Cadila Pharmaceuticals Ltd. vs.

State of Kerala 2 The Petitioner manufactured EC 350

(Vitamin E and C) capsulesand Cecure (multi-vitamin capsules) that were sold in medical shops
as dietary supplements. The issue before the Court was whether vitamin capsules fall under the
definition of drugs under the Drugs and Cosmetics Act and therefore, required license. The
Petitioner contended that the vitamin capsules in question were for general well-being, and not a
cure or prevention of any disease or disorder. Therefore, they did not fall within the definition of
the term drugs within the meaning of S.3 (d) (1).
The high court disagreed with the submission . It stated that the vitamin capsules in question were
not used by any person as a general dietary supplement. In cases of vitamin deficiency doctors
prescribe these vitamin capsules of a definite dosage, which mitigate or prevent diseases arising..
These vitamins capsules therefore squarely fall within the definition of drugs under the Act.

Chimanlal vs. State of Maharashtra3 the issue before the Supreme Court was whether
absorbent cotton, wool, roller bandages and gauze are drugs under the Act.
The Supreme Court held that the definition of drugs in S.3(d) of the Drugs Act is comprehensive
enough to cover not only medicines but also substances intended to be used for or in treatment of
diseases of human beings. Absorbent cotton, wool, roller bandages and gauze are substances
used for or in treatment of disease, and hence are drugs for the purposes of the Act.

Laxmikant vs. Union of India8 where the Central Government, in exercise of its powers under
Section 33EE of the Act, banned in public interest the manufacture and sale of all ayurvedic drugs
licensed as toothpaste/ toothpowders containing tobacco. The Appellant contended that they used
only 4 per cent of tobacco and there was no conclusive evidence to show that such a minute
quantity could pose a threat to health.
The Supreme Court held that the Central Government in consultation with the Ayurvedic, Siddha
and Unani Drugs Technical Advisory Board, an Expert Body constituted under Section 33D of the
Act, had arrived at a conclusion that tobacco contained carcinogenic elements, and therefore, its
use should be banned in toothpastes. Hence, the Court held that even though the ban offends the
right to carry on trade, it is justified in public interest and falls under Article 19(6) of the
Constitution being a reasonable restriction on the right to carry on trade or business.

Holy Cross Hospital vs. State of Kerala16 the Petitioner was a charitable hospital that stocked
medicines for its patients. The petition challenged the order of Drug Controller enforcing the
system of Drugs Licence to Petitioners hospital. Section 18 of the Act states that sellers, stockiest
and persons similarly situated are obliged to secure license before stocking drugs.
The high court, however, held that the broad classification between private or charitable hospitals
and hospitals/dispensaries under the supervision of Government or local medical bodies was valid
and there was nothing unconstitutional in requiring private hospitals to get license for stocking
drugs.

Sagar Medical Hall vs. State of Bihar,20 a petition was filed against the order of State
Government restraining the regional licensing authorities from issuing or renewing licence for
the wholesale and retail sale of drugs. The State Governments justification for its policy decision
was that the ban on the issuance of wholesale and retail drug licences was a temporary measure to
prevent the spurt of spurious drugs. There were adequate drug stores to meet public need.
The high court held that the grant and renewal of drug licence is governed by statutory rules and
nowhere do such rules provide that the license can be declined or renewal refused on the ground
that the State Government reckons that the number of shops are sufficient to meet demand of
public. Thus, executive decisions of the State cannot override the statutory provisions. The
growth of drug stores is to cater the needs of public.