Rejecting the proposal of the Ministry of Health and
Family Welfare to set up a Central Drugs Authority, to check
malpractices in drug manufacturing, a Parliamentary panel has, instead,
recommended creation of a professionally-managed Central Drugs
Administration under the amended Drugs and Cosmetics Act.
In
its 79th report on the Drugs and Cosmetics (Amendment) Bill, 2013, the
Parliamentary Standing Committee on Health and Family Welfare has said
that there was a need for effective discharge of enforcement activities,
which requires a strong, professionally-managed administration that can
take action against unscrupulous manufacturing companies.
The
panel pointed out that neither the Mashelkar Committee report nor the
Committee on Health and Family Welfare had recommended constitution of a
Central Drugs Authority as proposed in the Bill, but had instead
recommended strengthening of the existing Drugs Regulatory body (Central
Drugs Standard Control Organisation).
"The proposed
Central Drugs Authority is studded with bureaucratic heads of seven
central ministries and four secretary and additional secretary/joint
secretary-level bureaucrats as ex-officio members with the Health
Secretary as its chairperson. Its composition is unprecedented as no
other regulatory body in the country or outside has such a composition
and it is not acceptable to the Committee," it said.
The
Committee said that the central drugs administration should be headed
by a chief drug controller general of India of the rank of
secretary/special secretary who possesses the requisite technical and
professional expertise for the role.
The panel also
said that the chief controller general should be selected by a committee
headed by the Cabinet Secretary with the review of the functioning of
CDA to be done by a panel of independent experts under the Act.
There should be three separate sections dealing with clinical trials, cosmetics and medical technologies, the
panel noted.
The
panel also raised the issue of the flooding of markets with food
supplements making claims of possessing medicinal properties and pointed
out that the current drug regulating authorities had no control over
them.
"The Committee recommends that if any such food
supplement claims to have medicinal properties (and) effectiveness in
curing disease, they should also be brought under the purview of the
proposed Central Drugs Administration for the purpose of their import,
sale and distribution," it said.
As regards
compensation for injury or death due to clinical trial, the committee
has recommended that Principal Investigator appointed by the Chief Drug
Controller of India (as recommended by Committee) and the Ethics
Committee should be given responsibility for determining the cause of
injury or death. The Chief Drug Controller of India should act as
Appellate Authority for both, the ``subject’’ and the ``sponsor’’.
The
Chief Drug Controller should refer such appeals to the Serious Adverse
Event Panel of experts, which will give the final decision, the
committee said.
-The Hindu
