Madras High Court
M/S.Biomed Healthcare Products ... vs State Of Tamil Nadu on 13 July, 2022
Author: N. Sathish Kumar
Bench: N. Sathish Kumar
Crl.O.P.No.9913 of 2022
IN THE HIGH COURT OF JUDICATURE AT MADRAS
DATED: 13.07.2022
CORAM
THE HONOURABLE MR. JUSTICE N. SATHISH KUMAR
Crl.O.P.No.9913 of 2022
and Crl.MP.Nos.5848 & 5849 of 2022
1. M/s.Biomed Healthcare Products Pvt.Ltd.,
Utarkhand (India) Rep.by
Jagdish Chand Arora, Director
2. Jagdish Chand Arora
3. Deepak Chand Arora
4. Nirmal Kanta Arora
5. Suresh Kumar Khurana ... Petitioners
-Vs-
State of Tamil Nadu
Rep.by
Drugs Inspector,
Ponneri Range & Poonamallee I Range i/c,
O/o.The Assistant Director of Drugs Control,
Thiruvallur Zone 201, 1st floor, J.N.Road,
Thiruvallur 602 001. ... Respondent
Prayer: Criminal Original petition filed under Section 482 of the Code
of Criminal Procedure to call for records in C.C.No.111 of 2021 on the
file of the Chief Judicial Magistrate, Thiruvallur and quash the same.
https://www.mhc.tn.gov.in/judis
1/11
Crl.O.P.No.9913 of 2022
For Petitioners : Mr.T.D.Selvan Babu
For Respondent : Mr.E.Raj Thilak
Addl.Public Prosecutor
ORDER
This Criminal Original Petition has been filed to call for records in C.C.No.111 of 2021 on the file of the Chief Judicial Magistrate, Thiruvallur and quash the same.
2. The crux of the allegation in the complaint is that A1 is the Manufacturer company M/s.Bio-Med Healthcare Products Pvt.Ltd., Unit- II, Plot No.62-65, Sector - 6A, SIDCUL, Haridwar 249 403, Uttarakhand (India) represented by Thiru.Jagdish Chand Arora, Director of M/s.Bio- Med Healthcare Products Pvt.Ltd., Haridwar and A2 to A5 are Directors. The sample of the Disposable Syringe with Needle 5ml Size 24GX1(0.55x25mm) Lot No.0517009 has been sent for analysis on 18.12.2017 to the Government Analyst, Department of biological control, King Institute of Preventive Medicine & Research, Guindy, Chennai 600 032 and the same was reported as Not of Standard Quality by the Government Analyst, Drugs special, Guindy, Chennai 600 032 dated 15.05.2018 for the reason that the sample does not confirm to https://www.mhc.tn.gov.in/judis 2/11 Crl.O.P.No.9913 of 2022 requirements for sterility. Thereafter, Show Cause notice dated 14.06.2018 was issued to M/s.Bio-Med Healthcare Products Pvt.Ltd., and on 26.07.2018 a reply dated 11.07.2018 from M/s.Bio-Med Healthcare Products Pvt.Ltd., was received in which the petitioners have stated that they are having manufacturing drug licence No.123/UA/SC/P- 2007 and that the batch manufacturing record, sterility record and sterilisation process of the disposable syringe were verified and no deviation was noticed. They also stated that M/s.Bio-Med Healthcare Products Pvt.Ltd., is not accepting the result of the sterility failure submitted by Government of Tamil Nadu Testing Laboratory. They have requested the respondent to submit the sample to Central Drugs Laboratory (CDL), Kolkatta for further verification. Along with the reply, they have not submitted the Manufacturing licence & renewal and endorsement copy of the product, Master formula record, Raw material analysis records, Raw material register, Label records and In process control records and other particulars of the subject drug. Hence on 10.08.2018 further particulars were called for but no reply was received till 03.09.2018, hence reminder was also sent on 03.09.2018. On perusal of the records submitted by the company M/s.Bio-Med Healthcare https://www.mhc.tn.gov.in/judis 3/11 Crl.O.P.No.9913 of 2022 Products Pvt.Ltd., it was found that the company was holding drug licence. On scrutiny of the BMR, Sterility Testing records, it is clear that the subject drug manufacturing was completed on 10.01.2017. The sterility test was started on 11.01.2017 and completed on 25.01.2017 but the product was distributed to TNMSC on 13.01.2017. Hence it is clear that the products were distributed to TNMSC before completion of sterility test. On 20.09.2018 after submitting the proposal, some documents were received from M/s.Bio-Med Healthcare Products Pvt.Ltd., However, the Master formula record and raw materials analysis records of the subject drug were not submitted by the Firm. It is in contravention of Section 18 B of the Drugs and Cosmetics Act, 1940, hence the complaint.
