Central Government’s Notification banning 344 FDC drugs quashed

Delhi High Court: A Single Judge of the Delhi High Court Rajiv Sahai Endlaw, J. vide his order and judgment  struck down the notification dated 10 March, 2016 issued by the Central Government, through its Department of Health & Family Welfare (“Notification”); whereby 344 Fixed Dose Combination (FDC) Drugs were banned with immediate effect. FDCs are combinations of two or more active pharmaceutical ingredients in fixed ratios, given in the form of a single dose. The Notification banning the FDC’s in question was in furtherance of ‘technical recommendations’ given by an Expert Committee (under Prof. Kokate; “Kokate committee”) appointed by the Central Government. The committee found that the FDCs in question were risk for human consumption and had safer alternatives available in the market therefore extended no ‘therapeutic justification’.

The notification is issued under Section 26-A of the Drugs and Cosmetics Act, 1940:

26-A. Power of Central Government to 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, then, that Government may, by notification in the Official Gazette, prohibit the manufacture, sale or distribution of such drug or cosmetic.”

The petitioners challenged the notification banning the drugs on account of –

(a) No show-cause notice was issued to the petitioners prior to the notification banning FDC’s;

(b) No opportunity of hearing was given to the petitioners before the imposition of the ban;

(c) No safer alternatives to the FDC’s were disclosed by the notification;

(d) No time was afforded to the petitioners for phasing out drugs already in the market;

(e) No scientific evidence was relied on by the Kokate committee while coming to the conclusion that the FDC’s extended no therapeutic use;

(f) The State has proceeded solely on the basis of the Kokate Committee report and completely ignored the inbuilt examination of Sections 5 and 7 of the Drugs and Cosmetics Act. (Section 5 provides for a technical advisory board and Section 7 provides for a drugs consultative committee.)

The respondents defended the notification by raising the following grounds –

(a) The drugs of the petitioners did not form a part of the list of approved FDC’s was published on the website of the Central Drugs Standard Control Organization (CDSCO) in the year 2013;

(b) The petitioners did not raise any objection to the Drugs controller upon not finding their name on the website as an approved FDC;

(c) There is no rule of natural justice that is required to be followed in a legislative action and a notification under Section 26A is a legislative action;

(d) Since Section 26-A starts from a non obstante clause the state need not compulsorily take the advice from the board (under Section 5) and the committee (under Section 7) constituted under the Act.

The Court allowed the writ petitions and quashed the Notification banning the FDC’s on the ground that the purpose of having a committee and a board (under Sections 5 and 7 of the Act) would be defeated if their advice was not considered. The Court relied on the decisions in M/s L & T Mc. Neil Ltd. v. Government of Tamil Nadu, (2001) 3 SCC 170, Buddhadev Maity v. Union of India,  2010 SCC OnLine Del 1975 (authored by Rajiv Endlaw, J.) and Harish Uppal v. Union of India, (2003) 2 SCC 45 to hold that consultation under the Act with such specially constituted bodies is necessary and therefore the notification was bad in law. [Pfizer Limited v. Union of India, 2016 SCC OnLine Del 6150, decided  on 1.12.2016]

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