Centre to set up govt-industry panel to look into concerns
over Spurious Drugs Bill
The health ministry will soon constitute a high-powered committee consisting
of representatives from the government and the industry to look into the concerns
of the industry arising out of the Drugs and Cosmetics (Amendment) Bill which
has received the assent of the President recently. The Bill stipulates stricter
penalties like life imprisonment and non-bailable arrest for manufacturing and
selling spurious drugs.
The high-powered panel will define guidelines, based on the 1993 Drug Consultative
Committee guidelines, for implementing the Act which is yet to be notified by
the health ministry. The committee's recommendations will have legal teeth as
these will be notified by the ministry. A decision to this effect was taken
at a meeting between the senior health ministry officials and the industry held
on January 12. The nitty gritties of the panel will be worked out by the ministry
soon.
One of the major issues that the panel will have to address first is the apprehensions
of the industry on misuse of the provisions of the Act by the drug inspectors
as the Act gives sweeping powers to the drug inspectors and the police to initiate
action against the erring drug manufacturers and marketers. The industry pleads
that the prosecution powers should not be vested with the drug inspectors but
with senior officials at DCGI level only. The panel will reach an agreement
on this issue.
Another issue before the panel is the issue of solving the dispute arising out
of defining the quality of medicines after testing. The industry demands that
any dispute on quality on testing should be resolved by
testing the controversial medicine at a government laboratory but supervised
both by industry and government representatives. The panel will take up this
issue too. Another major issue before the joint panel is regarding strengthening
of reference standards. The health ministry officials who attended the meeting
agreed to address this issue also.
The development is a major achievement for the industry as ever since the Bill
was passed by Parliament, the industry has been making concerted efforts to
rectify the Bill to incorporate certain provisions to safeguard the interests
of genuine manufacturers.
"The health ministry officials were very positive in their approach towards
the industry's concerns. They have agreed to address all the problems arising
out of this issue," said SPIC vice-chairman Lalit Jain after attending
the meeting. "It is a good development that the ministry officials agreed
to form the committee to address the concerns of the industry. We are positive
that the committee will be able to find a solution to safeguard the interests
of the genuine manufacturers," said FOPE vice-chairman Vinod Kalani.
By amending the Act, while the government is hell bent to clean the drug market
of spurious drugs, the industry is wary of the unintended consequences and the
resultant harassment to the licensed and bona fide manufacturers. Major concern
of the industry in the Bill is the lack of provisions to safeguard the interests
of the genuine drug manufacturers. There is no mention of definition on substandard
drugs in the Bill. Since there is no separate definition of substandard drug
in the Bill, if any drug is found substandard the manufacturer will be charged
for manufacturing and selling of adulterated or spurious drugs.
Source: The Hindu
19th January 2009
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