1. The State has filed this appeal against the judgment of acquittal dated 29-9-1973 passed by the Judicial Magistrate, First Class, I Court), Bangalore City in CC. 341 of 1971 acquitting the respondents of the offence punishable under S. 27(b) of the Drugs and Cosmetics Act, 1940 (??? referred to as the ‘Act’).
2. FW. 1 P.L Narasimhan, the Drugs Inspector visited the Govt. Medical Scores, Bangalore, which is a licensed premises, on 10-2-1970. He took samples in four portions of the drug Potassim Bicarbonate I.P bach No. 116. PW. 2 H. Abdul Rahim, Asst. Director and PW. 3 K. Venkatarama Iyengsr, Secretary of the Govt. Medical Scores, who were in possession of this drug were present at that time. The seizure, according to the prosecution, was made under S. 22(b) of the Act. PWs. 2 & 3 disclosed the name of Vikram. Chemical Laboratries, Bangalore as the supplier as required under S. 18A of the, Act. PW. 1 sent one of the samples to respondent 1 as required by S. 23 of the Act. He sent another sample to the Govt. Analyst who on examining it, sent his report as per Ex. P3. On perusing the report, it was found that the drug was sub-standard and therefore, the respondents had committed an offence punishable under S. 27(b) of the Act. A case was filed against the respondents. Simple denial is the only defence of the respondents. They further contended that they received the drag in bulk quantities in gunny-bags from the manufacturer in Bombay and they ware simply concerned with re-packing and after re-packing into small quantities they supplied to the Govt. Medical Stores and therefore, they have not committed any offence. Various technical contentions as against the applicability of Ss. 22 & 23 of the Act and the admissibility of the report of the Govt. Analyst as per Ex. P3 under the provisions of the Act were also raised. The remaining contention is that the drug might have become sub-standard in view of the climatic conditions.
3. The learned Magistrate held that taking of sample was not in accordance with the provisions of S. 22 of the Act and therefore, S. 23 would not be attracted and further that Rule 46 of the Drugs and Cosmetics Rules, 1945, (hereinafter referred to as the ‘Rules’) had not been complied with and fence Ex. P3 is not conclusive evidence in this case lie, on this basis, acquitted the respondents. He also observed that the drug might have become sub-standard because of defective storage and for that the respondents were not responsible.
4. The evidence of PWs. 1 to 3 is more than sufficient to establish that PW. 1 the Drugs Inspector took samples of the said drug from the Govt. Medical Stores on 10-2-1970 and that the said drug had been supplied by the responden's to the Govt. Medical Stores. The very evidence establishes that four portions of the sample were taken and one portion of it was ??? by PW1 to the respondents and further that after receipt of Ex. P3 from the Govt. Analyst, PW. 1 sent a copy of it to the respondents. It is an admitted fact that respondents held licence for repacking and they did repack the drug in question after receiving it from the manufacturer in Bombay and supplied the repacked drug in closed containers under their own label writing that it was repacked by them, to the Govt. Medical Stores.
5. Sec. 22(1)(b) of the Act reads as follows:
“(1) Subject to the provisions of S. 23 and of any rules made by the Central Govt. in this behalf, an Inspector may, within the local limits of the area for which he is appointed,—
(a) ……..
(b) take samples of any drug or cosmetic which is being manufactured, or being sold or is stocked or exhibited for sale, or is being distributed;”
6. The learned Magistrate has concluded that the Drugs Inspector is not to take sample of a drug which was sold or was distributed several years earlier under the above provision. It is on this reasoning that the learned Magis rate has held that the taking of samples was not in accordance with the provisions of S. 22 of the Act. It is plain that the learned Magistrate has ignored the words ‘is stocked’ in Cl. (b) of S. 22(1) of the Act. The drug was found stocked in the Govt. Medical Stores and PW. 1 took samples from that stock. We are convinced that S. 22(1)(b) of the Act does apply to the facts and circumstances of the case and the learned Magistrate was wrong in the view taken by him.
7. Sri C.B Motaiya learned Counsel for the respondents-accused contended that the samples of the drug were not taken in the presence of the respondents and therefore, S. 23(3) of the Act would not be called into play and as such the respondents could not be hauled up for such an Offence. Sub-sets. (3) and (4) of S. 23 of the Act read as follows:
“23(3): Where an Inspector takes a sample of a drag or cosmetic for the purpose of a test or analysis, he shall intimate such purpose, in writing in the proscribed 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:
Frovided that where the sample is taken from premises whereon the drug or cosmetic is being manufactured, it shall be necessary to divide the sample into three portions only:
Provided further that where the drug or cosmetic is made up of containers of small volume, instead of dividing a sample as aforesaid, the Inspector may, and if the drug or cosmetic be such that it is likely to deteriorate or be otherwise damaged by exposure shall, take three 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 Govt. 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”.
8. A perusal of the above provision makes it clear that when the samples of drugs are taken from a, premises where the drug is not, being manufactured, the sample should be taken in four portions and one of such portions has to be sent to the person whose name address and other particulars are disclosed to the Drugs Inspector under S. 18A of the Act. S. 18A of the Act reads as follows:
“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.”
9. It is in the evidence of PWs. 2 & 3 that they supplied the name, address and other particulars of respondents 1 & 2 to PW. 1. It is hence manifest that when samples of drugs stocked are taken from the premises where they are not being manufactured, the provisions of S. 23(4) and S. 18A of the Act come into play. In view of the provision in law being as above, the contention of Sri Motaiya, learned Counsel for the respondents that the respondents ouhg to have been present when the samples were taken and in view of the fact that they were not present, they could not be held liable for such an offence, is not sustainable.
