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AIDCOC wants Centre to focus on increasing adequate manpower within the regulatory agency
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Suja Nair Shirodkar
December 29 , 2014
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Concerned by the dearth of drug regulators in the country, the All India
Drugs Control Officers' Confederation (AIDCOC) has urged the government
to urgently focus on strengthening the regulatory mechanism with
adequate manpower. The association pointed out that immediate
intervention from the government with clear focus on beefing up the
numbers is essential, especially since 2015 will be busy year for Indian
regulators with some drugs going off patent.
Come next year, lot
of top blockbuster drugs will be going off patent, providing
opportunities galore for generic Indian companies. While, this opens up
huge market for the generic players, it will also throw challenging
regulatory scenarios for the Indian regulators, who though competent are
not adequate to meet the growing requirements, according to experts.
Ravi
Uday Bhaskar, secretary general of the AIDCOC pointed out that while
the generic industry is booming with activities, there aren't enough
drug regulators either in the state or in the CDSCO to actively regulate
and monitor their movement effectively. Sadly, the gap in the ratio of
regulators currently working compared to their actual requirement is
huge.
He informs that according to statistics there are only
close to 2100 drug officials in the drug regulatory department, i.e.
1800 drug regulators from all the states combined while close to 300
officials in the CDSCO to look over the smooth and effective functioning
of the Drugs and Cosmetics Act.
"There is no question on the
efficaciousness and quality parameter of the drugs that are manufactured
in India, neither on the capabilities of the Indian drug regulators.
However, the MNC lobbies working against the generic companies are sure
to misutilise whatever loopholes they may find to tarnish the Indian
image. Thus not addressing the issues of manpower crunch when we have
the time is like giving them an opportunity in a platter. Steps needs to
be taken on an immediate basis to address this lacunae and ensure that
we provide no opportunity for the critics to hold us from any growth
opportunity," he stressed.
Another concerning fact that the
association has been trying to bring into attention of the Centre has
been the under usage of the allotted seats, wherein the state
governments have repeatedly failed to fill it up. Citing examples, he
said that states like Maharashtra, which is one of the leading generic
hubs of the country, West Bengal etc have vacant seats which are yet to
be filled. This gross oversight is committed even when there is a huge
dearth of drug officials in the state, due to loose planning and red
tape in the system.
Experts point out that while the 12th five
year plan did touch base with need for strengthening the regulatory
mechanism through up-gradation of the facilities and capacity building
measures, not much have been done about increasing the manpower. Bhaskar
stressed that, to ensure a healthy growth environment, the government
needs to act upon addressing it at the earliest, as it is the reputation
of the Indian industry as well as the regulatory agency at stake.
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