Himachal Pradesh High Court
Naresh Kumar vs State Of Himachal Pradesh on 28 April, 2023
Author: Sushil Kukreja
Bench: Sushil Kukreja
1 IN THE HIGH COURT OF HIMACHAL PRADESH, SHIMLA .
Cr.MP (M) No.401 of 2023 Reserved on: 28.03.2023 Decided on : 28.04.2023 Naresh Kumar ....Petitioner Versus State of Himachal Pradesh ....Respondent Coram The Hon'ble Mr. Justice Sushil Kukreja, Judge Whether approved for reporting?1 For the petitioner: Mr. N.K. Thakur, Senior Advocate with Mr. Divya Raj Singh, Advocate.
For the respondent:Mr. B.N. Sharma and Mr. Raj Kumar Negi, Additional Advocates General with Ms. Leena Guleria, Deputy 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
1. Whether reporters of Local Papers may be allowed to see the judgment?
::: Downloaded on - 01/05/2023 20:41:07 :::CIS 236AD of the Drugs and Cosmetics Act, 1940 (hereinafter .
referred to as 'DAC Act').
2. 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 Drug Inspector from Mohit Bansal during the course of search of vehicle bearing registration No.UP80FC-7530 (Creta Car), at Baddi Police Barrier, the detail of which is given as under:-
Sr. Product Quantity/ Value in 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 - 737 121.
2. Roseday 28950 3,65,638/- M/s USV Private Ltd. Khasra
10 tablets No. 1342/1/2 Hill Top Industrial
tablets Area Jharmajri, Baddi, Solan,
H.P.
3. Montair 50720 10,76,684/- Cipla Ltd. Unit II Taza Block
10 tablets Sikkim 737133 India.
3. For the aforesaid spurious medicines, said Mohit Bansal could not produce any licence or authorization and subsequently, 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 ::: Downloaded on - 01/05/2023 20:41:07 :::CIS 3
2. Atorva 10 31650 2,15,874/- M/s Zydus Healthcare 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 recovered spurious medicines, a huge stock of loose tablets of Calcium, Torsemide and active raw materials as Amplodipine alongwith excepients PvPK 30, plain & printed foils and packaging material used for manufacturing of spurious drugs, was also recovered and all the drugs and material recovered were seized and thereafter three persons, namely, Mohit Bansal, Vijay Kaushal and Atul Gupta were arrested on 22.11.2022. During interrogation, accused Mohit Bansal disclosed that Naresh Kumar (petitioner herein), an employee of M/s USV Limited Baddi, was doing the work of coating of spurious medicines and as per the allegations against the petitioner, he was found to be involved in coating the drugs in Lab of M/s Trizal Formulations Baddi, Solan, H.P and in sequel to the aforesaid recoveries and the involvement of the petitioner in the alleged offence, the instant case was registered against him and he was arrested on 27.11.2022.
::: Downloaded on - 01/05/2023 20:41:07 :::CIS 45. During the course of further investigation on .
01.12.2022, a huge stock of following spurious drugs was also recovered:-
Sr. Product Quantity/ Value in Manufacturer name, as No. name tablets rupees per the label claim.
1. Glimisave 66000 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 further allegation against the petitioner was that he also manufactured the spurious tables of same drug, brand and company at M/s Trizal Formulations, Plot No.29 DIC Baddi, Solan, H.P. in connivance with other accused persons, which he used to manufacture at M/s USV P Ltd. Baddi, Solan, H.P. The test and analysis reports of all samples were received from ::: Downloaded on - 01/05/2023 20:41:07 :::CIS 5 Regional Drugs Testing Laboratory (RDTL), Chandigarh, .
wherein it was found that the samples were not of standard quality and also being spurious in nature.
7. Learned 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 coating of spurious medicines without knowing and realizing as to what were the contents of medicines. He also contended that the investigation of the case is almost complete and nothing remains to be recovered from the petitioner, hence, it is prayed that the petitioner be enlarged on 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 ::: Downloaded on - 01/05/2023 20:41:07 :::CIS 6 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 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 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 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 ::: Downloaded on - 01/05/2023 20:41:07 :::CIS 7
(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:
Provided 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.(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 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 ::: Downloaded on - 01/05/2023 20:41:07 :::CIS 8 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.
