Rameshwar Puri vs The State of Punjab

M.M. Punchhi, J.—The Petitioner. Rameshwar Puri, in the partnership with one N.K. Gaddi , manufactured Gramycaetin(sic) Chloramphenicol Palmitate Oral Suspesion drug in their laboratory-Messrs Gram Laboratories, Mmili(sic). The drug was manufactured and packed in 50 grams glass bottles cap sealed A lot there of, as is the case of the the Petitioner, was sold to Messrs Gian Enterprises. Moga. Cash Memo., however, as claimed by the Petitioner, was interpolated to read as if the lot land had been sold to R.K. Medical Agencies, Jalandhar, the propreror whereof is one Rajinder Kumar. Allegedly. Rajinder Kumar sold the lot or a part thereof to Messrs Gupta Medical Stores Jalandhar Cantt. The Drug Inspector when visiting Messrs Gupta Medical Stores, Jalandhar Cantt. on 30th September, 1981. purchased eight bottles allegedly each contaming 50 mes of the- drug for analysis. He divided these eight bottles into lots of two each One lot was sent for analys''s to the Public Analyst. The Public Analyst opined that the sample sent was not of standard quality defined under the Drugs and Cosmetics Act, 1940 (for short the Act) This led to the prosecution of Kamal Kumar, retail-dealer, Rajinder Kumar the wholesale dealer and the Petitioner and his partner as the manufacturers of the drug. This petition, is to challenge the proceedings terming to bean abuse of the process of the Court and leading to injustice to the Petitioner.

File has been summoned and the learned Counsel have been heard.

It is clear from the file that the Petitioner stands charged under the following counts:

Thirdly, in the same year you. Rameshwar Puri and N.K. Gaddi partners of M/s Gram Loboratory, S. A S. Nagar. Mohali, sold gramycetin batch No. 004 manufactured by you to Ms R. K. Medical Agency, Jalandhar, declared as not of standard quality and thereby committed an offence punishable u/s 27(b) read with Section 18 (a) (i) of the Drugs & Cosmetics Act, 1940, and within my cognizance.

Fourthly in the same year you Rameshwar Puri and N.K. Gaddi partners of M/s Gram Laboratory S. A S. Nagar, Mohali, manufactured gramycetin batch No. 004 and sold to M/s R.K. Medical Agency. Jalandhar a misbranded drug and there by committed an offence punishable u/s 27 (a) (1) read with Section 17(f) of the Drugs & Cosmetics Act 1940 and within my cognizance.

"The first afore-referrd to charge pertains to the drug being not of standard quality. Section 27 (b) in the year 1981, when all such activity took place, provided that whosoever himself or by any other person on his behalf manufactures for sale, sells, stocks or exhibits for sale or distributes any drug other than a drug referred to in Clause (a) in contravention of any of the provisions of Chapter IV of the Actor any rules made thereunder, shall be punishable with imprisonment for a term which may extend to three years or with fine or with both. And Section 18(a)(1) provides for prohibition for a person for himself or by any other person on his behalf to manufacture for sale, or sell, or stock or exhibit for sale, or distribute any drug which is not of standard quality. Section 16 describes what are standards of quality and in relation to a drug means that the drug should comply with the standards set out in the second schedule. Second Schedule sets out standards of drugs to be manufatured for sale, sold, stocked or exhibited for sale or distributed. Item 5 thereof covers the drug in question under the head ''Other drugs'' and refers to standards set out in Pharmacopoeia of India. The requirement is that standards of identity, purity and strength be such as specified in the edition of Pharmacopoeia of India for the time being in force and such other standards as may be prescribed. Care is taken as well to provide for drugs whose standards are not specified in the Indian Pharmacopeoia. but we are not concerned in the instant case with that situation. In Pharmacopoeia of India, applicable to the times, Chlorophemcol Palmitate Oral Suspension has been described as below:

Chloramphenicol Palmitate Oral suspension contains Chloramphenicol Palmitate suspended in a suitable vehicle. It may contain dispersing, flavouring, colouring and buffering agents. It contains not less than 95.0 percent and not more than 115.0 percent of the stated amount of chloramphenicol.

Its usual strength prescribed is 125 mg of chloramphenicol in 5 ml.

