Section 38 of the Drugs and Cosmetics Act, 1940 - Rules to be Laid Before Parliament
Section 38 provides parliamentary oversight over rules made under the Drugs and Cosmetics Act, 1940. It requires every rule made under the Act to be placed before both Houses of Parliament and permits Parliament to modify or annul the rule in accordance with the procedure stated in the section.
Text and effect of Section 38
Every rule made under the Act is to be laid, as soon as may be after it is made, before each House of Parliament while Parliament is in session. The required laying period is a total of thirty days, which may fall within one session or across two or more successive sessions.
If, within the period specified by Section 38, both Houses agree to modify a rule or agree that the rule should not be made, the rule thereafter operates only in its modified form or ceases to have effect, as the case may be. A modification or annulment does not invalidate anything already done under the rule before that change takes effect.
What does "laid before Parliament" mean?
For Section 38, laying a rule before Parliament means formally placing subordinate legislation made under the Act before both the Lok Sabha and the Rajya Sabha. The section therefore subjects rule-making under the Act to legislative scrutiny after the rule is made.
Thirty-day laying period
The total period is thirty days while Parliament is in session. The thirty days need not occur in a single session; they may be completed in two or more successive sessions. The statutory procedure then gives both Houses an opportunity to agree on modification or annulment within the time contemplated by Section 38.
Effect of modification or annulment
Where both Houses agree on a modification, the rule thereafter has effect in the modified form. Where both Houses agree that the rule should not be made, it thereafter has no effect. Section 38 expressly protects the validity of acts already done under the rule before its modification or annulment.
Legislative history
Section 38 was inserted by section 30 of Act 13 of 1964 with effect from 15 September 1964. Its parliamentary scrutiny wording was subsequently amended by section 40 of Act 68 of 1982 with effect from 1 February 1983.
Official source
The current central Act can be checked on the official India Code portal. Readers dealing with a particular rule, amendment or compliance issue should also verify the applicable subordinate legislation and notifications in force on the relevant date.
India Code - Drugs and Cosmetics Act, 1940
Note: This page explains Section 38 for general legal information. For a specific proceeding or compliance question, the applicable rule, notification, amendment and relevant judicial decisions should be checked separately.