Gauhati High Court
PIL/16/2018 on 6 June, 2024
Author: Suman Shyam
Bench: Suman Shyam
Page No.# 1/9
GAHC010032342018
THE GAUHATI HIGH COURT
(HIGH COURT OF ASSAM, NAGALAND, MIZORAM AND ARUNACHAL PRADESH)
Case No. : PIL/16/2018
1. Sri Manjit Gogoi,
Son of Sri Padmeswar Gogoi,
The President of Tai Ahom Yuva Parishad,
Bhadoi Anchalik Committee,
P.O.- Bhadoi Panchali,
Dist- Dibrugarh, Assam, PIN- 786191.
2. Sri Sonjay Borphukan,
Son of Sri Pushpa Borphukan,
The Secretary respectively of Tai Ahom Yuva Parishad,
Bhadoi Anchalik Committee,
P.O.- Bhadoi Panchali, Dist- Dibrugarh,
Assam, PIN- 786191.
....Petitioners
-Versus-
1. The State of Assam, (Represented by the
Commissioner/ Secretary to the Govt. of Assam)
Department of Health and Family Welfare,
Secretariat, Dispur, Guwahati- 781006.
2. The Union of India, represented by the Secretary
to the Govt. of India,
Ministry of Health and Family Welfare,
Nirman Bhawan, New Delhi- 110011.
3. The Director, National Health Mission (NHM),
Assam, Saikia Commercial Complex, Srinagar Path,
Christian Basti, Assam, Guwahati- 781005.
Page No.# 2/9
4. The Director of Health Service, Government of
Assam, Hengrabari Health Complex,
Guwahati, PIN- 781036, Assam.
5. The Joint Director, Health Service,
Government of Assam, District- Dibrugarh, Assam.
6. The Joint Director, Health Service,
Government of Assam, District- Barpeta,
Assam, PIN- 781301.
7. The Joint Director Health Service,
Government of Assam, District- Sivasagar, Assam,
PIN- 785640.
8. The Joint Director, Health Service,
Govt. of Assam, District- Tinsukia, Assam,
PIN- 786125.
9. The Joint Director Health Service,
Government of Assam, District- Cachar, Silchar,
Assam, PIN- 788007.
10. The Joint Director, Health Service,
Govt. of Assam, District- Dhemaji, Assam,
PIN- 787067.
11. The Joint Director, Health Service,
Government of Assam, District- Nalbari, Assam,
PIN- 781335.
12. The Joint Director, Health Service,
Government of Assam,
District- Goalpara, Assam, PIN- 783101.
Page No.# 3/9
13. The Joint Director, Health Service,
Government of Assam, District- Lakhimpur,
Assam, PIN- 787001.
14.The Joint Director, Health Service,
Government of Assam, District- Sonitpur, Assam, PIN-
784001.
15. The Joint Director, Health Service,
Government of Assam,
District- Darrang, Assam, PIN- 784125.
16. The Joint Director, Health Service,
Government of Assam, District- Hailakandi,
Old Hospital Road,
Hailakandi Town, Assam, PIN- 788151.
17. The Drugs Controller of Assam,
Hengrabari, Guwahati- 36.
....Respondents
-BEFORE-
HON'BLE THE CHIEF JUSTICE MR. VIJAY BISHNOI
HON'BLE MR. JUSTICE SUMAN SHYAM
For the petitioners : Mrs. M.D. Choudhury,
Mr. D. Gogoi,
Ms. M. Baruah, Advocates
For the respondents : Mr. B. Gogoi, S.C., Health Department
Mr. R.K.D. Choudhury, DSGI
Date of Hearing : 04.06.2024
Date of Judgment : 06.06.2024
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JUDGMENT & ORDER (CAV)
(Vijay Bishnoi, C.J.)
