Himachal Pradesh High Court
Vijay Kaushal vs Of on 22 December, 2023
Author: Sushil Kukreja
Bench: Sushil Kukreja
1 IN THE HIGH COURT OF HIMACHAL PRADESH, SHIMLA .
Cr.MP (M) No.601 of 2023 Reserved on: 20.11.2023 Decided on : 22.12.2023 Vijay Kaushal ....Petitioner Versus of State of Himachal Pradesh ....Respondent Coram rt The Hon'ble Mr. Justice Sushil Kukreja, Judge Whether approved for reporting?1 _______________________________________________________ For the petitioner: Mr. Ajay Kochhar, Senior Advocate with Mr. Vivek Sharma & Mr.Bhairav Gupta, Advocates.
For the respondent: Mr. Jitender Kumar Sharma, Additional Advocate General.
________________________________________________ Sushil Kukreja, Judge The instant bail application has been filed by the petitioner under Section 439 of the Code of Criminal Procedure for releasing him on bail in a complaint case under Section 18(a)(i) read with Sections 17 & 17B, 18(a) (vi), 18(c), 22(3) and 36AD of the Drugs and Cosmetics Act, 1940 (hereinafter referred to as 'DAC Act').
1. Whether reporters of Local Papers may be allowed to see the judgment?
::: Downloaded on - 22/12/2023 20:33:45 :::CIS 22. The brief facts of the case, as per the reply/status .
report filed by the respondent-State, are that on 22.11.2022, a huge stock of spurious medicines was recovered by the Drugs Inspector from one Mohit Bansal during the course of search of vehicle bearing registration No.UP80FC-7530 (Creta Car), at of Baddi Police Barrier, the detail of which is given as under:-
Sr. Product Quantity/ Value in
rt Manufacturer name, as per the
No name tablets rupees label claim.
1. Zerodol 190100 39,73,090/- M/s IPCA Laboratories Ltd.
TH4 tablets Melli Jorethang Road Gom
Block Bharikhola, South District
Sikkim-737121.
2. Roseday 10 28950 3,65,638/- M/s USV Private Ltd. Khasra
tablets tablets No. 1342/1/2 Hill Top Industrial
Area Jharmajri, Baddi, Solan,
H.P.
3. Montair 10 50720 10,76,684/- Cipla Ltd. Unit II Taza Block
tablets Sikkim 737133 India.
3. Said Mohit Bansal could not produce any licence/ authorization for the aforesaid spurious medicines and thereafter on the same very day, during the course of search of his godown, the following spurious medicines were also recovered:-
Sr. Product Quantity/ Value in Manufacturer name, as No. name tablets rupees per the label claim.
1. Montair 10 295800 62,79,245/- Cipla Ltd. Sikkim.
tablets
2. Atorva 10 31650 2,15,874/- M/s Zydus Healthcare ::: Downloaded on - 22/12/2023 20:33:45 :::CIS 3 tablets tablets Sikkim.
.
3. Roseday-10 97420 12,30,414/- M/s USV Limited Baddi.
tablets tablets
4. Zerodol TH4 71080 14,85,572/- M/s IPCA Laboratories
tablets Limited, Sikkim.
4. Besides the above-mentioned recovered spurious of medicines, a huge stock of loose tablets of Calcium, Torsemide and active raw materials as Amplodipine alongwith excepients rt PvPK 30, plain & printed foils and packaging material used for manufacturing of spurious drugs, was also recovered from the said godown and all the drugs and material recovered were seized and thereafter three persons, namely, Mohit Bansal, Atul Gupta and Vijay Kaushal (petitioner herein) were arrested on 22.11.2022. During interrogation, the petitioner disclosed that he had done the foiling/primary packing i.e. labeling of the compressed tables at M/s Trizal Formulations in association with other accused persons and thereafter, during search of manufacturing unit on 24.11.2022, a huge quantity of allopathic spurious drugs (loose tablets), raw materials (API and excepients, rubber stereos, scrap of foils and processed material and the machineries and change parts used in the ::: Downloaded on - 22/12/2023 20:33:45 :::CIS 4 manufacturing and packaging of spurious drugs were also .
