Madhya Pradesh High Court
M/S Micro Labs Ltd. Unit Iiii vs Union Of India on 22 March, 2024
Author: Pranay Verma
Bench: Pranay Verma
1
IN THE HIGH COURT OF MADHYA PRADESH
AT I N D O R E
BEFORE
HON'BLE SHRI JUSTICE PRANAY VERMA
MISC. CRIMINAL CASE No. 47281 of 2022
BETWEEN:-
M/S MICRO LABS LTD. UNIT IIII THROUGH
AUTHORIZED REPRESENTATIVE SHRI
1.
ASHOK KUMAR R.S. NO. 63/3 AND 4
THIRUVANDARKOLI (PONDICHERRY)
MR. DILIP SURANA S/O G.C. SURANA, AGED
ABOUT 56 YEARS, OCCUPATION:
2.
MANAGING DIRECTOR 45/3, FAIR FIELD
LAYOUT, BANGLORE (KARNATAKA)
MR. ANAND SURANA S/O G.C. SURANA,
AGED ABOUT 51 YEARS, OCCUPATION:
3.
DIRECTOR 45/3, FAIR FIELD LAYOUT,
BANGLORE (KARNATAKA)
SMT. ARCHANA SURANA W/O MR. DLIP
SURANA, AGED ABOUT 56 YEARS,
4.
OCCUPATION: DIRECTOR 45/3, FAIR FIELD
LAYOUT, BANGLORE (KARNATAKA)
SMT. MONICA SURANA W/O MR. ANAND
SURANA, AGED ABOUT 49 YEARS,
5.
OCCUPATION: DIRECTOR 45/3, FAIR FIELD
LAYOUT BANGALORE (KARNATAKA)
.....PETITIONERS
(BY SHRI VEER KUMAR JAIN, LEARNED SENIOR ADVOCATE WITH MS.
VAISHALI JAIN - ADVOCATE)
AND
Signature Not Verified
Signed by: NEERAJ
SARVATE
Signing time: 22-03-2024
16:17:48
2
UNION OF INDIA, MINISTRY OF HEALTH AND
FAMILY WELFARE THROUGH SHRI BASANT
KUMAR YADAV DRUG INSPECTOR O/O THE
CENTRAL DRUG STANDARD CONTROL
ORGANIZATION (CDSCO), DIRECTOR
GENERAL OF HEALTH SERVICES MINISTRY
OF HEALTH AND FAMILY WELFARE GOVT. OF
INDIA OFFICE AT ORGANIZATIONASST. DRUG
CONTROLLER (INDIA) SUB ZONAL OFFICE 67-
72 TYPE 1 QUARTER GRIFFINS COLONY
PIPLIYAHANA M.Y. HOSPITAL MAIN ROAD
(MADHYA PRADESH)
.....RESPONDENT
(BY SHRI ASHUTOSH SHARMA - ADVOCATE)
.................................................................................................................
Reserved on : 15.02.2024
Pronounced on : 22.03.2024
................................................................................................................
This petition having been heard and reserved for orders, coming
on for pronouncement this day, the court passed the following:
ORDER
1. This petition under Section 482 of the Cr.P.C. has been preferred by the petitioners for quashing the complaint and proceedings in Special Case No.88/2020 under the Drugs and Cosmetics Act, 1940 pending before the VIth Additional District Judge, Indore.
2. The facts of the case are that the petitioner No.1 is a company namely M/s. Micro Labs Limited which is engaged in the activity of manufacture and sale of medicines. Petitioners 2 to 5 are the Directors of the said company. On 31.01.2017 drug sample of thyrotop 100 (thyroxcin sodium tablet ip" Batch No.TRHY 2023) was taken and confiscated by the Drug Inspector from the premises of pharmacy store, Signature Not Verified Signed by: NEERAJ SARVATE Signing time: 22-03-2024 16:17:48 3 R.R. CAT, near Rajendra Nagar Post, CAT 452013 under Section 23 of Drugs and Cosmetics Act, 1940. A portion of the sealed drug was sent on 03.02.2017 to the Government Analyst, Central Government Testing Laboratory, Mumbai with form No.18 pursuant to which on 12.07.2017 the drug sample was declared as not of standard quality. On 17.07.2017 notice under Section 18-A of the Act, 1940 was sent to Umesh Kumar Lokhande Pharmacist restraining him from disposing of the remaining quantity of drug and to disclose the name and address of the person from whom the drug was acquired. By letter dated 01.08.2017 he informed that the drug was supplied by M/s. New Mamta Medicos, Indore. On inquiry M/s. New Mamta Medicos disclosed on 17.08.2017 that the drug was procured from M/s. Aditya Pharma, Indore which in turn by its letter dated 07.09.2007 informed that the drug was procured from petitioner's Indore Office vide invoice dated 30.10.2015. The Indore Office informed that the drug was procured from M/s. Micro Labs Limited, Tamil Nadu. Thereafter by letter dated 24.10.2017 it was informed that the drug was manufactured by M/s. Micro Labs Limited, Pondicheri.
