1997 JTR(SC) 703
1997 2 CLT(SC) 332 ; 1997 3 ICC 368 ; 1997 2 JLJ 83 ; 1997 5 JT 39 ; 1997 3 Scale 681 ; 1997 4 SCC 739 ; 1997 2 SCJ 307 ; 1997 3 SCR 861 ; 1997 KHC 1362 ; 1997 4 Supreme 544
1997(4) Supreme 544
SUPREME COURT OF INDIA
K. Ramaswamy and D.P. Wadhwa, JJ.
Laxmikant -Appellant
versus
Union of India & Ors. -Respondents
Civil Appeal No. 3000 of 1997
(Arising out of SLP (C) No. 13616 of 1996)
Decided on 11-4-1997
Counsel for the Parties :
For the Appellant : R.F. nariman, Sr. Adv., Rajiv S. Ray and Rakesh K. Sharma, Advocates.
For the Respondent/Union of Idnia : P.P. Malhotra, Sr.Adv., Ms. Anubha Jain, M.P. Shorawala, Mrs. Anil Katiyar, Advocates.
For State of Madhya Pradesh : K.N. Shukla, Sr. Adv., Prashant Kumar and S.K. Agnihotri, Advocates.
IMPORTANT POINT
Notification imposing total prohibition on use of tobacco in preparation of Tooth powder and toothpaste is well justified in Public Interest Covered by Article 19(6) of Constitution.
Act Referred :CONSTITUTION OF INDIA : Art.19(1)(g), Art.19, Art.19(6)
(A) The impugned notification prohibiting the manufacture and sale of all Ayurvedic tooth-pastes and tooth-powders containing tobacco was issued under Section 33-DDE of the Drugs and Cosmetics Act, 1940. The appeal invokes Article 19(1)(g) read with Article 19(6) of the Constitution, challenging the total ban on the ground that it offends the right to carry on trade. The Court examined the validity of the ban under Article 19(6) in the context of public health, considering whether the prohibition was justified despite encroaching upon the trade rights of manufacturers using minimal tobacco content. The analysis underscores that the states regulatory power under the Act coupled with the constitutional mandate to protect public health can sustain restrictions that would otherwise impinge upon Article 19(1)(g).
(B) Key legal principles include: (i) the states power to impose reasonable restrictions on trade under Article 19(6) in the interest of public health and safety; (ii) the hierarchy of rights where restrictions grounded in health emergencies and scientific consensus can override fundamental trade rights; (iii) the role of expert technical bodies in informing regulatory policy; and (iv) the necessity for total prohibition where substantial evidence links even low levels of a substance to severe health risks such as cancer.
Facts of the case:
The appellant, a manufacturer of tooth paste using tobacco as one of the ingredients, challenged a notification issued under Section 33-DDE of the Drugs and Cosmetics Act, 1940, that prohibited the manufacture and sale of all Ayurvedic drugs licensed as tooth-pastes/tooth-powders containing tobacco. The notification was based on the opinion of an Expert Committee constituted under the Act, which concluded that tobacco use in tooth-pastes and tooth-powders posed significant health risks, including cancer, and that there was no safe threshold for its use. The High Court upheld the notification, and the appeal reached this Court by special leave.
Findings of Court:
The Court noted the Expert Boards unanimous opinion that there was no rationality in using tobacco in tooth powder/pastes, given the availability of safe antiseptics. It reviewed international consensus, including recommendations from a conference at the All India Institute of Medical Sciences and a WHO collaboration, that tobacco is a major public health hazard with sufficient scientific evidence of ill-effects. The Court held that the total ban was justified in public interest under Article 19(6) of the Constitution, even though it offended the right to carry on trade under Article 19(1).
Issues:
Whether a total prohibition on the use of tobacco in tooth-pastes and tooth-powders is valid under Article 19(6) of the Constitution when it impacts the trade rights of manufacturers using small quantities of tobacco; whether the Expert Committees opinion and international scientific consensus sufficiently support the ban; and whether the public interest in preventing cancer and protecting health outweighs the right to trade.
