State of Kerala v. Accredited Molecular Testing Laboratories Association (AMLA) and others

## **IN THE HIGH COURT OF KERALA AT ERNAKULAM** # **PRESENT** # **THE HONOURABLE THE CHIEF JUSTICE MR.S.MANIKUMAR** ## **&** **THE HONOURABLE MR. JUSTICE SHAJI P.CHALY** **TUESDAY, THE 14[TH] DAY OF DECEMBER 2021 / 23RD AGRAHAYANA, 1943** **WA NO. 1439 OF 2021** **AGAINST THE JUDGMENT IN WP(C) 11632/2021 OF HIGH COURT OF KERALA DATED 4.10.2021** ## **APPELLANT/1ST RESPONDENT IN WPC:** **STATE OF KERALA, REPRESENTED BY ITS PRINCIPAL SECRETARY, HEALTH AND WELFARE DEPARTMENT, GOVERNMENT SECRETARIAT, THIRUVANANTHAPURAM-695001.** **BY ADVS.** **ADVOCATE GENERAL SRI.K.GOPALAKRISHNA KURUP SPECIAL GOVERNMENT PLEADER SRI. T.B. HOOD SR. GOVERNMENT PLEADER SRI.V. MANU** ## **- RESPONDENTS/PETITIONERS & RESPONDENTS 2 6 IN WPC:** - **1 ACCREDITED MOLECULAR TESTING LABORATORIES ASSOCIATION (AMLA),** - **HAVING ITS OFFICE AT MANIKKATH CROSS ROAD, RAVIPURAM, ERNAKULAM, REPRESENTED BY ITS SECRETARY, MR. BERLY CYRIAC.** - **2 SANKARS HEALTHCARE SCANS & DIAGNOSTICS, OPP. T.D. HIGH SCHOOL, NEAR GENERAL HOSPITAL JUNCTION, ALAPPUZHA, REPRESENTED BY ITS CEO, DR. R. ANIKUMAR.** - **3 DIANOVA DIAGNOSTICS (P) LIMITED, GOOD SHEPHERD ROAD, KOTTAYAM, REPRESENTED BY ITS MANAGING DIRECTOR, BY DR. SAJIMON THOMAS.** _**W.A.Nos..1439/2021 & 1467/2021**_ 2 - **4 MICROLAB LABORATORIES, OPP. DISTRICT GOVERNMENT HOSPITAL, KOZHENCHERRY-689541, REPRESENTED BY ITS MANAGING PARTNER, MR. BINU K. THOMAS.** - **5 KDC LAB, MISHAL TOWERS, OPP. LITTLE FLOWER SCHOOL, KANHANGAD-671315, REPRESENTED BY ITS ACCOUNTS MANAGER, MR. RENJITH C.** - **6 APOLLO MEDICAL LAB, 2ND FLOOR, CITY CENTRE, FORT ROAD, KANNUR-670001, REPRESENTED BY ITS MANAGING PARTNER, MR. P. PRASADAN.** - **7 LE AYUSH LABORATORY LLP, PRASHANTH BUILDING, NEAR MEDICAL COLLEGE, KOZHIKODE-673008, REPRESENTED BY ITS PARTNER, MR. NIDHEESH P.K.** - **8 CARE REFERENCE LABORATORIES, 19/31 G AND 19/31 H, AMI GALLERIA, MAVOOR ROAD, KOZHIKODE-673008, REPRESENTED BY ITS MANAGING PARTNER, MR. JUSTIN THOMAS KUMAR.** - **9 DNA DIAGNSTICS & RESEARCH CENTRE, COCHIN THEROTH ENCLAVE, AYISHA ROAD, PONNURUNNY, VYTTILA, ERNAKULAM-682019, REPRESENTED BY ITS MANAGING DIRECTOR, MR. ANAND P.S.** - **10 HI-TECH DIAGNOSTIC CENTRE, NEAR PUBLIC STADIUM, PALARIVATTOM, COCHIN-682025, REPRESENTED BY ITS MANAGING PARTNER, MR. SURESH VARGHESE.** - **11 EL LAB METROPOLIS, NORTH SQUARE, PARAMARA ROAD, COCHIN-682018, REPRESENTED BY ITS LAB HEAD, DR. RAMESH KUMAR.** - **12 NEUBERG DIAGNOSTICS (P) LIMITED, THOMBRA ARCADE, BEHIND KALOOR METRO STATION, ELAMAKKARA ROAD, KALOOR, COCHIN-682017, REPRESENTED BY ITS GENERAL MANAGER, MR. S. LEKSHMINATHAN.** _**W.A.Nos..1439/2021 & 1467/2021**_ 3 - **13 HYGEAMED LABORATORIES, DOOR NO.29/4883/3, ADITHYA ARCADE, KUNNATHUMANA LANE, SHORANUR ROAD, THRISSUR-680022, REPRESENTED BY ITS MANAGING PARTNER, MR. PRAVEEN N.M.** - **14 UNION OF INDIA, REPRESENTED BY ITS SECRETARY, HEALTH AND FAMILY WELFARE, NIRMAN BHAVAN, NEW DELHI-110011.