drug regulation, commercial liability, statutory compliance, Supreme Court India
0  16 Mar, 2001
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Amery Pharmaceuticals and Anr. Vs. State of Rajasthan

  Supreme Court Of India Criminal Appeal /300/2001
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Case Background

As per case facts, a Drug Inspector sampled "Ashoka Liquid Extract" from a retailer, which was later reported as "mis-branded, adulterated and spurious drug" by the Government Analyst. The manufacturer, ...

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CASE NO.:

Appeal (crl.) 300 of 2001

PETITIONER:

AMERY PHARMACEUTICALS AND ANR.

RESPONDENT:

STATE OF RAJASTHAN

DATE OF JUDGMENT: 16/03/2001

BENCH:

K.T. THOMAS & R.P. SETHI

JUDGMENT:

JUDGMENT

2001 (2) SCR 449

The Judgment of the Court was delivered by

THOMAS, J. Leave granted.

Appellant, a pharmaceutical concern, succeeded in stalling prosecution

proceedings launched against it by a Drug Inspector for a long period of

well over a decade by now, and the trial remians where it started at. In

the meanwhile the appellant concern and its proprietor sauntered through

all the tiers of the judicial hierarchy and reached the apex Court and at

all these forums they have one technical objection about the

maintainability of the prosecution launched against them.

The events started on 30-4-1998 when a Drags Inspector visited a medical

retail shop at Kota (Rajasthan) and purchased a drag formulation by the

trade name "Ashoka Liquid Extract". The said purchase was made for the

purpose of sampling it under the provisions of the Drags and Cosmetics Act,

1940 (for short "the Act"). When one of the portions of sample was tested

by the Government Analyst (Jaipur) he reported that the sample was "mis-

branded, adulterated and spurious drug". The retailer disclosed the address

of M/s. Chetan Medical Stores, Kota (as the distributor or wholesaler) from

whom the drug was obtained. On being contacted the said distributor dis-

closed the name of the appellant concern and its proprietor as the manufac-

turers of the drug.

A complaint was filed by the Inspector on 5.12.1990 against all the persons

for the offences under Section 27(b), (c) and (d) of the Act. After hearing

the arguments at the preliminary stage the trial magistrate framed a charge

for the aforesaid offences against the appellants alone and the remaining

accused were discharged. Appellants thereupon filed a revision petition

before the Sessions Court contending that no charge could have been framed

against them because the Inspector did not send or give one portion of the

sample to the appellants and thereby the mandatory provision contained in

Section 23(4)(iii) of the Act was not complied with. The Sessions Judge

repelled the said contention as well as certain other contentions (which

are not relevant as they were not followed up by the appellants later).

Nonetheless, the Sessions Judge expressed the view that there is no

material on record to show that the drug is spurious. Hence the count under

Section 27(c) of the Act was deleted from the charge while the remaining

counts were upheld as per the order passed by the Sessions Judge on

23.11.1995. Appellants thereafter moved the High Court of Rajasthan under

Section 482 of the Code of Criminal Procedure by focussing on the

contention that there was non-compliance with the provision contained in

Section 23(4)(iii) of the Act on the premise that the Inspector did not

deliver one portion of the sample to the appellants. A Single Judge of the

High Court declined to accede to the said contention and dismissed the

petition filed by the appellants as per the order impugned in this appeal.

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Mr. Alok Singh, learned counsel for the appellants contended that non-

supply of one portion of sample to the manufacturer, who is joined as an

accused in the complaint, has resulted in depriving him of a valuable right

to test the correctness of the report of the Government Analyst. Learned

counsel further contended that the consequence of such non-supply is that

the conclusiveness attached by law regarding the findings mentioned by the

Government Analyst is lost and the report of the Government Analyst would

not be binding on the manufacturer. In order to examine the correctness of

the above contention we may look at the relevant provisions of the Act.

Section 27 of the Act renders a person who manufactures for sale or for

distribution, or who sells or stocks or offers for sale any adulterated or

spurious drug, liable to a punishment with imprisonment for a time which

shall not be less than one year though a maximum is provided. Section 23 of

the Act empowers an Inspector to take sample of any drug for the purpose of

test or analysis. Section 25 empowers a Government Analyst to whom a

portion of the sample has been submitted for test, to deliver a report to

the Inspector, in triplicate, stating the facts discerned in the test or

analysis.

Section 25(2) of the Act says that the Inspector shall deliver one copy of

the report to the person from whom the sample was taken, another copy of

the report to the person whose name and address have been disclosed to the

Inspector. The third copy shall be retained by the inspector for use in any

prosecution in respect of the sample. Section 25(3) of the Act reads thus :

"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 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."