Ratio Decidendi:
The Court determined that the states regulatory power under the Drugs and Cosmetics Act, combined with its constitutional obligation to protect public health, justified a total ban on tobacco in tooth-pastes and tooth-powders. The existence of safe alternatives, the unanimous expert opinion against any safe level of tobacco use, and authoritative international recommendations established that the prohibition was a reasonable restriction in the interest of public health under Article 19(6), despite infringing on trade rights under Article 19(1)(g).
Result:
The appeal is dismissed and the notification is upheld, with no costs awarded.
(A) The impugned notification prohibiting the manufacture and sale of all Ayurvedic tooth-pastes and tooth-powders containing tobacco was issued under Section 33-DDE of the Drugs and Cosmetics Act, 1940. The appeal invokes Article 19(1)(g) read with Article 19(6) of the Constitution, challenging the total ban on the ground that it offends the right to carry on trade. The Court examined the validity of the ban under Article 19(6) in the context of public health, considering whether the prohibition was justified despite encroaching upon the trade rights of manufacturers using minimal tobacco content. The analysis underscores that the states regulatory power under the Act coupled with the constitutional mandate to protect public health can sustain restrictions that would otherwise impinge upon Article 19(1)(g).
(B) Key legal principles include: (i) the states power to impose reasonable restrictions on trade under Article 19(6) in the interest of public health and safety; (ii) the hierarchy of rights where restrictions grounded in health emergencies and scientific consensus can override fundamental trade rights; (iii) the role of expert technical bodies in informing regulatory policy; and (iv) the necessity for total prohibition where substantial evidence links even low levels of a substance to severe health risks such as cancer.
Facts of the case:
The appellant, a manufacturer of tooth paste using tobacco as one of the ingredients, challenged a notification issued under Section 33-DDE of the Drugs and Cosmetics Act, 1940, that prohibited the manufacture and sale of all Ayurvedic drugs licensed as tooth-pastes/tooth-powders containing tobacco. The notification was based on the opinion of an Expert Committee constituted under the Act, which concluded that tobacco use in tooth-pastes and tooth-powders posed significant health risks, including cancer, and that there was no safe threshold for its use. The High Court upheld the notification, and the appeal reached this Court by special leave.
Findings of Court:
The Court noted the Expert Boards unanimous opinion that there was no rationality in using tobacco in tooth powder/pastes, given the availability of safe antiseptics. It reviewed international consensus, including recommendations from a conference at the All India Institute of Medical Sciences and a WHO collaboration, that tobacco is a major public health hazard with sufficient scientific evidence of ill-effects. The Court held that the total ban was justified in public interest under Article 19(6) of the Constitution, even though it offended the right to carry on trade under Article 19(1).
Issues:
Whether a total prohibition on the use of tobacco in tooth-pastes and tooth-powders is valid under Article 19(6) of the Constitution when it impacts the trade rights of manufacturers using small quantities of tobacco; whether the Expert Committees opinion and international scientific consensus sufficiently support the ban; and whether the public interest in preventing cancer and protecting health outweighs the right to trade.
Ratio Decidendi:
The Court determined that the states regulatory power under the Drugs and Cosmetics Act, combined with its constitutional obligation to protect public health, justified a total ban on tobacco in tooth-pastes and tooth-powders. The existence of safe alternatives, the unanimous expert opinion against any safe level of tobacco use, and authoritative international recommendations established that the prohibition was a reasonable restriction in the interest of public health under Article 19(6), despite infringing on trade rights under Article 19(1)(g).
Result:
The appeal is dismissed and the notification is upheld, with no costs awarded.
ORDER
Leave granted. We have heard counsel on both sides.
2. This appeal, by special leave, arises from the judgment passed by the Madhya Pradesh High Court at Jabalpur Bench, on November 23, 1995.
3. The appellant is a manufacturer of tooth paste, using tobacco as one of the ingredients therein. The Government exercising the power under Section 33-DDE of the Drugs and Cosmetics Act, 1940 (for short, the "Act") issued notification as under :
"MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health)
NOTIFICATION
New Delhi, the 30th April, 1992.
