Sidhartha Mitra and another vs Dr. Kuldip Singh

Adarsh Kumar Goel, J.—This petition has been filed for quashing of a complaint, Annexure P-1 under the provisions of the Drugs and Cosmetics Act, 1940 (for short, the Act) filed by the Respondent herein. In the complaint, it is alleged that on 21.10.1992, when the complainant, Medical Officer in Civil Hospital, Jagadhri was on round, he saw a bottle of Futodrip-10 to be administered to an indoor patient Mukhtiar Singh who was suffering from kidney failure. The said bottle was full of fungus which was "apparently obvious from the bottle and can be seen with naked eyes." The complainant stopped its administration to the patient and returned the bottle to the chemist. The complainant purchased four bottles from the chemist one of which was same which was earlier returned by the attendant and seal of which was broken and another bottle was full of fungus "obvious to the naked eyes". It was further alleged that accused committed offence by selling the drug which was adulterated. Preliminary evidence comprised of statement of Respondent, C.W.-1, Smt. Sunita Sharma, C.W.-2, who was licensee of the chemist shop and C.W.-3 Roshan Lal, attendant of the patient. The Petitioners were summoned on the basis of preliminary evidence comprising of the above witnesses and the report of the Government Analyst, Ex. PX to the following effect:

The sample contains lot of white fibrous mast (mass ?) appeared to be fungus.

It does not pass the test for pyrogen.

It does not pass the test for sterility as it contains bacteria and fungi.

In support of this petition for quashing, learned Counsel for the Petitioners submitted that even if all the allegations in the complaint are accepted as correct, no case was made out for proceeding against the manufacturer at the initial stage and the manufacturer should have been summoned only for a manufacturing defect and initial liability was of the chemist. He referred to the provisions of Section 19(2)(b) of the Act and the judgment reported in Narinder Kumar Mangilal Dani v. State of Maharashtra, 2002 (1) RCR 313, Paras 2, 3 and 6. He submitted that a warning was notified on the bottle to the effect that the solution was not to be used if container was found leaking or if solution was not clear. He also referred to extract from "Principles and Practice of Intravenous Therapy" published by Little, Brown and Company, Boston Toronto, to the effect that prior to use, containers of fluid should be thoroughly examined to detect any hole as any accidental puncture may occur which may provide a point of entry for microorganisms. He also referred to Pharmaceutical Dosageforms Parenteral Medications by Pharmaceutical Dosageforms, Parenteral Medications, published by Marcel Dekker, INC, New York and Basel to the effect that contamination may occur due to hairlines cracks invisible to the naked eye which may exist in a container. He also referred to receipt Annexure P-6 mentioning that sale to the chemist was made in good condition.

Learned Counsel for the complainant submitted that these contentions could not be appreciated in a petition for quashing in view of law laid down in Joginder Pal Vohra v. State of Haryana, 1997 (4) RCR 584.

I have considered the rival submissions and perused the record.

There is allegation in the complaint that the drug in question was contaminated. The trial Court obtained a report from the Government analyst, Ex. PX referred to in para 7 of the impugned order confirming that the sample was not of standard quality and contained fungus. The trial Court found sufficient ground to proceed u/s 27 of the Act.

According to the judgment relied upon by the learned Counsel for the Petitioner, which refers to earlier judgment in M/s Prem Pharmaceuticals and Ors. v. State of MP, 1989 Cri. LJ 2028 and Pharmacopoeia of India, visible solid particles could develop on account of natural phenomenon if there was variation in temperature and therefore, label was required to indicate that the drug should not be used if it contained visible solid particles.

At this stage, in a petition u/s 482 of the Code of Criminal Procedure, question as to whether fungus developed naturally or on account of manufacturing defect cannot be decided. There is no material to hold that fungus cannot relate to any act or omission of manufacturer. Merely because a label has been put giving a caution that the drug should not be used if it carried fungus which was visible, liability of manufacturer is not ruled out. Whether manufacturer is at fault or not, is a question of fact. It is not possible to lay down that whenever there is visible fungus, the same is only on account of natural phenomenon. Prayer for quashing can be accepted only by accepting the prosecution to be true.

In view of the above, prayer for quashing cannot be accepted. However, I am of the view that order of summoning in such a case ought not to be passed mechanically without going into the question as to who was prima facie responsible for the contamination in the drug.

In view of the above, a direction is issued to the trial Court not to enforce the order of summoning before deciding the question of prima facie liability of the accused. Since the matter is a technical one, the Petitioners will be at liberty to appear before the trial Court to place their view-point in the matter.

It is made clear that the observations made herein above will not be treated as an expression of opinion on merits either way and the trial Court will be liberty to pass a fresh order in accordance with law. The parties will appear before the trial Court for further proceedings on October 24, 2005.

Order accordingly.