On 6th October 2022, The High Court Of Judicature At Bombay in a single bench consisting of Justice Milind N. Jadhav observed that the Concerned Authorities should refrain from passing an order of the suspension of licence under rule 66(1) of the Drugs and Cosmetics Rules, 1945 without properly considering the explanation given by the concerned party. (M/s. Raj Pharma V. State of Maharashtra & Another)
Facts of the Case:
Petitioner, a partnership firm, holds a valid license issued under Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945. It runs a pharmaceutical shop in Mumbai. On 11. 07.2014, Respondent No.2 conducted inspection of Petitioner’s premises and found the following violations:
- that Petitioner was selling drugs over the counter;
- that Petitioner did not sell drugs to the authorized person;
- that details of drugs provided to Doctors between 01.04.2014 to 30.06.2014 were not made available; and
- that Petitioner did not produce the pricelist of drugs.
A Show cause notice dated 19.07.2014 was issued under Rules 61(1) and 67-H calling for explanation from Petitioner as to why its license should not be suspended/cancelled for the violations. On 25.07.2014, Petitioner filed reply to show cause notice and furnished detailed explanation along with documents. It was contended that there was no violation of Rules. On 28.11.2014, respondent 2 passed an order and suspended the license for 60 days. Thereafter, the petitioner filed a statutory appeal u/S 66(2) of the rules before respondent1. The respondent no.1 on 12.06.2015 passed an order directly suspending the Petitioner's license for 60 days to 10 days. Aggrieved by the same, petitioner filed the present writ petition.
Contentions of the Petitioner:
The counsel for the petitioner submitted that “the impugned order is unsustainable since Petitioner had produced the entire details sought for by Respondent No.2 vide the show cause notice, as also by Respondent No.1 during the hearing of statutory Appeal. Order dated 28.11.2014 passed by Respondent No.2 itself records that Petitioner has produced entire details. The authorities did not consider or discuss the material and explanation provided by Petitioner and passed the orders for suspension merely on extraneous grounds which are not germane to facts and circumstances. order dated 28.11.2014 and the impugned order dated 12.06.2015 is in juxtaposition with the explanation offered by Petitioner in reply to the show cause notice. Hence, those orders should be set aside.”
Contentions of the Respondents:
The counsel for the respondents submitted that “The Affidavit-in-Reply dated 11.04.2016 filed by the Respondent No.2 and the reply to show cause notice dated 25.07.2014, states that the explanation offered by Petitioner was found to be unsatisfactory and hence the original order came to be passed. The impugned order in the present petition is a reasoned order passed after hearing the Petitioner. the provisions of Rule 65 of the said Rules directly apply to the Petitioner’s case since it holds a license under the said Rules in Form 20B and 21B and conditions for holding such license fall under Rule 65. Hence, the petition should be dismissed.”
Observations and judgement of the Court:
The Hon’ble court observed that “Petitioner has provided the ID proofs and authority letters along with his explanation. He has provided the authority letters from two out of the three purchasers; in so far as the third purchaser is concerned, Petitioner has furnished the details of sale made to Dreamland Medicals situated at Daman. Hence the Petitioner has not suppressed any information to the knowledge of the Petitioner from the licensing authority on being called upon to do so. Moreover, the Petitioner has provided details of the licensee who has purchased the Scheduled drugs against the bill number and date which finds specific mention in paragraph No.2 of the original order dated 28.11.2014 passed by Respondent No.2. Prima facie, Petitioner has complied with the provisions of Rule 65(3) and there seems to be no dereliction on its part whatsoever. As far as the charges under rule 9(3) are concerned, the petitioner r has produced on record the singed orders and requisitions made by doctors and therefore it was incumbent upon Respondent No.2 to consider the same and give a reasoned finding thereon. In respect of the charge under Section 65(6), Petitioner has confirmed that the invoice issued by the Petitioner contains all details of pricing of medicines as required and there is no suppression of any material fact whatsoever in respect of the requirement of this particular provision.”
Both the orders dated 28.11.2014 and 12.06.2015 passed by Respondent No.2 Licensing Authority and Respondent No.1 respectively were quashed and set aside. The petition stood disposed.
Case: M/s. Raj Pharma V. State of Maharashtra & Another
Citation: Writ Petition No. 5586 Of 2015
Bench: Justice Milind N. Jadhav
Date: October 06, 2022
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