Himachal Pradesh High Court
Dr. Kewal Krishan And Another vs State Of H.P. & Others on 11 January, 2018
Author: Sureshwar Thakur
Bench: Sureshwar Thakur
IN THE HIGH COURT OF HIMACHAL PRADESH, SHIMLA Cr.MMO No. 357 OF 2016.
Reserved on: 5th January, 2018.
.
Date of Decision: 11th January, 2018.
Dr. Kewal Krishan and another .....Petitioners.
Versus State of H.P. & others ....Respondents.
Coram r
The Hon'ble Mr. Justice Sureshwar Thakur,
Judge.
Whether approved for reporting? Yes.
For the petitioner: Mr. Abhishek Sethi with Mr. Subhash Verma, Advocates.
For the respondents: Mr. R.S. Thakur, Addl.
A.G. Sureshwar Thakur, Judge.
The Drugs Inspector concerned, instituted a complaint under Section 18(a) (I) read with Section 17- A (f) against the accused named therein, for commission, of, offences punishable under Section ::: Downloaded on - 15/01/2018 23:03:22 :::HCHP 2 27(b)(i) and 27(d) of the Drugs and Cosmetics Act, 1940 ( hereinafter referred to as the Act) and Rules , of, 1945 made thereunder. In the complaint, it is .
alleged that, upon, the Drugs Inspector concerned, on 28.3.2008, inspecting the premises, of, one Sanjeev Kumar Gautam, Proprietor of M/s Gautam Medical Agency, Vill. Parnal, P.O. Nalti, Tehsil Ghumarwin, District Bilaspur, H.P., hers observing, existence, of, lot of flake like particulate matter and suspended matter in the Dexa Injection 20 ml, B. No. SAP-1333, manufactured by M/s Anrose Pharma 147, Mauza Sansiwala Barotiwala Industrial Area. The Drugs Inspector, withdrew therefrom, sample(s), of the aforesaid drug, as, depicted in form-17, form-17 whereof is enclosed, with, the complaint, as Annexure PC, (i) AND thereupon divided, into four portions, the sample(s) withdrawn therefrom. From amongst four portions, of, the sample(s) drawn, from, the aforesaid drug, kept in the premises of M/s Gautam Medical Agency, (a) one portion was sent on 28.4.2008, on form-18, to, the Government Analyst, through registered post, for its analyses. Upon the aforesaid ::: Downloaded on - 15/01/2018 23:03:22 :::HCHP 3 sample, sent to, the Government Analyst, for analyses, the latter in his report appended, as, Annexure PH with the complaint, made a declaration, .
of, the sample of the drug sent to it, for, analysis, not, conforming to its prescribed standard quality.
Accused Sajeev Kumar Gautam, is the retailer of the apposite drug. Accused Dr. Saneh Goyal, is, the proprietor of M/s Sri Balaji Distributors,, Shop NO.9, Sector 01, Divya Bhawan Complex Parwanoo, District Solan, H.P., AND also is the distributor of the apposite drug. Accused Dr. Kewal Krishan is the proprietor of M/s Sri Balaji Medicos, Shop No.3, Sector-01, Divya Bhawan Complex, Parwanoo, wherefrom whom, accused Sanjeev Kumar Gautam, purchased the apposite drug. Accused Ankit Agarwal and Anil Kumar Agarwal, are, the manufacturer(s), of, the apposite drug.
2. The apposite drug is a life saving drug.
Provisions of Section 18 of the Act, read as under:
"18 Prohibition of manufacture and sale of certain drugs and cosmetics. --From such date as may be fixed by the State Government by ::: Downloaded on - 15/01/2018 23:03:22 :::HCHP 4 notification in the Official Gazette in this behalf, no person shall himself or by any other person on his behalf--
(a) [manufacture for sale or for distribution, or sell, .
or stock or exhibit or offer for sale,] or distribute--
(i) any drug which is not of a standard quality, or is misbranded, adulterated or spurious;
[(ii) any cosmetic which is not of a standard quality, or is misbranded, adulterated or spurious;]] [(iii) any patent or proprietary medicine, unless there is displayed in the prescribed manner on the label or container thereof 79 [the true formula or list of active ingredients contained in it together with the quantities, thereof];]
(iv) any drug which by means of any statement design or device accompanying it or by any other means, purports or claims 80 [to prevent, cure or mitigate] any such disease or ailment, or to have any such other effect as may be prescribed;
[(v) any cosmetic containing any ingredient which may render it unsafe or harmful for use under the directions indicated or recommended;
(vi) any drug or cosmetic in contravention of any of the provisions of this Chapter or any rule made thereunder;] ::: Downloaded on - 15/01/2018 23:03:22 :::HCHP 5
(b) [sell, or stock or exhibit or offer for sale,] or distribute any drug 83 [or cosmetic] which has been imported or manufactured in contravention of any of the provisions of this Act or any rule .