** - **15 INDIAN COUNCIL FOR MEDICAL RESEARCH, V. RAMALINGASWAMI BHAWAN, P.O. BOX NO.4911, ANSARI NAGAR, NEW DELHI-110029, REPRESENTED BY ITS SECRETARY AND DIRECTOR GENERAL.** - **16 KERALA MEDICAL SERVICES CORPORATION LIMITED, THYCAUD P.O., THIRUVANANTHAPURAM-695014, REPRESENTED BY ITS MANAGING DIRECTOR.** - **17 SANDOR MEDICALS PVT. LTD., 8-2-326/5, ROAD NO.3, BANJARA HILLS, HYDERABAD500034, REPRESENTED BY ITS MANAGING DIRECTOR.** - **18 NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORIES, NABL HOUSE, PLOT NO.45, SECTOR 44, GURUGRAM, HARYANA-122003, REPRESENTED BY ITS CEO.** **BY ADVS. R1 TO 13 BY SRI.PAUL JACOB** - **R14, 15, 18 BY MANU S., ASG OF INDIA R16 BY SRI.M.AJAY** **THIS WRIT APPEAL HAVING COME UP FOR ADMISSION ON 14.12.2021, THE COURT ON THE SAME DAY DELIVERED THE FOLLOWING:** _**W.A.Nos..1439/2021 & 1467/2021**_ 4 # **IN THE HIGH COURT OF KERALA AT ERNAKULAM PRESENT THE HONOURABLE THE CHIEF JUSTICE MR.S.MANIKUMAR** **&** **THE HONOURABLE MR. JUSTICE SHAJI P.CHALY** **TUESDAY, THE 14[TH] DAY OF DECEMBER 2021/23RD AGRAHAYANA, 1943** **WA NO. 1467 OF 2021** **AGAINST THE JUDGMENT IN WP(C) 10997/2021 OF HIGH COURT OF KERALA DATED 4.10.2021** ## **APPELLANT/1ST RESPONDENT IN WPC:** **STATE OF KERALA REPRESENTED BY ITS PRINCIPAL SECRETARY, HEALTH AND WELFARE DEPARTMENT, ROOM NO.603, 6TH FLOOR, ANNEXE II, SECRETARIAT, THIRUVANANTHAPURAM-695001.** **BBY ADVS.** **ADVOCATE GENERAL SRI.K.GOPALAKRISHNA KURUP SPECIAL GOVERNMENT PLEADER SRI. T.B. HOOD SR. GOVERNMENT PLEADER SRI.V. MANU** ## **- RESPONDENTS/PETITIONERS & RESPONDENTS 2 6 IN WPC:** - **1 DEVI SCANS (P) LTD., KUMARAPURAM, TRIVANDRUM-695011, REPRESENTED BY ITS MANAGING DIRECTOR, MR.NISARUDEEN.** - **2 JEEVA SPECIALTY LABORATORY, M.G.ROAD, THRISSUR, KERALA-680004, REPRESENTED BY ITS MANAGING PARTNER MR.C.BALACHANDRAN.** - **3 MEDIVISION SCAN & DIAGNOSTIC RESEARCH CENTRE PVT.LTD., GROUND FLOOR, MERCY ESTATE, M.G.ROAD, RAVIPURAM, KOCHI-682016, REPRESENTED BY ITS DIRECTOR MR.BERLY CYRISC.** _**W.A.Nos..1439/2021 & 1467/2021**_ 5 - **4 R-CELL DIAGNOSTICS & RESEARCH CENTRE, 27/29E, FCC BUILDING, NEAR FEDERAL BANK TOWER, ARAYIDATHUPALAM, KOZHIKODE, KERALA-673016, REPRESENTED BY ITS MANAGING PARTNER, MR.RUSSEL MOHAMMED.** - **5 SAROJ DIAGNOSTIC LABORATORY, OLIVE ARCADE, MALAPARAMBA JUNCTION, NEAR ASCENT ENT HOSPITAL, KOZHIKODE, KERALA-673009, REPRESENTED BY ITS MANAGING DIRECTOR, MR.ARUN JYOTHIS K.C.** - **6 AZA DIAGNOSTIC CENTRE, STADIUM PUTHIYARA ROAD, OPP. TO SABHA SCHOOL, CALICUT, KERALA-673004, REPRESENTED BY ITS CHIEF OPERATING OFFICER MR.JAVED ISLAM.** - **7 ASWINI DIAGNOSTIC SERVICE, CHINTHAYALAPPU JUNCTION, JAIL ROAD, CALICUT673004, REPRESENTED BY ITS MANAGING PARTNER MR.A.GEERISHAN.** - **8 JANATHA DIAGNOSTICS, TIRURANGADI P.O., CHEMMAD, MALAPPURAM DISTRICT676306, REPRESENTED BY ITS GENERAL MANAGER MR.ABDUL BASHEER.** - **9 DANE DIAGNOSTICS PVT.LTD., 18/757, RC ROAD, NEAR SHADIMAHAL, PALAKKAD678014, KERALA, REPRESENTED BY ITS DIRECTOR, DR.M.SUSHAMA.** - **10 CENTRAL LABORATORIES, BUND ROAD, KANJANI, THRISSUR-680612, REPRESENTED BY ITS MANAGING DIRECTOR, MR.ABILASH K.S.