GSR-443(E).-Whereas, the Central Government is satisfied on the basis of evidence and other material before it that the use of tobacco in tooth-pastes/tooth-powders is likely to involve risk to human beings and that is necessary and expedient in the public interest so to do;
Now, therefore, in exercise of powers conferred by Section 33(EED) of the Drugs and Cosmetics Act, 1940 (23 of 1949, the Central Government hereby prohibit the manufacture and sale of all Ayurvedic Drugs licensed as tooth-pastes/tooth-powders containing tobacco.
(No. X. 11014/3/91-DM-S & PFA)
H.S. Lamba, Jt. Secy."
Calling that notification in question, the appellant filed a writ petition in the High Court. The High Court has upheld the notification and dismissed the same. Thus this appeal, by special leave.
4. When the matter came up before this Court for admission on 30.7.1996, this Court noted as under :
"The petitioner has impugned the notification of the Govt. of India, Ministry of Health and Family Welfare dated 30.4.92 prohibiting the use of tobacco in the manufacture and sale of all Ayurvedic drugs including tooth powder and tooth paste containing tobacco. The High Court on elaborate consideration upheld the bar prohibiting the use of tobacco. Shri R.F. Nariman, learned counsel for the petitioner, contends that what was prohibited was use of 50% and more of tobacco in the preparation of the Ayurvedic drugs including tooth paste and tooth powder containing tobacco. The petitioner is using only 4% tobacco. The petitioner is using only 4% tobacco. If there is evidence or reports to indicate that even 4% tobacco also would cause hazardous effects including cancerous to close the manufacturing of tooth paste and tooth powder. Issue notice on this limited question."
5. On that basis, notice was issued. Counter affidavit has been filed by the respondents stating that the view that there should be total ban of use of tobacco in the preparation of tooth paste was taken by the Government in consultation with the Expert Committee constituted in that behalf and that, therefore, the notification is valid in law. Shri R.F. Nariman, learned senior counsel appearing for the appellant, contended that in view of the divergent views expressed by the members of the Board, total ban is not correct proposition; the permitted use of 4% would not be injurious to the health of the user of tooth paste and that, therefore, the view taken is not factually correct in law. We find no force in the contention.
6. It is an admitted position that the Expert Body of Ayurvedic, Siddha and Unani Drugs Technical Advisory Board was constituted under Section 33-EED of the Act. The Board has gone into the question and opined as under :
"The Board has in depth discussed the side effects of Nicotine compared to its advantages as a drug in tooth powder and tooth paste. Since there are many safe antiseptics available, the Board unanimously decided that there is no rationality in using tobacco in the tooth powder/pastes and approved the action taken by the Government, in public interest in prohibiting tobacco in Ayurvedic Drugs."
7. It is true that various authorities have expressed their views in this behalf. But on consideration of various views the Committee ultimately decided thus :
"Considering the various view points, the Committee decided that manufacturers should be told that use of tooth pastes or powders containing tobacco is fraught with the risk of cancer and dissuaded from marketing such products. In the case of Orissa, the Chairman agreed to a communication being sent by the D.G.H.S. to the Director of Medical Education and Training to discourage the use of Gudakhu in Orissa, Copies of this letter would be endorsed to the Director of Medical and Health Services in other States and also to the Members of the Committee."
8. Similar view was also expressed at an International Seminar held on 27th and 28th July, 1991 at All India Institute of Medical Sciences, New Delhi and the Conference also made similar recommendations which read thus :
"The Conference recognised tobacco as major public health hazard and also noted that no further research was needed to start tobacco control activities, as sufficient scientific evidence is already available about the ill-effects on health due to use of tobacco besides its being addictive."
9. Therefore, the International Conference held in collaboration with the World Health Organisation was of the opinion that the ban on use of tobacco in toothpaste and toothpowder should totally be imposed since it is prone to cancer. Under these circumstances, the view taken by the Government of India imposing total prohibition on the use of tobacco in the preparation of toothpowder and toothpaste is well justified in the public interest covered by Article 19(6) of the Constitution, though it offends the right to carry on trade guaranteed under Article 19(1) of the Constitution. The imposition of total ban is in the public interest.
10. The appeal is accordingly dismissed. No costs.
Appeal dismissed.
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