made thereunder;
(c) [manufacture for sale or for distribution, or sell, or stock or exhibit or offer for sale,] or distribute any drug 83 [or cosmetic], except under, and in accordance with the conditions of, a licence issued for such purpose under this Chapter"
The aforesaid provisions, of, Section 18 of the Act, cast a stringent statutory interdiction, against, any person manufacturing, distributing, selling, stocking "for" exhibiting or offering for sale (any drug which is not of a standard quality), (i) thereupon, each of the accused, who respectively are stockists, retailers, distributors and manufacturers, attract vis-a-vis each, the stringency(ies), of, the statutory interdictions, cast in the apposite hereinabove extracted provisions, of Section 18 of the Act, (ii) conspicuously "against"
each, of, manufacturer(s), distributor(s)or seller(s) or stockist(s), vis-a-vis the apposite drug, pronounced, by the CTL concerned, in its report to be, of, a quality not conforming vis-a-vis its statutorily prescribed quality, ::: Downloaded on - 15/01/2018 23:03:22 :::HCHP 6
(iii) hence manufacturing, distributing or selling it.
With the report of the CTL concerned, hence, voicing the aforesaid echoings AND it remaining extantly .
unchallenged. Consequently, at this stage when, no evidence, of vigorous evidentiary worth exists on record, for hence displacing its probative worth, thereupon, all echoings occurring therein, enjoin(s), imputation of prima faice credence thereto.
Consequently, each of the accused in their respective capacity(ies) as manufacture(s), distributor(s), stockist(s) and retailer(s) thereof, hence, attract(s) stringency(ies), of, the mandate of Section 18 of the Act.
3. Be that as it may, sub-section (4) of Section 23 of the Act, prescribes, the procedure for adoption besides adherence, by the Drugs Inspector, for his taking the sample of the apposite drug besides purveying(s), of, extracted therefrom, samples thereof, vis-a-vis the statutorily therein designated persons/entities. Provisions of Section 23 of the Act are extracted hereinafter:-
::: Downloaded on - 15/01/2018 23:03:22 :::HCHP 7"23. Procedure of Inspectors.--(1) Where an Inspector takes any sample of a drug [or cosmetic] under this Chapter, he shall tender the fair price thereof and may require a written .
acknowledgement therefor.
(2) Where the price tendered under sub-section (1) is refused or where the Inspector seizes the stock of any drug [or cosmetic] under clause (c) of section 22, he shall tender a receipt therefor in the prescribed form.
(3) Where an Inspector takes a sample of a drug 1[or cosmetic] for the purpose of test or analysis, he shall intimate such purpose in writing in the prescribed form to the person from whom he takes it and, in the presence of such person unless he wilfully absents himself, shall divide the sample into four portions and effectively seal and suitably mark the same and permit such person to add his own seal and mark to all or any of the portions so sealed and marked: Provided that where the sample is taken from premises whereon the drug 1[or cosmetic] is being manufactured, it shall be necessary to divide the sample into three portions only: Provided further that where the drug 1[or cosmetic] is made up in containers of small volume, instead of dividing a sample as aforesaid, the Inspector may, and if the drug 1[or cosmetic] be such that it is likely to deteriorate or be otherwise damaged by exposure shall, take three ::: Downloaded on - 15/01/2018 23:03:22 :::HCHP 8 or four, as the case may be, of the said containers after suitably marking the same and, where necessary, sealing them.
(4) The Inspector shall restore one portion of a .
sample so divided or one container, as the case may be, to the person from whom he takes it, and shall retain the remainder and dispose of the same as follows:--
(i) one portion or container he shall forthwith send to the Government Analyst for test or analysis;
(ii) the second he shall produce to the Court before which proceedings, if any, are instituted in respect of the drug [or cosmetic]; and [(iii) the third, where taken, he shall send to the person, if any, whose name, address and other particulars have been disclosed under section 18A.] (5) Where an Inspector takes any action under clause (c) of section 22,--
(a) he shall use all despatch in ascertaining whether or not the drug 1[or cosmetic] contravenes any of the provisions of section 18 and, if it is ascertained that the drug [or cosmetic] does not so contravene forthwith revoke the order passed under the said clause or, as the case may be, take such action as may be necessary for the return of the stock seized;
(b) if he seizes the stock of the drug [or cosmetic], he shall as soon as may be, inform [a Judicial ::: Downloaded on - 15/01/2018 23:03:22 :::HCHP 9 Magistrate] and take his orders as to the custody thereof;
(c) without prejudice to the institution of any prosecution, if the alleged contravention be such .
that the defect may be remedied by the possessor of the drug [or cosmetic], he shall, on being satisfied that the defect has been so remedied, forthwith revoke his order under the said clause.
