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1999 Supreme(Cal) 394

High Court Of Calcutta
S. B. SINHA, M. H. S. ANSARI
DRUG CONTROLLER GENERAL OF INDIA - Appellant
Versus
W.B.SMALL SCALE MANUFACTURERS ASSOCIATION - Respondent
M. A. T.  2705  Of  1997
Decided On : 07/27/1999

Advocates Appeared:
AJAY KUMAR GUPTA, AMAL KUMAR MITRA, BIDYUT KUMAR ROY

The Central Government's satisfaction under Section 26A of the Drugs and Cosmetics Act is subjective and not subject to judicial review, and the principles of natural justice are not applicable to policy decisions taken by the government in the public interest.

Headnote:

DRUGS AND COSMETICS ACT, 1940 - SECTION 26A - NOTIFICATION PROHIBITING MANUFACTURE, SALE AND DISTRIBUTION OF FIXED DOSE COMBINATION OF HYDROXYQUINOLINE GROUP OF DRUGS - VALIDITY - SATISFACTION OF CENTRAL GOVERNMENT - PRINCIPLES OF NATURAL JUSTICE - COMPLIANCE.

Fact of the Case:

A notification was issued by the Central Government under Section 26A of the Drugs and Cosmetics Act, 1940, prohibiting the manufacture, sale, and distribution of fixed dose combination of Hydroxyquinoline group of drugs, except for preparations meant for external use. The notification was challenged in a writ petition, arguing that it did not specify the grounds on which the Central Government arrived at a satisfaction that such prohibition was necessary in the public interest.

Finding of the Court:

The High Court quashed the impugned notification, holding that it did not comply with the principles of natural justice as it did not provide any reasons for the prohibition and did not give the manufacturers an opportunity to be heard. The court also directed the Central Government to reconsider the matter afresh in accordance with the principles of natural justice and administrative fair play.

Issues: 1. Whether the impugned notification was valid in law? 2. Whether the Central Government was required to comply with the principles of natural justice before issuing the notification? 3. Whether the writ court could interfere with the policy decision of the Central Government?

Ratio Decidendi: 1. The notification was issued under Section 26A of the Drugs and Cosmetics Act, which empowers the Central Government to prohibit the manufacture, sale, or distribution of any drug or cosmetic if it is satisfied that its use is likely to involve any risk to human beings or animals or that it does not have the therapeutic value claimed for it. 2. The satisfaction of the Central Government is a subjective satisfaction and is not required to be supported by any reasons. 3. The principles of natural justice are not applicable to policy decisions taken by the government in the public interest. 4. The writ court cannot interfere with the policy decision of the Central Government unless it is arbitrary, mala fide, or violative of fundamental rights.

Final Decision: The High Court's judgment was set aside, and the appeal was allowed.

( 1 ) THE instant appeal is directed against a Judgment and order dated 14-2-97 reported in AIR 1997 Cal 186 passed by a learned Single Judge in C. O. No. 5043 (W) of 1996 whereby and whereunder the Notification No. G. S. R.-793 (E), issued under Section 26a of the Drugs and Cosmetics Act, 1940 (in short the Act) and published in the Gazette dated 13th December, 1995 was quashed and set aside.

( 2 ) BY the impugned Notification dated 13th December, 1995 a prohibition on manufacture, sale and distribution of fixed dose combination of Hydroxyquinoline group of drugs with any other drug, except for preparations meant for external use, was imposed.

( 3 ) THE impugned Notification has been issued in exercise of the power vested in the Central Government under Section 26a of the Act which reads as under :-"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. "

( 4 ) THE contention of the respondents-writ petitioners assailing the impugned notification was that except reproducing the language of Section 26a of the Act, the impugned Notification does not specify the ground on which the Central Government arrived at a satisfaction that the manufacture, sale and distribution of fixed dose combination of Hydroxyquinoline group of drugs with any other drug, except for preparations meant for external use was required to be prohibited in the public interest.

( 5 ) THE above contention found favourwith the learned single Judge in quashing the impugned notification. The Ld. single Judge observed that there was nothing on record to show that any expert committee was constituted to examine the matter in consultation with the manufacturers of the drugs in question and directed that the order under appeal shall remain in abeyance for a period of two months from the date thereof to enable the Central Government to consider the matter afresh in accordance with the principles of natural justice and administrative fair play. It was further directed that while reconsidering the matter, the Central Government should take the assistance of a committee of experts which should give the representative of the manufacturers of the drug in question, including the petitioners a reasonable opportunity of hearing and placing relevant research papers and documents.

( 6 ) WHILE giving directions for hearing the appeal expeditiously an interim order staying the operation of the Judgment under appeal was passed on 3-2-99.

( 7 ) ). It is the case of the Drug Controller General of India, appellant before us, that before issuing the final notification the matter was referred to before the Technical Sub-Committee of Drugs Technical Advisory Board whereby the Technical Sub-Committee has recommended the case for external use after examination of various fixed dose combination of Hydroxyquinoline group of drugs with any other drug. It is the submission of the appellant that the Sub-Committee is a statutory body which may advice the Central/state Government for implementation of the Act. The recommendations made by the said Sub-Committee were accepted by the Central Government and thereafter the impugned notification was issued in exercise of the power vested in it under Section 26a of the Act.

( 8 ) IT is the further submission of the Ld. Counsel for the appellant that the impugned notification was issued as a measure of carrying
















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