Gujarat High Court
Nirma Limited Thro' Ajay Bhushanlal ... vs State Of Gujarat on 11 October, 2022
Author: Vaibhavi D. Nanavati
Bench: Vaibhavi D. Nanavati
R/SCR.A/9866/2016 JUDGMENT DATED: 11/10/2022
IN THE HIGH COURT OF GUJARAT AT AHMEDABAD
R/SPECIAL CRIMINAL APPLICATION NO. 9866 of 2016
FOR APPROVAL AND SIGNATURE:
HONOURABLE MS. JUSTICE VAIBHAVI D. NANAVATI
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1 Whether Reporters of Local Papers may be allowed
to see the judgment ?
2 To be referred to the Reporter or not ?
3 Whether their Lordships wish to see the fair copy
of the judgment ?
4 Whether this case involves a substantial question
of law as to the interpretation of the Constitution
of India or any order made thereunder ?
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NIRMA LIMITED THRO' AJAY BHUSHANLAL KHUSHU & 1 other(s)
Versus
STATE OF GUJARAT & 1 other(s)
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Appearance:
MR MIHIR JOSHI, SENIOR ADVOCATE withdrawn
MR RAHEEL PATEL, ADVOCATE for
GANDHI LAW ASSOCIATES(12275) for the Applicant(s) No. 1,2
MR HARSHEEL D SHUKLA(6158) for the Respondent(s) No. 2
PUBLIC PROSECUTOR for the Respondent(s) No. 1
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CORAM:HONOURABLE MS. JUSTICE VAIBHAVI D. NANAVATI
Date : 11/10/2022
ORAL JUDGMENT
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R/SCR.A/9866/2016 JUDGMENT DATED: 11/10/2022
1. By way of this present application under Article 226 and 227 of the Constitution of India and under section 482 of the Code of Criminal Procedure 1973, the writ applicants herein have prayed for quashing and setting aside the complaint being Criminal Case No. 4547 of 2015 lodged by the respondent No. 2 before the Chief Judicial Magistrate Court, Viramgam for alleged offences under section 16(1)(a), 18(1)(i) r/w section 34 and punishable under section 27 of the Drugs and Cosmetics Act, 1940 and the order passed by the learned Chief Judicial Magistrate, Viramgam issuing summons to the petitioners.
2. The facts giving rise to the filing of the present petition reads as under:-
2.1 The petitioner No. 1 is a company incorporated under the provisions of Company's Act, 1956 and is engaged in the manufacturing and sale of Soda Ash, Linear Alkaline Benzene, Soaps and Detergents and Cement at various locations in the State of Gujarat and in India. Page 2 of 37 Downloaded on : Sun Dec 25 03:48:34 IST 2022
R/SCR.A/9866/2016 JUDGMENT DATED: 11/10/2022 2.2 The petitioner No. 1 was also engaged in manufacturing drugs and pharmaceuticals at village Sachana Taluka Viramgam, Gujarat. The petitioner No. 2 is the accused No. 2 in the complaint being Criminal Case No. 4547 of 2015 and is the Managing Director of petitioner No. 1 - Company.
2.3 The petitioner No. 1 was manufacturing drugs and pharmaceutical products under a license bearing No. G/28/1221 granted by the Food and Drugs Control Administration, Gujarat to manufacture for sale (or for distribution) of drugs specified in Schedule thereto for a period of 5 years from 20.06.2006 to 19.06.2011. The same came to renewed on 29.12.2011 for a period of another 5 years from 20.06.2011 to 19.06.2016. 2.4 The petitioner No. 1 was manufacturing Ceftriaxone and Sulbactam for Injection 1.5 gm with Sterile Water for injection in combi-pack sold under brand Nirixone-S. The Page 3 of 37 Downloaded on : Sun Dec 25 03:48:34 IST 2022 R/SCR.A/9866/2016 JUDGMENT DATED: 11/10/2022 same was also added in the list of approved produces as per the Form-28 after issuance of license. The Healthcare Division of petitioner No. 1 was demerged and transferred into Aculife Healthcare Private Limited vide order of this Court dated 20.04.2015. After the demerger of the Healthcare Division, the license under Form 8 dated 29.12.2011 was canceled on 05.10.2015 by Food and Drugs Control Administration, Gujarat and pursuant to which the petitioner stopped manufacturing Drugs and Pharmaceutical products.
