Both these applications u/s 482 Cr.P.C. have been filed for quashing the entire proceeding of Case No. RC NO 1(S) 2003/SIC IV/LKO, CBI Vs. Rajiv Gulati and others, u/s 275/420 I.P.C. and Section 27 of the Drugs and Cosmetics Act 1940, pending in the court of Special Judicial Magistrate (C.B.I.), Ghaziabad, U.P.
As both the applications u/s 482 Cr.P.C. have been filed for quashing the proceedings of the same case, hence are being decided by a common order.
It appears from the record of the case that an F.I.R. was lodged by O.P. No. 1, Dr. Sharad Gupta against the applicants Rajiv Gulati and Sandeep Gupta at Police Station New Agra, District Agra, on 30.8.2002 at 8.00 P.M. It was alleged in the FIR that the informant himself is a doctor, whose father Sri Devbrat Gupta was suffering from diabetes for the last about 15 years. For the control of diabetes he was using 30/70 U-100 Huminsulin of Eli Lilly Company for the last three years. On 24.6.2002 at about 12.00 in the noon the complainant purchased four vials of Huminsulin of the above Company from Ravi Medical Store, Fountain, Agra. He took the receipt of this Insulin on 3.7.2002. Out of these four vials he used one vial for the treatment of his father. Immediately after using the insulin his father got paralysis attack and started feeling uneasiness. He was, then, admitted in the hospital. The informant returned one vial to the representative of the Company on 2.7.2002. He also informed the Chief Medical Officer, Agra, on telephone, who got sealed the whole insulin of the Batch to which the disputed insulin belonged through Drug Inspector. A request was made for taking action against Mr. Rajiv Gulati, Chairman Cum Managing Director, Eli Lilly and Company (India) Pvt. Ltd. and Mr. Sandeep Gupta, Director, Marketing & Sales, of this Company.
The investigation of this case was ordered to be conducted by the C.B.I. under the orders of the High Court, Allahabad, passed in Criminal Misc. Writ Petition No. 6052 of 2002, Mr. Sandeep Gupta Vs. State of U.P. and others. The C.B.I. registered the case at Crime No. RC NO 1(S) 2003/SIC IV/LKO.
The investigation of the CBI disclosed that the drug Huminsulin is imported in India from France and marketed in India by M/s Eli Lilly and Company (India) Pvt. Ltd. The medicine, which was used by the informant Dr. Sharad Gupta was given to the representative of the Company by the informant for examination. An analysis report was received from France mentioning that the vial collected from the informant had "frosting phenomenon" indicating clumping of insulin crystals on the surface of the vial. This phenomenon could result in a loss of potency due to exposure to outside temperature beyond the prescribed limit of 2-8 degrees Centigrade.
During the investigation sample of the drug seized by the local police and the Drug Inspector, Agra, was also sent to Central Drug Laboratory, Kolkata, from where the report was received mentioning "sealed samples were not of standard quality as the sample does not conform to the manufacturing specifications in respect of assay (total insulin activity). The subsequent opinion of the Central Drug Laboratory, Kolkata, said that the "sample sealed by the police and the Drug Inspector did not indicate any adulteration".
During investigation by the C.B.I. the matter was also referred to All India Institute of Medical Sciences, New Delhi, for expert opinion, from where it was opined that the paralysis suffered by the father of the informant could not be attributed to the drug in question. It had also been opined that the total insulin activity (assay) of 92.7% in the sample sealed by the Drug Inspector is within the acceptable limit and is not likely to cause any adverse effect. However, total insulin activity (assay) of 70.38% in the sample sealed by the police i.e. the sample given by the complainant could be due to degradation on account of use or transport or storage and hence could not be co-related with the disease / paralysis.
The investigation revealed that the consignment of huminsulin had travelled from France to Delhi, thereafter to Lucknow and then to M/s Cash Chemist Agency, Agra. No evidence was found to fix responsibility for the less percentage of total insulin activity in the sample seized by the Drug Inspector and by the local police.
CBI investigation also revealed that there was no evidence to prove at what stage the minimum required temperature of 2-8 degree C. of the said drug was not maintained and in view of the opinion of the experts that the drug huminsulin was not adulterated and the drug was not likely to cause any adverse effect, no criminal case was found to have been made out against the applicants. The CBI after investigation submitted the final report.
