Rejects Health Ministry’s proposal for setting up a Central Drugs Authority
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.
Keywords: Drugs and Cosmetics Act, Drugs act amendment, Parliamentary Standing Committee on Health and Family Welfare, Central Drugs Administration, drug manufacturing India, Indian pharma industry, quality control measures