2.5 The impugned complaint came to be filed against the writ applicants by the respondent No. 2 on 02.11.2015. It is stated that before or after the impugned complaint filed by the respondent No. 2 - Drug Inspector being Criminal Case No. 4547 of 2015, there is no such incident which had occurred after the strict warning given by the Food and Drugs Control Department, Gujarat vide letter dated 03.10.2015.
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3. It is the case of the complainant - respondent No. 2 that the accused No. 1 manufactured drugs not of standard quality being Nirixone-S (Ceftriaxone and Sulbactam for injection) B. No. 6C30037, D/M. 03/2013, D/ E. 02/2015 along with Sterile Water for Injection Batch No. 7501978, D/M. 08/2012, D/E-07/2017 Manufactured by M/s Nirma Limited (Healthcare Division) Sachana Gujarat. It is also the case of the complainant that the accused No. 1 had supplied the said batch of drug as per the list submitted. The samples of the aforesaid drugs along with the other samples were drawn by Shri Virendra Singh, Drugs Inspector on 28.09.2013 from the custody of Mr. Deepak Bhatt - accused No. 3 under the provisions of Drugs and Cosmetics Act. The said collected drug were divided into three equal portions (under section 23 of the Act) and it was effectively sealed packed and suitably marked. The intimation in writing was duly filled up relevant Form No. 17 and Form No. 17-A along with one sealed potions of the sample which was handed over to accused No. 3 and the same was acknowledged and Page 5 of 37 Downloaded on : Sun Dec 25 03:48:34 IST 2022 R/SCR.A/9866/2016 JUDGMENT DATED: 11/10/2022 signed. Out of the two samples which were retained by Shri Virendra Singh - Drug Inspector one portion of sealed sample was sent for test / analysis to the Government Analyst, Central Drugs Laboratory, Kolkata in a sealed packet. Thereafter, the sample was tested and declared "Not of Standard Quality" by the Government Analyst, Central Drugs Laboratory, Kolkata with respect to test "Particulate Matter and Clarity of Solution" vide report No. 32-11/2013-SS/DCA(A)-103/5022 dated 07.02.2014. The said report was forwarded by Shri Virendra Singh - Drug Inspector vide letter 50/NSQ/Guj/2014/5233 on 17.02.2014 to the manufacturer under section 25 of the Act and it was requested to furnish comments on the test reports along with manufacturing documents, details of manufacturing process etc and quality control Chemist responsible for manufacturing and release of subject batch of the drug. By letter dated 14.03.2014 bearing No. NHL/Reg/DDCI/2013-14/ 162 forwarded his comments and challenged the test report. The said report came to be challenged by the manufacturer by application No. 180 of Page 6 of 37 Downloaded on : Sun Dec 25 03:48:34 IST 2022 R/SCR.A/9866/2016 JUDGMENT DATED: 11/10/2022 2014 in the Court of Principal Senior Civil Judge and Additional Chief Judicial Magistrate, Viramgam for retest of the sample and the same sample was forwarded on Form No. 1 with Serial No. 454/14 dated 01.08.2014 to Director, Central Drugs Laboratory, Kolkata. The said sample was declared Not of Standard Quality with respect to "Particulate matter and Clarity of Solution" by Director I/c. Central Drugs Laboratory, Kolkata in Form No. 2 report No. 2-1/2014-SS/CC-84/335 dated 03.09.2014. Thereafter, the Competent Authority/Controlling Authority by letter No. 24/Prosecution/DDC(I)2014 dated 13.02.2015 granted permission to launch prosecution against the petitioner No. 1 for manufacturing of Not of Standard Quality Drug. It is the case of the complainant that the accused No. 1 through accused Nos. 1 to 5 are manufacturers of "Not of Standard Quality Drug" failed in "Particulate Matter and Clarity of Solution" of drug which is violation as per the provisions as laid down for the offences as stated above. In view of above, the respondent No. 2 by filing the impugned complaint prayed for the reliefs as stated in Page 7 of 37 Downloaded on : Sun Dec 25 03:48:34 IST 2022 R/SCR.A/9866/2016 JUDGMENT DATED: 11/10/2022 Paragraph 23 of the complaint as stated below.
