Parliamentary panel calls for creation of Central Drugs Administration for stronger tabs

NEW DELHI: A Parliamentary panel has recommended creation of a professionally-managed Central Drugs Administration to check malpractices in drug manufacturing after rejecting the proposal for the setting up of a Central Drugs Authority under the amended Drugs and Cosmetics Act.

In its report on the Drugs and Cosmetics (Amendment) Bill, 2013, the Parliamentary Standing Committee on Health has said that there is a need for effective discharge of enforcement activities which requires a strong, professionally-managed administration which 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 and had instead recommended strengthening of the existing Drugs Regulatory body (CDSCO).

"The proposed CDA 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.

"The proposed CDA and 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.