3. The learned counsel appearing for the petitioners submitted that the respondent issued a Show Cause Notice dated 14.06.2018 to the first petitioner for alleged contravention of Section 18(a) (i) of the Drugs and Cosmetics Act 1940 for alleged manufacture of not of standard quality (NSQ) drug to which the first petitioner replied by its letter dated 11.07.2018 that they do not agree with the report of the Government https://www.mhc.tn.gov.in/judis 4/11 Crl.O.P.No.9913 of 2022 Analyst and requested the respondent to send the sample to Appellate Central Drugs Laboratory (CDL), Kolkata. The respondent was not satisfied with the reply and thus filed the impugned complaint before the trial Court and the trial Court sent the sample produced before it to the Appellate Central drugs Laboratory for reanalysis. The Central Drugs Laboratory by its report dated 08.02.2019 declared the sample to be of Standard Quality and it passes the test for sterility. According to Section 25(4) of the Drugs and Cosmetics Act, 1940 the report of the Central Drugs Laboratory is conclusive and binding. Therefore prosecution in this regard is not maintainable. In respect of other aspects, it is the submission of the learned counsel that even in the complaint itself, it is stated that only raw material analysis records and master formula records were not submitted whereas his contention is that those records were sent and certificate of analysis with regard to master formula and also raw materials were sent to the respondent.
4. The learned Additional Public Prosecutor submitted that in view of the CDL report, certain records have not been filed and there is a violation of the Act and therefore prosecution is maintainable. He further https://www.mhc.tn.gov.in/judis 5/11 Crl.O.P.No.9913 of 2022 submitted that the records for usage of raw materials should be maintained, as they have not filed the same prosecuting the petitioners for violation of the Act is maintainable.
5. Heard both sides.
6. The particulars of raw materials and analysis report sent to the petitioners on various dates from 01.11.2017 to 14.01.2017 and other dates have not been disputed. Therefore, the raw materials report already submitted is also not disputed. This Court is of the view that even assuming that there is some variation which is minor in nature admittedly the raw materials and master formula is relating to the production of Syringe, when Syringe is found to be of Standard Quality by the CDRL the requirements sought by complainant under which Show Cause notice became irrelevant though there may be variation it appears that it is only a minor variation.
7. It is also to be noted that in the guidelines for taking action and samples of Drugs declared spurious are not of standard quality, the https://www.mhc.tn.gov.in/judis 6/11 Crl.O.P.No.9913 of 2022 guidelines framed u/s.33 (P) of the Act category (C) of the guidelines narrates the following:
Category (C) (Minor defects):
Drugs manufactured by the licensed manufacturers found not of standard quality because of defects arising out of minor variations in quality. Such defects may arise because of inadequate pre-formulation development studies, lack of in process controls exercised by the manufacturer or unsuitable conditions under which drugs are stored or transported. Examples of some such the defects are as under:
(i) Broken or chipped tablets
(ii) Presence of spot / discolouration / uneven coating.
(iii)Cracking of emulsions.
(iv) Clear liquid preparations showing sedimentation.
(v) Change in colour of the formulation.
(vi) Slight variation in net content.
(vii)Formulations failing in weight variation.
(viii)Formulations failing to respond to the colour test.
(ix) Isolated cases of presences of foreign matter.
(x) Labelling error including nomenclature mistake, Rx, Nrx, Red Line, Schedule H. Caution, Colour etc.
8. On a perusal of the above guidelines further, it is very clear that the State Drug Control Organisation for uniform implementation of the https://www.mhc.tn.gov.in/judis 7/11 Crl.O.P.No.9913 of 2022 provision of the Drugs and Cosmetics Act and Rules made thereunder. While implementing new provisions, the State Regulatory Authorities should ensure that the law is implemented in a comprehensive way. In order to effectively use the said instrument of law, it is necessary to have Standard Operative Procedures set in each State to examine and process various violations of the provisions of the Act. The State Drug Central Organizations should have internal mechanism of checks and balances to ensure that law abiding manufacturers and sellers of drugs are not harassed or put to a disadvantageous position. Care should be taken that while violations with criminal intent or gross negligence leading to serious defects are dealt with heavy hand, the violations involving minor variations in quality by licensed manufacturers are resolved through administrative measures.
9. The above guidelines also stipulate that the prosecution must be only for serious violations. Considering the guidelines the prosecution for such minor variation is not warranted and in any event it is not the case of the prosecution that since there are variations in the raw materials or master formula records there was Standard quality of syringe has been https://www.mhc.tn.gov.in/judis 8/11 Crl.O.P.No.9913 of 2022 produced when the Syringe sample itself found to be standard quality this Court is of the view that continuing the prosecution for minor variation is sheer abuse of process of law.
10. Subject to the above, this Criminal Original Petition stands allowed. The complaint taken on file in C.C.No.111 of 2021 for the offence punishable under Section 200 of Criminal Procedure Code for the Contraventions under Section 18(a) (i), Section 18 B of the Drugs and Cosmetics Act 1940 punishable under Section 27(d) of the said Act, on the file of the Chief Judicial Magistrate, Thiruvallur is hereby quashed. Consequently, the connected miscellaneous petitions are also closed.
13.07.2022 Index : Yes/No Internet : Yes/No Speaking/Non speaking order dpq https://www.mhc.tn.gov.in/judis 9/11 Crl.O.P.No.9913 of 2022 To
1. The Drugs Inspector, Ponneri Range & Poonamallee I Range i/c, O/o.The Assistant Director of Drugs Control, Thiruvallur Zone 201, 1st floor, J.N.Road, Thiruvallur 602 001.
2. The Chief Judicial Magistrate Court, Thiruvallur.
3. The Public Prosecutor High Court of Madras.
https://www.mhc.tn.gov.in/judis 10/11 Crl.O.P.No.9913 of 2022 N. SATHISH KUMAR,J.
dpq Crl.O.P.No.9913 of 2022 13.07.2022 https://www.mhc.tn.gov.in/judis 11/11