23. In the circumstances, it is respectfully prayed that your Honour would be graciously pleased.
(a) To take cognizance's of the offences as per provision under section 32 of the Drugs and Cosmetics Act 1940 and the Drugs and Cosmetics Rules (As amended)
(b) That the accused persons intentionally and knowledgeably with a guilty mind have committed the offence of manufacturing the not of standard quality drugs in connivance of each other. They have violated the provision as laid down under section 16(1)(a) and committed offences under section 18(a)(i) read with Section 34 of Drugs and Cosmetics Act 1940 and liable to be proceeded against and punished under section 27 of the said Act Page 8 of 37 Downloaded on : Sun Dec 25 03:48:34 IST 2022 R/SCR.A/9866/2016 JUDGMENT DATED: 11/10/2022 In the aforesaid facts and circumstances and in view of the cognizable offence committed them it is therefore humbly prayed that your Honour would be graciously pleased to issue process against the above named Accused persons being Nos. 1 to 5 under the relevant Law Rules and Provisions of the Drugs and Cosmetics Act 1940.
(c) To issue process / summons against the accused under Section 32 of the Drugs & Cosmetics Act 1940 & the Drugs Cosmetics Rules 1945 (as amended) U/s 16(1) & 18(a)
(i) read with Section 34 of said Act in order to bring the accused for trial.
(d) To direct the accused persons under Section 27 of the Drugs & Cosmetics Act 1940 & Drugs & Cosmetics, Rules 1945 (as amended) for necessary compliance as Page 9 of 37 Downloaded on : Sun Dec 25 03:48:34 IST 2022 R/SCR.A/9866/2016 JUDGMENT DATED: 11/10/2022 required under the provisions of the Drugs & Cosmetics Act, 1940 & Rules made there under.
(e) To exempt the complainant from personal appearance in the court on each and every date of the case till further order unless specifically called for us the said compliant is a Public Servant and remains busy with his duties for the interest of public at large.
(f) To pass such order or orders as you
Honors may deem fit and proper for the
ends of justice.
Submissions made by learned senior counsel Mr. Mihir Joshi on behalf of the petitioners:-
4. Mr. Mihir Joshi, learned senior counsel with learned advocate Mr. Raheel Patel for Gandhi Law Associates Page 10 of 37 Downloaded on : Sun Dec 25 03:48:34 IST 2022 R/SCR.A/9866/2016 JUDGMENT DATED: 11/10/2022 appearing for applicant herein submitted that the first report dated 17.02.2014 on Form No. 13 issued by the Government Analyst did not contain any reasons or findings and for concluding that the said sample was not of Standard Quality. However, by the said process the petitioners were constrained to enter into the needless proceedings under section 25(4) of the Act and the subject complaint which culminated into the impugned case which is nothing but an abuse of the process of law. Mr. Joshi, learned senior counsel submitted that the trial Court filed to appreciate that when the first report dated 17.02.2014 on Form 13 contained no reasons as to why the sample failed in "Particulate Matter test" and "Clarity of Solution test", it as not open for the Central Drug Laboratory to supply reasons during re-testing.
4.1 The very fact that in the re-test report dated 03.09.2014, on Form No. 2 the sample has been shown to failed particulate test without a finding as to existence of any foreign matter shows that the Central Drugs Page 11 of 37 Downloaded on : Sun Dec 25 03:48:34 IST 2022 R/SCR.A/9866/2016 JUDGMENT DATED: 11/10/2022 Laboratory had prepared the Form No. 2 without applying its mind and only with a view to support its conclusion in the first report dated 07.02.2014 on Form No. 13. The aforesaid cannot be a reason to fasten criminal liability upon the petitioners herein. Mr. Joshi, learned senior counsel further submitted that the report dated 07.02.2014 on Form No. 13 and 03.09.2014 on Form No. 2 are both illegal in view of the fact that the Government Analyst could not have concluded in the report on Form No. 13 that the sample failed the test for particulate matter without ascertaining and giving a finding that foreign matter is found. In absence of any foreign matter the sample could not have failed for particulate matter and no prosecution in respect thereof could have been launched. In view of above, according to Mr. Joshi, learned senior counsel the Criminal Complaint as well as the impugned order thereof are illegal and are required to quashed and set aside.