Now we know the usual strength of chloramphenicol in 5 ml. dose is 125 mg. Signicantly it is the usual strength and not by any means the prescribed strength. Rather it is nobody''s case that strength prescribed is such and cannot exceed 125 mg. in 5 ml. quantity. The Public Analyst in his report, however, while accounting results of the samples declared that each 5ml. containing 126 ml. cloramphenicol against the declared quantity of 125 mg per 5 ml doses. Despite the small difference of 1 mg. found out in the contents and the declaration per 5 ml. doses, the Public Analyst did not opine the variation leading to the sample being of sub-standard quality. The report of the Public Analyst on the file is significantly silent on this. Rather on the contrary the opinion is specific that the sample was not of standard quality for the reason that its net contents were found 23.366 grams per container against the claim of 50 gram per container. Thus, as contended by the learned Counsel for the Petitioner, the prosecution of the Petitioner u/s 27(b) read with Section 18(a)(i) of the Act on the supposition that there is marginal difference between the presence of chloramphenicol per 5 ml. dose without the supportive opinion of the Public Analyst of its being sub-standard, is wholly without jurisdiction and in any case improper. On the record, it is plain that the Public Analyst does not consider this to be a sub-standardisation. The Drug Inspector complainant spelling it out in this manner and pursuing the prosecution in that regard appears to me nothing but to abuse the process of the Court as the opinion of the Public Analyst on a subject like the present one covered by Pharmacopoeia of India is normally to be given due weight. Now when the Public Analyst does term the article to be sub-standrad I fail to see how the Drug Inspector can term it so and prosecute the Petitioner. Sequely, I fail to see how the prosecution of the Petitioner under charge ''thirdly'' can be allowed to proceed. In these circumstances and for the view above taken charge against the Petitioner u/s 27(b) read with Section 18(a) (i) of the Act is hereby quashed.

On charge ''fourthly'' it is not disputed on behalf of the Petitioner that it was clearly specified on the lable of the two phials sent to the Public Analyst that there was 50 grams of drug in each glass bottle and the said bottles were cap sealed. It is equally not disputed that the drug per bottle was almost less than a half than its declared contents re: each bottle. The charge u/s 27(a) (i) read with Section 17(f) is sought to be established in this manner. Section 17 (f) provides that a drug shall be deemed to be misbranded if its label or container or anything accompanying the drug bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular. Section 27(a)(i) says that whoever himself or by any other person on his behalf manufactures for sale, sells, stocks or exhibits for sale or distributes any drug deemed to be mis-branded under some clauses, inclusive of Clause (f) of Section 17, shall be punishable with imprisonment for a term which shall not be less than one year but which may extend to 10 years and shall also be liable to fine. So, the offence, in the instant case does not relate to any false claim ''for the drug'' but is said to arise because the label on the sample bottles was false or misleading in particulars regarding net contents and that the statement made thereon was false or misleading. The statement so made in order to be false or misleading in any particular must be one which is knowingly wrong, deceptive or untruthful; besides knowing capable of drawing someone into error or to cause to mistake, containers, as said, before, were glass bottles and the liquid net contents thereof were visible to the naked eye. Anybody seeing those bottles, to be less than even half the quantity declared, could have rejected them as being unacceptable. Thus, there can be no deliberate design or device to knowingly make a false statement or a misleading statement so as to pass off the drug as of the proclaimed quantity in the instant case having regard to the quantity found in the two sample bottles. The matter can be viewed in a different way also. Suppose the bottle was totally empty or had even a fraction of its contents in it. In that state nobody with a grain of sense could have said that anyone has tried to knowingly make a false or misleading statement, design or device to pass off the drug in the some contents as proclaimed on the label. On the otherhand, suppose the bottle of 50 ml. contains 48 ml. drug. Then undermeasuring to the tune of 2 ml. per bottle under a statement that it is 50 ml. would obviously be false or misleading, for anyone cannot detect on first glances the under-mearing of the drug. But as said before, here we have a case falling mid-way in the proclaimed measure and the actual measures. This could have been noticed by any buyer at any level. Thus, it cannot be said that the statement attributed to the Petitioner''s firm was knowingly false or misleading in any particular. There undoubtedly has been a mistake somewhere either in intial packing, later handling or at any other stage or at any other level, even of pilfering of the contents. But it cannot be said on the facts as alleged by the prosecution that the Petitioner who was the manufacturer of the drug had knowingly and designedly made a statement which he knew to be false or misleading in the particular of the contents of the drug in the bottles examined. Thus, to my mind, the prosecution of Petitioner under charge ''fourthly'' u/s 21 (a) (i) read Section 17 (f) of the Act is also nothing but an abuse of the process of the Court liable to be quashed at this stage.

For the foregoing reasons, this petition is accepted and the charges against the Petitioner stand quashed.