Section 26B of the Drugs and Cosmetics Act 1940: Central Government Power During an Epidemic or Natural Calamity
Section 26B gives the Central Government a specific emergency power to regulate or restrict the manufacture, sale or distribution of an essential drug when an emergency arises from an epidemic or natural calamity and action is necessary or expedient in the public interest.
Text and meaning of Section 26B
Section 26B - Power of Central Government to regulate or restrict manufacture, etc., of drug in public interest.
The provision operates without prejudice to the other provisions of Chapter IV. Where the Central Government is satisfied that a drug is essential for meeting an emergency caused by an epidemic or natural calamity, and considers regulation or restriction necessary or expedient in the public interest, it may act through a notification published in the Official Gazette to regulate or restrict the manufacture, sale or distribution of that drug.
When can the Central Government use Section 26B?
The statutory power is tied to an emergency setting. The provision requires a connection between an essential drug and an emergency arising because of an epidemic or natural calamity. It also requires the Central Government to be satisfied that intervention is necessary or expedient in the public interest.
- Essential drug: the drug must be essential to meet the requirements of the relevant emergency.
- Specified emergency: the emergency must arise due to an epidemic or natural calamity.
- Public interest: the Government must consider the proposed action necessary or expedient in the public interest.
- Gazette notification: the statutory action is taken by notification in the Official Gazette.
- Permitted controls: the notification may regulate or restrict manufacture, sale or distribution of the drug.
What does "regulate or restrict" cover?
Section 26B expressly identifies three parts of the drug supply chain: manufacture, sale and distribution. The precise controls depend on the terms of the Gazette notification issued under the section. Accordingly, the notification itself should always be checked to determine the drug covered, the nature of the restriction or regulation, its territorial or operational scope, and its duration.
Section 26B compared with Section 26A
| Provision | Principal statutory setting | Power stated in the Act |
|---|---|---|
| Section 26A | Public-interest control where statutory concerns include risk to humans or animals, lack of claimed therapeutic value, or absence of therapeutic justification for ingredients in the stated quantity. | Regulate, restrict or prohibit manufacture, sale or distribution of a drug or cosmetic. |
| Section 26B | An essential drug required for an emergency arising from an epidemic or natural calamity. | Regulate or restrict manufacture, sale or distribution of the drug. |
Legislative history
Section 26B was inserted by Section 5 of the Drugs and Cosmetics (Amendment) Act, 2008 (Act 26 of 2008) and came into force on 10 August 2009. It forms part of Chapter IV of the Drugs and Cosmetics Act, 1940, dealing with manufacture, sale and distribution of drugs and cosmetics.
Practical legal point
Section 26B is an enabling provision. In a particular case, the operative legal requirements will be found in the relevant Official Gazette notification issued under the section, read with the Drugs and Cosmetics Act, 1940 and other applicable rules or orders.
Official legal resources
India Code - Drugs and Cosmetics Act, 1940
CDSCO - Acts and Rules
For current compliance or litigation, verify the latest statutory text and the applicable Gazette notification from an official source.