Madras High Court
Embiotic Laboratories Pvt Ltd vs Union Of India on 1 April, 2021
Author: M.Nirmal Kumar
Bench: M.Nirmal Kumar
Crl.O.P.No.23942 of 2015
IN THE HIGH COURT OF JUDICATURE AT MADRAS
RESERVED ON : 28.09.2020
PRONOUNCED ON : 01.04.2021
CORAM
THE HONOURABLE MR.JUSTICE M.NIRMAL KUMAR
Crl.O.P.No.23942 of of 2015
1.Embiotic Laboratories Pvt Ltd.,
Represented by its Managing Directors,
Mr.Kantilal Vajeraj jain &
Mr.Harish Kumar Kantilal Jain
No:20C, Kumbalgodu Industrial Area,
1st Phase, Kumbalgodu,
Bangalore – 560 074.
2.Kantilal Vaajeraj Jain
Managing Director of
M/s.Embiotic Laboratories Pvt Ltd.,
No:20C, Kumbalgodu Industrial Area,
1st Phase, Kumbalgodu,
Bangalore – 560 074.
3.Harish Kumar Kantilal Jain
Managing Director of
M/s.Embiotic Laboratories Pvt Ltd.,
No:20C, Kumbalgodu Industrial Area,
1st Phase, Kumbalgodu,
Bangalore – 560 074. ... Petitioners / Accused
Vs.
Union of India
Represented by, Drugs Inspector,
Office of the Deputy Drugs Controller (India),
Central Drugs, Standard Control Organization,
South Zone, 2nd Floor, Shastri Bhawan Annex,
Chennai – 600 006. ... Respondent / Complainant
Complainant
Page 1 of 12
Crl.O.P.No.23942 of 2015
PRAYER: Criminal Original Petition is filed under Section 482 of
the Code of Criminal Procedure, to call for the records in
C.C.No.3031 of 2015, on the file of IV Metropolitan Magistrate,
Saidapet, and quash all further proceeding against the accused.
For Petitioners : Mr.P.Ramesh Kumar
For Respondent : Mr.P.Ayyaswamy
Addl.Central Government
Standing Counsel
ORDER
This Criminal Original Petition has been filed praying to quash the proceedings in C.C.No.3031 of 2015, on the file of IV Metropolitan Magistrate, Saidapet.
2. The short facts of the case is as follows:-
The respondent / complainant filed the present complaint for an offence under Sections 18(a)(i) r/w 27(d) of Drugs and cosmetics Act, 1940, against the petitioners, on the allegations that the Drug Inspector drew samples of Enteric Coated Aspirin Tablets B.P.(Elispirin 150), Batch No.ELP 122, Manufacturing Date :December 2013, Expiry Date : November-2015, from the premises Page 2 of 12 Crl.O.P.No.23942 of 2015 of ESIC Hospital, K.K.Nagar, Chennai and sent the same for analysis to the Government Analyst, Central Drugs Testing Laboratory, Chennai, on 04.04.2014 and the Government Analyst by his opinion dated 30.05.2015 declared the samples as Not of Standard quality as the subject drug does not confirm to B.P(British Pharmacopeia) with respect of the test for dissolution. Thereafter, the respondent called upon the ESIC Hospital, K.K.Nagar, Chennai, to disclose the name and address of the person from whom the subject drug was acquired. The said ESIC Hospital, K.K.Nagar, Chennai replied that the subject drug was acquired from the petitioners / accused herein. Consequently, a notice was issued to the petitioners herein on 05.08.2014 along with the third portion of the sample that was drawn. The petitioners / accused by reply dated 16.08.2014 called upon the respondent / complainant to provide the original analytical report along with the protocol of analysis which was supplied by the respondent / complainant on 19.09.2014 and thereafter, the respondent / complainant, after obtaining sanction from the drug Controller, New Delhi, filed the present complaint. Page 3 of 12 Crl.O.P.No.23942 of 2015
3. The learned counsel appearing for the petitioners made his contention by relying on the Government Analyst Report, the result of test for dissolution Phosphate Buffer does not complete. As per Section 16 of the Drugs and Cosmetics Act, the Standard of Quality prescribed thereon is that the Second Schedule has to be looked into and as per the Second Schedule, under Clause 5(b), the drug in question mentioned as other drug, drugs not included in the Indian Pharmacopoeia, but which are included in the official pharmacopoeia of any other Country and according to the Second Schedule, Clause 5(b), the standard of identity, purity and strength specified in the edition of such official pharmacopoeia. According to the petitioners, as per the Government Analyst Report, the test for identification, average weight and uniformity of weight are complied with as specified in the Second Schedule.