[(6) Where an Inspector seizes any record, register, document or any other material object under clause (cc) of sub-section (1) of section 22, he shall, as soon as may be, inform 3[a Judicial Magistrate] and take his orders as to the custody thereof.]"
Sub-section 4 of Section 23 of the Act, mandates, of the Drugs Inspector, upon, withdrawing sample(s) AND taking sample(s), of, the relevant drug (a) his being under the statutory mandate(s), contemplated in sub-
section (3), being enjoined to divide it into four portions; (b) his effectively sealing and suitably, marking, each of the sample(s) and permitting such person to add his own seal and mark to all or any of the portions, so sealed and marked. (c) Thereafter, his being enjoined, to restore one portion, from, amongst ::: Downloaded on - 15/01/2018 23:03:22 :::HCHP 10 the four portions, of, the sample(s) "drawn from", the container purportedly holding the spurious drug vis-a-
vis the person, from, whom or from whose premises, .
he makes the apposite collections; (d) and his being enjoined to retain the apposite remainders and dispose of the same (i) "BY" one portion or container being forthwith sent to the Government Analyst; (ii) the second portion, being enjoined, to be retained by the Drugs Inspector concerned, for his/her being enabled, to, produce, it, before the Court; (iii) the third portion being enjoined, to be sent, to the person, whose name and addresses and other particulars, have been disclosed, under, Section 18A of the Act.
The mandate of clause (iii) to sub-section (4), of Section 23 of the Act, hence, obviously also casts a statutory obligation, upon, the Drugs Inspector concerned, to also beget compliance with the mandate, of, Section 18A of the Act, provisions where of stand extracted herein after:-
"[18A. Disclosure of the name of the manufacturer, etc.--Every person, not being the manufacturer of a drug or cosmetic or his agent for the distribution thereof, shall, if so required, disclose to the Inspector ::: Downloaded on - 15/01/2018 23:03:22 :::HCHP 11 the name, address and other particulars of the person from whom he acquired the drug or cosmetic.]"
Compliance whereto would occur, upon, his/her .
apposite endeavours vis-a-vis the retailer concerned, from whose premises, the relevant collections are made, sequelling the retailer, hence, making disclosures, to the Inspector concerned, of the names, addresses either of the manufacturer, if, he receives it directly, from, the manufacturer or, of, the duly authorised distributor of the drug concerned, (I) wheretowhom respectively, the Drugs Inspector, is enjoined to supply one sample portion, from, amongst the four sample portions, of, the sample withdrawn, from, the container purportedly, holding, the spurious drug.
4. The phraseology of sub-section (4), of Section 23 of the Act, is cast in a mandatory coinage, whereto, hence, strict compliance therewith, is enjoined to be meted. The necessity(ies) of meteings, of, strict compliance therewith, is, sparked by the factum of it preserving a valuable statutory right, in ::: Downloaded on - 15/01/2018 23:03:22 :::HCHP 12 the manufacturer or the distributor, to enable him/them, to controvert, the report of the government analyst concerned. Apparently, preservation(s), of, .
the aforesaid statutory right in the manufacturer or the distributor, is, embedded in the legislature, hence, intending to overrule, the possibility of occurrence(s) of, tampering(s) with the sample, especially at the laboratory concerned, (i) besides for dispelling any aura of partisan imbuing the report prepared, by the government analyst concerned, upon, the sample sent to it, for analysis, by the Drugs Inspector concerned.
Imperatively, (ii) hence, for eradicating the aforesaid auras of suspicion (iii) AND also for ensuring that the manufacturer or distributor of the purported spurious drug, is enabled to dispel, arousals, of all the aforestated skepticism(s) seeping, into the analysis of the sample, made, at the government laboratory concerned. (iv) The legislature has thereupon bestowed valuable statutory rights, upon, the manufacturer or the distributor of the drug concerned.