3. On 08.11.2017 a letter along with one copy of the Test Analysis Report of the Government Analyst, Central Government Testing Laboratory, Mumbai in form No.13 as per provisions of Section 25 (2) of the Act, 1940 and one portion of the sealed drug sample was sent to the petitioner at Pondicheri. By its letter dated 21.07.2017 the petitioner No.1 replied contending that the drug manufactured was released for sale after it was declared of standard quality. The petitioners did not agree with the result of the test or analysis as given in the test report of Signature Not Verified Signed by: NEERAJ SARVATE Signing time: 22-03-2024 16:17:48 4 the Government Analyst. They requested in the aforesaid letter to cause the sample to be analyzed at the appellate laboratory (Central Drug Laboratory, Calcutta) as per Section 25 (3) of the Act, 1940. However the same was not done as per the petitioner and the complaint was filed before the trial Court.
4. This petition has been preferred by the petitioners on the ground that there has been violation of the statutory provisions of Section 25(3) and 25(4) of the Act, 1940 in getting the samples tested from Central Drug Laboratory. The petitioners had specifically made a request for sending the sample to the appellate laboratory but the said letter was wholly ignored and no action thereupon was taken hence the petitioners cannot be charged for the alleged offences. The petitioners have been deprived of their statutory right of getting the drug sample examined by the appellate laboratory and the complaint has also been filed in violation of the time frame as provided for under Section 25(3) and 35 of the Act, 1940. The directors, petitioners 2 to 5 of the company petitioner No.1 could not be prosecuted. The proceedings hence deserve to be quashed. Reliance has been placed by the learned counsel for the petitioners on the decision of the Supreme Court in Medicamen Biotech Limited and Another V/s Rubina Bose, Drug Inspector (2008) 7 SCC 196, Laborate Pharmaceuticals India Limited and Others V/s. State of Tamil Nadu (2018) 15 SCC 93 and of this Court in M.Cr.C. No.26128/2017 decided on 07.01.2020 M/s. Glaxo India Limited V/s. State of Madhya Pradesh.
5. Per contra, learned counsel for the respondent has submitted that Signature Not Verified Signed by: NEERAJ SARVATE Signing time: 22-03-2024 16:17:48 5 the petitioners 2 to 5 are equally responsible for the business of the company. There has not been any violation of the statutory provisions of the Act, 1940. All the grounds as have been raised by the petitioners in this petition can very well be raised by them before the trial Court itself but they have approached this Court in exercise of power under Section 482 of the Cr.P.C. immediately upon receiving the summons from the trial Court hence the petition itself is not maintainable. The petitioners 2 to 5 are the Directors of the company and were privy to the manufacturing of medicine by the company. The allegations against them of preparing sub standard medicines are serious in nature hence they cannot be absolved of their criminal liability under the provisions of the Act, 1940. It is hence submitted that the petition deserves to be dismissed. Reliance has been placed on the decision of the Apex Court in Dinesh B. Patel and Others V/s. State of Gujrat and Others (2010) 10 S.C.R. 319, Glaxo Smithkline Pharmaceuticals Ltd. and Another V/s. State of M.P. (2011) 9 S.C.R. 606, Dueful Laboratory and Another V/s. State of Rajasthan and Others 1998 CRILJ 4534 and Vikas Rambal and Others V/s. The State represented by Drug Inspector (Crl. O.P. No.11184 of 2019 and Crl. M.P. No.5726 of 2019).