** - **11 UNION OF INDIA REPRESENTED BY ITS SECRETARY, HEALTH AND FAMILY WELFARE, NIRMAN BHAVAN, NEW DELHI-110011.** - **12 INDIAN COUNCIL FOR MEDICAL RESEARCH V.RAMALINGASWAMI BHAWAN, P.O.BOX NO.4911 ANSARI NAGAR, NEW DELHI-110029, REPRESENTED BY ITS SECRETARY AND DIRECTOR GENERAL.** _**W.A.Nos..1439/2021 & 1467/2021**_ 6 - **13 KERALA MEDICAL SERVICES CORPORATION LTD. THYCAUD P.O., THIRUVANANTHAPURAM-695014, REPRESENTED BY ITS MANAGING DIRECTOR.** - **14 SANDOR MEDICAIDS PVT.LTD., 8-2-326/5, ROAD NO.3, BANJARA HILLS, HYDERABAD-500034, REPRESENTED BY ITS MANAGING DIRECTOR.** - **15 NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORIES, NABAL HOUSE, PLOT NO.4, 4S, SECTOR 44, GURUGRAM, HARYANA-122003, REPRESENTED BY ITS CEO.** **BY ADVS.** **P. RAVINDRAN (SR.) R1 TO 10 BY SRI.PAUL JACOB R11 & 12 BY SRI.MANU S., ASG OF INDIA R13 BY SRI. M. AJAY R15 BY SMT. APARNA C.MENON** **THIS WRIT APPEAL HAVING COME UP FOR ADMISSION ON 14.12.2021, THE COURT ON THE SAME DAY DELIVERED THE FOLLOWING:** _**W.A.Nos..1439/2021 & 1467/2021**_ 7 ## J U D G M E N T Dated this the 14[th] day of December, 2021 ## S. Manikumar, CJ. These writ appeals having filed by State of Kerala/respondent No.1 in both writ petitions, against the judgment in WP(C). No.10997 of 2021 and WP(C). No.11632 of 2021 dated 4.10.2021, by which the writ court while setting aside Exhibits P10 and P11, directed the State of Kerala, represented by Principal Secretary, Health and Family Welfare Department, Thiruvananthapuram, to take a fresh decision regarding the rate at which RT-PCR test shall be conducted by private laboratories. 2. For brevity, Exhibit P10 Government Order is extracted: ## GOVERNMENT OF KERALA ## Abstract Health & Family Welfare Department - Re-fixing the rate for RT PCR test for COVID19 - Sanction Accorded - Orders issued. ---------------------------------------------------------------------- ## HEALTH & FAMILY WELFARE (F) DEPARTMENT G.O.(Rt)No.980/2021/H&FWD Dated,Thiruvananthapuram, 30/4/2021 ---------------------------------------------------------------------- _**W.A.Nos..1439/2021 & 1467/2021**_ 8 - Read 1. G.O.(Rt)No. 12/2021/H&FWD dated. 01/01/2021 2. Judgment of Hon'ble High Court, Kerala in WP(C) No.255/2021 (F) dated 14/01/2021 3. G.O.(Rt) No. 371/2021/H&FWD dated 08.02.2021. ## ORDER Real Time PCR test is the gold standard for the diagnosis of COVID19 as per ICMR guidelines. In the month of February 2020, only imported kits were available for Covid- 19 diagnosis and there were only very few companies globally supplying the kits and consumables. Initially ICMR has approved only 3 companies for the supply of PCR kits required for COVID19 diagnosis. Gradually the situation improved, more firms started manufacturing these kits and different types of tests were approved by ICMR and rates came down. Subsequently after doing a thorough market analysis through its procurement agency KMSCL (Kerala Medical Services Corporation Limited), Government have fixed the rates of RT PCR test through approved Private Labs as Rs. 1500 as per Government Order read as 1 st paper above. 