MANUFACTURE. SALE AND DISTRIBUTSION OF DRUGS AND COSMETICSCentral

Section 16 of The Drugs and Cosmetics Act, 1940

(1)This Act may be called the Drugs 1[and Cosmetics] Act, 1940.
(2)It extends to the whole of India 2* * *.
(3)It shall come into force at once; but Chapter III shall take effect only from such date3 as the Central Government may, by notification in the Official Gazette, appoint in this behalf, and Chapter IV shall take effect in a particular State only from such date3 as the State Government may, by like notification, appoint in this behalf : 4[Provided that in relation to the State of Jammu and Kashmir, Chapter III shall take effect only from such date5 after the commencement of the Drugs and Cosmetics (Amendment) Act, 1972 (19 of 1972), as the Central Government may, by notification in the Official Gazette, appoint in this behalf.]

Summary

In Chapter IV, standard quality for a drug means it meets the requirements specified in the Second Schedule of the Act.
For cosmetics, standard quality means complying with whatever standards are officially set down by the rules.
The Central Government has the power to change or add to the Second Schedule to update the quality standards for drugs and cosmetics.
The government must consult with the Drugs Technical Advisory Board and give at least three months' notice in the Official Gazette before amending these standards.

Practical examples

1Anil manufactures aspirin tablets in his lab on July 10, 2026. To verify that his tablets are of standard quality under Section 16, he checks the Second Schedule of the Act and ensures his product matches the purity and strength standards listed there.

2A company plans to manufacture a new eyeliner in November 2026. Under Section 16, the company must follow the specific packaging, color, and chemical limit rules that the government has prescribed in the regulations for cosmetics to meet standard quality.

3The health ministry decides that a new international vaccine standard should be added to the Second Schedule. Following Section 16, the Central Government publishes a notification in the Gazette on January 5, 2026, giving three months' notice to the public of this change.

FAQ

1. What does standard quality mean for a drug under Section 16 of the Drugs and Cosmetics Act 1940?

Under Section 16 of the Drugs and Cosmetics Act, 1940, standard quality for a drug means that it complies with the quality standards set out in the Second Schedule of the Act.

2. How are quality standards set for cosmetics under Section 16 of the Drugs and Cosmetics Act 1940?

Under Section 16 of the Drugs and Cosmetics Act, 1940, a cosmetic is of standard quality if it complies with such standards as may be prescribed by the rules under the Act.

3. Can the government change the Second Schedule under Section 16 of the Drugs and Cosmetics Act 1940?

Yes, under Section 16 of the Drugs and Cosmetics Act, 1940, the Central Government can add to or amend the Second Schedule by publishing a notification after consulting the Board.

4. How much notice must the government give before changing drug standards under Section 16 of the Drugs and Cosmetics Act 1940?

Under Section 16 of the Drugs and Cosmetics Act, 1940, the Central Government must give not less than three months' notice in the Official Gazette before amending the Second Schedule.

Test yourself

Q1.Under Section 16 of the Drugs and Cosmetics Act, 1940, where are the quality standards for drugs specified?

Q2.Under Section 16 of the Drugs and Cosmetics Act, 1940, how is "standard quality" defined for cosmetics?

Q3.Under Section 16 of the Drugs and Cosmetics Act, 1940, what is the minimum notice period the Central Government must give before amending the Second Schedule?

Q4.Under Section 16 of the Drugs and Cosmetics Act, 1940, whom must the Central Government consult before amending the Second Schedule?

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MANUFACTURE. SALE AND DISTRIBUTSION OF DRUGS AND COSMETICSCentral

Section 16 of The Drugs and Cosmetics Act, 1940

(1)This Act may be called the Drugs 1[and Cosmetics] Act, 1940.
(2)It extends to the whole of India 2* * *.
(3)It shall come into force at once; but Chapter III shall take effect only from such date3 as the Central Government may, by notification in the Official Gazette, appoint in this behalf, and Chapter IV shall take effect in a particular State only from such date3 as the State Government may, by like notification, appoint in this behalf : 4[Provided that in relation to the State of Jammu and Kashmir, Chapter III shall take effect only from such date5 after the commencement of the Drugs and Cosmetics (Amendment) Act, 1972 (19 of 1972), as the Central Government may, by notification in the Official Gazette, appoint in this behalf.]

Summary

In Chapter IV, standard quality for a drug means it meets the requirements specified in the Second Schedule of the Act.
For cosmetics, standard quality means complying with whatever standards are officially set down by the rules.
The Central Government has the power to change or add to the Second Schedule to update the quality standards for drugs and cosmetics.
The government must consult with the Drugs Technical Advisory Board and give at least three months' notice in the Official Gazette before amending these standards.