4.2 Mr. Joshi, learned senior counsel further submitted Page 12 of 37 Downloaded on : Sun Dec 25 03:48:34 IST 2022 R/SCR.A/9866/2016 JUDGMENT DATED: 11/10/2022 that the complaint is not maintable in view of the fact that not only the conclusions given in the report dated 07.02.2014 on Form No. 13 and 03.09.2014 on Form No. 2 with respect to the particulate matter are drawn but also in light of the fact that the Government Analyst has given a positive finding that the samples were sterile and no endo-toxins were found. The sample in question passed the test of sterility and endo-toxins and no foreign matter was observed after constituting the injection. It is apparent that in the absence of any foreign matter, what the Government Analyst noticed is in the vial, upon constituting the injection, was the Ceftriaxone and Sulbactam powder since the Government Analyst according to Mr. Joshi, learned senior counsel appears to have failed in properly shaking the contents before examining it.
4.3 The Court below has issued summons without examining the fact that the sample could not have failed the particulate matter test in absence of any foreign Page 13 of 37 Downloaded on : Sun Dec 25 03:48:34 IST 2022 R/SCR.A/9866/2016 JUDGMENT DATED: 11/10/2022 matter and since the sample was found to be sterile, failure of clarity of solution test depends on how well the shaking is done since proper mixing is the subjective use of the sample.
4.4 Mr. Joshi, learned senior counsel also submitted that the allegations in the impugned complaint against threat to general public on account of samples failing the particulate matter test and clarity of solution test are incorrect in view of the fact that the samples have passed the sterility test and endo-toxin test as stated above. The quantum of drugs/medicines in the constituted injections were found to be within the limits prescribed under IP 2010. The question of the drug posing any threat whatsoever to any person according to Mr. Joshi, learned senior counsel is clearly a bald, incorrect and exaggerated allegations devoid of any legal proof. He further submitted that the respondent No. 2 launched the prosecution several months after the period to launch the prosecution ended. The Drug Controller General (I) vide letter dated Page 14 of 37 Downloaded on : Sun Dec 25 03:48:34 IST 2022 R/SCR.A/9866/2016 JUDGMENT DATED: 11/10/2022 13.12.2015 granted approval to the CDSCO, Zonal Office, Ahmedabad to launch prosecution within 45 days and therefore the respondent No. 2 had no authority to launch the prosecution on 02.11.2015. It is also submitted that the letter dated 03.10.2015 by the Commissioner, Food and Drugs Control Administration, Gandhinagar informed that no action was proposed to be taken against the petitioner No. 1. The petitioner No. 1 was strictly warned and asked to remain careful in the future and this fact was brought to the knowledge to CDSCO, Zonal Office, Ahmedabad vide letter dated 09.10.2015. The respondent No. 2 ought not to have launched the prosecution in view of the said letter dated 03.10.2015 by the Commissioner, Food and Drugs Control Administration, Gandhinagar. The aforesaid initiation of prosecution by the respondent No. 2 inspite of the communication by Commissioner, Food and Drugs Control Administration, Gandhinagar dated 03.10.2015 can be said to be abuse of process of law. 4.5 Mr. Joshi, learned senior advocate submitted that the Page 15 of 37 Downloaded on : Sun Dec 25 03:48:34 IST 2022 R/SCR.A/9866/2016 JUDGMENT DATED: 11/10/2022 allegation was never that the product as dispatched by the petitioner No. 1 was not of standard quality. The allegation was never that the size of the vial was not large enough. Mr. Joshi, learned senior advocate submitted that without admitting that the sample failed the test of clarity of solution and was not of standard quality still however, as per the said guidelines it was a minor defect and strict warning was given by the Commissioner, Food and Drug Control Department which was communicated vide letter dated 03.10.2014 and the same was sufficient. The launch of prosecution was uncalled for and as stated above, abuse of process of law. Mr. Joshi, learned senior counsel submitted that the samples were drawn on 13.09.2013 and it has been falsely stated by respondent No. 2 that the said samples were drawn on 28.09.2013. The samples were stored after drawing and not clearly disclosed on any of the reports. The respondent No. 2 could have sent the samples for testing to any other laboratory such as the Central Drug Testing Laboratory or Regional Drug Testing Laboratory at Mumbai, Chennai etc. However, the Page 16 of 37 Downloaded on : Sun Dec 25 03:48:34 IST 2022 R/SCR.A/9866/2016 JUDGMENT DATED: 11/10/2022 respondent No. 2 with malafide intention sent the sample to Government Analyst, Central Drug Laboratory, Kolkata knowing fully well that the re-test of the sample would also be carried out at the same laboratory. The report on Form No. 2 is not signed either by the Director, Central Drug Laboratory, Kolkata or other authorised officer and the same is signed by I/c Drug Director which is not permissible. The protocols for analysis are not stated on the report of Form No. 13. Mr. Joshi, learned senior advocate lastly submitted that in view of above submissions, the impugned complaint instituted against the petitioners herein deserves to be quashed and set aside.
