MIANGUL HASSAN AURANGZEB, J.----Through the instant writ petition, the petitioner , M/s Farmaceutics International, impugns the order dated 07.02.2018, passed by the Appellate Board of the Drug Regulatory Authority of Pakistan (D.R.A.P .")/respondent No.3 dismissing its appeal against the order dated 19.12.2017, passed by the Central Licensing Board of D.R.A.P ./respondent No.4, whereby its drug manufacturing licence was cancelled.
2. The record shows that on 03.11.2009, the petitioner's drugs manufacturing licence was renewed by respondent No.4 for a period of five years. On 28.11.2014, the petitioner submitted an application before respondent No.4 for the renewal of its licence. On 21.03.2016, the Assistant Drug Controller (Licensing)/respondent No.6 called upon the petitioner to furnish certain documents. The required documents were provided by the petitioner to respondent No.6 on 13.05.2016.
3. On 16.10.2017, the Secretary , Central Licensing Board, D.R.A.P ./respondent No.5 issued a notice to the petitioner to show cause as to why its application for the renewal of drugs manufacturing licence may not be cancelled due to violation of Rules 5(2A), 12 and 16 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 ("the 1976 Rules") read with section 41 of the Drugs Act, 1976 ("the 1976 Act"). On 21.10.2017, the petitioner submitted a reply to the said show cause notice to respondent No.5 and provided certain documents.
4. On 01.11.2017, the petitioner was issued a notice of personal hearing scheduled to be held on 09.11.2017. After the personal hearing, respondent No.4, vide letter dated 19.12.2017, cancelled the petitioner's drug manufacturing licence. Against the said dedision dated 19.12.2017, the petitioner preferred an appeal before respondent No.3.
Vide order dated 07.02.2018, respondent No.3 modified respondent No.5's said decision dated 19.12.2017 by converting the cancellation of the petitioner's drug manufacturing licence into its suspension for a period of six months. Aggrieved by the said order dated 07.02.2018, the petitioner filed the instant writ petition.
5. Learned counsel for the petitioner , after narrating the facts leading to the filing of the instant petition, submitted that the petitioner's application dated 28.11.2014 for the renewal of its licence was kept pending by D.R.A.P . for a period of seventeen long months; that vide letter dated 21.03.2016, respondent No.6 called upon the petitioner to furnish the documents which had already been provided by the petitioner along with its application dated 28.11.2014; that the show cause notice dated 16.10.2017 did not specify any deficiency in the petitioner's functioning so as to warrant the cancellation of its licence; that the petitioner had shown complete compliance with Rule 5(2A) and Rule 16 of the 1976 Rules; that even during the personal hearing, the petitioner had not been informed as to the deficiencies in its functioning; that it was only after the appellate order dated 07.02.2018 was passed that the petitioner came to know that its licence was suspended primarily because the qualifications of its Quality Control Incharge and Production Incharge were found to be deficient; that the qualifications of the petitioner's Quality Control Incharge and Production Incharge are in accordance with the requirements of Rule 60(e) of the 1976 Rules; that Hematology is a branch of Medicine and M.Sc. in Hematology Technology which is considered equivalent to M.Sc. in Medicine; and that even otherwise since the petitioner has been functioning since the past several years, it has no intentio n to violate any provision of .the 1976 Rules or the 1976 Act and shall rectify any deficiency and replace any of its employees so as to strictly compl y with the said Rules and Act.
Learned counsel for the petitioner prayed for the writ petition to be allowed in terms of the relief sought therein.
6. On the other hand, learned counsel for the contesting respondents submitted that the qualifications of the petitioner's Quality Control Incharge and Production Incharge fell short of the requirements of Rule 16(e) of the 1976 Rules; that a Quality Control Incharge of a licensee was required to possess a degree in Pharmacy or a Masters degree in Science with Chemistry or a degree in Medicine or Pharmacology (for pharmacological testing) or a degree in Microbiology (for microbiological testing); that the petitioner's Quality Control Incharge only had an M.Sc. in Hematology Technology which did not qualify her to work as a Quality Control Incharge; that the petitioner's Production Incharge did not have the required ten years experience under the 1976 Rules; that the requirements of the 1976 Rules could not be relaxed for the petitioner; and that respondent No.3 had taken a lenient view against the petitioner by suspending its licence for a period of six months. Learned counsel for the contesting respondents took a fair stance by submitting that if the petitioner rectifies its deficiencies and appoints a Quality Control Incharge and Production Incharge in accordance with the requirements of Rule 16(e) of the 1976 Rules, respondent No.3 would reconsider the petitioner's appeal and decide the matter in accordance with the law .
7. I have heard the contentions of the learned counsel for the contesting parties and have perused the record with their able assistance. The facts leading to the filing of the instant petition have been set out in sufficient detail in paragraphs 2 to 4 above and need not be recapitulated.
8. The contesting parties are at odds on the question whether the petitioner's Quality Control Incharge and Production Incharge possessed the qualifications and experience as required under Rule 16(e) of the 1976 Rules, which is reproduced herein below:- "(e) The Quality Control Department shall be independent of the, manufacturing unit and its incharge shall be whole time employee of the manufacturer and shall possess a degree in pharmacy , or a degree in science with chemistry or a degree in medicine or pharmacology (for pharmacological testing) or a degree in microbiology (for microbiological testing) and has sufficient experience in testing of drugs: Provided that in the case of drugs specified in Schedule C, the Central Licensing Board may allow the applicant to make arrangements with some other institution approved by the Central Licensing Board for such tests to be regularly carried out on his behalf by that institution."
9. Learned counsel for the contesting respondents is correct in his submission that the requirements of the 1976 Rules cannot be relaxed for the petitioner . The impugned order dated 07.02.2018 does not address the petitioner's contentions regarding M.Sc. in Hematology Technology being equivalent to M.Sc. in Medicine. This coupled with the fact that the learned counsel for the contesting respondents had fairly submitted that respondent No.3 would reconsider the petitioner's appeal provided it cures all its deficiencies and appoints staff, including Quality Control Incharge and Production Incharge, having experience and qualifications required under the 1976 Rules, necessitates the remand of this matter to respondent No.3 to reconsider the petitioner's position regarding strict compliance with the requirements of the 1976 Rules specially Rule 16(e) thereof. Consequently , this petition is allowed ; the impugned order dated 07.02.2018 is set-aside ; and the matter is remanded to respondent No.3 with the direction to reconsider the petitioner's appeal and to determine whether the petitioner is fully compliant with the 1976 Rules. The petitioner shall not be shown any relaxation with the requirements of the 1976 Act and the rules made thereunder . The interim relief granted to the petitioner shall continue until an order is passed in the post- remand proceedings by respondent No.3. There shall be no order as to costs.