Sheeba Antony v. State of Kerala and Others

IN THE HIGH COURT OF KERALA AT ERNAKULAM PRESENT: THE HONOURABLE MR.JUSTICE K.M.JOSEPH & THE HONOURABLE MR. JUSTICE A.HARIPRASAD MONDAY, THE 13TH DAY OF JANUARY 2014/23RD POUSHA, 1935 WA.No. 1571 of 2013 () IN WP(C).19522/2013 -------------------------------------------- AGAINST THE JUDGMENT IN WP(C) 19522/2013 of HIGH COURT OF KERALA DATED 25-09-2013 APPELLANT(S)//PETITIONER IN WPC NO. 19522/2013: --------------------------------------------------------------------------- SHEEBA ANTONY, AGED 46, W/O. ANTONY THARIAN, PROPRIETRIX, M/S. MEDCARE 39/1085 C7, MADATHILPARAMBIL BUILDING, PALARIVATTOM ERNAKULAM. BY ADV. SRI.VARGHESE C.KURIAKOSE RESPONDENT(S)/RESPONDENTS IN WPC NO. 19522/2013: ---------------------------------------------------------------------------------- ## 1. STATE OF KERALA REP. BY CHIEF SECRETARY, DEPARTMENT OF HEALTH SECRETARIAT, TRIVANDRUM-695001. 2. THE SECRETARY DEPT. OF HEALTH, SECRETARIAT, TRIVANDRUM-695001. 3. THE ASST. DRUGS CONTROLLER OFFICE OF THE ASST. DRUGS CONTROLLER, CENTRAL ZONE ERNAKULAM-682030. BY GOVERNMENT PLEADER SHRI P.A.ABOOBACKER THIS WRIT APPEAL HAVING BEEN FINALLY HEARD ON 12-12-2013, THE COURT ON 13-01-2014 DELIVERED THE FOLLOWING: ## **K.M.JOSEPH & A.HARIPRASAD, JJ.** ## **-------------------------------------W.A. No.1571 of 2013** **-------------------------------------Dated this the 13[th] day of January, 2014.** ## **JUDGMENT** ## A.Hariprasad, J. Appellant is the writ petitioner, who claimed, but failed to get the reliefs mentioned herein below: _“(i) Issue a writ, order or direction, in the nature of mandamus, or any other appropriate writs calling for the records relating to Ext.P6 order and quashing the same, holding the same as illegal and unjust._ _(ii) Issue a writ, order or direction, in the nature of mandamus or other appropriate writ calling for the records leading to Ext.P9 and quashing the same as illegal, unwarranted and suffering from infirmities such as failure to consider the impact of rule 66 proviso urged in the appeal and hold that Ext.P9 order is vitiated by malafides._ _(iii) Allow the petitioner to recover the full costs incurred for the institution and conduct of this writ petition from the respondents.”_ 2 WA No.1571 of 2013 2. Facts, stated in brief, are the following: Appellant is the proprietrix of M/s.Medcare, a retail allopathy medical shop. She is running the shop under due licences issued by the authorities including those under the Drugs and Cosmetics Act, 1940 (“the Act”, for short) and the Drugs and Cosmetics Rules, 1945 (“the Rules”, for short). Appellant contended that her medical shop is an air- conditioned one, thereby preventing direct fall of sun light into the shop. Appellant has always taken maximum care to keep up cleanliness and hygiene. All the medicines in the shop are kept properly. Appellant appointed a registered pharmacist under whose direct supervision seven employees are working. On 18.10.2012 a joint inspection was conducted by the Drug Inspectors, Zone I and III of Ernakulam District. Appellant had given satisfactory explanations to all the queries put forth by the Drug Inspectors. Appellant states that the Drug Inspectors, though were apparently satisfied at the time of inspection about the running of the shop, gave a contrary report based on which the 3[rd] respondent issued a show cause notice (Ext.P1). In Ext.P1 the following seven charges were levelled against the appellant: i. Drug licences were not exhibited in the premises open to public. 3 WA No.1571 of 2013 - ii. Separate bill books were not maintained as required under law. - iii. Purchase records were not serially numbered. - iv. Drugs, which carry a label direction to be stored below - 25[o] c, were stored above 30[o] c. - v. Drugs were stored against the label directions. - vi. Name and address of the seller and the date on which the prescription is dispensed was not noted at the time of dispensing the drugs. - vii. Certain drugs were sold without sales records. Appellant gave a reply to these charges (Ext.P2). All the allegations are controverted specifically. After submitting Ext.P2, the appellant submitted Ext.P5 representation before the 3[rd] respondent. Thereafter the appellant's husband was heard by the 3[rd] respondent and Ext.P6 order was passed. As per Ext.P6, 3[rd] respondent ordered that drug licence of the appellant be suspended for a period of four days. Aggrieved by Ext.P6, appellant approached the 2[nd] respondent by a statutory appeal. Ext.P7 is the copy of the appeal memorandum. Thereafter the appellant approached this Court with W.P.