Hari Dev Nargotra vs Sandoz India Limited

Hari Dev Nargotra, (hereinafter referred to as the complainant in the complaint preferred under Section 15 of the Jammu and Kashmir

Consumer Protection Act of 1987) has since died. He died during the pendency of complaint on 10th Feb '98. His widow and three sons were

brought on the record as legal heirs. The complainant had undergone kidney transplant operation on 29th May '96,. This was in Sir Ganga Ram

Hospital, New Delhi. According to the complainant, the doctor attending on him advised to take a medicine namely Sandimmun Neoral Liquid.

The prescription in this regard was given by Dr. A.K. Bhalla. As per the complainant, he had purchased this medicine from Sandoz India Ltd, sales

office, New Delhi. This medicine was purchased on different occasions. The first purchase is said to have been made on 29th May '96 vide invoice

No. 2208. The second purchase was vide invoice No. 4883 issued on 10th Oct '96. The other invoices are 4347 dt. 24th Oct '96, 4603 dt. 19th

Nov '96 and 1205 dt. 26th March ' 97 respectively. According to the complainant when he purchased the medicine vide notice No. 1205 dt. 26th

March '97 and used the same, he developed some abnormal symptoms. He was admitted in the hospital. The doctor attending on him examined

the medicine purchased vide invoice No. 1205. It was found that the bottle containing the liquid medicine indicated the date of expiry as Dec' 97.

This was as per the second label affixed on the original one. In the original label, the date of expiry was Dec '96. The other bottles containing the

liquid medicine were also examined and it was found that the fife span of the medicine was two years but it was upgraded by putting another label

on the original one which was affixed on the bottle. According to the complainant, as the life of the medicine stood expired and it was on account

of this factor, the complainant's recovery progress was hampered. The complainant claimed damages to the extent of Rs. 20 laces.

Respondent manufacturer of the medicine in question filed an affidavit which is to the effect that the Drug Controller of India verified the stability

of the drug and was of the opinion that the medicine would remain stable for a period of three years from the date of manufacture. It was on the

basis of the stability report, another label was affixed. It is accordingly submitted that to say that the medicine had out lived its life and that on

account of this factor, the complainant suffered some problem is not correct. Para 4 of the affidavit filed in this regard is being reproduced below :

That Sandoz Pharma Limited, Switzerland, the erstwhile manufacturers of the drug, from whom the respondent has imported the product into

India, have generated data and carried out extensive stability studies which conclusively establish that the product remains stable for a period of

three years from its date of manufacture. Hereto annexed and marked as Exhibit 1 is a copy of the Stability Report dt. 7th May, 1996 on the

product generated by the manufacturer Sandoz Pharma Limited, Switzerland. Based on this report, the respondent applied to the Drugs Controller

of India for extension of the shelf life of the drug from two years to three years. The Drugs Controller of India, in turn, independently verified the

stability of the drug by sending a sample thereof to the Central Drug Research Laboratory, Calcutta and after being satisfied that the claim of the

Manufacturers with regard to the stability of the drug was correct, granted his approval to the extention of the shelf life by a period of one year.

Hereto annexed and marked as Exhibit 2 is a copy of the said approval dated 23rd December, 1996 granted by the Drugs Controller of India in

this behalf. It was pursuant to this approval that the Respondent relabelled the drug, Sandimmum Neoral Liquid Batch Nos. 151 and 152) with the

revised expiry date.

Thus, the stand taken by the respondentSandoz India limited is that the Drug Controller of India had verified the shelf life of the medicine and as it

was found that the medicine would remain stable for three years, restickering was done. The permission granted by the Drug Controller of India

has been placed on the record as Exhibit 2 For facility of reference, this is also being reproduced below:

.""....Reference letter No The case has been examined by this Directorate in the light of test reports submitted by the Director Central Drugs

Laboratory. Calcutta. This Directorate has no objection for the Restickering of Sandimmun Neoral Liquid B, Nos. 151 & 152 by the firm for

extension of life period.