11. 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 rupees ten lakh or three times value of the drugs confiscated, whichever is more. It reads as under:-
"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 ::: Downloaded on - 01/05/2023 20:41:07 :::CIS 9 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
(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, 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 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 ::: Downloaded on - 01/05/2023 20:41:07 :::CIS 10 Capsules). In addition to these requirements, the following Specific Requirement shall also be followed, namely:-
.
1. GENERAL ............ ........... ..........
2 SIFTING, MIXING AND GRANULATION
........... .......... ........
3. COMPRESSION (TABLETS)
......... ........... ........
4. COATING (TABLES)
4.1. Air supplied to coating pans for drying purposes shall be filtered air and of suitable quality. The area shall be provided with suitable exhaust system and environmental control (temperature, humidity) measures.
4.2 Coating solutions and suspensions shall be made afresh and used in a manner, which shall minimize the risk of microbial growth. Their preparation and use shall be documented and recorded.
5. FILLING OF HARD GELATIN CAPSULE ......... ........... ..............
6. PRINTING (TABLES AND CAPSULES) ......... .......... ...........
7. PACKAGING (STRIP AND BLISTER) ......... ........... ..........."
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, coating of the medicines is also one of the specific requirements to be followed in the manufacture of the drugs besides sifting, mixing and granulation, compression (tablets), ::: Downloaded on - 01/05/2023 20:41:07 :::CIS 11 filling of hard gelatin capsule, printing (tablets and capsules) and .
packaging (strip and blister).
15. To re-call the facts of the instant case, as per the investigation, petitioner Naresh Kumar was involved in manufacturing of spurious drugs in connivance with Mohit Bansal of M/s. USV P Ltd at M/s Trizal Formulations and it was found that he was employed as senior packer in coating and inspection area at M/s USV P Ltd. During investigation, his attendance records and employment details were also obtained and it was also found that he had worked with M/s USV P Limited for manufacturing of Roseday 10 tablets. It was further revealed during investigation that the petitioner manufactured the spurious tablets of same drug, brand and company at M/s Trizal Formulations plot No. 29 DIC Baddi Solan HP in connivance with other accused persons which he used to manufacture at M/S USV P Ltd. Baddi Solan, H.P. 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 as Mohit/01, Mohit/02, Mohit/12, Mohit/23 ::: Downloaded on - 01/05/2023 20:41:07 :::CIS 12 and Mohit/25 are 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 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 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 its true character and its lack of identity with such other drug; or ::: Downloaded on - 01/05/2023 20:41:07 :::CIS 13
(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
(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 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 his own godown at Agra UP, which medicines were recalled and seized.
::: Downloaded on - 01/05/2023 20:41:07 :::CIS 1419. The contention of learned counsel for the petitioner .
that the petitioner was only working as a labourer and was doing the work of coating of spurious medicines without knowing and realizing as to what were the contents of medicines, deserves to be rejected as according to Part IB of Schedule M of the Drugs Rules, 1945, coating of the medicines is also one of the specific requirements to be 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 case, the petitioner has failed to satisfy the conditions for grant ::: Downloaded on - 01/05/2023 20:41:07 :::CIS 15 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 pretty well that the drugs were spurious and he has thus jeopardized the life of the innocent persons and therefore, the case would fall under the category of "heinous crime" affecting the life of innocent citizens. Merely because he is in custody since 27.11.2022, is no ground to override the mandatory provisions of the aforesaid Section of the DAC Act. Moreover, the petitioner is resident of District Muradabad, UP 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.
21. In view of the above discussion, the present bail application is dismissed. Pending miscellaneous application(s), if any, also stands disposed of.
::: Downloaded on - 01/05/2023 20:41:07 :::CIS 1622. Be it stated that any expression of opinion given in .
this order does not mean an expression of opinion on the merits of the case and the trial Court will not be influenced by any observations made therein.
( Sushil Kukreja )
April 28, 2023 Judge
(VH)
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