Ahmedabad, March 12: The Drug Controller General of
India (DCGI) has initiated a slew of regulatory measures to
rein in the rapidly growing pharmaceutical industry,
especially clinical trials and registration of Contract
Research Organisations (CROs).
"For the first time audits of clinical trials are being
conducted. During the audits, we have found glaring
deficiencies as the sponsors, monitors and CROs do not adhere
to protocols," DCGI Surinder Singh said while speaking at
Inform Ex.
Inform Ex is a three-day exhibition of specialty
chemicals and pharmaceuticals being hosted outside USA for the
first time.
"We intend to take stringent action against these CROs,
sponsors and clinical research associates (monitors) for not
taking appropriate safeguards while conducting clinical
trials," he added.
Another step towards regulation of clinical trials is to
make CROs registration mandatory, so that all the relevant
information such as target audience can be brought into public
domain, Singh said.
"Registration of CROs in the country will become
mandatory from June once we notify the guidelines. The minimum
norms which a CRO should adhere to has been drafted and
approved by advisory bodies like Drug Control Committee and
Drug Technical Advisory Board," Singh said.
"The draft-guidelines will now be put in public domain
for comments, and suggestions will be incorporated before it
is notified," Singh said.
"The move will help bridge the operational gap between
local and international CROs, and also ensure that they adhere
to quality norms while taking part in clinical trials," he
added.
Referring to India's positioning in clinical trials and
vis-a-vis its market share Singh said "India pharma industry
is the fourth largest globally in clinical trials, both in
terms of volume and value."
"The market of clinical trials which is currently at USD
385 million here is likely to touch USD 1.2 billion by 2010 as
projected by management consulting firm McKinsey," Singh said.
On stepping up its regulatory framework in Gujarat, DCGI
Chief Surinder Singh said "Gujarat would soon have an
independent zonal office."
"Four more zonal offices, one each in Ghaziabad, Mumbai,
Chennai and Kolkata would also come up."
"Another DCGI zonal office is proposed at Hyderabad and
two sub-zonal offices will come up at Bangalore and Chandigarh
within next 2-3 months," Singh said.
Emphasizing on strong need for increasing vigilance
system in pharma sector, Singh said "we have suggested the
(Higher and Technical) ministry that all 290 medical colleges,
both public and private, should be brought under the ambit of
pharma vigilance."
"All the 290 medical colleges in the country will have
pharma vigilance centres, to provide information to national
monitoring centre, which can be linked to international
monitoring centres," Singh said adding provision for funds for
the same too has been made.
Referring to international collaborations for
introduction of best practices in pharma segment, Singh said
"we have identified areas of clinical trials, and medical
devices and IVP products with USFDA,".
"USFDA has proposed to open another office in Mumbai,
besides the one recently opened in New Delhi," he said.
The Indian pharma regulating agency has also collaborated
with international agencies like Health Canada and World
Health Organisation (WHO) to develop profound understanding of
the international best practices.
"Since, India happens to be the biggest exporter of
pharma products to Brazil and Cuba, these two countries have
also expressed keen interest in opening offices here," Singh
said.
As part of strengthening the workforce, DCGI has got
approval of ministry to fill up 50 per cent of posts lying
vacant for the last 15 years. "Thirty per cent of the post
lying vacant have been filled up, and work on remaining 20 per
cent is in the pipeline."
DCGI has also got approval of Ministries of Health and
Finance to create 72 new posts besides the existing ones.
Bureau Report
First Published: Thursday, March 12, 2009, 00:00