10. Sec. 25(2) of the Act provides that the Inspector, shall on receipt of the report from the Govt. Analyst in regard to the analysis of the sample taken by him under S. 23 of the Act, send a copy of it to the person whose name, address and other particulars have been disclosed under S. 18A of the Act. We have already shown that PW. 1 has complied with this provision by sending a copy of Ex. P3 to the respondents. We therefore, hold that the learned Magistrate was not right in holding that the provisions of Ss. 22 & 23 of the Act had not been complied with.
11. Now it is to be sain whether Ex. P3 can, in view of S. 25(3) of the Act, be considered as conclusive evidence of the fact disclosed in it. Rule 46 of the Rules reads as follows:
“46. On receipt of a package from an Inspector containing a sample for test or analysis, the Govt. Analyst shall compare the seals on the packet with the specimen impression received separately and shall note the condition of the seals on the package. After the test or analysis has been completed, he shall forthwith supply to the Inspector a report in triplicate in Form 13 of the result of the tests or analysis, toge her with full protocols of the tests or analysis applied;
Explanation: It shall be deemed to be full and sufficient compliance with the requirement of the rule in respect of the supply of “protocols of the tests or analysis applied”, if—
(1) for pharmacopoeial drug, where the tests or methods of analysis prescribed in the official pharamacopoeia are followed, references to the specific tests or analysis in the pharmacopoeias are given in the report;
(2), (3), (4), (5) ****”
12. The contention of the defence is that Ex. P3 is not in conformity with this rule and therefore, S. 25(3) of the Act would not be applicable and so Ex. P3 would not be conclusive evidence without the examination of the concerned Govt. Analyst. The learned Magistrate has upheld this contention. A reading of Ex. P3 shows that the analysis made by the Govt. Analyst has been described therein in a particular manner. A reference to the Pharmacopoeia of India discloses that Potasium Bicarbonate is a Pharmacopoeial drug. The requirements to make it accord to the standard of the Pharmacopoeia of India (IP) are mentioned in page 574 of Pharmacopoeia of India, 1966 (Second Edition). A reference to the said requirements shows that the very same things are mentioned in Ex. P3. The Govt. Analyst has recorded his analysis against the particular heads. By taking into consideration Rule 46 of the Rules, it is clear to our mind that Ex. P3 is in accordance with Rule 46 and the contention of the defence that failure of the Govt. Analyst to describe in Ex. P3 the ‘Protocol Tests’ conducted, by him maker Ex. P3 not in conformity with S. 25 of the Act, has to fail. What the Govt. Analyst has done in Ex. P3 is to refer to the tests or methods of analysis prescribed for Polasium. Bicarbonate in page. 574 of the Book Pharmacopoeia of India, 1966 (Second Edn) and record his findings as against such methods or tests. It is exactly what is contemplated in Explanation (1) to Rule 46 of the Rules. Therefore, we are clearly of opinion that Ex. P3 is conclusive evidence of the facts mentioned therein by the Govt. Analyst as laid down by S. 25(3) of the Act. The view of the learned Magistrate that the drug was supplied by the manufacturer to the respondents according to the standard of the British Pharmacopoeia and therefore, the standard prescrbiad in Pharmacopoeia of India would not be applicable, is on the face of it untenable in view of the Second Schedule to the Act.
13. On the basis of what is found in the preceding paragraphs, we hold that the drug Potasium Bicarbonate that was in stock in the Govt. Medical stores had been supplied by the respondents as re-packers and it was substandard.
14. It was contended on behalf of the respondents that they are not manufacturers and hence they were not liable to be prosecuted in view of Section 19(3) of the Act. S. 3(f) of the Act defines ‘manuacture’ as follows:
“‘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 and distribution but does not include the compounding or dispensing of any drug, or the packink of any drug or cosmetic, in the ordinary course of retail business; and ‘to manufacture’ shall be construed accordingly.”
15. It is an admitted fact that the respondents received the drug in bulk from the manufacturers in Bombay and repacked the same in closed containers of smaller tins and supplied the drug to various customers including the Govt. Medical Stores. A reference to Rule 70 of the Rules shows that a licence is required for repacking of drug, such a licence is granted in Form 25. It is admitted that the respondents are such licence holders. The definition of ‘manufacture’ makes it abundantly clear that it includes packing also. It therefore, follows that the respondents are in law considered as manufacturers. Hence the contention of Sri C.B Motaiya that the respondents are not manufacturers has to fail. The observation of the learned Magistrate that the drug might have became sub-stsndard because of defective storage by PWs. 1 to 3 and therefore, the respondents could not be made liable for such defective storage cannot be accepted as it is clear from the evidence that the drug had been supplied to the Govt. Medical Stores in closed containers and the containers were in tact. A reference to page 575 of the book Pharmacopoeia of India, 1966 (Second Edn) shows that the storage prescribed is in a well-closed container. It has been found that Potasium Bicarbonate., had been stored in the closed containers in the Govt. Medical Scores. Moreover Ex. P3 shows that it contained extraneous substances also. Hence it will have to be held that the drug had not become sub-standard because of the storage.
16. In view of the foregoing reasons we hold that the prosecution has satisfactorily established the charge against the respondents. We therefore, allow this appeal and set aside the order of acquittal passed by the Judicial Magistrate, First Class (I Court), Bangalore City in CC. 341 of 1971. We convict the respondents for having committed an offence punishable under S. 27(b) of the Drugs and Cosmetics Act, 1940. We sentence ??? one of them to pay a fine of Rs. 2000. We direct that on failure at respondent 2 to pay the fine, he has to undergo simple imprisonment for the month.