1988 (2) TMI 351 - HC - Central Excise

Summary

Issues:
Challenging the validity of a notification banning the manufacture of a fixed dose combination of corticosteroids with any other drug for internal use under Section 26A of the Drugs and Cosmetics Act, 1940.

Analysis:
The petitioners contested the ban on their drug, "Cartasmyl," arguing its benefits for asthma patients and alleging the ban lacked proper justification under Section 26A of the Act. The background revealed the government's historical stance on fixed dose combinations, particularly for asthma treatment, supported by expert opinions. A previous case challenged a similar ban on "Celestamine," where the court found insufficient grounds for the ban, emphasizing the need for proper justification under Section 26A.

The petitioners claimed that the government's decision lacked new evidence post-1984 to warrant the ban imposed in 1988, suggesting a lack of due diligence. Section 26A empowers the government to ban drugs lacking therapeutic value or posing risks, ensuring patients are not misled about a drug's efficacy. The court noted conflicting medical opinions on the banned drug's utility, highlighting the government's discretion in such matters, as per legal precedents.

The Government justified the ban based on the Drugs Technical Advisory Board's recommendation due to potential harm from long-term corticosteroid use in asthma therapy. However, the court found the material presented did not sufficiently support the ban, questioning the Board's decision-making process and lack of concrete evidence considered. The court stressed the importance of having relevant material before imposing such bans under Section 26A.

The court granted interim relief, citing the apparent benefits of the banned drug for asthma patients and urging the Government to reassess the decision with fresh consideration and stakeholder input. The court emphasized the need to prevent harmful medicines while ensuring access to beneficial ones, signaling the importance of a well-informed and justified decision-making process. The ruling issued a rule for further proceedings and interim relief, emphasizing the need for a thorough reevaluation by the Government before final disposition.

Overall, the judgment underscores the importance of evidence-based decision-making in drug regulation, emphasizing the need for proper justification and stakeholder consultation when imposing bans under Section 26A of the Act.