(C) No.6004 of 2013 and it was disposed of by Ext.P8 4 WA No.1571 of 2013 judgment. Pursuant to the direction in Ext.P8, 2[nd] respondent heard and disposed Ext.P7 appeal by Ext.P9 order. Exts.P6 and P9 are impugned in the writ petition. 3. Heard the learned counsel for the appellant and the learned Government Pleader. 4. As mentioned above, in Ext.P1 notice seven distinct charges have been levelled against the appellant. According to the appellant, during the relevant time, there was a public out cry that medicines were sold by retailers at high prices. In fact, the Media was highlighting this aspect without understanding things correctly and ignoring the pricing policy of the Central Government. Officers of the Drugs Department in order to satisfy the Media conducted raids in many medical shops, including the one of the appellant. Appellant would contend that none of the charges levelled against her is true or legally sustainable. 5. Chapter IV of the Act deals with the provisions relating to manufacture, sale and distribution of drugs and cosmetics. Section 22 of the Act deals with the powers of the Inspectors appointed under Section 21 of the Act. Rule 66 of the Rules deals with cancellation and suspension of licences, which reads as follows: 5 WA No.1571 of 2013 _“_ _**66. Cancellation and suspension of licences** .- (1) The licensing authority may, after giving the licensee an opportunity to show cause why such an order should not be passed by an order in writing stating the reasons therefore, cancel a licence issued under this Part or suspend it for such period as he thinks fit, either wholly or in respect of some of the substances to which it relates, if in his opinion, the licensee has failed to comply with any of the conditions of the licence or with any provisions of the Act or rules thereunder:_ _Provided that, where such failure or contravention is the consequence of an act or omission on the part of an agent or employee, the licence shall not be cancelled or suspended if the licensee proves to the satisfaction of the licensing authority -_ _(a) that the act or omission was not instigated or connived at by him or, if the licensee is a firm or company, by a partner of the firm or a director of the company, or_ _(b) that he or his agent or employee had not been guilty of any similar act or omission within twelve months before the date on which the act or omission in question took place, or where his agent or act or_ 6 WA No.1571 of 2013 _omission in question took place, or where his agent or employee had been guilty of any such act or omission, the licensee had not or could not reasonably have had, knowledge of that previous act or omission, or_ _(c) if the act or omission was a continuing act or omission, he had not or could not reasonably have had knowledge of that previous act or omission, or_ _(d) that he had used due diligence to ensure that the conditions of the licence or the provisions of the Act or the rules thereunder were observed._ _(2) A licensee whose licence has been suspended or cancelled may, within three months of the date of order under sub-rule (1), prefer an appeal against that order to the State Government, which shall decide the same.”_ 6. Learned counsel for the appellant contended that a scrutiny of the above provision will show that the 3[rd] respondent committed a grave illegality in suspending the licence without regard to the provisions in Rule 66. Assuming that the charges levelled against the appellant are true, the authority could not have suspended the license, contended the learned counsel for the appellant. Appellant further contended that her shop is run by a qualified pharmacist, assisted by seven sales staff. It is, therefore, contended that the aspects mentioned in the proviso to Rule 66(1) were 7 WA No.1571 of 2013 not considered properly by the 3[rd] respondent. Learned counsel for the appellant, without admitting any charge, would argue that if at all there was any act or omission allegedly noted by the Drug Inspectors, which may be termed as violation of the conditions in the license, then also it should have been seen that the appellant's agents or employees must have done that. The act or omission was not instigated or connived at by the appellant. Appellant or her agent or employee was not guilty of any similar act or omission within twelve months before the date on which the irregularities were noticed. It is submitted by the learned counsel that these aspects in the proviso to Rule 66(1) were not considered by