Macleods Pharmaceuticals Ltd & Ors. v. Union of India & Ors. (Madras HC, 2012)

• Validity: Was the ban notification on Gatifloxacin under Section 26A valid?
• Natural Justice: Did the Government need to hear industry voices before banning?
• DTAB: Was consultation with the Drugs Technical Advisory Board compulsory?

• No supplying omissions: Courts cannot add words to a statute the legislature left out.
• Legislative function: Section 26A action is legislative; natural justice is not a pre-condition.
• Precautionary principle: If human health is at risk and science is uncertain, courts and the State can act early to prevent harm.

The Madras High Court upheld the ban. The Government’s decision under Section 26A is legislative in nature. Courts use a different, limited standard when reviewing legislative acts. Natural justice is not required here.

• DTAB not mandatory: Section 26A does not require DTAB consultation; courts cannot “fill in” missing words.
• Precautionary principle: When human health may be at risk, early action is justified even if science has uncertainty.
• Committee sufficiency: The Sub-Committee of experts and its notes showed relevant considerations; that was enough.
• Immediate withdrawal: If a drug is harmful, the State should act without delay, regardless of how long it has been sold.

Section 26A actions are legislative. Therefore, natural justice does not apply. Courts cannot add consultation requirements not present in the statute. In public health matters, the precautionary principle supports preventive bans even when scientific certainty is incomplete.

• Shows how India balances drug safety with industry interests.
• Clarifies that DTAB consultation is not compulsory under Section 26A.
• Strengthens the use of the precautionary principle for public health protection.

1. Legislative nature: Ban under Section 26A is legislative; natural justice is not required.
2. No DTAB mandate: Statute does not force DTAB consultation.
3. Precaution first: Health risks justify early, protective bans.

Mnemonic: “Legis—No Notice—Protect Health”

1. Legis: Section 26A is legislative.
2. No Notice: Natural justice hearing is not needed.
3. Protect Health: Precautionary principle supports the ban.

Issue: Validity of the Gatifloxacin ban under Section 26A.

Rule: No supplying omissions; legislative function; precautionary principle.

Application: Sub-Committee considered risks and withdrawals; statute does not require DTAB; health risk justified action despite uncertainty.

Conclusion: Ban upheld; court will not interfere as if it were administrative action.

Section 26A

Central Government power to prohibit drugs for public safety.

DTAB

Drugs Technical Advisory Board; expert body under the Act.

Precautionary Principle

Act early to prevent health harm even when science is not conclusive.

Legislative Function

Law-making type action; courts review with restraint; hearings not required.

• Cases applying the precautionary principle in health/environment contexts.
• Indian decisions treating delegated legislation with judicial restraint.