Mumbai: The Bombay high court has directed that the Food and Drugs Administration (FDA) shall forthwith revoke suspension or cancellation of licences once an establishment rectifies deficiencies.“We have noticed in several matters listed before us, that even after an establishment has duly complied with the deficiencies pointed out by the respondents, the suspension or cancellation order is not revoked… In our view, there cannot be any justification for requiring an establishment to approach this court merely to secure revocation of an order which has ceased to have any efficacy,” said acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad on August 28.The petition was by Siddharth Agro, which procures and stores raw milk and supplies it to large processing units in Maharashtra. On July 15, the FDA (Pune) suspended the licence of Siddharth Agro’s milk chilling unit at Ambegaon in Pune district. State advocate Priyabhushan Kakade said at a July 29 re-inspection, several deficiencies persisted. The petitioner’s advocate, Manoj Badgujar, said the FDA must carry out a fresh inspection to ascertain subsequent developments.To ascertain the factual position regarding compliance, the HC directed FDA to undertake fresh inspection of the petitioner’s establishment on Aug 31. They referred to several matters where after suspension or cancellation was not revoked after compliance. “The result of such inaction is extremely serious, as the establishment is prevented from carrying on its business. This causes financial loss to the establishment and has a cascading effect on its employees and supply chain,’’ they added.They also said “such litigation is wholly avoidable” and “unnecessarily burdens both the establishment and the court”. Further, it is this “continued inaction” that compelled them to impose compensatory payment on FDA in another matter (Rs 5 lakh to a Pune dairy). “An establishment which has cured the deficiencies cannot be penalised further due to the inaction of the respondents,” they added.“To prevent recurrence and to ensure that the statutory regulatory mechanism operates in a fair, effective and efficient manner,” the HC directed that “in all such cases” once the FDA is satisfied through auto-generated report that the deficiencies have been duly rectified, it shall forthwith revoke the suspension or cancellation order.“The same principle shall apply in the present case,” they said. The July 15 order shall stand automatically revoked upon issuance of the auto-generated report, evidencing compliance percentage, “provided the petitioner is said to be legally compliant.” FDA shall take “consequential steps including issuing formal orders, without requiring the petitioner to approach this court again.”
