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. 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.
FDA Compliance Order Revoked Upon Report Submission
A recent ruling states that the July 15 order will be automatically revoked once an auto-generated compliance report is issued, confirming that the petitioner meets legal requirements. The FDA will then take necessary actions, including the issuance of formal orders, without requiring the petitioner to return to court for further approval. This decision underscores the importance of compliance in regulatory processes.