the authorities. We have carefully gone through the reply (Ext.P2) sent by the appellant to Ext.P1 show cause notice. Nowhere in Ext.P2 it is mentioned that the appellant is not directly conducting the shop nor the the irregularities alleged were attributable to her agents or employees. In fact, in Ext.P2 reply, the entire allegations in Ext.P1 were stoutly denied. We have also noticed the contentions raised by the appellant in Ext.P5 letter sent to the 3[rd] respondent. There also no contention referable to the proviso to Rule 66 was raised by the appellant. In otherwords, there is no case set up in Ext.P2 that the omission/irregularity were the consequence 8 WA No.1571 of 2013 of the acts of her employees. First time such a contention was raised in Ext.P7 appeal memorandum before the 2[nd ] respondent. In paragraph 5 of Ext.P9, the said contention was specifically considered and it was negatived. Therefore, we find that the appellant is not entitled to take shelter under the proviso to Rule 66 of the Rules to avoid an action against her. Learned counsel for the appellant further argued that the authorities did not give the appellant an opportunity of being heard before suspension of the licence and thereby violated the principles of natural justice. 7. Per contra, learned Government Pleader would contend that the reply submitted by the appellant to Ext.P1 notice coupled with the reasonings mentioned in Ext.P6 order would show that the appellant had been afforded a reasonable opportunity of being heard. In fact, her husband appeared before the authorities and contested on her behalf. Furthermore, Ext.P9 order also shows that the appellant's representative (husband) was heard and the contentions were considered by the authorities. Learned Government Pleader, therefore, would contend that there is no violation of natural justice in this case. 8. Learned counsel for the appellant contended that the seven allegations in Ext.P1 are absolutely incorrect. In answer to the first 9 WA No.1571 of 2013 allegation that there was no proper exhibition of drug licence in the premises, it is contended by the appellant that the licence was prominently displayed in the shop. It is also asserted that her shop is an airconditioned one, properly secured by glass panes. 9. The second allegation against the appellant is that separate bill books were not maintained as required under Rules 65(3)(1) and 65(4) (1) of the Rules. In answer to this allegation, appellant submitted that bills and accounts are now computer generated. Appellant infact separately kept the copies of bills and they were shown to the Drug Inspectors. Appellant's explanation for non-compliance of the Rule is that when the Rules were framed in 1945, computers were not even contemplated. As the technology has advanced, old system of keeping books of accounts is to be treated as dispensed with. We are unable to appreciate this contention of the appellant. As long as the provisions in the Rules mandate the keeping of records in a particular manner, the appellant cannot avoid compliance of the provision merely quoting technical advancement. 10. Third ground mentioned in Ext.P1 against the appellant is that the purchase records were not serially numbered. According to the authorities, this amounted to violation of Rule 65(4)(2) of the Rules. 10 WA No.1571 of 2013 Appellant would contend that this allegation is totally wrong. All these disputes are purely questions of fact. We will have to be mindful of our limitations in appreciating facts while exercising jurisdiction of judicial review of administrative actions. 11. Fourth allegation is regarding storage of medicines at a temperature higher than that is recommended by the prescriptions in the label of the medicines. According to the appellant, the shop is an airconditioned one and this allegation is absolutely false. Based on the report of the Inspectors, the 2[nd] respondent, while disposing of the statutory appeal of the appellant, mentioned in paragraph 4 of Ext.P9 order that though the shop was air-conditioned, at the time of inspection the air-conditioners were not switched on. Therefore, the temperature in the shop was not kept below 25[o] c as required. Although the appellant disputed this fact, the question whether the air-conditioner was working or not at the time of inspection remains to be a question of fact. As mentioned above, we have jurisdictional limitations in this writ appeal for dealing with vexed questions of fact. 12. Another allegation which is more serious in nature is that the appellant had stored