4. The learned Additional Central Government Standing Counsel appearing for the respondent would submit that the Court below already taken cognizance of the offences and therefore, the present petition cannot be entertained under Section 482 of Cr.P.C. The points raised by the petitioners are to be decided only during Page 4 of 12 Crl.O.P.No.23942 of 2015 trial. Further, the complaint lodged under Section 18(a)(i) of the Drugs and Cosmetics Act and Section 16 of the Drugs and Cosmetics Act would not apply. The Aspirin is a life saving drug and the dissolution is one of the important factor in analysing and finding the standard of drug. In this case, the drug has failed to sustain in its quality. Hence, the petitioners prima facie committed the offences and therefore, prayed for dismissal of the petition.
5. I have heard the learned counsels appearing on either side and perused the materials available on record.
6. It is not in dispute that 01.04.2014, the Drug Inspector went to the premises of M/s. ESIC Hospital, K.K.Nagar, Chennai, disclosed his identity, drawn sample of Enteric Coated Aspirin Tablets B.P.(Elispirin 150), Batch No.ELP 122, Manufacturing Date :December 2013, Expiry Date: November-2015, Quantity : 560 (10 x 14 x 4) Tablets, manufactured by 2nd and 3rd accused Firm, wherein, A2 and A3 are Managing Directors and both are taking active part in the business of manufacturing the drug, after following the procedures prescribed under Section 23 of the Drugs and Cosmetics Act. Thereafter, divided the sample into four Page 5 of 12 Crl.O.P.No.23942 of 2015 portions, sealed them separately, marked them by affixing his own seal and signed and ESIC seal marked by Dr.A.Sivakumar, Store Manager, ESIC Hospital. One sealed portion of the sample was sent to the Government Analyst, Central Drugs Testing Laboratory, Chennai, under Form 18, on 04.04.2014. The Government Analyst, Central Drugs Testing Laboratory, Chennai, vide its Test Report No.CDTL/Form-18/11/0177/2014-15, dated 30.05.2014, declaring that the sample is not of standard quality, since it does not confirm to the British Pharmacopeia.
7. As per the Certificate of Test for Analysis Government Analyst under Section 25(1) of the Drugs & Cosmetics Act, 1940', dated 30th May 2014, the subject sample declared as not of standard quality for the reason that the sample does not conform to Britishi Pharmacopeia with respect to the test of “Dissolution”. It is necessary to reproduce a portion of the 'Certificate of Test for Analysis by Government Analyst, under Section 25(1) of the Drugs & Cosmetics Act, 1940', dated 30th May 2014, in order to understand the actual and standard parameters of the samples, which taken for analysis. In the said report, in column, 'Test for Dissolution', it has been given as follow:- Page 6 of 12 Crl.O.P.No.23942 of 2015
Test For Dissolution:-
a.Acid Medium Complies Lt: NMT 5% of Claim b.Phosphate Buffer Does not Comply Lt: NLT 75% of Claim (Ph.6.8) (Abt.10% of Claim) Each Enteric Coated Tablet contains:-
Content of Obtained Claim/Tab % of Claim Limits / Av.wt.
