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[Cites 10, Cited by 1]

Himachal Pradesh High Court

Sh. Ankur Gulati & Another vs State Of Himachal Pradesh & Others on 22 July, 2016

Author: Tarlok Singh Chauhan

Bench: Tarlok Singh Chauhan

IN THE HIGH COURT OF HIMACHAL PRADESH, SHIMLA Cr.MMO No. 241 of 2015 .

Date of decision: 22.7.2016 Sh. Ankur Gulati & Another. ...Petitioners Versus State of Himachal Pradesh & others. ...Respondents Coram The Hon'ble Mr. Justice Tarlok Singh Chauhan, Judge.

of Whether approved for reporting?1 No. For the Petitioners: rt Mr. Anand Sharma, Advocate.

For the Respondents: Ms.Meenakshi Sharma, Additional Advocate General with Mr.J.S. Guleria, Assistant Advocate General, for respondent No. 1.

Mr.R.K. Gautam, Senior Advocate with Mr.Gaurav Gautam, Advocate, for respondent No. 2.

                                            Mr.Jagan    Nath,                Advocate,           for
                                            respondent No. 3.





                  Tarlok Singh Chauhan J. (oral).





The petitioners by medium of this petition under Section 482 of the Code of Criminal Procedure read with Article 227 of the Constitution of India have sought quashing of proceeding lodged against them under Section 32(2) of the Drugs and Cosmetic Act 1940 and Rules 1945 under Section 18(a)(i) read with Section 17-B

(d) punishable under Section 27(d) and 27(c) of the Drugs & Cosmetics Act 1940.

2. The brief facts leading to filing of the instant petition is that the Drug Inspector (complainant) visited the premises of M/s Whether the reporters of the local papers may be allowed to see the Judgment? Yes ::: Downloaded on - 15/04/2017 20:52:09 :::HCHP 2 Cr.MMO No. 241 of 2015 Elnova Pharma (respondent No. 2) on 3.1.2012, of which the petitioners are directors and in the course of inspection eleven .

samples of drug EP-KOFF Capsules, B. No. EPKSG 1102 in the form of Soft Gelatin Capsules manufactured for sale by the aforesaid firm was drawn. The sample of drug EP-KOFF Capsules, B. No. EPKSG 1102 in the form of Soft Gelatin Capsules manufactured by of the aforesaid firm was also amongst eleven samples, which were drawn on Form-17. The sample of drug was referred to the rt Government Analyst C.T.L. Kandaghat, District Solan, H.P. for the purpose of test and on analysis, the drug was found to be "NOT OF STANDARD QUALITY" vide report dated 29.6.2012. After receipt of the adverse analysis report, a copy thereof was sent to respondent No. 2 and in response to the same, respondent No. 2 enclosed certain documents and informed that they were not satisfied with the report and wish to challenge the same.

3. All the documents were thereafter submitted by the Drug Inspector to State Drugs Controller cum Controlling Authority, seeking permission therein to launch prosecution against the firm and also for re-testing of the samples from Central Drug Laboratory (CDL) Kolkata as per the provisions of the Drugs and Cosmetics Act, 1940 and Rules 1945 made there under. In response to the same, the State Drugs Controller cum Controlling Authority vide his letter dated 25.9.2012 directed the complainant to move an application under Section 25(4 and 25(5) of the Act, which was accordingly done by moving the application before the learned Chief Judicial Magistrate, Nahan and as per orders passed by the learned ::: Downloaded on - 15/04/2017 20:52:09 :::HCHP 3 Cr.MMO No. 241 of 2015 Magistrate, sample was sent for analysis to Central Drugs Laboratory and the drug was found to be "NOT OF STANDARD .

QUALITY". It was further found that the contents of both the drugs i.e. Guaiphenesin and Bromhexine Hydrochloride was 'nil' in the said drug. After receipt of the adverse report and after obtaining sanction to prosecute, the prosecution was launched against the of petitioners and proforma respondents No. 2 and 3 for having contravened various provisions of the Act, as already mentioned above.

