Section 26A of the Drugs and Cosmetics Act, 1940: Central Government Power to Regulate, Restrict or Prohibit Drugs and Cosmetics
Section 26A empowers the Central Government, in specified public-interest circumstances, to regulate, restrict or prohibit the manufacture, sale or distribution of a drug or cosmetic by notification in the Official Gazette.
Text of Section 26A
26A. Powers of Central Government to regulate, restrict or prohibit manufacture, etc., of drug and cosmetic in public interest.
Without prejudice to any other provision contained in this Chapter, if the Central Government is satisfied that the use of any drug or cosmetic is likely to involve any risk to human beings or animals, or that any drug does not have the therapeutic value claimed or purported to be claimed for it, or contains ingredients and in such quantity for which there is no therapeutic justification, and that in the public interest it is necessary or expedient so to do, the Central Government may, by notification in the Official Gazette, regulate, restrict or prohibit the manufacture, sale or distribution of such drug or cosmetic.
What Section 26A Means
The provision is a public-health power contained in Chapter IV of the Drugs and Cosmetics Act, 1940. The words "without prejudice to any other provision contained in this Chapter" indicate that the power under Section 26A operates in addition to other powers and restrictions under Chapter IV.
Action under Section 26A requires satisfaction of the Central Government on the statutory grounds and a further conclusion that regulation, restriction or prohibition is necessary or expedient in the public interest. The legal measure is implemented through a notification in the Official Gazette.
Grounds on Which the Power May Be Exercised
| Statutory ground | Meaning in the provision |
|---|---|
| Risk to human beings or animals | The use of a drug or cosmetic is considered likely to involve such risk. |
| Lack of claimed therapeutic value | A drug does not have the therapeutic value claimed or purported to be claimed for it. |
| No therapeutic justification | A drug contains ingredients, and quantities of those ingredients, for which there is no therapeutic justification. |
| Public interest | The Central Government must also be satisfied that regulatory action is necessary or expedient in the public interest. |
Nature and Scope of the Central Government's Power
Once the statutory conditions are met, the Central Government may choose among three forms of intervention: it may regulate, restrict or prohibit the manufacture, sale or distribution of the concerned drug or cosmetic. The exact legal effect therefore depends on the terms of the particular Gazette notification issued under Section 26A.
Amendment History
Section 26A was inserted by the Drugs and Cosmetics (Amendment) Act, 1982 (Act 68 of 1982), with effect from 1 February 1983. The Drugs and Cosmetics (Amendment) Act, 2008 (Act 26 of 2008) amended Section 26A by substituting the words "regulate, restrict or prohibit" for "prohibit", with effect from 10 August 2009.
Contravention of a Section 26A Notification
Section 28B deals specifically with manufacture, sale or distribution of a drug or cosmetic in contravention of a notification issued under Section 26A. Readers dealing with compliance or prosecution should therefore read the applicable Section 26A Gazette notification together with Section 28B and other relevant provisions of the Act.
Recent Regulatory Use
Section 26A continues to be used for regulatory action concerning drugs, including fixed-dose combinations (FDCs). CDSCO publishes relevant prohibition and restriction notifications and maintains official material concerning FDCs. Because individual notifications can be issued, amended, revoked or affected by later regulatory or judicial action, the current notification should always be checked before relying on an older list.
India Code - Drugs and Cosmetics Act, 1940
Legislative notes: Section 26A inserted by Act 68 of 1982, section 21 (w.e.f. 1-2-1983). The words "regulate, restrict or prohibit" were substituted by Act 26 of 2008, section 4, for "prohibit" (w.e.f. 10-8-2009).