WYETH LEDERLE LTD Vs. STATE OF BIHAR

JUDGEMENT

(1.) HEARD the learned counsel for the petitioner and also the counsel for the State.

(2.) THE short point is involved in this writ petition. The petitioner firm is not a manufacturer firm but they are doing repacking and re -labelling of drugs imported from other countries. Similarly Premarin tablets were imported from Ireland in bulk and then re -packing and relabelling being made in the petitioner company and then sold in the market. Previously packings were there of 20 Premarin tablets in one pack but permission was sought from the Drugs Controller by the petitioner for containing 28 tablets on one pack which is clear from Annexure -2/1. Then by Annexure 2/4 permission had been granted by the Drugs Controller but the local drug authorities have started taking exception to such packings of 28 tablets in one pack and, as such, the business premises of the petitioner was visited and then an order has been passed as contained in Annexure -8 and while passing that order in Annexure -8 it appears that no show cause were given to the petitioner. Moreover for such defects even if taken to be valid as pointed out that instead of 20 tablets 28 tablets in one pack has been repacked, then also by Annexure -8 the respondent authorities have asked the suspension of the business of the petitioner as a whole for 45 days which is against all norms on the face of it. At the first instance it was said that there was violation of Rule 105(1) of the Drugs and Cosmetics Rules but afterwards it has been said that it was violation of Rule 105(2) of the Rules. As per Rule 105(2) the packs should contain tablets to the multiple of 5 and this is the grievance of the respondent authorities that if from 20 tablets it is raised to 28 tablets then multiple of 5 does not remain. But it appears that on the face of it the local authority had committed mistake because the Premarin tablets are imported drug in finished form from Ireland which is outside the scope of Rule 105(2) of the Rules as per provisio of that Rule. In that way even if it is construed that no permission has been given by the Drugs Controller for repacking of 28 tablets in one pack although it appears that such permission has been granted although not specifically being stated in Ext. 2/4 but still then also no violation of rules is there to invite penal provisions. Moreover the vindictiveness of the respondent authority is clear on the face of it. For one drug even if there is some irregularity in repacking or relabelling there cannot be any question of shutting down the whole business of the petitioner and construing that position this court by an interim order dated 3.7.2002 allowed the petitioner to run business except that of Premarin tablets only. Now it appears that objection raised regarding repacking and re -labelling of Premarin tablets has got no substance. In that way Annexure -8 is quashed as a whole. Practically there is no requirement of quashing the same now within the period of 45 days has already been over. But only for cautioning the local authority of the respondents and for furture guideline Annexure -8 has been quashed as a whole.