6. I have considered the submissions of the learned counsel for the parties and have perused the record.
7. It would also be relevant to refer to the relevant provisions of the Act, 1940 which are as under :-
"25. Reports of Government Analysts.--(1) The Government Analyst to whom a sample of any drug 1[or cosmetic] has been Signature Not Verified Signed by: NEERAJ SARVATE Signing time: 22-03-2024 16:17:48 6 submitted for test or analysis under sub-section (4) of section 23, shall deliver to the Inspector submitting it a signed report in triplicate in the prescribed form.
(2) The Inspector on receipt thereof shall deliver one copy of the report to the person from whom the sample was taken 4[and another copy to the person, if any, whose name, address and other particulars have been disclosed under section 18A], and shall retain the third copy for use in any prosecution in respect of the sample. (3) Any document purporting to be a report signed by a Government Analyst under this Chapter shall be evidence of the facts stated therein, and such evidence shall be conclusive unless the person from whom the sample was taken 5[or the person whose name, address and other particulars have been disclosed under section 18A] has, within twenty-eight days of the receipt of a copy of the report, notified in writing the Inspector or the Court before which any proceedings in respect of the sample are pending that he intends to adduce evidence in controversion of the report. (4) Unless the sample has already been tested or analysed in the Central Drugs Laboratory, where a person has under sub-
section (3) notified his intention of adducing evidence in controversion of a Government Analyst's report, the Court may, of its own motion or in its discretion at the request either of the complainant or the accused cause the sample of the drug 1[or cosmetic] produced before the Magistrate under sub-section (4) of section 23 to be sent for test or analysis to the said Laboratory, which shall make the test or analysis and report in writing signed by or under the authority of, the Director of the Central Drugs Laboratory the result thereof, and such report shall be conclusive evidence of the facts stated therein.
(5) The cost of a test or analysis made by the Central Drugs Laboratory under sub-section (4) shall be paid by the complainant or accused as the Court shall direct."
8. In Medicaman Biotech Limited and Another (supra) it has been held by the Apex Court that if right under Section 25(3) and 25(4) is lost due to delay in filing the complaint, the complaint should be quashed. It has been held as under :-
"19. In the affidavit filed to the petition by Dr. D. Rao, Deputy Drugs Controller, and in arguments before us, it has been repeatedly stressed that the delay in sending of the sample to the Central Drugs Laboratory had occurred as the appellant had avoided service of summons on it till 9-5-2005. This is begging the question. We find that there is no explanation as Signature Not Verified Signed by: NEERAJ SARVATE Signing time: 22-03-2024 16:17:48 7 to why the complaint itself had been filed about a month before the expiry of the shelf life of the drug and concededly the filing of the complaint had nothing to do with the appearance of the accused in response to the notices which were to be issued by the Court after the complaint had been filed. Likewise, we observe that the requests for retesting of the drug had been made by the appellant in August/September 2001 as would be clear from the facts already given above and there is absolutely no reason as to why the complaint could not have been filed earlier and the fourth sample sent for retesting well within time. We are, therefore, of the opinion that the facts of the case suggest that the appellants have been deprived of a valuable right under Sections 25(3) and 25(4) of the Act which must necessitate the quashing of the proceedings against them."
9. Further in Laborate Pharmaceuticals Limited (supra) it has been held that in the matter of retesting of samples if the liability of causing delay is on the authorities and not the medicine company criminal proceedings against medical company has to be quashed. It has been held as under :-
"6. A reading of the provisions of Sections 23(4) and 25 of the Act would indicate that in the present case the sample having been taken from the premises of the retailer had to be divided into four portions; one portion is required to be given to the retailer; one portion is required to be sent to the Government Analyst and one to the court and the last one to the manufacturer whose name, particulars, etc. is disclosed under Section 18-A of the Act. In the present case, admittedly, one part of the sample that was required to be sent to the appellant (manufacturer) under Section 23(4)(iii) of the Act was not sent. Instead, what was sent on 22-3-2012 was only the report of the Government Analyst. When the part of the sample was not sent to the manufacturer, the manufacturer could not have got the same analysed even if he wanted to do so and, therefore, it was not in a position to contest the findings of the Government Analyst. In the present case, the sample was sent to the appellant manufacturer on 10-8-2012 and on 13-9-2012 the appellant had indicated its desire to have another part of the sample sent to the Central Laboratory for reanalysis. This was refused on the ground that the aforesaid request was made much after the stipulated Signature Not Verified Signed by: NEERAJ SARVATE Signing time: 22-03-2024 16:17:48 8 period of 28 days provided for in Section 25(3) of the Act.