recovered and since the heavy machines, change parts and equipments were used for manufacturing of spurious drugs, as such, the premises of M/s Trizal Formulations, Baddi, Solan was sealed. On 25.11.2022, the team of Drugs Inspector alongwith of the police officials visited the shop of accused Mohit Bansal and during the search, huge stock of allopathic medicines was rt recovered and the said stock of spurious drugs was manufactured at M/s Trizal Formulations, which was seized by local Drugs Inspector of Agra from the wholesale premises of Mohit Bansal. On 27.11.2022, a huge stock of loose tablets, packaging material, used rubber stereos, active raw material alongwith die and punches was also recovered from the residence of accused persons Mohit Bansal and Atul Gupta and on the same day, accused Naresh Kumar, an employee of M/s USV Limited Baddi, was also arrested for doing the work of manufacturing/coating of spurious medicines in association with other accused persons at M/s Trizal Formulations.
5. During the course of further investigation on 01.12.2022, Mohammad Qaiser Imam and Naresh Kumar, ::: Downloaded on - 22/12/2023 20:33:45 :::CIS 5 Asst. Manager Zydus Lifesciences Ltd. Ahmedabad submitted .
that products and foils of their firm which were recovered from the accused person did not belong to M/s Zydus Lifesciences and thereafter a huge stock of following spurious drugs was also recovered:-
of Sr. Product Quantity/ Value in Manufacturer name, as No. name tablets rupees per the label claim.
1. Glimisave 66000 rt 806652/- M/s Eris Lifesciences M2 tables tablets Limited, Amingaon North Guwahati Kamrup Assam
2. Roseday 10 43950 555088/- M/s USV Private Limited tablets tablets Plot No.6 & 7E HPSIDC, Indl. Area Baddi, Solan H.P.
3. MONTAIR 67350 1429705/- M/s Cipla Ltd., Unit II Taza tables tablets Block Rorathang Sikkim.
6. It was alleged that the petitioner alongwith other accused persons manufactured the aforesaid spurious tablets and transported the same to Agra through M/s TCI Express (Courier service) to his own godown at Agra and thereafter these medicines were recalled and seized on 04.12.2022 and on 23.12.2022, detailed comparative reply between the spurious drugs recovered from accused Mohit Bansal and genuine product of same batch of M/s Sydus Healthcare Limited Uit II, Sikkim was received from M/s Zydus Healthcare Limited and it ::: Downloaded on - 22/12/2023 20:33:45 :::CIS 6 was confirmed that the Atorva 10 tablets B. no.I202140 and foils .
of Atorva 20 tablets recovered from accused Mohit Bansal and other accused persons were spurious in nature. In the reply received from M/s Eris Lifesciences Limited on 16.01.2023, it was confirmed that the drugs of M/s Eris Lifesciences recovered of from accused Mohit Bansal and other accused persons were spurious in nature. The test and analysis reports of all samples rt were received from Regional Drugs Testing Laboratory (RDTL), Chandigarh, wherein it was found that the samples were not of standard quality and also being spurious in nature. During the course of investigation, the statements of the helpers working at M/s Trizal Formulations, namely Shivam Thakur and Naval Kumar were recorded under Section 164, Cr.P.C, whereby it was confirmed that petitioner Vijay Kaushal was doing the manufacturing/packaging i.e. labeling of spurious drugs alongwith other accused persons.
7. Learned Senior Counsel for the petitioner contended that the petitioner is innocent and he has been falsely implicated in this case. He further contended that the petitioner was only working as a labourer and was doing the work of packaging the ::: Downloaded on - 22/12/2023 20:33:45 :::CIS 7 drugs and he was neither a qualified person in the field of .
manufacturing or dealing with the drugs, nor he was having any knowledge about the drugs being spurious and he was assigned the work of operating machine used for packaging the medicine.
He also contended that the investigation of the case is almost of complete and nothing remains to be recovered from the petitioner, hence, it is prayed that the petitioner be enlarged on rt bail.
8. Per contra, the learned Additional Advocate General opposed the bail application on the ground that the petitioner does not deserve to be released on bail as he has been found involved in a serious offence of the manufacture of the drugs which are found spurious. It is also contended that the aforesaid spurious drugs are consumed by the patients which could cause serious results and the minimum sentence provided for manufacturing/ selling and dealing with the spurious drugs is ten years, which may extend to life imprisonment, as such, the petitioner is not entitled to be released on bail.