medicines against label directions. This allegation is 11 WA No.1571 of 2013 divided into three sub headings. Firstly, storage facilities have not been provided for the drugs with label direction that they had to be stored in a dark place/protected from light. According to the report, they were left in a corner of the shop. Secondly, certain drugs mentioned in Ext.P1, which are date expired drugs, were stored among the stock-in-trade. Learned Single Judge considered these allegations in _extenso_ and found that the explanation offered by the appellant is not at all satisfactory. In Ext.P6 this allegation was specifically considered by the 3[rd] respondent and entered into a definite finding. Appellant would contend that date expired drugs were kept enclosed in a plastic container with a label 'not for sale'. Authorities while considering the matter in Exts.P6 and P9 found that such drugs, with expiry date November, 2011, were found to be stocked even on the date of inspection conducted on 18.10.2012. If the date expired drugs were to be destroyed or replaced, there was no tangible reason for keeping them for a period of about one year along with the stock-in-trade. Considering all these aspects, the contention of the appellant was rejected in Ext.P9. We do not find any legal infirmity in the reasoning mentioned by the 2[nd] respondent in Ext.P9 pertaining to this charge. Thirdly, it is mentioned that the drugs which carried label direction to be protected from 12 WA No.1571 of 2013 moisture were stored in a refrigerator and thereby the appellant violated the prescriptions in the label. In answer to this charge, it was contended that the refrigerator available in the medical shop was a moist free one. Appellant would submit that this aspect was not cross checked by the Drug Inspectors. We would think this again is a disputed fact which cannot be decided in this proceedings. 13. Appellant has offered an explanation to the 6[th] charge too. According to her, the date of sales are borne out from the bills. It is also contended by the appellant that this charge is highly obscure. 14. The seventh charge is that certain drugs were sold without sales records. According to the authorities this caused violation of Rules 65(4)(3)(i) and 65(9) of the Rules. This charge is also considered in Exts.P6 and P9. We do not find any reason to hold that the reasonings adopted in Exts.P6 and P9 are either perverse or illegal. 15. Learned counsel for the appellant strongly relied on the decision in **Mst.Saleha Khatun Bewa v. State of Assam and others (AIR** **1977 Gauhati 18)** . This decision was placed before the learned Single Judge also. Facts therein would show that a medical shop run by a pardanasin lady, who happened to be a widow, was ordered to be closed 13 WA No.1571 of 2013 down for violation of licence conditions. The allegation was that rectified spirit was kept in her shop in violation of the provisions of the Rules. Petitioner therein contended that she was an old pardanasin lady and the shop was run through her servants. Further it was contended that rectified spirit was not stored in her medical shop and if at all so, that is not a drug coming under the provisions of the Act or the Rules. The court specifically put a question as to whether rectified spirit was a drug covered by Schedules C and C(I) under the Rules. There was no definite answer from the authorities to this query. On the facts also, it was found that the petitioner therein was not directly responsible for the conduct of the shop. In that context, the impugned order was set aside and the matter was remitted to the Drugs Controller for necessary action. On going through the facts in the above decision and those in this case, we are of the firm view that the dictum in **Mst.Saleha Khatun Bewa** 's case (supra) is not applicable to this case. Appellant was given adequate opportunity to meet the charges levelled against her. Authorities below properly considered the matter and arrived at the findings in Exts.P6 and P9. Judicial review proceedings cannot be equated to an appellate jurisdiction as it is only supervisory in nature. Keeping in mind our jurisdictional restriction in 14 WA No.1571 of 2013 interfering with disputed facts, we are of the view that there is no perversity or illegality in the orders passed by the authorities. Learned Single Judge considered the matter elaborately and decided the case correctly. No interference is required at our hands. In the result, appeal is dismissed. ## **K.M.JOSEPH, JUDGE.** ## **A. HARIPRASAD, JUDGE.** **cks**