HARI DEV NARGOTRA Vs. SANDOZ INDIA LTD

JUDGEMENT

(1.) HARI Dev Nargotra, (here -in -after 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 life 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 complainants recovery progress was hampered. The complainant claimed damages to the extent of Rs. 20 laces.

(2.) 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 respondent -Sandoz 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, re -stickering 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 Re -stickering of Sandimmun Neoral Liquid B. Nos. 151 & 152 by the firm for extension of life period.

(3.) THUS , as indicated above, the stand taken by respondent is that re -stickering 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.