The notification issued by the Central Government under S. 26-A of the Drugs and Cosmetics Act, 1940, banning the manufacture and sale of fixed dose combination steroids was not arbitrary or violative of Arts. 14 and 19(g) of the Constitution.

M. RAMA JOIS, J.

1. In all these petitions presented under Art. 226 of the Constitution, the petitioners have questioned the legality of the notification issued by the Central Government dated 3/11/1988, under S. 26-A of the Drugs and Cosmetics Act, 1940, (hereinafter referred to as the Act), insofar as it bans the manufacture and sale of the fixed dose combination steroids on the ground that it is arbitrary and, therefore, not authorised by S. 26-A of the Act, and also violative of Arts. 14 and 19(g) of the Constitution.

2. The brief facts of the case as stated in the Writ Petition No. 6882 of 1988 are these. The petitioner is a company incorporated under the Companies Act, 1956. Inter alia it carries on the business of preparation, manufacture, sale and distribution of drugs and pharmaceutical products. Some of the formulations which are being manufactured by the company are Cortomine tablets; Cortomine Forte tablets and Beta-Asmatide tablets. These tablets are combinations of steroid with other drugs. The petitioner company had secured necessary licence for manufacturing the above formulation. The Central Government by notification dated 3/11/1988, issued under S. 26-A of the Act, has banned the manufacture and sale. Fixed dose combination of corticosteroids with any other drug for internal use, as also fixed dose combination of chloromphenicolo with any other drugs for internal use. Questioning the legality of the said notification, the petitioners have presented the petition.

3. The pleas of the petitioners are as follows :-

That the question as to whether fixed dose combinations containing steriods should be allowed to be manufactured or not had been the subject matter of consideration by the Central Government on the basis of the opinion tendered by the Drugs Technical Advisory Board (for short the Board and on the basis of the said opinion, the Central Government had issued an earlier notification under S. 26-A of the Act on 23/07/1983, and in the said notification, though fixed dose combination of steroids for internal use was banned, the formulation made for treatment of asthama was not banned. The fixed dose combinations which are being manufactured and sold by the petitioner company are those meant for the treatment of asthama, and there was no basis or justification for the Central Government to impose ban on the said fixed dose combinations which are meant for the treatment of asthama, and, therefore, the notification was liable to be struck down as arbitrary and, therefore violative of the fundamental rights of the petitioner guaranteed under Arts. 14 and 19(g) of the Constitution.

4 In the written statement filed on behalf of the Union of India, it is stated that the DTAB in its meeting held on 31-12-1981 gave a considered opinion for imposing a ban on fixed dose combinations of steroids for internal use for treatment of ailments other than asthama and in the opinion furnished it was expressly stated that the question of banning fixed dose combinations even for the treatment of asthama required further examination, and, that it was in view of this opinion that the Central Government had issued the notification dated 23/07/1983. It is further stated that the Technical Advisory Committee in its 40th meeting held on 22/04/1988, after due consideration of the matter, had given the opinion that a total ban should be imposed on fixed dose combinations containing steroids including the combinations meant for the treatment of asthama. It is further stated that it was on the basis of the technical opinion so rendered that the Central Government had issued the notification under S. 26-A of the Act and, therefore, it can neither be contended that it was arbitrary and therefore not authorised by S. 26-A of the Act nor can it be said to be violative of Arts. 14 and 19(g) of the Constitution.

5. Shri J. K. Sibal, Senior Advocate, appearing for the company contended that apart from the material on which the earlier or