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Section 6 of Drugs and Cosmetics Act 1940 - Central Drugs Laboratory

Section 6 of the Drugs and Cosmetics Act, 1940 provides for the establishment of the Central Drugs Laboratory under the control of a Director appointed by the Central Government. It also empowers the Central Government to prescribe the functions and procedures connected with the Laboratory through rules.

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Section 6 - The Central Drugs Laboratory

(1) The Central Government shall, as soon as may be, establish a Central Drugs Laboratory under the control of a Director to be appointed by the Central Government, to carry out the functions entrusted to it by this Act or any rules made under this Chapter:

Provided that, if the Central Government so prescribes, the functions of the Central Drugs Laboratory in respect of any drug or class of drugs or cosmetic or class of cosmetics shall be carried out at the Central Research Institute, Kasauli, or at any other prescribed Laboratory and the functions of the Director of the Central Drugs Laboratory in respect of such drug or class of drugs or such cosmetic or class of cosmetics shall be exercised by the Director of that Institute or of that other Laboratory, as the case may be.

(2) The Central Government may, after consultation with the Board, make rules prescribing:

(a) the functions of the Central Drugs Laboratory;

(d) the procedure for the submission to the said Laboratory under Chapter IV or Chapter IVA of samples of drugs or cosmetics for analysis or test, the forms of the Laboratory's reports thereon and the fees payable in respect of such reports;

(e) such other matters as may be necessary or expedient to enable the said Laboratory to carry out its functions;

(f) the matters necessary to be prescribed for the purposes of the proviso to sub-section (1).

Legislative note: Clauses (b) and (c) of sub-section (2) were omitted by the Drugs (Amendment) Act, 1955. References to cosmetics were inserted by subsequent amendments. The statutory text should therefore be read with the amendments made to the Act and the applicable rules.

Meaning and Scope of Section 6

Section 6 creates the statutory framework for the Central Drugs Laboratory. The provision requires the Central Government to establish the Laboratory under the control of a Director appointed by the Central Government.

The Laboratory performs functions assigned by the Drugs and Cosmetics Act, 1940 and the rules made under the relevant Chapter. Section 6 therefore operates together with the Drugs Rules, 1945, which contain more detailed provisions concerning the functions of the Laboratory and the handling and testing of samples.

Central Government's power to prescribe other laboratories

The proviso to Section 6(1) permits the Central Government to prescribe that functions relating to a particular drug, class of drugs, cosmetic or class of cosmetics may be performed by the Central Research Institute, Kasauli, or another prescribed laboratory.

Where this occurs, the Director of the relevant Institute or prescribed laboratory exercises the corresponding functions of the Director of the Central Drugs Laboratory for those products.

Drugs Rules 1945 and the Central Drugs Laboratory

Section 6(2) is one of the enabling provisions under which the Central Government has made rules relating to the Central Drugs Laboratory. Part II of the Drugs Rules, 1945 deals specifically with the Central Drugs Laboratory.

Rule 3 - Functions of the Laboratory

Rule 3 of the Drugs Rules, 1945 prescribes functions of the Central Drugs Laboratory. These include analysis or testing of specified samples sent to the Laboratory under the Act and such other duties as may lawfully be entrusted to it by the Central Government or, subject to the prescribed conditions, by a State Government.

Rule 3A and prescribed institutions

The Drugs Rules also provide for specified categories of drugs to be tested or dealt with by prescribed institutions. This gives practical effect to the proviso contained in Section 6(1), under which functions of the Central Drugs Laboratory may be assigned to the Central Research Institute, Kasauli, or another prescribed laboratory.

Importance of the Central Drugs Laboratory

The Central Drugs Laboratory forms part of the statutory drug-control framework established under the Drugs and Cosmetics Act, 1940. Its laboratory functions support regulatory testing and analysis required under the Act and the applicable rules.

The statutory framework is important because regulatory decisions concerning the quality and compliance of drugs and other regulated products may depend upon laboratory analysis carried out in accordance with the Act and the rules.

Section 6 should be read together with other provisions of the Act, particularly the provisions concerning the Drugs Technical Advisory Board, standards of quality, import of drugs and cosmetics, Government Analysts and procedures for testing and analysis.

Official Legal Resources

For the current statutory and regulatory material, readers should also consult the official Central Drugs Standard Control Organisation resources maintained by the Ministry of Health and Family Welfare.

Legal reference page on Section 6 of the Drugs and Cosmetics Act, 1940. Readers should verify subsequent amendments, rules and official notifications where the current regulatory position is material.