2. Against this Private Labs approached Hon’ble High court and as per the Judgment read above, Government heard the petitioners and as per Government Order read as 3 rd paper above the rate of RT PCR test through private labs has been revised to Rs.1700/ - . 3. Mean while, Government in a view to increase _**W.A.Nos..1439/2021 & 1467/2021**_ 9 the number of COVID RT PCR tests, decided to explore the possibilities for the procurement of Mobile RT PCR lab services from the private agencies to do the services such as visiting the identified sites, to collect the samples of the identified segments, to do testing and data transfer to the Lab Diagnosis Management system and to do File No.HEALTH-F2/8/2021-HEALTH testing by RT PCR technology. The rates arrived by KMSCL for doing RT PCR tests through Static and Mobile RT PCR labs is Rs.448.20/per test. In the meantime as part of Airport surveillance strengthening, KMSCL and District Administration explored the possibilities of engaging Private (Static Labs) labs for doing RT PCR in the same rates of Rs 448.22/- per test. There are 10 Static Labs (Private) across the State which are doing the RT PCR tests including the sample collections and biomedical waste management along with LDMS portal updation in 24 Hrs @448.20/-per test. As per the latest market rates of the VTM, RNA Extraction kits, PCR test kits and consumables arrived through market analysis, it is understood that the direct cost for kits and consumables (excluding HR and Other overheads) per test shall be in the range of Rs.135 to 240/-. While going through the cost per test for RT PCR through Private Labs in other States with similar or lesser case load, it was obvious that the rates in Haryana, Telangana, Uttarakhand are Rs. 500/- and Rs. 400/- in case of Odisha. _**W.A.Nos..1439/2021 & 1467/2021**_ 10 4. Government examined the current market rates of VTM, RNA Extraction kits, PCR test Kits and other consumables for the RTPCR test and compared the Cost per test in Private Labs for RT PCR in other States , the cost per tests agreed by the 10 Static Labs engaged in Airport Surveillance and 10 Mobile RT PCR labs deployed in Districts in detail. 5. In the above circumstances, Government are pleased to revise the cost per test for RT PCR to Rs 500/(Rupees Five Hundred Only ) with immediate effect. ## (By order of the Governor) RAJAN NAMDEV KHOBRAGADE PRINCIPAL SECRETARY” ## 3. Directions issued by the writ court on 4.10.2021 in WP(C). No.10997 of 2021 and WP(C). No.11632 of 2021 are extracted: “31. In the result, Exts.P10 and P11 are set aside. The 1[st] respondent is directed to take a fresh decision regarding the rate at which the RT-PCR tests shall be conducted by the private laboratories in the State after discussing with the owners or representative of such private laboratories, within three weeks from the date of receipt of a copy of this judgment. To facilitate the process of discussion and taking a decision, the order setting aside Exts.P10 and P11 is kept in abeyance for one month. However, the above direction to keep in abeyance Ext.P11 _**W.A.Nos..1439/2021 & 1467/2021**_ 11 should not be understood to be a permission to take coercive action against the petitioners or similarly situated persons.” 