9911796707
TMI Blog1988 (2) TMI 351X X X X Extracts X X X X X X X X Extracts X X X X ..... d dose combination of carticosteroids with any other drug for internal use. 2. The petitioners are manufacturers of a drug called Cartasmyl , which is a fixed dose combination of corticosteroids and bronchodilators. They contend that this drug is of great benefit to asthma patients. They also contend that the ban imposed by the aforesaid notification has been done without being properly satisfied, as required under Section 26A of the Act. 3. Few facts need to be mentioned. Sometime in the year 1980 the question of the rationality or otherwise of the various fixed dose combinations then available in the market began to exercise the mind of the Government. The then Drugs Controller, Dr. S.S. Gothoskar, had invited the views of the manufa ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... It ought to be noted that during the hearing of that writ petition on affidavit of Raghunath Prasad Hinnaria, Deputy Drugs Controller, had been filed. In that affidavit the Government had supported the use of fixed dose combination of carticosteroids with bronchodilators on the ground that the said combination was useful for the treatment of bronchial asthma. This was naturally consistent with the opinion expressed by Dr. Gothoskar referred to above. 5. It is contended by the petitioners that after 1984 nothing has happened which could have legitimately led the Government to impose the ban in November 1988. It is the contention of the petitioners that the ban is based upon total non-application of mind and on total absence of material whi ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... h he wants me to hold that the banned drug is highly useful and is a boon to persons who are suffering from bronchial asthma. There are, on the other hand, certain observations in other medical literature which reduce the value of the opinion on which Mr. Desai relies. If there are two contrary views and if one of them commends itself to the authority under Section 26A of the Act, then this Court would not normally interfere with the order passed under Section 26A. Mr. Dalal, the learned Advocate appearing for the Union of India, has invited any attention to some judgments of the Supreme Court which point to the limited jurisdiction of Courts while dealing with the opinion formed by the Government on the basis of expert views. In P.K. Tejan ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ications of the total ban of certain medicines, for which appropriate direction was sought, the Supreme Court observed that a judicial proceeding of the nature initiated is not an appropriate one for determination of such matters. I am in agreement with the proposition that if, after considering the rival medical opinions in support of or against a particular drug, the authority accepts one opinion and proceeds to exercise its power under Section 26A of the Act, this Court would be hesitant to interfere with the exercise of that power. The question in this petition, however, is whether there was any material before the Government when it proceeded to pass the impugned order. 8. On behalf of the Government it is stated that the Drugs Techn ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ems to be more in the nature of opinion. The members of the Board themselves do not seem to have been given the benefit of a particular information which could have enabled them to take a view contrary to the view which had been taken earlier by the Drugs Controller. It has not been mentioned, for example, that any medical literature or the results of any clinical test were made available to the members of the Board who met on 22nd April 1988. While considering this question, one cannot forget the fact that the Government of India had taken a decision that the fixed dose combination of corticosteroids with bronchodilators was a good and effective drug for the treatment of bronchial asthma as early as in the year 1983. That view was re-affir ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... basis of the satisfaction as required under Section 26A of the Act before imposing the impugned ban. 10. It is also interesting to note the following to be found in the minutes of the Board meeting held on 22nd April 1988 :- The Chairman welcomed the members attending the meeting and stated that meeting of the Board could not be held after December, 84 because then Drugs Controller (India), Dr. S.S. Gothoskar retired in November, 1985 and it took sometime for Government to appoint new Drugs Controller (India). Thereafter the term of the elected and nominated members of the Board had expired and it took time to reconstitute the Board. Since the reconstituted Board is meeting for the First time, the Chairman requested all the members to ..... X X X X Extracts X X X X X X X X Extracts X X X X
|
