Judgement

P. JAGANMOHAN REDDY, J.:- 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