Submissions made by learned counsel Mr. Harsheel Shukla on behalf of the respondent:-
5. On the other hand, Mr. Harsheel Shukla learned advocate for the respondent No. 2 vehemently submitted that the process / summons issued against the accused / Page 17 of 37 Downloaded on : Sun Dec 25 03:48:34 IST 2022 R/SCR.A/9866/2016 JUDGMENT DATED: 11/10/2022 petitioner to bring the accused for trail, the action initiated on the basis of Form No. 13 report No. 32-11/2013-SS/DCA(A)-103/5022 dated 07.02.2014 of the Government Analyst, CDL, Kolkata and the Director I/c CDL, Kolkata in Form 2 report No. 2-1/2014-SS/CC-84/335 dated 03.09.2014 clearly mentions that the sample was declared not of standard quality with respect to "particulate matter" and "clarity of solution". Mr. Shukla, learned advocate submitted that as per section 25 of the Act the report signed by or under the authority of the Director, Central Drug Laboratory, Kolkata under section 4 of the Act is an evidence of the facts stated therein and such an evidence can be said to be a conclusive evidence.
Mr. Shukla, learned advocate further submitted that the present writ application at the instance of petitioner - accused in the impugned criminal complaint not be entertained at this stage in view of the fact that the complaint is only at the stage of issuance of summons and it is open for the applicants herein to take any contentions available under the law after the applicants appear before Page 18 of 37 Downloaded on : Sun Dec 25 03:48:34 IST 2022 R/SCR.A/9866/2016 JUDGMENT DATED: 11/10/2022 the Court below pursuant to the summons issued in the impugned complaint. Mr. Shukla, learned advocate relied upon the affidavit filed by the respondent No. 2 and submitted that the petition not be entertained and that the same be dismissed.
6. The notice came to be issued vide order dated 26.12.2016 and ad-interim relief in terms of Paragraph 43B came to be granted in favour of the petitioners and the same relief had been extended from time to time till the matter was taken up for hearing.
Analysis:-
7. Heard learned advocates appearing for the respective parties and perused the material on record. The petitioner No. 1 is a Company engaged in the business of manufacture and sale of Soda Ash, Linear Alkaline Benzene, Soaps and Detergents and Cement at various locations in the State of Gujarat and in India. Before the Page 19 of 37 Downloaded on : Sun Dec 25 03:48:34 IST 2022 R/SCR.A/9866/2016 JUDGMENT DATED: 11/10/2022 healthcare division of the petitioner was demerged into Aculife Health Care Private Limited vide order dated 20.04.2015, passed by this Court the petitioner No. 1 was also manufacturing drugs and pharmaceuticals at village Sachana Taluka Viramgam, Gujarat.
7.1 The petitioner No. 2 is the accused No. 2 in the complaint being Criminal Case No. 4547 of 2015 and is the Managing Director of the petitioner No. 1 - Company. The Food and Drugs Inspector - Shri Virendra Singh on inspection of the premises of M/s Nirma Limited (Health Care Division) Sachana, Viramgam drew samples of the impugned injection along with other samples. On 28.09.2013 from the custody of accused No. 3, the petitioner herein as contradicted the aforesaid fact by stating that the sample in question of Nirixone-S (Ceftriaxone and Sulbactam for injection) was drawn on 03.09.2014 however the same was kept in custody of the respondent authority and infact the samples were drawn on 13.09.2020 which was the date of visit of Shri Virendra Page 20 of 37 Downloaded on : Sun Dec 25 03:48:34 IST 2022 R/SCR.A/9866/2016 JUDGMENT DATED: 11/10/2022 Singh - Drug Inspector and that it was incorrectly stated that the said sample was drawn on 28.09.2013. The said sample was analyzed by the Government Analyst, Central Drugs Laboratory, Kolkata whose report in Form 13 dated 07.02.2014 which is duly produced at pg. 50 declared the sample as "not of standard quality" for not confirming to the test of "particulate matter" and "clarity of solution".