Thus, as indicated above, the stand taken by respondent is that restickering was done after permission was obtained from the Drug Controller of

India and in doing so, no compromise was made with regard to the efficacy of the medicine in question.

After evidence was recorded, the State Commission took note of the fact that the complainant had undergone Kidney transplantation on 29th

May 96. He was advised to take a life saving drug. He had been using this medicine. It has also been found that on the bottles purchased by the

complainant restrickering was done. After taking note of the pleading of the parties, the Commission was of the view that the controversy which is

required to be resolved is as to whether restickering was done unauthorisedly and whether the death of the complain ant was caused because of

administration of a medicine which had outlived its shelf life. The State Commission was of the view that as restickering was done with the

permission of Drug Controller of India and as it had duly certified that the shelf life of the medicine is three years, therefore, no case was made out

for grant of damages. It is this view formed by the State Commission which is subject matter of challenge in this Appeal.

We have heard learned counsel for the parties. We are of the opinion that this is a case where restickering was done with the prior permission of

Drug Controller of India. The medicine in question was sent for examination to the Central Drug Research Laboratory, Calcutta. The medicine was

subjected to test with regard to its stability. It was after taking these steps permission was accorded to affix a second label on batch Nos. 151 and

The medicine in question was purchased by the complainant out of batch No. 152. Thus, restickering was done after obtaining a valid

permission. If this be the position, then so far as this aspect of the matter is concerned, the view expressed by the State Commission cannot be

faulted.

The second question which is re quired to be taken note of is as to whether on account of administration of the drug in question any further

compli cation was caused to the complainant.

Dr Suresh Saraf, who appeared on behalf of complainant stated that notwith standing the fact that the medicine is administered, the possibility of

a particu lar patient rejecting transplant organ can not be rule out. He also stated that per centage of rejection of transplanted or gan increases with

the lapse of time. The duration within which transplant would be rejected depends upon patient to patient. He further stated...""the survival rate of

patient is 90% during 1st year, by Illrd year, it is between 70 to 80%. The survival rate beyond five years is 50%... He also stated...""despite the

administration drugs like Sandimmun, the rejection of the transplant continues.... despite be ing given the capsules, the complainant never recovered

and he ultimately died of Renal failure with septiemea."" He fur ther stated that...""before the marketing of the drug in question in India, the Drug

Controller has to give his permission to market the drug. If the statement of Dr. Suresh Saraf who was looking after, the complainant is taken note

of, then. it becomes apparent that notwithstanding the fact that the medicine is being administered, there may be a rejection of transplant organ.

Thus, in the present case, to say that the shelf life of the drug had expired and that restickering was done unauthorisedly cannot be sustained. The

opinion of the doctor who appeared and was looking after the complainant was to the effect that notwithstanding the fact that medicine is

administered, the patient may still reject the transplant. Therefore, to say that some complications took place on account of the fact that the

medicine which was administered had out lived its shelf life is factually incorrect. The death of the complainant occurred on account of his Renal

failure and not as a result of the intake of the medicine in question. In view of the above, we do not find any merit in this appeal and the same is

dismissed. The complainant is, however, held entitled to cost of litigation. This is because, there was a reasonable belief with him for forming an

impression that shelf life of the medicine stood expired. The fact that restickering was done could give rise to this plea. This plea stood dispelled

only in view of the circumstances explained by the respondent manufacturer. In these circumstances, we deem it proper to allow the cost of

litigation which is fixed at Rs.5000/, to be paid to the legal heirs of the complainant.

We also observe that whenever restickering is done, the patient should be informed about this fact and this fact should also be mentioned in the

invoice. Had this been done, then this litigation could have been avoided. Necessary directions in this regard would be issued to the manufacturers

of drugs by the Drug Controller of India. Otherwise, as indicated above, there is no merit in this appeal which is dismissed as such.