rt

4. The learned counsel for the petitioner has laid challenge to the launch of prosecution on the following grounds:-

"(A) As to whether the drug namely EP-KOFF Capsules, B.No. EPKSG 1102, Mfg. date-10/2011, Ex. Date-09/2013, Qualify the criteria to come in the preview of Not of Standard Quality, Misbranded Drugs, Adulterated Drug, Spurious Drug as defined U/s-16, 17, 17-A and 17-B respectively of Drugs & Cosmetics Act.
(B) As to whether the prosecution has been able to make out a prima-face case against the Accused No. 2 & 3, in accordance with the provisions contained in Sec.-34(1) of Drugs & Cosmetic Act and whether the complainant has not conducted investigation properly to establish that the Accused No.-2 & 3 as person in-charge of and were responsible persons to the company for the conduct of the business of the company at the time when the drug in question was manufactured.
(C) As to whether the Test of Analysis report of Govt. Analyst, Kandaghat and Director of C.D.L. Calcutta in which full protocol of test not furnished, is admissible in evidence as Drugs and Cosmetic Rules 57(1), 46 and 6 requires that furnishing "Protocols of test is mandatory".

(D) As to whether the drug in question was tested or analyzed as per the validated provisions of Second Schedule, para ::: Downloaded on - 15/04/2017 20:52:09 :::HCHP 4 Cr.MMO No. 241 of 2015 no.-1 of Drugs and Cosmetic Act 1940 and Rule 124-B of the Drugs and Cosmetics Rules 1945, as the drug in question named EP-KOFF Capsule, is a Patent & Proprietary Medicine, which is not included in INDIAN .

PHARMACOPOEIA (I.P.), BRITISH PHARMACOPEIA (B.P.), UNITED STATES PHARMACOPEIA (U.S.P.) or any other Pharmacopeia, as the drug EP-KOFF Capsule is not a Pharmacopeial product."

5. In so far as the grounds contained in (A), (C) and (D) are of concerned, the same are essentially a matter of trial and this Court at this stage has to act with circumspection and cannot scuttle the rt prosecution by venturing into the merits of these grounds.

Therefore, the only surviving ground for adjudication at this stage is ground (B).

6. The learned counsel for the petitioners would then argue that in view of the affidavits of petitioners No. 1 and 2, they cannot be prosecuted in the instant case. Much reliance is placed upon the contents contained in paras 3 to 5 of the affidavits filed by petitioner No.1 which reads as under:

"3. That the said firm is technically managed by the qualified employees who are responsible for the day to day conduct and control of the business activities and I am not responsible for the routine working and other government concerning activities of the department.
4. That Sh. Rohit Kumar son of Sh. Ram Ootar aged 27 years permanent resident of Janderpur, P.O. Gairowala (Shiv) Teh- Bijnour, Distt. Bijnour (U.P.) is full time appointed competent person of the above said firm responsible for manufacturing of drugs for the sale and/or distribution who possesses qualification as prescribed under Rule 71 (1) (a) or 71 (1) (b) and 76(1) (a) or 76(1) (b) of the Drugs and Cosmetics Rules 1945 and he is not engaged anywhere else in any kind of service or business to the best of my knowledge.
::: Downloaded on - 15/04/2017 20:52:09 :::HCHP 5 Cr.MMO No. 241 of 2015
5. That Sh. A.K. Saxena son of Sh. O.P. Saxena, aged 47 years permanent resident of Kaushal Puri, P.O. R.K. Nagar, Teh- Kanpur, Distt. Kanpur (U.P.) is full time appointed competent person of the above said firm responsible for testing of all .
substances to be used for or incorporated in the drugs for sale and/or distribution who possesses qualification as prescribed under Rule 71(4-A) and/or 76(4-A) of the Drugs and Cosmetics Rules, 1945 and he is not engaged anywhere else in any kind of service or business to the best of my knowledge".

of The aforesaid portion is extracted from the affidavit filed by petitioner No.1 and the similar contents appear in the affidavit of rt petitioner No.2.

7. On the strength of these affidavits, the petitioners would claim that if at all anybody was the person in-charge and responsible to the Company for conducting of its business, it was either Sh. Rohit Kumar or Sh. A.K. Saxena of both of them, but in no manner could the petitioners be prosecuted as they were neither the person in-charge nor were responsible persons to the Company for the conduct of the business of the Company.