Unless the fullest deference to the legislative intent is meted, thereupon, the salutory purpose aforesaid, ::: Downloaded on - 15/01/2018 23:03:22 :::HCHP 13 behind the statutory contemplations, existing in clause (iii) of sub-section (4) to Section 23 of the Act, would be satiated besides rather would not be .
rendered redundant. Consequently, it was incumbent, upon, the drugs inspector concerned, to ensure, qua his meteing, the strictest compliance vis-a-vis the mandatory statutory provisions, borne, in clause (iii) to sub-section (4) of Section 23 of the Act. For gauging, from, the records, of, the Drugs Inspector hence begetting, the strictest compliance, with, the mandate of clause (iii) to sub-section (4) of Section 23 of the Act, this Court had proceeded to delve into the records apposite thereto. The petitioners/Accused No.2 and 3 are the stockists of the drug concerned and accused No.4 and 5 are the manufacturers of the relevant drug. A perusal of Annexure PK, appended, with the complaint instituted, before, the learned trial Court,
(a) makes a disclosure, of, the distributor of the relevant drug, being, supplied by the Drugs Inspector, with a copy of report of 9.6.2008 and a copy of purchase invoice No.SC-230 of 3.10.2007. However, therein there is, no, recital of the Drugs Inspector ::: Downloaded on - 15/01/2018 23:03:22 :::HCHP 14 concerned, who though, was statutory obliged to also purvey a portion of the sample, of, the drug withdrawn, from, the container concerned, or to .
hence, supply, it, to the accused concerned, hence rather visibly, not, supplying, it, vis-a-vis the accused concerned, (b) besides likewise in Annexure PL, Annexure whereof, embodies a communication, addressed by the office of the Drugs Inspector concerned, vis-a-vis the manfacturer, an echoing exists therein, of, his purveying vis-a-vis the manufacturer, a copy of the report of the CTL concerned, yet therein, there occurs no recital, of the Drugs Inspector concerned, also purveying vis-a-vis the manufacturer, a portion, of the sample withdrawn, from, the container purportedly holding the apposite spurious drug. Corollary(s) whereof, is that with the Drugs Inspector concerned, blatantly infracting the mandate of clause (iii), to, sub-section (4) of Section 23 of the Act, whereas, strict compliance therewith hence was mandatory, thereupon, the salutary purpose, behind the aforesaid bestowal(s), of, statutory rights, upon, the manufacturer and the ::: Downloaded on - 15/01/2018 23:03:22 :::HCHP 15 distributor, of the drug concerned, stands apparently defeated. In aftermath, the petitioners herein when hence, stand deprived of an indefeasible implied .
statutory opportunity, to controvert the report of the Government Analyst, thereupon an inference being garnered, of, the aforesaid report being imbued, with a vice of skepticism, also hence, non compliance(s) vis-
a-vis the aforesaid mandatory statutory provisions, by the Drugs Inspector, staining the prosecution case, with an aura of invention or concoction.
5. In taking the aforesaid view, this Court finds support from a decision of this Court, rendered, in Cr.MP (M) No.992 of 1989, titled as Kiran Dev Singh versus State of H.P., decided on 24.5.1990, relevant paragraph No.23 whereof reads as under:-
"23. In view of what we have stated above, it appears clear that the decision in Manager, Medical Pharmaceutical Processors, Amritsar v. State of H.P. and others (1983 Cr.L.J. 67) does not lay down the correct law. The provisions of the Act, when read in the light of the scheme thereof, lead to the unmistakable conclusion that it is incumbent upon the Drug Inspector to make, a copy of the report of the ::: Downloaded on - 15/01/2018 23:03:22 :::HCHP 16 Analyst as also a part of the sample, available to the manufacturer where his identity becomes known before he is actually proceeded against from the initial stages by being made a party to the complaint filed by .
the Inspector. This is the mandate of law lest the manufacturer is deprived of an effective opportunity for a defence to the effect that the drug manufactured by him, out of which the sample was drawn, is not lacking in necessary standard of quality. The manufacturer should have access to the report and a part of the sample drawn from his product within a reasonable period to enable him to exercise the right to adducing evidence in controversion of the report of the analyst which describes his product as lacking in necessary standards of quality."
6. In aftermath, with the grave prejudice being caused, to, the distributors of the drug concerned, who, have petitioned this Court, for quashing of the complaint and for quashing of the consequential proceedings launched in sequel thereto AND pending before the learned trial Court, thereupon, this court deems it fit and proper, to quash the complaint, as also, the consequential thereto proceedings, initiated against the petitioners herein.
::: Downloaded on - 15/01/2018 23:03:22 :::HCHP 177. For the foregoing reasons, the instant petition is allowed and the summoning orders, of, 23.04.2011 borne in Annexure P-8, only, in respect of .
the petitioners herein are quashed. All pending applications are also dismissed. No costs. Records be sent back.
11 th
January, 2018
(jai)
r to (Sureshwar Thakur)
Judge.
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