Learned counsel for the appellants contended that the conclusiveness of the

report of the Government Analyst as envisaged in the sub-section would nail

the manufacturer with the findings in the report as he would otherwise be

disabled from controversing the said findings, because he has no right to

challenge such findings due to the absence of a portion of the sample with

him.

The aforesaid contention is advanced on a misconception that the mode of

challenge against the report of the Government Analyst is by sending the

portion of the sample kept with the vendor (the person from whom the sample

was taken). The requirement of sub-section (3) is that one of the persons

to whom the copy of the report is given, if he wants to challenge the

report, has to notify the trial court or the Inspector concerned of the

intention to adduce evidence in controversion of the report. If he does not

do so within 28 days of receipt of a copy of the report of the Government

Analyst its consequence would be that the facts contained in the report

would become conclusive as against those persons. The notice to be given

shall convey the intention of the person concerned, "to adduce evidence in

controversion of the report". If such a notice is given, it is open to the

person who gives such notice, to adduce any evidence for the purpose of

contradicting the findings in the report. But if such person fails to give

any such notice within the said period of 28 days the findings in the

report would operate as conclusive evidence against the person who failed

to give such notice.

One of the modes of challenging the report is indicated in sub-section (4)

of Section 25. It reads thus :

"Unless the sample has already been tested or analysed in the Central Drugs

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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 for the drug 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."

If the person who was given a copy of the report of the Government Analyst

notifies his intention to challenge the report it is open to the court to

forward the portion of the sample kept in the court, to the Central Drugs

Laboratory. The sub-section further envisages that any of the parties

involved in the criminal proceedings (the accused as well as the

complainant) can make a request to the court that the portion of the sample

produced by the Inspector before the Magistrate may be sent to the Central

Drugs Laboratory. When the said Central Drugs Laboratory sends a report

after conducting the analysis or tests, the facts contained therein become

conclusive evidence.

In this context it is useful to refer to the procedure prescribed for the

Inspector to follow while taking sample of the drug or medicine etc.

Section 23 of the Act contains the procedure to be followed. If the sample

is taken from a retailer or a distributor, the Inspector shall divide the

sample into four portions, seal and mark them and permit the person from

whom the sample was taken to add his own seal or mark on such portions of

the sample. Sub-section (4) of Section 23 is the relevant provision to be

referred to now. It reads thus :

"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 Govern-ment

Analyst for test or analysis;

(ii) the second he shall produce to the Court before which proceed-ings, 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."

In this context it is necessary to extract Section 18A of the Act also

which is as under :

"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 the

name, address and other particulars of the person from whom he acquired the

drug or cosmetic."

Thus, the obligation of the Inspector is to give one portion of the sample

to the person whose name, etc. have been disclosed as the person from whom

the vendor acquired the drug. The requirement of the provision would stand

complied with when the Inspector gives one portion of the sample to the

person from whom he took the sample, and forward the second portion to the

Government Analyst and the third portion to the court (before which the

prosecution is pending) and the fourth portion to the person whose name and

address, etc. were disclosed by the vendor. This position is made very

clear as can be seen from the first proviso to sub-section (3) of Section

23 of the Act. That proviso says that "where the sample is taken from

premises whereon the drug is being manufactured, it shall be necessary to

divide the sample into three portions only." (emphasis supplied). In such

case one portion shall be given to the manufacturer and the remaining two

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portions are to be dealt with in accordance with clause (i) and clause (ii)

of sub-section (4), i.e. one portion to be sent to the Government Analyst

and the second to be produced before the court. In such a case, there is no

utility for clause (iii) of the sub-section. This aspect of non-utility of

the third clause in such a situation is amplified by the words employed in

that clause itself, (i.e. "where taken")- In other words, where it is not

taken, that clause has no utility.

Thus, in a case where the drug or medicine has passed from the manufacturer

to a wholesaler (a distributor) and then to a retailer, the obligation of

the Inspector (who takes the sample from a retailer) as for giving portions

of the sample would end up by giving it to the retailer and also to the

distributor (from whom the retailer bought the drug).

It was contended that since a manufacturer is not entitled to get a copy of

the report of the Government Analyst as of right (when the sample was taken

from a retailer) the manufacturer would be disabled from challenging the

correctness of the facts stated in the report and such deprivation would

visit him with hard consequences as the facts stated in the report would

become conclusive evidence against him. Learned counsel submitted that such

a provision which disables an accused from disproving the correctness of

the facts contained in a document which would nail him down, is unfair and

unreasonable besides being oppressive. This amounts to violation of the

fundamental right enshrined in Article 21 of the Constitution, according to

the learned counsel.