9. I have heard the learned Senior Counsel for the petitioner as well as the learned Additional Advocate General for ::: Downloaded on - 22/12/2023 20:33:45 :::CIS 8 the State and also gone through the records carefully. For the .
disposal of this application for grant of bail, Section 36-AC of DAC Act is relevant, which may be quoted as below:-
"36 AC. Offences to be cognizable and non-bailable in certain cases.
(1) Notwithstanding anything contained in the Code of of Criminal Procedure, 1973 (2 of 1974),-
(a) every offence, relating to adulterated or spurious drug and punishable under clauses (a) and (c) of sub-section (1) of rt section 13, clause (a) of sub-section (2) of section 13, sub-
section (3) of section 22, clauses (a) and (c) of section 27, section 28, section 28A, section 28B and sub-sections (1) and (2) of section 30 and other offences relating to adulterated drugs or spurious drugs, shall be cognizable.
(b) no person accused, of an offence punishable under clauses (a) and (c) of sub-section (1) of section 13, clause (a) of sub-section (2) of section 13, sub-section (3) of section 22, clauses (a) and (c) of section 27, section 28, section 28A, section 28B and sub-sections (1) and (2) of section 30 and other offences relating to adulterated drugs or spurious drugs, shall be released on bail or on his own bond unless
(i) the Public Prosecutor has been given an opportunity to oppose the application for such release; and
(ii) where the Public Prosecutor opposes the application, the Court is satisfied that there are reasonable grounds for believing that he is not guilty of such offence and that he is not likely to commit any offence while on bail:
::: Downloaded on - 22/12/2023 20:33:45 :::CIS 9Provided that a person, who, is under the age of sixteen years, or is a woman or is sick or infirm, may be released on .
bail, if the Special Court so directs. (2) The limitation on granting of bail specified in clause (b) of sub-section (1) is in addition to the limitations under the Code of Criminal Procedure, 1973 (2 of 1974) or any other law for the time being in force on granting of bail.
of (3) Nothing contained in this section shall be deemed to affect the special powers of the High Court regarding bail under section 439 of the Code of Criminal Procedure, 1973 (2 rt of 1974) and the High Court may exercise such powers including the power under clause (b) of sub-section (1) of that section as if the reference to "Magistrate" in that section includes also a reference to a "Special Court" designated under section 36AB."
10. This Section provides that notwithstanding anything contained in the Code of Criminal Procedure, every offence as mentioned in the provision shall be cognizable and no person accused of such offence shall be released on bail unless the Public Prosecutor has been given opportunity to oppose the application for such release and where Public Prosecutor opposes the application, the Court is satisfied that there are reasonable grounds for believing that the accused is not guilty of such offence and he is not likely to commit any offence while on bail.
::: Downloaded on - 22/12/2023 20:33:45 :::CIS 1011. Section 27 of the DAC Act provides that the persons .
found guilty for the manufacture, sale etc. of the adulterated and spurious drugs shall be liable to be punished with imprisonment for a term which shall not be less than ten years and which may extend to a term of life with fine which shall not be less than of rupees ten lakh or three times value of the drugs confiscated, whichever is more. It reads as under:-
rt "27. Penalty for manufacture, sale, etc., of drugs in contravention of this Chapter.- Whoever, himself or by any other person on his behalf, manufacturers for sale or for distribution, or sells, or stocks or exhibits or offers for sale or distributes.
(a) any drug deemed to be adulterated under Section 17A or spurious under Section 17B or which when used by any person for or in the diagnosis, treatment, mitigation, or prevention of any disease or disorder is likely to cause his death or is likely to cause such harm on his body as would amount to grievous hurt within the meaning of S. 320 of the Indian Penal Code, solely on account of such drug being adulterated or spurious or not of standard quality, as the case may be, shall be punishable with imprisonment for a term which shall not be less than five years but which may extend to imprisonment for life and shall also be liable to fine which shall not be less than ten lakh rupees or three times value of the drugs confiscated, whichever is more."
(b) xxx xxx
(c) xxx xxx
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11
(d) xxx xxx."
.
