NOVUS PHARMACEUTICAL LTD Vs. UNION OF INDIA

JUDGEMENT

(1.) Rule, by consent of Counsel returnable forthwith. By consent of Counsel and at the request of Counsel taken up for hearing.

(2.) All the Petitioners who are, or as the case may be, were licensed pharmaceutical units within the jurisdiction of the principal bench of this Court at Mumbai, moved these proceedings initially before the Aurangabad Bench seeking a postponement of a notification dated 30th June, 2005 by which the Drugs and Cosmetics (Fifth Amendment) Rules, 2005 were notified. The Petition was transferred before the Principal Seat of the Court at Mumbai. The grievance of the Petitioners is that as a result of the amendments that have been brought to the Drugs and Cosmetics Rules by the amended provisions, several changes were required to be made by manufacturers in respect of plant, equipment, machinery and maintenance of records. The submission was that this would involve a high cost for which funds were required to be raised. The Petitioners received notices from the Food & Drugs Administration of the State Government calling upon them to comply with the provisions of Schedule M as amended, failing which it was stated that their licences would be suspended. The licences of the Petitioners were suspended. Though the order of suspension is an appealable order, it has been submitted that since the notification was issued by the Union of India, no purpose would be served by exhausting the remedy of an appeal. In sum and substance, it has been urged that reasonable time should have been granted to the manufacturers to comply with the amended requirements of the rules.

(3.) Now the principal prayer urged in the petition, prayer clause (a), is simplicitor for an extension of time to comply with the provisions of the rules. There is no challenge to the constitutional validity of the rules nor is any such challenge pressed before the Court. The rules constitute delegated legislation made in pursuance of the power vested in the delegate by the competent legislation. This Court in the exercise of its jurisdiction under Article 226 of the Constitution would not be justified in entertaining any such plea. Once the rules are valid, as indeed they must be regarded in the absence of any challenge in these proceedings, it would be manifestly impossible to grant any relief of the nature that has been sought. That plainly lies outside the jurisdiction of the writ Court under Article 226 of the Constitution. The Petitioners have remedies available in law against the order of suspension. In so far as the grant of reasonable time for compliance is concerned, this Petition comes up at the end of April 2006, nearly ten months after the date that was prescribed for the enforcement of the rules.