Against the final report a protest petition was filed by the informant on which the parties were heard by the Special Judicial Magistrate (CBI), Ghaziabad, who rejected the final report submitted by the CBI and summoned the applicants Rajiv Gulati and Sandeep Gupta to face trial for the offences punishable u/s 275/420 I.P.C. and Section 27 of the Drugs and Cosmetics Act 1940 vide order dated 2.8.2005. This order of cognizance has been challenged by the applicants by means of the above mentioned applications u/s 482 Cr.P.C. and it has been requested that the whole proceedings of Case No. RC NO 1(S) 2003/SIC IV/LKO, CBI Vs. Rajiv Gulati and others, u/s 275/420 I.P.C. and Section 27 of the Drugs and Cosmetics Act 1940, pending in the court of Special Judicial Magistrate (C.B.I.), Ghaziabad, U.P. be quashed.
Affidavits between the parties have been exchanged.
I have heard Mr. G. S. Chaturvedi, learned Senior Counsel, assisted by Mr. Amit Saxena, learned counsel for the applicants, learned AGA for the State, Mr. Dilip Kumar, learned counsel assisted by Mr. Rajiv Gupta and Mr. Rajarshi Gupta, learned counsel for O.P. No. 1 and perused the record.
It was admitted by Mr. Chaturvedi that Mr. Rajiv Gulati is Chairman Cum Managing Director, Eli Lilly and Company (India) Pvt. Ltd. Gurgaon. and Mr. Sandeep Gupta is Director, Marketing & Sales, of this Company. This Company is only a subsidiary of Eli Lilly and Company based in France. The applicants cannot be found guilty for committing any offence for the following reasons:
(i)that the huminsulin of the applicants' Company purchased by the informant was not adulterated as per the definition of sections 17A(a) and 17A(b) of the Drugs and Cosmetics Act 1940,
(ii)that the drug travelled from the Company of the applicants at Gurgaon to Lucknow and from there to Agra and then to the informant. In such circumstances it cannot be said that as to where the cold chain was broken, which was necessary to be maintained for preserving the efficacy of the drug.
(iii)that the record shows that the paralysis, which is said to be the cause of the death of the father of the informant had not taken place due to the administration of the drug purchased by the informant.
To the above, it was argued by Mr. Dilip Kumar, learned counsel for the informant that it being the responsibility of the applicants to maintain the efficacy of the drug and the drug was adulterated, hence they cannot escape their liability for the offences punishable u/s 275/420 I.P.C. and Section 27 of the Drugs and Cosmetics Act 1940.
In view of the above arguments, the prime question for determination is as to whether the drug, which was purchased by the informant was adulterated at the time when it was purchased by him.
What is an "adulterated drug" is defined u/s 17A of the Drugs and Cosmetics Act 1940. A "drug" shall be deemed to be adulterated
(a) if it consists, in whole or in part, of any filthy, putrid or decomposed substance; or
(b) if it has been prepared, packed or stored under insanitary conditions whereby it may have been contaminated with filth or whereby it may have been rendered injurious to health; or (C) if its container is composed in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or
(d) if it bears or contains, for purpose of colouring only, a clolour other than one which is prescribed; or
(e) if it contains any harmful or toxic substance which may render it injurious to health; or
(f) if any substance has been mixed therewith so as to reduce its quality or strength.
From the analysis report obtained during the investigation only this much was found that the total insulin activity of the sample collected from the Stockist was 92.7% and the sample collected from the informant was having total insulin activity of 70.38%. The analysis report did not say that any of the conditions as mentioned in section 17A of the Drugs and Cosmetics Act 1940 was available to brand the sample as adulterated. It is also on the record that the Central Drug Laboratory, Kolkata, had specifically opined that the sample was not adulterated. Thus, from the whole evidence only this much is indicated that the insulin purchased by the informant was not adulterated. However, the sample collected from the Chemist was having 92.7% total insulin activity and the sample, which was taken from the informant was having total insulin activity of 70.38%. The panel of doctors of All India Institute of Medical Sciences, Delhi, were also required by the CBI to give report about the samples and nowhere it was said in the report that the sample was adulterated. It was said by the doctors of AIMS, Delhi, that 92.7% insulin activity was well within the acceptable limit and was not likely to cause any adverse effect. Therefore, from the evidence on the record it is very much clear that up to the stage of the responsibility of maintaining the cold chain by the applicants the efficacy of the medicine was 92.7% and after that it deteriorated when it remained in the custody of the informant. Nowhere it was said that mere reduction in the total insulin activity would be termed as adulterated within the meaning of section 17A of the Drugs and Cosmetics Act 1940. Unless the contravention of any of the conditions mentioned in this section is proved, the drug cannot be said to be adulterated. Because no where it has been shown that any of the conditions necessary for bringing a case within the definition of adulteration was available in the present case inspite of the fact that the efficacy of the drug had reduced due to not maintaining the cold chain the drug cannot be said to be adulterated.
