International Institute Of v. National Glp Compliance
IN THE HIGH COURT OF JUDICATURE AT MADRAS
DATED: 10.04.2017
CORAM
THE HON'BLE MR. JUSTICE M.DURAISWAMY W.P.Nos.27191 of 2015 & 18970 of 2016 M.P.No.1 of 2015 in W.P.No.27191 of 2015 & W.M.P.No.16535 of 2016 in W.P. No.18970 of 2016 International Institute of Biotechnology & Toxicology (IIBAT) Rep by its President cum Secretary Arun Rajkumar Fredrick BDO Officers Road Padappai Kancheepuram District Tamil Nadu - 601 301, India ... Petitioner in both WPs v.
1 National GLP Compliance Monitoring Authority (NGCMA) Department of Science and Technology Technology Bhawan New Mehrauli Road New Delhi 110 016, India 2 The Chairman National GLP Compliance Monitoring Authority (NGCMA) Department of Science & Technology Technology Bhawan, New Mehrauli Road New Delhi 110 016, India 3 The Head National GLP Compliance Monitoring Authority (NGCMA) Department of Science & Technology Technology Bhawan, New Mehrauli Road New Delhi 110 016, India
4 Union of India Ministry of Science and Technology Anusandhan Bhawan 2, Rafi Marg New Delhi - 110 001 India .. Respondents in both WPs W.P.No.27191/2015 filed under 226 of the Constitution of India for the issuance of writ of Certiorarified mandamus calling for the records of the respondents relating to the impugned order dated 22.7.2015 in DST/GST (App) - 97/2013 passed by the 2nd respondent herein in Appeal No.1 of 2014 on his file and quash the same and direct the respondents 2 and 3 to issue re-certification for GLP seamlessly with effect from 19.7.2013. W.P.No.18970/2016 filed under 226 of the Constitution of India for the issuance of writ of Certiorarified mandamus, calling for the records in D.O. No. DST/ GLP (App) - 97/ 2013, dated 02.05.
2016 on the file of the 3rd Respondent Head NGCMA, quash the same and direct the 2nd Respondent Chairman NGCMA to seamlessly grant Good Laboratory Practice (GLP) re-certification to the Petitioner Institute Test Facility situated at Survey No.563 & 564, BDO Office Road, Padappai- 601 301 Kancheepuram District, Tamil Nadu State, India, for the period from 19.07.2016 to 19.07.2019 (5th GLP cycle).
For Petitioner : Mr.R.Thiagarajan, Sr. Counsel - for R1 in both the WPs for Ms.S.Sriniranjani For Respondent : Mr.A.Murugan, CGC in both the WPs COMMON ORDER The petitioner has filed the Writ Petition in W.P.No.18970/2016 to issue a writ of Certiorarified mandamus, to call for the records dated 02.05.2016 on the file of the 3rd Respondent, to quash the same and direct the 2nd respondent seamlessly grant Good Laboratory Practice (GLP) re-certification to the Petitioner Institute Test Facility situated at Survey No.563 & 564, BDO Office Road, Padappai- 601 301 Kancheepuram District, Tamil Nadu State, India, for the period from 19.07.2016 to 19.07.2019 (5th GLP cycle).
2. As per Clause 10 of the terms and conditions, for obtaining and maintaining GLP Certification by Test Facility, a Test Facility, wishing to continue its GLP compliance status beyond the existing cycle, will have to submit a fresh
application to the 2nd respondent, NGCMA, in the prescribed Form [Document No.GLP-102], along with the requisite fees, at least six months prior to the expiry of the existing GLP Certification. As per the terms and conditions, The NGCMA will undertake an inspection for re-certification through a team of inspectors before the expiry of existing GLP Certification and the Inspection will be held any time within the said period of six months.
3. The grievance expressed by the petitioner is that though the petitioner has submitted an application in terms of Clause 10, as early as on 02.12.2015 before the third respondent, the authorities have not carried out the inspection on account of the pendancy of the earlier writ petition in W.P.No.27191 of 2015.