1. This PIL petition is filed by the petitioner No.1, who is the President of Tai Ahom Yuva Parishad, Bhadoi Anchalik Committee and petitioner No.2, who is the Secretary of the above referred Parishad, raising serious concern about the Infant Mortality Rate (hereinafter referred to as 'IMR' for short) and Maternal Mortality Rate (hereinafter referred to as 'MMR' for short) in the State of Assam. It is the case of the petitioners that the drugs supplied by the National Rural Health Mission (hereinafter referred to as 'NRHM' for short) in various hospitals and the medical facility centres in the State of Assam are substandard and are not giving desired results to the poor patients of the State of Assam. The petitioners have, therefore, prayed for the following relief:
"a. Direct the respondent authorities to take steps to reduce the existing MMR and IMR.
b. Direct the respondent authorities to appoint adequate numbers of Drug Inspectors in the districts state for timely testing of the drugs.
c. Direct the Director, NHM, Assam to have the samples of Drugs/medicines examined/tested at the time of procurement/receipt in terms of Section 26 of the Act.
d. Black-list the supplies/manufactures whose drugs/medicines are found subsequently to be unfit.
e. Order an enquiry by appropriate authority to find out the various lapses on the part of the respondents which have resulted in such high MMR and IMR Page No.# 5/9 and supply so larger amount of substandard medicines in the state and take appropriate action against the defaulters to rectify the mistake and prevent future recurrence of such high mortality rate."
2. It is contended by the counsel for the petitioners that the IMR and MMR in the State of Assam are higher than the national IMR and national MMR. It is contended that the medicines supplied to the State of Assam under the NHRM by the various suppliers are substandard and the State of Assam is not taking effective steps for preventing supply of substandard drugs and medicines to the government hospitals and the medical facility centres across the State of Assam. To substantiate their claims, the petitioners have placed reliance on various newspaper reports as well as articles suggesting that the IMR and the MMR in the State of Assam is higher in comparison to the national IMR and MMR. It is contended by the petitioners that they sought information from the respondents through RTI and from the information received by them, it appears that in numerous cases the drugs/medicines supplied by the suppliers are found to be substandard.
The petitioners have also suggested and prayed that the samples of drugs/medicines supplied under the NHRM be directed to be examined and tested at the time of procurement itself and not after the same are supplied to various hospitals and medical facility centres for distributing the same to the patients.
3. It is contended on behalf of the respondent State that the National Health Mission, Assam use to follow strict quality parameters like issuing Despatch Clearance Certificate to the manufacturers prior to dispatch of the medicines to the districts. It is further contended that a manufacturer company supplying drugs/medicines is required to submit batch-wise analytical testing reports after testing the drugs/medicines in the Government approved NABL accredited Lab only. It is also contended that batch-wise testing reports from the Government approved Page No.# 6/9 NABL Lab are collected before allowing supply of drugs/medicines to districts and no batch of medicines or drugs has ever been supplied in any district without NABL report.
4. In the subsequent affidavits filed on behalf of the State, it is stated that the medicines supplied to the various hospitals under National Health Mission, Assam are tested and samples are sent for verifying the effectiveness of the drugs and whenever it is found that the drugs/medicines are substandard, proceeding is initiated against the suppliers in accordance with law.
5. In the affidavit filed on behalf of respondent No.3 on 24.07.2019, it is highlighted that the State of Assam is taking due care in procuring the drugs and medicines from the suppliers. The relevant paragraph of the said affidavit is reproduced hereunder:
"As per new Government drug procurement policy in Assam drugs belonging to WHO-GMP (World Health Organisation, Goods Manufacturing Practices) certified manufacturers are to be procured whereas earlier it was GMP only. As per CDSO, GOI GMP is sufficient for domestic manufacturers, but extra quality assurance and quality control has been followed by procuring drugs from WHO- GMP certified manufacturers.
Following this policy, NHM, Assam invited national bidding through e- Tendering and under which more than 100 nos. of WHO-GMP certified manufacturers have been empanelled. It includes many Indian and multinational companies like Novertis India, Pfizer, Sanofi India, Hetro Drugs, Bicon Ltd, Abbott India, Johnson & Johnson, Mylan Lab, Boehringer India, Bristol-Myers, Roche India, Piramal Heathcare, Sanofi India, Pfizer India, Panaca Biotech, Intas Pharmaceutical, Dr. Reddy's Cipla, Cadila, Theon Pharma, Akum Drugs, Ciron Drugs, Vivek Pharma, Bharat Biotech, Bharat Parenterals and many more.
