Pfizer Products India Private Limited & Anr v. Union of India

RAJIV SAHAI ENDLAW, J. MAY 18, 2016 bs..

* IN THE HIGH COURT OF DELHI AT NEW DELHI % Date of decision: 18th May, 2016. + W.P.(C) 9089/2015 & CM No.20576/2015 (for stay) PFIZER PRODUCTS INDIA PRIVATE LIMITED & ANR ..... Petitioners Through: Mr. P. Chidambram, Sr. Adv. with Mr. Cyrus Avdershir, Mr. Rahul Dwarkadas, Mr. Yuvraj Choksy and Ms. Aayushi Sharma, Advs. Versus UNION OF INDIA ..... Respondent Through: Mr. Sanjeev Narula, CGSC with Mr. Ajay Sondhi, Mr. Ajay Kalra, Mr. Rishikant Singh and Ms. Gunjan Sharma, Advs. CORAM: HON'BLE MR. JUSTICE RAJIV SAHAI ENDLAW 1. The petition, (i) impugns the notice-cum-order dated 15th September, 2015 of the respondent Drugs Controller General (India) (DCGI) rejecting the representation dated 10th July, 2015 of the petitioner with respect to the drug "Medrol" and reserving the right for initiating legal proceedings against the petitioner; (ii) seeks a mandamus to the respondent DCGI to re-consider the representation of the petitioner; and, (iii) seeks to restrain the respondent DCGI from enforcing the impugned notice-cum-order dated 15th September, 2015 with respect to drug "Medrol" or from taking any other coercive measure under the Drugs and Cosmetics Act, 1940 and the Rules framed thereunder. 2. It is the case of the petitioner (petitioner No.2 is the Senior Manager (Legal) of the petitioner No.1): (a) that the petitioner has been importing the drug "Medrol" from "Pfizer Italia S.r.l." Ascoli, Italy; (b) that as per Rule 96(1)(vii) of the Drugs and Cosmetics Rules, 1945, the statutory period of the life of a drug not specified under Schedule P of the Rules should not exceed 60 months from the date of manufacture; (c) that the Assistant Drugs Controller, Karnataka vide notice dated 25th June, 2015 directed the petitioner not to sell and / or distribute and to return and destroy certain batches of the drug "Medrol"; (d) that the Drugs Inspector, Chennai also vide notice dated 6th July, 2015 directed the petitioner to not dispose of the stock of the drug "Medrol" for a period of 20 days therefrom followed by show cause notice dated 7th July, 2015; (e) that the aforesaid action was by reading the date of expiry mentioned on the packaging of drug "Medrol" as 61 months and which is in violation of Rule 96(1)(vii) of the Rules supra; (f) that though the Drugs Authorities of the States of Maharashtra and Orissa also issued notice to the petitioner but did not follow the same; (g) that the petitioner represented in response to all the aforesaid notices that the date of expiry printed on the packaging of drug "Medrol" was of 60 months only and not of 61 months and that the drug was actually stable for 62 months; (h) that the petitioner filed writ petition under Article 226 of the Constitution of India before the High Court of Madras with respect to the proceedings initiated against it and vide interim order wherein, on the undertaking of the petitioner, not to sell the subject stock of the drug "Medrol" beyond December, 2017, further action against the petitioner was stayed; (i) that the petitioner also instituted a petition under Article 226 of the Constitution of India in the High Court of Karnataka and by interim order wherein, action against the petitioner was stayed, on the petitioner issuing a clarification that the drug already on the shelves of medical stores for distribution shall not be kept for sale beyond 60 months from the date of manufacture indicated on its packaging; (j) that the petitioner, vide its representation dated 10th July, 2015 to the respondent DCGI in its capacity as the Licensing Authority, represented (i) that "Medrol" with its current packaging and label is sold worldwide, with no objection / grievance having been raised by any country; (ii) that while the shelf life as printed may be interpreted as 60 months or 61 months, the drug is actually stable for 62 months and therefore there is no impact on the quality of the drug; (iii) that the drug is a fast moving drug and therefore the possibility of it being i