8. Strength is further sought to be drawn from the affidavits alleged to have been executed by Rajiv Tiwari and Arun Kumar Saxena, which have been placed on record as Annexures P-2/C and P-2/D, respectively, more particularly, the following contents of para-2 of Rajiv Tiwari which reads as under:

"2. That I shall also be working as over all Incharge-cum-sole person responsible for day to day conduct and control of business activities and the partner of the firm will not be responsible for day to day activity and control of the business and all Govt. concerning activities of the department."
::: Downloaded on - 15/04/2017 20:52:09 :::HCHP 6 Cr.MMO No. 241 of 2015

And para-3 of the affidavit of Arun Kumar Saxena, which reads as under:

.
"3. That I am the competent person responsible for testing of the drugs for sale and/or distribution of the above said firm and possesses qualification as prescribed under 71 (1) (a) or 71(1) (b) and 76(1) (a) or 76(1)(b)/Rule 71 (4-A) and/or 76(4-A) of the Drugs and Cosmetics Rules, 1945 i.e. B. Pharmacy/M.Sc. Chemistry/B.Sc./Other. The said qualification is done from D.A.V. of College Kanpur (name of College) under Kanpur (name of University) in the year 1991".

9. In addition thereto, strength is also sought to be drawn rt from the affidavit executed by one Diwakar Shukla wherein in para-

3, it has been mentioned as under:

"3. That I am the competent person responsible for testing of the drugs for sale and/or distribution of the above said firm and possesses qualification as prescribed under 71 (1) (a) or 71(1) (b) and 76(1) (a) or 76(1)(b)/Rule 71 (4-A) and/or 76(4-A) of the Drugs and Cosmetics Rules, 1945 i.e. B. Pharmacy/ M.Sc.
Chemistry /B.Sc. ./Other. The said qualification is done from R.G.C. Bhopal (name of College) Under Barkatullah (name of University) in the year 2004".

Further strength is also sought to be drawn from the affidavit executed by Sanjib Mohanty, wherein in paras 2 and 4, it has been mentioned as under:-

"2. That I shall also be working as production Co-ordinator and ensure planning of production activities and issuance of proper & correct formulation capsules as per panning to packing (Blister machines).
4. That I shall intimate the Drugs Licensing Authority, Drugs Control administration, Solan 173212, H.P. at least three months before leaving the firm without any failure."

10. Learned counsel for the petitioners would vehemently argue that under Section 34 of the Act, it is only the person in-

::: Downloaded on - 15/04/2017 20:52:09 :::HCHP 7 Cr.MMO No. 241 of 2015

charge and who were responsible persons to the Company for conducting of its business that can be prosecuted and at the .

relevant time it was either Rohit Kumar, Arun Kumar Saxena and Diwakar Shukla and Sanjib Mohanty, who are responsible for the conduct of business, therefore, all of them ought to have been prosecuted and under no circumstance, could the prosecution have of been launched against the petitioners.

11. I have considered the submissions of the petitioners and rt find that there can be no quarrel with the proposition that it is only the person, who at the time of complaint were the person in-charge and were the responsible persons to the Company for conducting of the business of the Company, who alone can be prosecuted and this was so held by this Court vide detailed judgment rendered in the case of Ashok Kumar Tyagi vs. State of H.P. and others, I.L.R. 2015 (II) H.P. page 937 and SLP (Criminal) No.85 of 2015 filed by the State of H.P. against the aforesaid decision stands dismissed by the Hon'ble Supreme Court on 24.9.2015.

12. But the moot question is as to whether any benefit can be derived by the petitioners on the basis of the affidavits or judgment rendered by this Court. To say the least, the conduct of the petitioners is not at all fair. It would be noticed that the premises of the petitioners were admittedly raided on 3.1.2012, while not only the affidavits of the petitioners but even those of Rajiv Tiwari, Arun Kumar Saxena, Diwakar Shukla and Sanjib Mohanty have been executed much later on 14.4.2013. That apart, the affidavits have been executed on stamp papers which have been purchased nearly ::: Downloaded on - 15/04/2017 20:52:09 :::HCHP 8 Cr.MMO No. 241 of 2015 two years back on 11.5.2011.Thus, the conduct of the petitioners in executing their affidavits and obtaining affidavits of three other .

persons namely Rajiv Tiwari, Arun Kumar Saxena, Diwakar Shukla and Sanjib Mohanty is not definitely above board, because admittedly none of the aforesaid four persons are accused in this case and are probably sought to be made scape-goats in this case.

of

13. The cumulative effect of the observation made hereinabove is that there is no merit in this petition and the same is rt accordingly dismissed along with pending application(s) if any.

Interim order granted on 7.8.2015 is vacated.

(Tarlok Singh Chauhan), Judge.

22nd July, 2016 (KRS) ::: Downloaded on - 15/04/2017 20:52:09 :::HCHP