4. When the writ petition came up for hearing on 07.06.2016 before this Court, a representation was made before this Court to direct the 2nd respondent to under take an inspection on the basis of the application submitted by the petitioner on 02.12.2015. It was also recorded by this Court in the order dated 07.06.2016 that "vide interim order passed on 31.08.2015 made in W.P.No.27191 of 2015 and M.P.No.1 of 2015, directed that the respondents to accept the fee to be remitted by the petitioner therein and keep the GLP Certification status alive until further orders and it did not prohibit the respondents from conducting the inspection with regard to the GLP compliance."
5. In these circumstances, this Court granted an order of interim direction, directing the 3rd respondent to entertain the petitioner's application dated 02.12.2015, if the papers are otherwise in order, and conduct the inspection in terms of Clause 10 of the "Terms and Conditions for obtaining and maintaining GLP Certification by a Test Facility [TF]". It was also made clear by this court that the result of such inspection need not be informed to the petitioner until further orders from this Court.
6. Subsequently, when the writ petition came up for hearing on 27.01.2017, this Court recorded that pursuant to the orders on 07.06.2016, inspections have been conducted and a report has been made ready and this Court directed the 3rd respondent to file a status report on the basis of the result of the inspection, by way of a report on the next hearing date on 15.02.2017.
7. Pursuant to the orders passed by this court dated 27.01.2017, the 3rd respondent filed the status report on
10.02.2017, wherein, in paragraph Nos. 5 and 6 it has been stated as follows:- "5. That based on the recommendations of the TC on GLP, the Competent Authority (Chairman-GLP Authority) approved grant of GLP re-certification to IIBAT, Padappai for the 5th cycle of GLP certification w.e.f. July 19, 2016 for a period of 3 years i.e. July 18, 2019 in the above mentioned areas of expertise. (Approval of Competent Authority attached as Annexure VI). 6.That since this Hon'ble Court vide order dated 07.06.2016 directed the respondents not to disclose ;the outcome of the inspection to the petitioner till further orders of this Hon'ble Court accordingly the respondents have not intimated the same to the petitioner and neither issued certificate to the petitioner in compliance of the orders of this Hon'ble Court." On a reading of clause 5 and 6, it is clear that the 1st respondent has issued the certificate to the petitioner.
8. Mr.A.Murugan, learned standing counsel appearing for the respondents submitted that the 1st respondent may be directed to issue the re-certification to the petitioner for the 5th cycle of GLP certification with effect from 19.07.2016 for a period of 3 years i.e. 18.07.2019.
9. In view of the submissions made by learned counsel on either side, the 1st respondent is directed to issue the GLP certification to the petitioner Institute Test Facility for the period from 19.07.2016 to 18.07.2019 (5th GLP cycle), as per the status report, within a period of one week from the date of receipt of a copy of this order. With these observations, the Writ Petition in W.P.No.18970/2016, is disposed of.
10. In view of the order passed in W.P.No.18970 of 2016, the relief sought for in the other writ petition in W.P.No. 27191 of 2015 has become infructuous. Accordingly, W.P.No. 27191 of 2015 is dismissed as infructuous.
No costs. Consequently, connected miscellaneous petitions are closed.
Sd/- Assistant Registrar //True Copy// Sub Assistant Registrar
Rj To 1 National GLP Compliance Monitoring Authority (NGCMA) Department of Science and Technology Technology Bhawan New Mehrauli Road New Delhi 110 016, India 2 The Chairman National GLP Compliance Monitoring Authority (NGCMA) Department of Science & Technology Technology Bhawan, New Mehrauli Road New Delhi 110 016, India 3 The Head National GLP Compliance Monitoring Authority (NGCMA) Department of Science & Technology Technology Bhawan, New Mehrauli Road New Delhi 110 016, India 4 Union of India Ministry of Science and Technology Anusandhan Bhawan 2, Rafi Marg New Delhi - 110 001 India +2cc to Mr.Sushma Harini, Advocate, S.R.No.21374 & 21872 +1cc to Mr.A. Murugan, Advocate, S.R.No.21467 NRII(CO) md(11/04/2017) W.P.Nos.27191 of 2015 & 18970 of 2016 M.P.No.1 of 2015 in W.P.No.27191 of 2015 & W.M.P.No.16535 of 2016 in W.P. No.18970 of 2016