7. The cognizance of the offence(s) alleged in the present case was taken on 4-3-2015 though it appears that the complaint itself was filed on 28-11-2012. According to the appellant the cough syrup had lost shelf life in the month of November 2012 itself. Even otherwise, it is reasonably certain that on the date when cognizance was taken, the shelf life of the drug in question had expired. The Magistrate, therefore, could not have sent the sample for reanalysis by the Central Laboratory.
8. All the aforesaid facts would go to show that the valuable right of the appellant to have the sample analysed in the Central Laboratory has been denied by a series of defaults committed by the prosecution; firstly, in not sending to the appellant manufacturer part of the sample as required under Section 23(4)(iii) of the Act; and secondly, on the part of the Court in taking cognizance of the complaint on 4-3-2015 though the same was filed on 28-11-2012. The delay on both counts is not attributable to the appellants and, therefore, the consequences thereof cannot work adversely to the interest of the appellants. As the valuable right of the accused for reanalysis vested under the Act appears to have been violated and having regard to the possible shelf life of the drug we are of the view that as on date the prosecution, if allowed to continue, would be a lame prosecution.
9. Consequently and for the reasons alluded we are of the view that the present would be a fit case to interdict the criminal trial against the appellant-accused. We order accordingly. Therefore, CC No. 263 of 2015 pending on the file of the XVth Metropolitan Magistrate, George Town, Chennai is hereby quashed. The appeal is allowed and the order of the High Court is set aside."
10. This Court in M/s. Glaxo India Limited (supra) was dealing with a precise issue as has been raised by the petitioners in this petition as regards the applicability of the provisions of Section 25(3) and 25(4) of the Act, 1940 and in that regard it was held that when valuable right of the medicine company is defeated, continuation of the prosecution would be a futile exercise. It has been held as under :-
"[8] The Supreme Court in the matter of State of HaryanaVs. Unique Farmaid P. Ltd (1999) 8 SCC 190 in a case where the Signature Not Verified Signed by: NEERAJ SARVATE Signing time: 22-03-2024 16:17:48 9 accused within the prescribed time had notified to the Inspector of the accused's intention to adduce evidence in controversion of the report, and requesting him to get the sample analysed from the CIL, but the Inspector had not taken action and filed the complaint, but by the time the accused was summoned by the trial court, the sample had expired rendering the sending of the sample to the CIL at that stage purposeless, has held that the accused was deprived of the right to get the sample tested by the CIL and was thereby prejudiced in his defence. In the said judgment the Hon.Supreme Court has upheld the order of the High Court quashing the complaint on the ground that continuance of the prosecution would amount to abuse of process of the Court by observing that:-
"11- Sub-section (1) of Section 30 which appears to be relevant only prescribes in effect that ignorance would be of no defence but that does not mean that if there are contraventions of other mandatory provisions of the Act, the accused have no remedy. Procedure for testing the sample is prescribed and if it is contravened to the prejudice of the accused, he certainly has right to seek dismissal of the complaint. There cannot be two opinions about that. Then in order to safeguard the right of the accused to have the sample tested from Central Insecticides Laboratory, it is incumbent on the prosecution to file the complaint expeditiously so that the right of the accused is not lost. In the present case, by the time the respondents were asked to appear before the Court, expiry date of the insecticide was already over and sending of sample to the Central Insecticides Laboratory at that late stage would be of no consequence. This issue is no longer res integra. In The State of Punjab v. National Organic Chemical Industries Ltd., JT (1996) 10 SC 480 this Court in somewhat similar circumstances said that the procedure laid down under Section 24 of the Act deprived the accused to have sample tested by the Central Insecticides Laboratory and adduce evidence of the report so given in his defence. This Court stressed the need to lodge the complaint with utmost dispatch so that the accused may opt to avail the statutory defence. The Court held that the accused had been deprived of a valuable right statutorily available to him. On this view of the matter, the court did not allow the criminal complaint to proceed against the accused. We have cases under the Drugs and Cosmetics Act, 1940 and the Prevention of Food Adulteration Act, 1954 involving the same question. In this connection reference be made to decisions of this Court in State of Haryana v. Brij Lal Mittal & Ors., [1998] 5 SCC 343 under the Drugs and Cosmetics Act, 1940; Municipal Corporation of Signature Not Verified Signed by: NEERAJ SARVATE Signing time: 22-03-2024 16:17:48 10 Delhi v. Ghisa Ram, AIR (1967) SC 970; Chetumal v. State of Madhya Pradesh & Anr., [1981] 3 SCC 72 and Calcutta Municipal Corporation v. Pawan Kumar Saraf & Anr., [1999] 2 SCC 400 all under the Prevention of Food Adulteration Act, 1954."
