AMBALAL D BHATT Vs. STATE OF GUJARAT

JUDGEMENT

(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:-

(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.