P. Jaganmohan Reddy, J. - (1.) The appellant (original accused No.2), a Chemist Incharge of the Injection Department of Sanitax Chemical Industries Ltd. Baroda (hereinafter referred to as S. C. I. Ltd., along with 5 others was charged under Section 304-A, I.P.C. for rashly and negligently manufacturing a solution of glucose in normal saline Batch No. 211105 which contained more than the permitted quantity of lead nitrate as a result of which 13 persons, to whom it was administered, died. At the relevant time the first accused K. K. Prabhakaran was the Chief Analyst of the Testing Laboratory, accused R. M. Patel the third accused was the words Superintendent. S. J. Mehta the fourth accused was Production Superintendent Manibhai B. Amin, proprietor of M/s. M. B. Amin and Company, Baroda, the fifth accused was the Managing Director, and H. M. Amin, the sixth accused, the son of the fifth accused was a Director and partner of S. C. I. Ltd. It was alleged that all these accused were responsible for the manufacture of the aforesaid solution contrary to the provisions of the Drug Control Act and Rules and for the sale of it. The trial Court convicted the appellant and K. K. Prabhakaran, the first accused and sentenced each of them to rigorous imprisonment of 8 months and a fine of Rupees 100/-, in default to serve 15 days' rigorous imprisonment. It acquitted the other accused. Against this conviction and sentence both the accused filed separate appeals before the Addl. Sessions Judge, Baroda who acquitted them of the offences with which they were charged. The State of Gujarat appealed against the acquittal of both these accused. The High Court convicted the appellant and convicted the appellant and sentenced him to 8 months' rigorous imprisonment as awarded by the trial Court but imposed no fine. The first accused was, however, acquitted. Against that Judgment this appeal is by certificate under Article 134 (1) (c) of the Constitution.
(2.) A few of the relevant facts as alleged by the prosecution are not really in dispute. S. C. I. Ltd. prepares glucose in normal saline, a solution containing dextrose, distilled water and sodium chloride (popularly known as common salt). It appears that sodium chloride contains certain quantities of lead nitrate but according to the American Pharmacopoeia, which is one of the Pharmacopoeias recognised by the Rules under the Act according to which drugs can be manufactured, lead nitrate of 5 parts in 1 million is the permissible limit, which works out to .000005%. The evidence shows that in order to prepare glucose in normal saline of the standard quality 5% of dextrose and 9% of sodium chloride are require to be dissolved in distilled water which is absolutely sterile and free from germs and bacteria. The solution thus prepared is meant for being injected into or given by drip to patients. The Production Report dated 12-11-62. Exhibit 165, shows that 2.35 kg of sodium chloride and 13 kgs. of dextrose with bidistilled water was utilised for preparing the solution of glucose in normal saline which was filled in 450 bottles, each of which contained 540 c.c. of the solution. The report further mentions in the column Details of Manufacture and Progress Report, the following:- "In about 70L boiled bidistilled water 4.0 kg. dextrose dissolved. Stirred well, volume made upto 80L. Similarly two more lots each of 80L. Solution prepared 20L prepared separately. Total 260L. Solution prepared". In this way each batch of 80 litres was filled in 100 bottles and the 5th batch in 50 bottles. Out of these 450 bottles some were rejected. Out of the remaining 394 bottles, 8 bottles were taken for analysis on 13th November, 1962 and the remainder were packed for sale. The report in respect of the 8 bottles taken for analysis was received on 29-11-62 from the first accused. It will appear that contrary to the mandatory requirements prescribed in Rule 96 (v) of the Drug Rules made under the Drugs Act 1940, each of the lots of 80 litres of solution manufactured, was not given a separate batch number but all the 5 lots consisting of 394 bottles were given as aforesaid only one batch No.211/05. In view of this, the analysis of only 8 bottles from the several lots could not indicate the quantity of lead nitrate in all the 5 lots. In the normal course, some of the bottles which were sold by the company were purchased by different hospitals, nursing homes and medical practitioners and were administered to several patients of whom 13 persons died. Immediately after these deaths, a report having been made by the doctors who administered that they suspected adulteration or contamination of the solution, that batch was withdrawn and about 125 bottles were sent for analysis by the Government Analyst. One of these, 51 bottles alone showed the contents to be of requisite standard prescribed under the Drugs Act with permissible deviation from the standards but the remainder disclosed lead nitrate very much over the permissible limits and was dangerous to human life. The High Court after considering the several exhibits regarding the issue of sodium chloride by the Stores to the Injection Department, and the Registers of the Injection Department maintained by the appellant, came to the conclusion that on 11-11-62 there was only 15 grams of sodium chloride in the Injection Department, and thereafter 5 kg. was received from the Stores Department by the appellant on 23-11-62. As against this, Exhibit 164 shows that he had utilised 2.340 kgs. of sodium chloride for preparing this solution of batch No. 211105. It further held that the production report shows that the 450 bottles were prepared on November 12, 1962 but as a matter of fact, according to Exhibit 232, the Injection Batch Book, the entire lot of 450 bottles was not prepared on one and the same day. 106 bottles of that batch were filled and sealed on 10-11-62 and the remaining 344 bottles were filled and sealed on 12-11-62. In view of these facts, the High Court observed as follows:- "The only possible conclusion that one can reach from the material disclosed by the various exhibits was that the appellant had used 2.340 kgs. of sodium chloride from a source or sources unknown as such there was a lack of homogeneity in the solution prepared by him". The explanation of the accused that there was a practice in the company of using the solutions contained in bottles rejected on the ground of dust when goods or drugs of the same kind came to be prepared later on, was not accepted as being incompatible and inconsistent with the entries made by him in Exhibit 164 and was a pure afterthought. It was further held that the appellant has not been able to show the source from which sodium chloride weighing 2.340 kgs. was obtained by him for preparing glucose in normal saline of batch No. 211105, and that the only possible conclusion of this negligence of the accused is that it was the cause of the death of 12 individuals who, it has been established, died because of the administration of contaminated drug. With respect of the death of the 13th person, there was no clear finding that his death was due to the administration of the glucose in normal saline of Batch No. 211105.
(3.) We may en passant mention that the learned Advocate for the appellant referred to prosecution of 10 accused including the appellant, the Store Keeper Vaghjibhai and the Chief Analyst Prabhakaran the first accused for the contravention of the Drugs Act. The appellant and the first accused were charged with contravention of Rules 78 (c), 109 (c), 111, 114 (h), 115 and 121 (a) which are offences under Ss. 18 (a) (I) and 18 (a) (v) of the Drugs Act punishable under Section 27 of that Act. Vaghjibhai was charged with the contravention of Rule 121 (a), an offence under Section 18 (a) (v) punishable under Section 27 of the Act. We were also informed that all of them were ultimately acquitted of these charges. Though the charge-sheet has been filed before us, no copy of the judgment has been brought to our notice. That there was a prosecution for the offences under the Drugs Act is mentioned by the appellant in his statement under Section 342, Criminal P. C. to the question that he along with other accused got the drug in question manufactured with culpable negligence for the purpose of administering to human beings in culpable violation of the provision of the Drugs Act and Rules which he was bound to follow. The learned Advocate for the appellant, however, states that even assuming that there was a contravention of the relevant rules, any lapse on the part of the appellant to conform to them is not the direct cause of the death of the 12 persons so as to make him liable to punishment under Section 304-A.;