In support of the above contention learned counsel cited some deci-sions.

In Drugs Inspector v. M/s. Modem Drugs and another, (1982) Drugs Cases 26

Madras, a single judge of the Madras High Court considered the contention

raised on behalf of a manufacturer, who was convicted under Section 27 of

the Act, that non-supply of copy of the report of the Govern-ment Analyst

and a portion of the sample had deprived him of the right to challenge the

correctness of the report. Learned single judge while appreci-ating the

difficulty of the Drug Inspector who was only obliged by law to make four

portions of the sample as the maximum, has observed that the legislature

should have envisaged a case like the present one where there are number of

accused persons who are entitled to have each one portion of the sample and

a copy of the report of the Government Analyst. Learned single judge

further suggested that the defect in the Act requires rectification. After

stating that it was the business of the legislature and not that of the

judge, the High Court has chosen to acquit the appellant manufacturer.

In Kiran Dev Singh v. State of Himachal Pradesh, (1990) Drugs Cases 324

(HP), a Division Bench of the High Court of Himachal Pradesh held thus :

"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 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 of adducing evidence in controversion of the report of the

analyst which describes his product as lacking in necessary standards of

quality."

Shir R.N. Trivedi, learned Additional Solicitor General contended that the

observations made in those decisions cannot be approved because it is open

to the manufacturer in prosecution cases against him to adduce evidence for

controversing the facts stated in the reports of Government Analyst in the

manner indicated in Sections 25(3) and (4) of the Act. Learned Additional

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Solicitor General invited our attention to a two-Judge Bench decision of

this Court in State of Haryana v. Brij Lal Mittal, [1998] 5 SCC 343. In

that decision the point convassed before us did not arise, because on the

facts therein it was admitted that the manufacturer was served with a copy

of the report of the Government Analyst, but he did not notify his

intention to adduce evidence in controversion of the said report. The legal

position convassed in this case relates to a situation where the Inspector

did not serve copy of the report to the manufacturer since he had no legal

obligation to do so. Now we have to seriously examine the contention of

both sides, particularly in view of the observations made in the decisions

of the High Courts cited supra.

Section 25(3) of the Act says that any document purporting to be a report

signed by a Government Analyst shall be evidence of the facts stated

therein "and such evidence shall be conclusive". The only exception

provided in the sub-section is, if the person from whom the sample was

taken or the person whose name, etc., have been disclosed under Section

18A, gives notice in writing that he intends to adduce evidence in

controversion of the report he has the liberty to disprove it. Of course

there is a time limit fixed for giving such notice. According to the

provision, such notice shall be given within 28 days of receipt of a copy

of the report.

When a manufacturer in a given situation is not entitled to get a copy of

the report of the Government Analyst as of right, as happened in this case,

what can he do for the purpose of challenging the report? There is yet

another situation when a manufacturer can be arraigned in the case. It is

envisaged in Section 32A of the Act. It reads thus :

"32A. Power of Court to implead the manufacturer, etc. - Where, at any time

during the trial of any offence under this Chapter alleged to have been

committed by any person, not being the manufacturer of a drug or cosmetic

or his agent for the distribution thereof, the Court is satisfied, on the

evidence adduced before it, that such manufacturer or agent is also

concerned in that offence, then, the Court may, notwithstanding anything

contained in sub-sections (1), (2) and (3) of section 319 of the Code of

Criminal Procedure, 1973, proceed against him as though a prosecution had

been instituted against him under section 32."

What would such a manufacturer, who is impleaded as per the above

provision, do when he too is not entitled to be supplied with either a

portion of the sample or even a copy of the report of the Government

Analyst?

The extent of the implication of the words "such evidence shall be

conclusive" as employed in Section 25(3) of the Act has to be understood

now. Section 4 of the Evidence Act says that when one fact is declared by

the said Act to be conclusive proof of another "the court shall, on proof

of one fact, regard the other as proved, and shall not allow evidence to be

given for the purpose of disproving it." The expression "conclusive

evidence" employed in Section 25(3) of the Act cannot have a different

implication as the legislative intention cannot be different. Such an

import as for the word "conclusive" in the interpretation of statutory

provisions has now come to stay. If so, what would happen if the

manufacturer is disabled from challeng-ing the facts contained in the

document which would visit him with drastic consequences when he is

arraigned in a trial. Any legal provision which snarls an indicted person

without affording any remedy to him to disprove an item of evidence which

could nail him down cannot be approved as consistent with the philosophy

enshrined in Article 21 of the Constitution. The first effort which courts

should embark upon in such a situation is to use the power of

interpretation to dilute it to make the provision amenable to Article 21.

