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1996 DIGILAW 914 (SC)

Drug Action Forum v. Union of India

1996-04-15

B.N.KIRPAL, J.S.VERMA

body1996
JUDGMENT : 1. The report of the Expert Committee headed by Prof. J.S. Bajaj, after its meeting held on 8th January, 1996 has been submitted. We have perused the report. The report contains the unanimous opinion of the Committee. 2. The unanimous opinion expressed in the above report is for withdrawing the use of Fixed Dose Combination (for short "FDC") of Streptomycin and Pencillin (for short "S&P") injection from the market in a phased manner. The further opinion of these experts expressed as its recommendation, is that the time upto 1st January 1997 may be given to the manufacturers to withdraw the drug for human use from the market. This time frame is considered appropriate by the Committee of Experts in the context of logistics of the pharmaceutical industries. The Committee has also made some other recommendations, which include the urgent need of a list of essential drugs at the national level and the recommendation made is for compilation of such a list on top priority with provision for updating and publishing the list regularly at periodic intervals. 3. Certain objections were filed on behalf of three manufacturers of the FDC of S&P injections. Shri F.S. Nariman and Shri A.K. Ganguly appearing for them were heard. On a consideration of their objections, we find no merit in them. The report of the Committee of Experts is detailed and gives cogent reasons based on authentic statistics and medical literature which fully support the conclusions reached in the report. No significant statistics or authentic materito the contrary has been shown to suppo the objections. In support of th objections, several certificates by medi practitioners have been filed to indica the extensive use of this FDC. In our opinion, the nature of these certificates which contain mere general statements is indicative of the indiscriminate use of this FDC and it does not support the submission that its availability is necessary for administering proper medical treatment for any specific illness, which is not possible in the absence of availability of such FDC. Moreover, this aspect also has been considered and adequately dealt with in the report of the Committee. We do not find any merit in the objections to the report and the submission made on behalf of these manufacturers not to direct phasing out of the use of the FDC of S&P injection. 4. Moreover, this aspect also has been considered and adequately dealt with in the report of the Committee. We do not find any merit in the objections to the report and the submission made on behalf of these manufacturers not to direct phasing out of the use of the FDC of S&P injection. 4. In view of the above conclusion reached by us, we reject the objections and accept the above report of the Committee of Experts with the recommendation therein for withdrawing the use of FDC of S&P injection from the market in a phased manner. 5. The question now is of the time for phasing out the FDC of S&P injection from the market. The Committee has recommended that time upto the 1st January, 1997. However, on an overall assessment of the situation and taking into account all the relevant factors, we consider it appropriate that the time for phasing out the FDC of S&P injection from the market should be fixed upto the 1st January, 1998. We direct accordingly. 6. We further direct that the concerned authorities would take the necessary steps forthwith to issue the necessary instructions/directions and to ensure their implementation to check indiscriminate use of this drug even during the period fixed for phasing it out. The authorities must ensure that the administration of the FDC of S&P injection is only on due certification of a qualified medical practitioner of the need of this injection and that the necessary record is maintained to account for the supply and use of the entire stock of the FDC of S&P injection. All necessary steps to ensure full compliance of these directions must be taken by the concerned authorities within a period of one month.