The said sample passed the test for sterility and bacterial endo-toxins. The petitioners were informed by the respondent authority by communication dated 17.02.2014 that the product being not of standard quality as per report dated 07.02.2014 on Form 13 by the Government Analyst and the petitioner No. 1 was directed to stop the sale and manufacturing of the product and to recall the product from the market store immediately. The respondent to the said letter dated 17.02.2014 informed that the petitioner No. 1 had stopped the sale / distribution of the product and had recalled the stock from marked immediately by sending letters to the distributors by RPAD. The petitioners also stated that the petitioners did Page 21 of 37 Downloaded on : Sun Dec 25 03:48:34 IST 2022 R/SCR.A/9866/2016 JUDGMENT DATED: 11/10/2022 not agree with the said report of the Government Analyst and requested that the sample be analyzed by the Central Drugs Laboratory, Kolkata under section 25(4) of the Act. Thereafter on 19.04.2014, the petitioner filed Criminal Miscellaneous Application No. 726 of 2014 under section 24(4) of the Act requesting that the sample be sent to Central Drugs Laboratory for retest. The said sample was sent by Form 1 dated 01.08.2014 for retesting to the Central Drugs Laboratory, Kolkata and the said report from Central Drugs Laboratory, Kolkata was received on 03.09.2014 on Form 2 which also reported that the sample was not of standard quality for not confirming the test of particulate matter and clarity of solution. It is noticed that both the reports i.e. the report on Form 13 and Form 1 conclusively held that the product was not of standard quality and not confirming to particulate matter and clarity of solution.
7.2 Drugs And Cosmetics Rules, 1945 Schedule V of Standards for Patent or Proprietary Page 22 of 37 Downloaded on : Sun Dec 25 03:48:34 IST 2022 R/SCR.A/9866/2016 JUDGMENT DATED: 11/10/2022 Medicines reads as under (Page: 70):-
4. General Standards for Different Categories of Patent or Proprietary Medicines. - In the case of pharmaceutical products containing several active ingredients, the selection shall be such that the ingredients do not interact with one another and do not affect the safety and therapeutic efficacy of the product.
The combination shall not also lead to analytical difficulties for the purpose of assaying the content of such ingredient separately. The substances added as additives shall be innocuous, shall not affect the safety or therapeutic efficacy of the active ingredients, and shall not affect the assays and identity tests in the amount present.
Subject to the provisions of these rules, Page 23 of 37 Downloaded on : Sun Dec 25 03:48:34 IST 2022 R/SCR.A/9866/2016 JUDGMENT DATED: 11/10/2022 patent or proprietary medicines shall comply with the following standards, namely: -
1. Patent or proprietary medicines shall comply with the general requirements of the dosage form under which it falls as given in the Indian Pharmacopoeia. If the dosage form is not included in the Indian Pharmacopoeia, but is included in any other pharmacopoeia, prescribed for the purpose of the Second Schedule to the Act, it shall comply with the general requirements of the dosage of such pharmacopoeia. Without prejudice to the generality of the foregoing requirements, general requirements shall include compliance with colour consistency, clarity, stability, freedom from contamination with foreign matter or fungal growth, defects like chipping and Page 24 of 37 Downloaded on : Sun Dec 25 03:48:34 IST 2022 R/SCR.A/9866/2016 JUDGMENT DATED: 11/10/2022 capping of tablets, cracking of the coating mottled appearance and other characteristic defects that can be perceived by visua inspection.
2. Without prejudice to the generality of the following paras, dosage forms of patent or proprietary medicines shall comply with the following requirements, namely:
(d) Injections: Medicines shall comply with the requirements for injections as laid down in the Indian Pharmacopoeia.
7.3 The Second Schedule : Standards To Be Complied With By Imported Drugs And By Drugs Manufactured For Sale, Sold, Stocked Or Exhibited For Sale Or Distributed (PAGE:74) Powders for injection:
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R/SCR.A/9866/2016 JUDGMENT DATED: 11/10/2022 Powders for injection are sterile, solid substances (including freeze-dried materials) which are distributed in their final containers and which, when shaken with the prescribed volume of the appropriate sterile liquid, rapidly form clear and practically particle-free solutions or uniform suspensions.
Test: Powders for injection comply with the requirements of test stated under individual monographs and with the following requirements.