Aspirin 150.41 150 mg 100.27 95% to 105% of
mg claim
8. In the report it was opined by the Government Analyst, Central Drugs Testing Laboratory, as below:-
“In the opinion of the undersigned, the sample referred to above I NOT OF STANDARD QUALITY as defined in The Drugs & Cosmetics Act, 1940, and Rules thereunder for the reasons given below, THE SAMPLE RECEIVED DOES NOT CONFORM TO BP STANDARDS WITH RESPECT TO TEST FOR DISSOLUTION ONLY.” Page 7 of 12 Crl.O.P.No.23942 of 2015
9. Before adverting to the rival contentions, it is worth while to refer Section 33 P of Drugs and Cosmetics Act, 1940, in which Categories B & C, reads as follows:-
“Category B (Grossly sub-standard drugs) (iii) Tablets / Capsules failing in dissolution test and active contents found less than 70% for thermo labile products and below 5% of the prescribed limits for thermo stable products.
Tablets/Capsules failing in dissolution test and active contents found less than 70% for thermo labile products and below 5 % of the prescribed limits for thermo stable products In the case of drugs manufactured by a licensed manufacturer under a valid manufacturing licence and found grossly sub- standard and where criminal intent or gross negligence is not established, weapon of prosecution should be used judiciously, where it is felt that administrative measures like suspension or cancellation of licenses or compounding of offences would not meet the ends of justice Page 8 of 12 Crl.O.P.No.23942 of 2015 In the case of drugs manufactured by a licensed manufacturer under a valid manufacturing licence and found grossly sub- standard and where criminal intent or gross negligence is not established, weapon of prosecution should be used judiciously, where it is felt that administrative measures like suspension or cancellation of licenses or compounding of offences would not meet the ends of justice.”
10. In this case, except the dissolution, the other parameters are not disputed by the prosecution. Category B of the above referred Act is very clear that the tablets / capsules failing in disintegration test and active contents found less than 70% for thermo labile products and below 5% of the prescribed limits for thermo stable products. As per report, the contents found 100.27%, as against the limits of 95% to 105% of claim and therefore, as rightly contended by the learned counsel for the petitioners, it cannot be classified as a sub-standard drug, as per Second Schedule. Further, a bare reading of Categories B & C of Section 33 P of Drugs and Cosmetics Act, 1940, would make it clear that in case of violation of the said Act, a criminal prosecution could not be initiated. Admittedly, the drug viz., Page 9 of 12 Crl.O.P.No.23942 of 2015 Aspirin is a 'life saving drug'. When four samples were taken, out of which, one sample sent the Central Drugs Testing Laboratory, Chennai, which gave report against the manufacturer of the Tablet, it is not known why the prosecution has not send the sample to any other Lab like 'Central Drugs Laboratory (CDL) Kolkata, etc., to confirm the Analysis Report. Further, from the Analysis Report the identification, average weight and uniformity in weight were found tobe proper. Only in the test for dissolution, there is a variation within the limit, for which, no prosecution needed. In the light of the forgoing discussions, this Court is inclined to quash the proceedings.
11. In fine, this Criminal Original Petition stands allowed and the proceedings in C.C.No.3031 of 2015, on the file of IV Metropolitan Magistrate, Saidapet, is hereby quashed. Consequently, the connected miscellaneous petition is closed.
01.04.2021
Index : Yes/No
Internet : Yes/No
MPK
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Crl.O.P.No.23942 of 2015
To
1. The Drugs Inspector,
The Union of India
Office of the Deputy Drugs Controller (India), Central Drugs, Standard Control Organization, South Zone, 2nd Floor, Shastri Bhawan Annex, Chennai – 600 006.
2.The Additional Government Pleader High Court, Chennai.
Page 11 of 12 Crl.O.P.No.23942 of 2015
M.NIRMAL KUMAR, J.
MPK Crl.O.P.No.23942 of of 2015 01.04.2021.
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