4. Further, while quashing the above said Government Orders, the writ court withheld the above said decision for a period of one month and further directed the first respondent namely, State of Kerala represented by Secretary to Government, Health and Family Welfare Department to take a fresh decision. 5. Directions of the writ court have been considered and thereafter, Government have issued G.O(Rt).No.2381/2021/H&FWD dated 1.11.2021, keeping the maximum rate chargeable per RT-PCR Test for Covid-19, at Rs.500/-. It is also brought to the notice of this Court that the abovesaid Government Order has been challenged by the respondents/laboratories along with an Association of Laboratories in W.P(C). No.25046 of 2021, before a learned Single Judge and that the same is pending. 6. Mr. Paul Jacob, learned counsel appearing for respondents/Laboratories submitted that in the subsequent W.P(C). No.25046 of 2021 power of the Government to fix the rate for RT-PCR test for Covid-19 is also challenged. _**W.A.Nos..1439/2021 & 1467/2021**_ 12 7. In Writ Appeal Nos.1507 of 2021 and 1526/2021 the appellants/laboratories have challenged the correctness of the judgment of the learned Single Judge directing re-consideration of the issue by the State Government, having set aside Exhibits P10 and P11 respectively, and also pursued the matter in so far as declining to order compensation in terms of the judgment of Hon'ble Supreme Court in **Shashank Deo Sudhi v. Union of India & Ors** reported in **[(2020) 5 SCC 134]** . 8. Now that, direction of the learned Single Judge to re-consider the decision, regarding the rate at which RT-PCR test for Covid-19 should be conducted by the private laboratories in the State, has been implemented by issuing G.O.(Rt).No.2381/2021/H&FWD dated 1.11.2021, which is also stated to be under challenge, as aforesaid, there is no need to retain the Writ Appeal Nos.1439 of 2021 and 1467 of 2021 filed by the State Government, on the file of this Court. 9. However, we make it clear that in as much as the power of the State Government to consider the issue of fixing a rate for RT-PCR Test for Covid-19, has once again been raised in the writ petition, the appellant namely, State of Kerala in the instant appeals 1439 of 2021 _**W.A.Nos..1439/2021 & 1467/2021**_ 13 and 1467 of 2021, is permitted to raise all tenable contentions, whatever raised in the present writ appeals, before the learned Single Judge in W.P(C). No.25046 of 2021. Writ Appeal Nos. 1439 of 2021 and 1467 of 2021 are accordingly disposed of. Sd/S. Manikumar, Chief Justice Sd/Shaji P. Chaly, Judge sou.