Clarity of Solution: Consitute the injection as directed on the label (Not applicable to suspensions).
a) The solid dissolves completely, leaving no visible residue as undissolved matter.
b) The constituted injection is not Page 26 of 37 Downloaded on : Sun Dec 25 03:48:34 IST 2022 R/SCR.A/9866/2016 JUDGMENT DATED: 11/10/2022 significantly less clear than an equal volume of the diluent or of water for injections contained in a similar container and examined in the same manner. Particulate matter: Constitute the
injection as directed on the label; the solution is essentially free from particles of foreign matter that can be seen on visual inspection (PAGE:75).
7.4 The Guidelines For Taking Action On Samples Of Drugs Declared Spurious Or Not Of Standard Quality In Teh Light Of Enhanced Penalties Under The Drugs And Cosmetics (amendment) Act, 2008 Reads As Under (PAGE 86):-
CATEGORY C (MINOR DEFECTS) Drugs manufactured by the licensed Page 27 of 37 Downloaded on : Sun Dec 25 03:48:34 IST 2022 R/SCR.A/9866/2016 JUDGMENT DATED: 11/10/2022 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 Page 28 of 37 Downloaded on : Sun Dec 25 03:48:34 IST 2022 R/SCR.A/9866/2016 JUDGMENT DATED: 11/10/2022 the colour test.
(ix)Isolated cases of presences of foreign matter.
(x) Labelling error including nomenclature mistake, Rx, NRx, XRx, Red Line, Schedule H. Caution, Colour etc.
5. In the case of not of standard quality reports because of minor defects arising out of variations from the prescribed standards or contraventions of other provisions of chapter IV of the Act, administrative measures including suspension/cancellation or compounding of offences may be resorted to. Prosecution may only be launched where it is justifiably felt that above measures would not meet the ends of justice (Page:87).
7.5 Upon issuance of show cause notice by the Commissioner, Food and Drug Control Administration, Page 29 of 37 Downloaded on : Sun Dec 25 03:48:34 IST 2022 R/SCR.A/9866/2016 JUDGMENT DATED: 11/10/2022 Gujarat State for personal hearing on 14.09.2015. The petitioners remained present before the Commissioner, Food and Drug Control Administration and over and above the personal hearing submitted as under:-
1. The product is dry powder injectable.
2. We are filling the requisite quantity of powder in the glass vial of capacity of 10 ml.
3. After re-constitution, the vial is filled almost completely to make the solution, leaving very little space for dissolution.
4. As a corrective measure, we have changed the capacity of the vial to 20 ml making it easier to dissolve the powder
5. This change has made the process of dissolution easier.
7.6 The Commissioner, Food and Drug Administration by communication dated 03.10.2015 communicated that the explanation furnished by the petitioners are not Page 30 of 37 Downloaded on : Sun Dec 25 03:48:34 IST 2022 R/SCR.A/9866/2016 JUDGMENT DATED: 11/10/2022 considered satisfactory and added that no action is proposed to be taken against the petitioners at the relevant time. The petitioners were let off with a strict warning and were advised to be more careful in the future.
Thereafter, by communication dated 09.10.2015 the petitioner herein assured the Commissioner, Food and Drug Administration that the petitioners would be careful and further informed that the petitioners have changed the capacity of vials from 10 ml to 20 ml making it easier to dissolve the powder. They further added that the vial is filled almost completely to make solution, leaving very little space for dissolution and that the bigger capacity of vial makes the dissolution process easy and fast. 7.7 In the meantime, the respondent No. 2 issued a communication on 02.09.2015. Thereafter, the petitioner duly complied with the communication vide letter dated 07.09.2015. On one hand, the Commissioner, Food and Drug Administration by letter dated 03.10.2015 informed the petitioners that no action was proposed to be taken Page 31 of 37 Downloaded on : Sun Dec 25 03:48:34 IST 2022 R/SCR.A/9866/2016 JUDGMENT DATED: 11/10/2022 against the petitioners and strictly warned the petitioners to remain careful while on the other hand, after the expiry of 10 months, the respondent No. 2 herein lodged the impugned complaint on 02.11.2015 being Criminal Case No. 4547 of 2015.
7.8 Considering the aforesaid aspects and facts of the present a case it is pertinent to note that the petitioner was manufacturing Ceftriaxone and Sulbactam for injection 1.5 with sterile water for injection in combi-pack sold under brand Nirixone-S. The same was also added to the list of approved products as per Form 28 of the license. The petitioner has produced at Page: 150 counter of the said injection which reads as under:
Dissolve the contents of the vial in 10 ml of Sterile Water for Injections IP for I.V. use & 5 ml for I.M. use.