[9] In the matter of Medicamen Biotech Limited and another Vs. Rubina Bose, Drug Inspector (2008) 7 SCC 196 where the complaint was filed one month before the expiry of shelf life of the sample and the Magistrate could not get the sample tested in time, Apex Court has held that the right of the accused u/S.25(3) and 25(4) of the Act is lost due to delay in filing the complaint, therefore, the complaint is liable to be quashed u/S.482 of the Cr.P.C.
[10] In the matter of Northern Mineral Limited Vs. Union of India and another (2010) 7 SCC 726 when the similar issue came up in reference to the similar provision contained in the Insecticides Act, 1968 and before expiry of the shelf life of the sample no steps was possible to be taken for its test and analysis by the CIL, Hon'ble Supreme Court has taken a view that the valuable right of the accused for his defence was defeated, therefore, the continuance of the criminal prosecution against the accused is futile and abuse of process of the court.
[11] Similarly in the matter of Gupta Chemicals Private Ltd. and others Vs. State of Rajasthan and another (2010) 7 SCC 735 where the valuable right u/S.24 of the Insecticides Act, 1968 to get the sample of insecticides examined in Central Insecticides Laboratory was denied due to inaction and delay by the insecticides inspector and meanwhile the shelf life of substance had expired and the same had become untestable, it was held that the criminal proceedings were liable to be quashed.
[12] The present case stands on the same footing. In the present case also the complaint has been filed on 22nd April, 1997 whereas the expiry of the sample was done by the petitioner within the statutory period, but the sample was not sent to the CDL within time as a result of which the sample had expired and the valuable right of the petitioner u/S.25(3) and 25(4) of the Act was defeated. Hence, at this stage continuation of the prosecution will be a futile exercise."
Signature Not Verified Signed by: NEERAJ SARVATE Signing time: 22-03-2024 16:17:48 1111. In the present case upon receiving the letter dated 08.11.2017 from the Drug Inspector, the petitioners through their letter dated 21.11.2017 challenged the report of the Government Analyst and requested that the sample be analyzed at the appellate laboratory (Central Drugs Laboratory, Calcutta) with intention of adducing evidence in contravention of the test report. The same was however not done. The request of the petitioners was not accepted and in fact no communication was made to the petitioners in response to the request and the complaint was filed. There hence has been deprivation of the statutory rights of the petitioners. By the time the petitioners were summoned by the trial Court, the sample had expired. The samples were taken on 31.01.2017 and the complaint itself was filed on 07.11.2019 i.e. after a period of 34 months from the date of taking of the initial samples. It is not in dispute that the shelf life of the drug had already expired by them. The petitioners never got any opportunity to get the drug tested during its shelf life.
13. Thus, it is apparent that the valuable rights of the petitioners to get the sample examined by the Central Laboratory has been denied to them. The sample was not sent to the Central Laboratory within time, as a result of which the sample had expired. Thus continuation of the prosecution against the petitioners would be a futile exercise as has been held in the aforesaid decisions. Since they are of the Apex Court and this Court it is not necessary for this Court to dwell upon the judgments of the Madras as well as the Rajasthan High Court relied upon by the learned counsel for the respondent. Further more it is not necessary to advert to the other grounds as raised by the petitioners in Signature Not Verified Signed by: NEERAJ SARVATE Signing time: 22-03-2024 16:17:48 12 the petition for quashment of the proceedings.
14. As a result the petition deserves to be and is accordingly allowed and prosecution of the petitioners in Special Complaint Case No.88/2020 pending before VIth Additional District Judge, Indore Union of India V/s. Micro Labs Limited and Others is quashed. The petition is allowed.
(PRANAY VERMA) JUDGE ns Signature Not Verified Signed by: NEERAJ SARVATE Signing time: 22-03-2024 16:17:48