Gujarat High Court
Shivlalbhai Narshibhai Domadia & 3 vs State Of Gujarat & on 20 January, 2017
Author: J.B.Pardiwala
Bench: J.B.Pardiwala
R/CR.MA/33567/2016 ORDER
IN THE HIGH COURT OF GUJARAT AT AHMEDABAD
CRIMINAL MISC.APPLICATION (FOR QUASHING & SET ASIDE
FIR/ORDER) NO. 33567 of 2016
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SHIVLALBHAI NARSHIBHAI DOMADIA & 3....Applicant(s)
Versus
STATE OF GUJARAT & 1....Respondent(s)
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Appearance:
RAJDEEP A CHAUDHARI, ADVOCATE for the Applicant(s) No. 1 - 4
VISHAL K ANANDJIWALA, ADVOCATE for the Applicant(s) No. 1 - 4
PUBLIC PROSECUTOR for the Respondent(s) No. 1
RULE SERVED BY DS for the Respondent(s) No. 2
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CORAM: HONOURABLE MR.JUSTICE J.B.PARDIWALA
Date : 20/01/2017
ORAL ORDER
1. The case at hand is one more glaring example of the state of affairs in the government and municipal hospitals. Four innocent persons lost their vision after being operated upon for removal of cataract. The State, as the prosecuting agency, and the hospital where the surgery was performed, says that the patients lost their vision because the instruments got infected on account of the presence of bacteria in the Savlon liquid antiseptic which is being manufactured by the applicants. The entire blame, very conveniently, has been thrown on the head of the applicants without any investigation as regards the rash or negligent act on the part of the doctors or the other staff involved in the surgery.
2. On 22nd December, 2016, the following order was passed;
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" 1 As on date, there are three reports on record:
The first report is of the Sheth L.G. General Hospital, Department of Microbiology dated 21st March 2016. In the Savlon liquid antiseptic test, the presence of Pseudomonas aeruginosa Growth: Scanty was noticed.
The second report is of the N.H.L. Medical College dated 26th July 2016. In the said report, there is a reference of Achromobacter species.
The third report has been issued by the B.J. Medical College and Civil Hospital, Ahmedabad. The report of the B.J. Medical College and Civil Hospital indicates the presence of Pseudomonas aerugionasa isolated.
2 The last report dated 15th June 2016 is of the Government Analyst, Food and Drugs Laboratory, Vadodara. The report of the Food and Drugs Laboratory, Vadodara appears to be absolutely clear. It has been stated in the report that the sample confirms to the standard of Schedule V of the Drugs and Cosmetics Rules 1945 for patent or proprietary medicines.
3 As on date, there are conflicting reports, but the final report of the Government Laboratory as such makes the picture clear. I am told that a committee has been constituted to look into the matter. The committee is of three experts who are Doctors. The picture will be more clear once the report of the committee is received.
4 Although this Court has granted relief in terms of para 5(ii), yet it is open for the committee to proceed further and place its report for the perusal of this Court. The committee is requested to expedite the inquiry and file its report. Post the matter on 20th January 2017. Hopefully by 20th January 2017, the report of the committee should be on record.
5 A copy of this order be provided to Ms. Shruti Pathak, the learned A.P.P. for its onward communication."
3. Today, when the matter is taken up for further hearing, Page 2 of 6 HC-NIC Page 2 of 6 Created On Wed Jan 25 01:44:18 IST 2017 R/CR.MA/33567/2016 ORDER the learned APP informs that the committee of the experts has shown their inability to express any opinion since according to the members of the committee, they are all ophthalmologists and it would not be possible for them to consider the reports as regards the test of the Savlon liquid antiseptic.
4. The last report of the government analyst reads as under;
"LIQUID ANTISEPTIC HOSPITAL CONCENTRATE"
Result of the tests or analyst with protocols of test of analyst applied;
Order label:- Nil Container label:-1L.
Chlorhexidine Gluconate and Cetrimide Solution. Liquid Antiseptic Hospital Concentrate. Chlorhexidine Gluconate IP 7.5% Cetrimide IP 15.0% w/v.
For external use only.
For Guj. Govt. Supply only Not for sale.