12. Section 3 (f) of the DAC Act defines the terms 'manufacture', which reads as under:-
"(f) "manufacture" in relation to any drug [or cosmetic] includes any process or part of a process for making, of altering, ornamenting, finishing, packing, labelling, breaking up or otherwise treating or adopting any drug [or cosmetic] with a view to its [sale or distribution] but does not include the compounding or dispensing [of any drug, or the packing rt of any drug or cosmetic,] in the ordinary course of retail business; and "to manufacture" shall be construed accordingly."
13. Part IB of Schedule M of the Drugs Rules, 1945 provides for the Specific requirements for manufacture of oral solid dosage forms (Tablets and Capsules). It reads as under:-
"SPECIFIC REQUIREMENTS FOR MANUFACTURE OF ORAL SOLID DOSAGE FORMS (TABLETS AND CAPSULES) Note. - The General Requirements as given in Part 1 of this Schedule relating to requirements of Good Manufacturing Practices for Premises and Materials for pharmaceutical products shall be complied with, mutatis mutandis, for the manufacture of Oral Solid Dosage Forms (Tablets and Capsules). In addition to these requirements, the following Specific Requirement shall also be followed, namely:-
1. GENERAL ............ ........... ..........
::: Downloaded on - 22/12/2023 20:33:45 :::CIS 12 2 SIFTING, MIXING AND GRANULATION ........... .......... ........ . 3. COMPRESSION (TABLETS) ......... ........... ........ 4. COATING (TABLETS) ........... .......... ....... 5. FILLING OF HARD GELATIN CAPSULE ......... ........... .............. 6.PRINTING (TABLES AND CAPSULES) ......... .......... ........... 7. PACKAGING (STRIP AND BLISTER) of
7.1 Care shall be taken when using automatic tablet and capsule counting, strip and blister packaging equipment to ensure that all 'rogue' tablets capsules or foils from packaging operation are removed before a new packaging rt operation is commenced. There shall be an independent recorded check of the equipment before a new batch of tablets or capsules is handled.
7.2 Uncoated tablets shall be packed on equipment designed to minimise the risk of cross-contamination. Such packaging shall be carried out in an isolated area when potent tablets or Beta-lactum containing tablets are being packed.
7.3 The strips coming out of the machine shall be inspected for defects such as misprint, cuts on the foil, missing tablets and improper sealing.
7.4 Integrity of individual packaging strips and blisters shall be subjected to vacuum test periodically to ensure leak proofness of each pocket strip and blister and records maintained."
14. Thus, Part IB of Schedule M of the Drugs Rules, 1945 provided under the DAC Act, provides for the specific requirements to be followed in the manufacture of oral solid dosage forms (Tablets and Capsules) and as per the same, packaging of the medicines is also one of the specific requirements to be followed in the manufacture of the drugs ::: Downloaded on - 22/12/2023 20:33:45 :::CIS 13 besides sifting, mixing and granulation, compression (tablets), .
coating, filling of hard gelatin capsule, printing (tablets and capsules).
15. To re-call the facts of the instant case, as per the investigation, petitioner Vijay Kaushal was involved in manufacturing of spurious drugs in connivance with Mohit of Bansal of M/s USV P Ltd at M/s Trizal Formulations and it was found that he was an employee of the firm and he was doing the rt manufacturing/packing i.e. labeling of spurious drugs alongwith other accused persons. During investigation, it has also been prima facie revealed that the petitioner was in contact with accused Mohit Bansal through Whatsapp and he also shared photographs of stereo impression of batch number of spurious drugs through Whatsapp with accused Mohit Bansal on 14.11.2022. During the course of investigation, statements of Shivam Thakur and Naval Kumar were recorded under Section 164, Cr.P.C, in which they revealed that the petitioner was doing the manufacturing/ packaging i.e. labeling of spurious drugs alongwith other accused persons. The test and analysis reports of all samples were received on Form 13 from the government analyst RDTL, Chandigarh and it was found that samples coded ::: Downloaded on - 22/12/2023 20:33:45 :::CIS 14 as Mohit/01, Mohit/02, Mohit/12, Mohit/23 and Mohit/25 were .
not of Standard Quality in the quality parameters also besides being spurious in nature.