If any foreign matter is visible in the vial after dissolving the contents, please do not use the solution.
Page 32 of 37 Downloaded on : Sun Dec 25 03:48:34 IST 2022 R/SCR.A/9866/2016 JUDGMENT DATED: 11/10/2022 Store in a dry and dark place, at a temperature not exceeding 30C.
Keep medicines out of reach of children. 7.9 The aforesaid states that if any foreign matter is visible in the vial after dissolving the contents please do not use the solution. It appears from the aforesaid, that the petitioner herein has stated that if any visible foreign matter is found in the vial the said solution may not be used. Considering the above, this Court is of the opinion that even if the case of the prosecution is considered as it is the reports under Form 13 and Form 2 while declaring the product in question as not of standard quality with respect to particulate matter and clarity of solution as stated above, in case it is found that the product is not of a standard quality, then on minor defect being detected prosecution may not be launched unless it is felt that the above measures would not meet the ends of justice. 7.10 Commissioner, Food and Drug Administration had Page 33 of 37 Downloaded on : Sun Dec 25 03:48:34 IST 2022 R/SCR.A/9866/2016 JUDGMENT DATED: 11/10/2022 already warned the petitioners by communication dated 03.10.2015. The petitioner stopped using the said product and even all the stock was also withdrawn by the petitioner after receiving the said communication from the authority and the petitioner have also as stated above clearly mentioned on the counter of the injection that if any foreign material is found in the vial then the said injection may not be used. The respondent No. 2 launched the prosecution after a period of 11 months instead of initiating the prosecution within 45 days which itself in view of this Court is time barred. No fruitful explanation comes forth from the respondent No. 2 for delaying the launch of prosecution against the petitioners herein.
8. This Court has considered the following while considering the present petition and after perusing the documents on record and after taking into consideration the arguments made by the learned advocates for both the parties, the offence as alleged is not made out against the petitioner in view of the following:- Page 34 of 37 Downloaded on : Sun Dec 25 03:48:34 IST 2022
R/SCR.A/9866/2016 JUDGMENT DATED: 11/10/2022 8.1 It is also noted by this Court that while the said report of Form 13 and Form 2 state that the samples were declared not of Standard Quality with respect to test "Particulate Matter and Clarity of Solution", as stated above, the product (injection) is as such free from any foreign matter.
Moreover, it is clearly stated on the counter of the product (injection) in question that if any foreign material is found in the vial then the said injection may not be used.
8.2 The petitioner accused has declared that the production of the product (injection) is stopped as back as in the year 2015.
8.3 During the course of hearing also it was declared that the injection was withdrawn from the market as back as in the year 2015 and the usage has been stopped thereafter. Page 35 of 37 Downloaded on : Sun Dec 25 03:48:34 IST 2022
R/SCR.A/9866/2016 JUDGMENT DATED: 11/10/2022 8.4 The guidelines for taking action on Samples of Drugs Declared Spurious or not of Standard Quality in the light of Enhanced Penalties under the Drugs and Cosmetics (Amendment) Act, 2008 more particularly Clause 5 also clearly states that in case of products not of standard quality, if minor defects arising out of variations from the prescribed standards or contraventions of other provisions of Chapter 4 of the Act, administrative measures including suspension / cancellation or compounding of offences may be resorted to.
9. For the reasons recorded above, in view of this Court no fruitful purpose would be served by relegating the petitioners to go through the trial. This Court by exercising its powers deems it fit and hereby quashes and sets aside the compliant being Criminal Case No. 4547 of 2015 lodged by the respondent No. 2 before the Chief Judicial Magistrate Court, Viramgam for alleged offences under section 16(1)(a), 18(1)(i) r/w section 34 and punishable under section 27 of the Drugs and Cosmetics Act, 1940 Page 36 of 37 Downloaded on : Sun Dec 25 03:48:34 IST 2022 R/SCR.A/9866/2016 JUDGMENT DATED: 11/10/2022 and the order passed by the learned Chief Judicial Magistrate, Viramgam issuing summons to the petitioners. Hence, in view of above the petition is allowed and the rule is made absolute.
(VAIBHAVI D. NANAVATI,J) SHRIJIT PILLAI Page 37 of 37 Downloaded on : Sun Dec 25 03:48:34 IST 2022