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Former DCGI Dr Venkateswarlu Passed Away
The former Drug Controller General of India (DCGI), Dr M Venkateswarlu (61),
passed away on Sunday night at Mumbai, Maharashtra, succumbing to a massive
heart attack.
Dr Venkateswarlu, who has been ailing with kidney failure for
past several months, is acclaimed as the renovator of the Indian pharmaceutical
regulatory set up. He was the brain behind various paradigm shifting decisions
in his tenure in the Central Drug Standard Control Organisation (CDSCO) as Joint
Director and the DCGI.
The revision of age old Schedule M norms to update drug
manufacturing standards on par with the global Good Manufacturing Practices (GMPs),
Schedule Y norms to bring in quality of clinical trial practices up to the
standards of the Good Laboratory Practices (GLP) and Good Clinical Practices (GCP)
elsewhere has been initiated in his one and a half year stint as DCGI.
Dr Venkateswarlu took charge as the DCGI on August 2006 and
continued in the post till his retirement on January 2008. The tenure includes a
six months extension of his services as DCGI considering the importance of the
tasks pursued by him in the period. However, his action on strict implementation
of revised Schedule M and quick actions on the fixed drug combinations (FDCs)
sold in the country without the approval of DCGI has invited a lot of debate in
the pharma industry.
“His untimely demise is a heavy loss for the Indian
pharmaceutical industry and the regulatory authority,” said R P Meena, director
general of Drugs Control Administration, Andhra Pradesh. The All India Drug
Control Officers Confederation (AIDCOC) has marked their condolence to the
family of the deceased. “We are shocked with the untimely demise of Dr
Venkateswarlu, who has been an active member of confederation right from its
formation in 1995,” said Ravi Udayabhaskar, secretary general, AIDCOC.
Dr Venkateswarlu had always extended support to the pharma
industry with his expertise in regulatory and research knowledge, said an
industry source. He had also actively supported and worked behind various
industry related forums and has emphasised that the actions of the industry
should benefit the general public, added the source.
Dr Venkateswarlu’s body has been taken to Hyderabad, where he
hails from.
(http://www.pharmabiz.com/article/detnews.asp?articleid=50456
)
(Ref: Chronicle Pharmabiz Dated June 29, 2009)
AIMED Response to Budget 2009
We are pleased with some of the macro economic issues
addressed by the budget. We are pleased that the Government has decided to
abolish Fringe Benefit Taxes which was an unnecessary irritant and we are also
pleased with the higher allocation of the budget for the Healthcare Sector
especially with respect to the National Rural Healthcare Mission. India has got
one of the lowest allocations to Healthcare as a percentage of the GDP in the
world. For addressing the healthcare needs of ‘Aam Admi’ and of the rural masses
who do not have access to quality private healthcare we need to strengthen the
public healthcare in India at the Primary Healthcare and District Healthcare
level. The fine print of Budget is still not available of how this money will be
utilized whether for preventive healthcare (which is more cost effective in the
long run) or will be used to fight fires, in corrective healthcare.
At our Medical Devices Industry segment level we are
disappointed that our pre-budget presentations requesting a holistic development
and regulation of focus of the Medical Device Industry have seemingly not been
looked into. The Indian Medical Device Industry is currently mainly import
dependent and needs special focus and infrastructure development status at least
for the next 5 years. We have been requesting for abolishment of List 37 which
is prevalent from many years (the current notification is from year 2002) and
has a list of 111 life saving items. To encourage the indigenous development of
these products by the domestic industry we had suggested to abolish this list.
Otherwise India will continue to be 100% import dependent as before in these
products. We understand that the budget has added certain medical devices
related to heart care to be exempted from Custom Duty. While this will
definitely benefit the consumers in short term, India is losing in long term.
Either the similar exemptions should be made available for all our raw-materials
and inputs and subsidy support available on the cost of expensive R&D and the
highly capital intensive equipment required for the Medical Device Industry or
the multinational companies will continue to import and sell in India other than
be motivated to produce these items in India. Similarly the Indian indigenous
industry will not get motivation to produce any of these Devices falling under
this current list which comes in NIL or 5% rate of duty. How can you make a
product in India with the imported components and expensive machinery and make
it cheaper than these imports. The custom duty needs to be rationalized for
manufacturing these devices as has been done for the other medical devices to
enable the growth of the Medical Device Industry and to have its place in the
sun like Indian Pharmaceutical Industry.
The Indian Medical Devices manufacturing industry comprises
over 700 manufacturers producing a range of products which includes Medical
Disposables, Medical Diagnostic, Medical Electronics and Medical Equipments and
Implants.
AIMED (Association of Indian Medical Device Industry) is an
Umbrella Association of Indian Manufacturers of Medical Devices covering all
types of Medical Devices including consumables, disposables, equipments or
diagnostics representing the interest of over 150 Manufacturers of Medical
Devices to cover issues and address the manufacturer’s problem.
( Ref :
http://www.aimedindia.com/userlogin.asp?PRID=
1&type=PRD101) |