Mfg. Lic. No.:G/25/1069 Batch No.15313 Mfg. 11/2015 Exp. Date: 2 year from the St. of Mfg. Mfg. By GUJARAT PHARMA LAB (P) LTD. CHANGODAR- 382213 DIST. AHMEDABAD (GUJARAT) Description: Yellow coloured liquid.
Content : 1000 ml (Labelled : I.L.) Identification:
1. Chlorhexidine Gluconate:
High performance liquid chromatographic procedure reveals the presence of Chlorhexidin Gluconate by similarly in retention time of major peaks obtained with sample solution an standard of Chlorhexidine Gluconate in the assay. (Assay method is followed)
2. Cetrimide:
Thin layer chromatographic procedure reveals the prescience of Cetrimide (Method given in Clarke's Isolation and Identification of drugs under Certimide page Page 3 of 6 HC-NIC Page 3 of 6 Created On Wed Jan 25 01:44:18 IST 2017 R/CR.MA/33567/2016 ORDER No.440 followed) Assayed for Chlorhexidine Gluconate and Cetrimide Contents:
1. Chlorhexidine Gluconate :- 7.41 percent/v. I.e. 98.80 percent of the labelled content) (method is attached separately)
2. Cetrimide :-15.59 percent w/v. (I.e. 103.93 percent of the labelled content.) (method given in I.P. 2014 under "Cetrimide Emulsifying Ointment" on page no.1344 is followed) (Schedule V Limits:- The content of active ingredient in Pharmaceutical formulations should be less than 90 percent and not more than 110 percent of the labelled content)
3. Tests for Bacterial Growth: (Microbial count)
1) Total Aerobic count- Nil
2) Total Yeast and Mould count- Nil
3) Test for Staphylococcus aureus- Absent
4) Test for Prendamonas Aeruginosa - Absent
5) Test for Eschenchia coli- Absent
6) Test for Salmonella - Absent (method supplied by manufacturer is followed)
4. pH of Sample I-in200 - 5.95 I-in100 - 6.20 I-in30- 6.41.
Date-
(B.V. Mistry) Government Analyst"
5. The report referred to above is a clear indication that nothing was wrong with the product of the applicants and the antiseptic liquid confirmed to the Schedule-V of the Drugs & Cosmetics Rules, 1945 for patent or proprietary medicines.
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6. The four person who lost their eyesight were operated at the L.G. General Hospital, Ahmedabad. The Investigating Officer thought fit to seek the report of the test of the Savlon liquid antiseptic through a laboratory of Sheth L.G. General Hospital. Should I expect a fair report from the hospital itself, more particularly, when the operations were performed in the very same hospital?. To show that the investigation is being carried out in a fair manner, the tests were also carried out at the N.H.L Medical College and the B.J. Medical College. The N.H.L. Medical College is a college run by the Corporation and the B.J. Medical College is a Civil Hospital. All the three hospitals, in their reports, found fault with the Savlon liquid antiseptic for one reason or the other. However, the Government analyst, in his report, has given a clean chit to the applicants. I call upon the State to now explain what they propose to do further in the matter. Once there is a report of the Government Food & Drugs Laboratory, certifying the sample confirming to the standard of Schedule-V of the Drugs & Cosmetics Rules, 1945 for patent or proprietary medicines, should the applicants be prosecuted. This Court would like to know whether the Investigating Agency would like the samples to be tested through a Central Food and Drugs Laboratory and is it possible at this point of time?.
7. I wonder whether there is any investigation as regards any error or negligence on the part of the doctor while performing the surgery. If the entire fault is to be found with the Savlon liquid antiseptic manufactured by the applicants, then what was the necessity to transfer the staff and the superintendent and also was the necessity to transfer even Ms. Bina Desai (HOD) to the Nagri Hospital from L.G. Hospital.
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8. Why such unfortunate incidents are reported concerning the government or the municipal hospitals only?. The product manufactured by the applicants is being used by number of private hospitals also. Why such incidents have not been reported in any other hospital. The skill or the care with which the surgeries are performed at the government and municipal hospitals, should also be a matter of serious consideration before levelling any allegations against the manufacturer of a product used for the purpose of such surgery.
9. Less said the better as regards the investigation carried out so far.
10. Post the matter for further hearing on 2nd February, 2017 on top of the board.
(J.B.PARDIWALA, J.) Vahid Page 6 of 6 HC-NIC Page 6 of 6 Created On Wed Jan 25 01:44:18 IST 2017