In our view the court should lean to an interpretation as would avert the

consequences of depriving an accused of any remedy against such evidence.

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He must have the right to disprove or controvert the facts stated in such a

document at least at the first tier. It is possible to interpret the

provisions in such a way as to make a remedy available to him. When so

interpreted the position is thus: The conclusiveness meant in section 25(3)

of the Act need be read in juxtaposition with the persons referred to in

the sub-section. In other words, if any of the persons who receives a copy

of the report of the Government Analyst fails to notify his intention to

adduce evidence in controversion of the facts stated in the report within a

period of 28 days of the receipt of the report, then such report of the

Government Analyst could become conclusive evidence regarding the facts

stated therein as against such persons. But as for an accused, like the

manufacturer in the present case, who is not entitled to be supplied with a

copy of the report of the Government Analyst, he must have the liberty to

challenge the correctness of the facts stated in the report by resorting to

any other modes by which such facts can be disproved. He can also avail

himself of the remedy indicated in sub-section (4) of Section 25 of the Act

by requesting the court to send the other portion of the sample remaining

in the court to be tested at the Central Drugs Laboratory. Of course, no

court is under a compulsion to cause the said sample to be so tested if the

request is made after a long delay. It is for that purpose that a

discretion has been conferred on the court to decide whether such sample

should be sent to the Central Drugs Laboratory on the strength of such

request. However, once the sample is tested at the Central Drugs Laboratory

and a report as envisaged in Section 25(4) of the Act is produced in court

the conclusiveness mentioned in that sub-section would become

incontrovertible.

In Vetcha Venkata Raju v. State of Andhra Pradesh, (1994) Drugs Cases 94

(AP) a manufacturer was prosecuted in a situation similar to the present

case and he was convicted by the trial court which was confirmed by the

Sessions Court. He raised a contention before the High Court of Andhra

Pradesh that he is precluded from exercising a valuable right to get the

sample examined by the Central Drugs Laboratory as provided under Section

25(4) of the Act because the portion of the sample or copy of the report

was not supplied to him. As against the said contention the Public

Prosecutor in that case pointed out that any other manufacturer also would

be under such a disability if he is prosecuted in exercise of the powers

under Section 32A of the Act because there is no provision for serving him

with a copy of the report in such situation. A Single Judge of the Andhra

Pradesh High Court, in the wake of the above contentions, observed that if

the manufacturer is pros-ecuted by impleading him as per Section 32A of the

Act he cannot claim the right to be supplied with a copy of the report of

the Government Analyst, but if he is prosecuted in consequence of the

disclosure made under Section 18A such manufacturer would be entitled to a

portion of the sample as well as a copy of the report of the Government

Analyst. According to learned Single Judge, failure to supply such things

to the manufacturer who was made an accused as per Section 18A could cause

prejudice to him. But no such prejudice can be caused by a manufacturer

impleaded under Section 32A of the Act, according to the learned single

judge. Consequently the conviction and sentence passed on the manufacturer

in that case were set aside by the High Court.

We are unable to understand the rationale in drawing a hiatus between a

manufacturer who is arraigned as an accused at the first instance itself

and another manufacturer who is arraigned in exercise of the powers under

Section 32A of the Act, as regards his right to challenge a document

purporting to be the report of the Government Analyst. The right to

challenge the report must, as of right, be available to both such

manufacturers who are prosecuted for the offence.

When the provision can be interpreted in such a way as to avert absurd

consequences in the manner indicated above it is not congenial to the

interest of criminal justice to acquit the manufacturers of forbidden

medicines or drugs on a technical ground that there is a lacuna in the

legislation by not supplying copy of the report of the Government Analyst

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to the manufacturer in certain situations. To adopt the course of

acquitting such offending manufacturers only on the legislative lacuna (if

at all it is lacuna) would be hazardous to public health and the lives of

the patients to whom drugs are prescribed by medical practitioners would be

in jeopardy. Hence, when the legislative provision is capable of being

interpreted as we did now, the courts need not feel helpless in

administering criminal justice in accordance with the objects sought to be

achieved by the statute.

In the result we dismiss this appeal.

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