, commissioner of the Guj FDCA who played a
major role in integrating the E-governance programme throughout the state had
made this proposal during the Drug Consultative Committee (DCC) meeting that was
held in New Delhi, last month. It is understood that DCGI Dr G N Singh has shown
keen interest in this proposal and is said to have agreed to consider the same.
He informs that through this software the FDCA has been
successful in regulating the sales and manufacturing aspects related to drugs,
food and cosmetics; issuance of licenses, etc. “For us the safety and health of
our patients is a must and we are glad that we have been able to deliver best
services to all the stakeholders with the help of this software. It is with this
intention in mind that we have decided to share our software with others so that
even they can use this software to streamline and bring in better monitoring and
effective implementation of the D&C Act,” pointed out Dr Koshia.
This software enables the registration of all the pharmacists
and chemists within the state which prevents multiple illegal enrolment of
pharmacists.
As per the proposal, the state drug regulator has requested
the DCGI to act as a facilitator to ensure adoption for this software, NIC
Gujarat to act as a service provider while Gujarat FDCA who has played a vital
role in developing and adopting this software to give expertise to interested
parities. By agreeing to this agreement the Centre would be giving a legal
status to this software that has been developed by the Gujarat NIC.
(Ref: The Chronicle Pharmabiz dated January 2,2014)
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