As it is apparent from the record that from France to Gurgaon, Gurgaon to Lucknow and Lucknow to Agra (to the shop of the Chemist) the cold chain was maintained up to the standard that the efficacy of the drug at the shop of the Chemist was 92.7%, hence the applicants cannot be blamed for dereliction of their responsibility in the supply of drug in the prescribed standard required for maintaining its efficacy. There can be a possibility that the total insulin activity had reduced up to the residence of the informant due to his own fault. If this would not have happened due to the fault of the informant then certainly the sample taken from his residence would have also contained the insulin activity of 92.7%. Here I would also like to mention that the samples of the batch to which the disputed insulin belonged were taken from various places and were sent for chemical examination and in no sample any adulteration or any deficiency in the total insulin activity was found. In such view of the matter, this can well be said that the sample, which was collected from the informant had reduced in its total insulin activity due to the own fault of the informant for which no one can be held responsible. It is also pertinent to mention that the paralysis or the death of the father of the informant was not caused due to the administration of the drug as is the report of the panel of the experts of AIIMS, Delhi.
Now it is to be seen as to whether in a case where the drug was not adulterated an offence u/s 275 I.P.C. or 420 I.P.C. or 27 of the Drugs and Cosmetics Act 1940 is made out or not.
The offence u/s 275 I.P.C. is constituted only when any drug or medical preparation was found to be adulterated and because in the present case the drug in question was not adulterated, hence section 275 I.P.C. cannot be said to have been made out.
For constituting the offence u/s 420 I.P.C. it is necessary that deception would have been practised by the offender and by that deception fraudulently or dishonestly induced the person so deceived to deliver any property to any person or to consent that any person should retain any property or intentionally induces the person so deceived to do or omit to do anything, which he would not do or omit if he were not so deceived, and which act or omission causes or is likely to cause damage or harm to that person in body, mind, reputation or property.
From the evidence collected by the I.O. it is very much clear that no evidence was collected to the effect that the applicants had ever caused deception to the informant either by themselves or through the Chemist from where the medicine was purchased. The medicine was imported from France and was sent up to the shop of the Chemist in the same form, hence there could not be any occasion for deceiving the informant. The informant could be said to have been deceived only when the medicine did not have that much of potency, which was mentioned by the Company. The reduction in total insulin activity for about 8% could be due to natural causes and thus, it cannot be said that up to the stage of Chemist the drug was sold of the standard, which it was not having. Thus, in my opinion, no cheating is said to have been committed by the applicants or their Company.
Now comes Section 27 of the Drugs and Cosmetics Act 1940. This provision can be attracted only if any adulterated drug was sold and because no such drug is proved to have been sold, hence the offence punishable under this section is also not made out.
Once the offence punishable under section 275 or 420 I.P.C. or u/s 27 of the Drugs and Cosmetics Act 1940, was not made out, hence the Special Judicial Magistrate (C.B.I.), Ghaziabad, was not justified in summoning the applicants for the aforesaid offences as held by the Supreme Court in U. Dhar Vs. State of Jharkhand 2003(2) SCC 219BI. The order of the Magistrate summoning the applicants is also uncalled for as from the order it appears that the Magistrate had not applied his mind while issuing the summoning order as he did not consider the provisions of sections 275 and 420 I.P.C. and section 27 of the Drugs and Cosmetics Act 1940, in right perspective.
Thus, in view of the above, I am of the view that once no offence punishable u/s 275, 420 I.P.C. and u/s 27 of the Drugs and Cosmetics Act 1940, was made out the final report submitted by the C.B.I. should have been accepted and the protest petition filed by the informant- respondent no. 1 should have been dismissed and by not doing the same the Magistrate has passed an improper summoning order on 2.8.2005, which is liable to be set aside and the entire proceedings of the criminal case are also liable to be quashed.
Accordingly, both the applications are allowed and the summoning order dated 2.8.2005 passed by the Special Judicial Magistrate (C.B.I.), Ghaziabad, against the applicants and the entire proceedings of Case No. RC NO 1(S) 2003/SIC IV/LKO, CBI Vs. Rajiv Gulati and others, u/s 275/420 I.P.C. and Section 27 of the Drugs and Cosmetics Act 1940, pending in the court of Special Judicial Magistrate (C.B.I.), Ghaziabad, U.P. are hereby quashed.
DT/-07.10.2010 Pcl.