Page No.# 7/9 As a part of quality control process these drugs of the Multinational and Indian Companies are tested in (NABL) - National Accreditation Board for Testing & Calibration laboratories before dispatch of the drugs to the District Drug Warehouses/Medical College Drug Warehouses of the State. Upon the NABL reports batchwise a dispatch clearance certificates issued and without that no drugs would be received by the District/Medical College Drug stores because the drug online inventory software has been programmed accordingly."
In the said affidavit, the respondent No.3 has also contradicted the claim of the petitioners regarding the high rate of IMR and MMR in the State of Assam.
6. It is contended by the counsel representing the State that the petitioners have failed to substantiate their claim by producing enough material and proof that the high IMR and MMR in the State of Assam is on account of supply of substandard drugs/medicines in government hospitals and medical facility centres.
7. Rejoinder affidavit has been filed on behalf of the petitioners in response to the counter affidavit filed on behalf of the respondent No.3 and thereafter, another additional affidavit has been filed on behalf of the respondent No.3 pursuant to the Court's order dated 11.08.2023, wherein it is emphasised that the Drug Controller, Licensing and Controlling Authority, Assam and Managing Director, Assam Medical Service Corporation Limited, Guwahati are taking actions against the suppliers who have supplied substandard drugs/medicines.
8. Having gone through the material available on record, we are of the view that the issue raised in the writ petition is of great importance and it is the duty of the State to provide good medical and health facilities to the residents of the State, particularly, belonging to the lower strata of the society who cannot afford treatment in the private hospitals due to high cost. Under the National Health Mission, Assam, various drugs and medicines are supplied in the government hospitals and the medical facility centres and it is the duty of the State to take Page No.# 8/9 effective steps to ensure that the drugs and medicines supplied by the suppliers meet all the prescribed standards and not be of below the prescribed standard quality.
9. In response to the RTI query raised by one Rituraj Changmai, the National Health Mission, Assam has given the following information:
"Sir, This has reference to your letter No.NRHM/RTI-Act/524/2009-10/Pt-I (C)/21030 dated 31/10/2017 along with which you have sent one RTI application dated 30/10/17 from Sri Rituraj Sangmai. Our reply to the queries of Sri Rituraj Sangmai are furnished below:
Reply to Query No.5(a) There is no substandard medicines sent to any district. Because NHM, Assam use to follow strict quality parameters like issuing Despatch Clearance Certificate to manufacturers prior to dispatch medicines to district. Despatch Clearance is a procedure where, drugs manufacturing company submitted batch wise analytical testing reports tested in Govt. approval NABL accredited Lab only.
Reply to Query No.5(b) During last FY of Drugs Inspector have collect samples from different periphery and sent to Regional Drug Testing physical appearance like hardness/breakage etc. during storage/transportation. But their test samples were cleared from other Govt. approved NABL Lab. Then also NHM, Assam as well as Drug Controller, Assam has immediately informed to stop all such distribution & consumption of these batches, observed Not of Standard Quality as per RDTL report and issue show cause.
Reply to Query No.5(c) Districts were ordered to handover and exchange stock of that particular batches immediately. Hence, that information may be sought from Districts only.
Reply to Query No.5(d) Page No.# 9/9 Batch wise testing reports from Govt. approved NABL Lab has been collected before allowing to supply to districts. Without NABL report no batch has been supplied to any districts ever.
Reply to Query No.5(e) NHM Assam had never allow to supply any substandard medicines as it is a issue to quality health to patient community."
10. Having considered the facts and circumstances of the case, we are of the view that the State of Assam should strictly follow every protocol and the prescribed procedures while procuring drugs and medicines from the suppliers to reduce the possibility of supply of substandard drugs and medicines to the government hospitals and medical facility centres across the State of Assam. Accordingly, it is directed that if any case of supply of substandard drugs/medicines is detected, the State authority shall take stern action against the supplier, including penalty, or initiation of criminal proceedings, if law permits to do so.
11. We hope and trust that the State of Assam shall take effective steps to make sure that no substandard medicines and drugs be procured and distributed in the government hospitals/medical facility centres in the State of Assam under the National Health Mission, Assam.
With these observations and direction, this PIL is disposed of.
JUDGE CHIEF JUSTICE Comparing Assistant