16. Section 17B of the DAC Act defines the spurious drugs. It provides that a drug shall be deemed to be spurious if it of is manufactured under the name which belongs to another drug, or if it is an imitation, or is a substitute for another drug, or if the rt label or the container bears the name of an individual or the company purporting to be the manufacturer of the drug, which individual or the company is fictitious or does not exist; or if it has been substituted wholly or in part by another drug or substance; or if it purports to be the product of a manufacturer of whom it is not truly a product. Section 17B of the DAC Act reads as under:-
"17B. Spurious drugs.- For the purposes of this Chapter, a drug shall be deemed to be spurious.-
(a) if it is manufactured under a name which belongs to another drug; or
(b) if it is an imitation of, or is a substitute for, another drug or resembles another drug in a manner likely to deceive or bears upon it or upon its label or container the name of another drug unless it is plainly and conspicuously marked so as to reveal ::: Downloaded on - 22/12/2023 20:33:45 :::CIS 15 its true character and its lack of identity with such other drug; or .
(c) if the label or container bears the name of an individual or company purporting to be the manufacturer of the drug, which individual or company is fictitious or does not exist; or
(d) if it has been substituted wholly or in part by another drug or substance; or of
(e) if it purports to be the product of a manufacturer of whom it is not truly a product."
17. The definition of the 'spurious drugs' provided under rt the DAC Act is very wide. In view of the above definition for the drug to be spurious, it is not necessary that it should be first subjected to any Chemical examination. It would be deemed to be a spurious drug if any of the above clauses are satisfied. In this case, as per the investigation, M/s Cipla Ltd. also disclosed that drugs manufactured by Mohit Bansal and other accused persons labeled to be manufactured by M/s Cipla Ltd., are spurious in nature.
18. It was also revealed during investigation that the spurious medicines were manufactured by the petitioner in connivance with other accused persons and transported to Agra through M/s TCI Express (Courier service) to a godown at Agra UP, which medicines were recalled and seized.
::: Downloaded on - 22/12/2023 20:33:45 :::CIS 1619. The contention of learned Senior Counsel for the .
petitioner that the petitioner was only working as a labourer and was doing the work of operating machine used for packaging the medicine without knowing and realizing as to what were the contents of medicines, deserves to be rejected as according to of Part IB of Schedule M of the Drugs Rules, 1945, packaging of the medicines is also one of the specific requirements to be rt followed in the manufacture of oral solid dosage forms (Tablets and Capsules).
20. As per Section 36 AC of the DAC Act, apart from giving an opportunity to the Public Prosecutor to oppose the application for release on bail, the other twin conditions (i) the satisfaction of the Court that there are reasonable grounds for believing that the accused is not guilty of the alleged offence; (ii) that he is not likely to commit any offence while on bail, have to be satisfied. The conditions are cumulative and not alternative.
The satisfaction contemplated regarding the accused being not guilty has to be based on reasonable grounds. The expression "reasonable grounds" has not been defined in the Act but means something more than prima facie grounds. In the present ::: Downloaded on - 22/12/2023 20:33:45 :::CIS 17 case, the petitioner has failed to satisfy the conditions for grant .
of bail, as provided under Section 36 AC of the DAC Act. From the investigation, prima facie, it is evident that the petitioner was knowingly involved in the manufacture and transportation of spurious drugs in connivance with other accused, knowing of pretty well that the drugs were spurious and he has thus jeopardized the life of the innocent persons and therefore, the rt case would fall under the category of "heinous crime" affecting the life of innocent citizens. Merely because he is in custody since 22.11.2022, is no ground to override the mandatory provisions of the aforesaid Section of the DAC Act. Moreover, the petitioner is resident of District Indore, MP and if released on bail, he may flee from justice and it will be difficult to secure his presence during trial. It is needless to mention that the offences under the DAC Act are grave and serious in nature. Therefore, looking into the nature and gravity of offence and severity of punishment, in my considered view, the petitioner does not deserve to be released on bail.
::: Downloaded on - 22/12/2023 20:33:45 :::CIS 1821. In view of the above discussion, the present bail .
application is dismissed. Pending miscellaneous application(s), if any, also stands disposed of.
22. Be it stated that any expression of opinion given in this order does not mean an expression of opinion on the merits of of the case and the trial Court will not be influenced by any observations made therein.
rt
( Sushil Kukreja )
December 22, 2023 Judge
(VH)
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