Dr. S.M. Kantikar, Presiding Member.
1. The complainant No. 1, an IPS officer, was serving as Additional Director General of Police, CID, Hyderabad in the year 2003. The complainant No. 2 is the wife of complainant No. 1. The opposite party—M/s. Bharat Biotech International Limited (for short, ‘M/s Bharat Biotech’) is a pharmaceutical company engaged in manufacturing and marketing of different drugs, vaccines including the vaccine “Revac-B” for Hepatitis-B. Complaint:
2. For Hepatitis-B prophylaxis, complainant No. 1, Mr. M.L. Kumavat, took the first dose of Hepatitis-B vaccine ‘Energix-B’ manufactured by M/s. Smith Kline Beecham. He did not experience any adverse reaction. After about a month i.e. on 19.6.2001, he took second dose of vaccine with the trade name ‘Revac-B’ vaccine manufactured by M/s Bharat Biotech Ltd., the opposite party. The said vaccine was purchased from a regular medical shop and was administered by Dr. Indeever Reddy-doctor of the Police Department. The vaccine was administered at the complainant’s residence. Just after five minutes of administration of ‘Revac-B’ vaccine, complainant No. 1 started getting pain on right deltoid region which went on increasing and inflammation was started in that area. However, according to complainant No. 1, there was no such pain or reaction at the time of first dosage of ‘Energix-B’ vaccine. Furthermore, the swelling on the right deltoid region started increasing with discoloration of the skin on the entire deltoid region. The pain was intolerable and he started feeling breathless. The complainant No. 1 immediately rushed to nearby Vasavi Hospital, Khairatabad at 11.30 a.m. where Dr. Pushpa examined him and advised to apply analgesic cream on the deltoid region and to take ‘Avil’ and ‘Combiflam’ tablets. The complainant also called his departmental doctor, Dr. Reddy, who was shocked to see the condition of complainant No. 1. The complainant No. 1 had applied the analgesic cream and took the medicine also but the pain did not subside. He was unable to move his right arm or even the fingers of his right hand. Thereafter, he started feeling pain in the entire right side of the body. The reaction of the vaccine would develop a state of shock and paralysis in him. As advised by Dr. Reddy, complainant No. 1 approached Nizam Institute of Medical Sciences, Hyderabad (NIMS) at 3.45 p.m. apprehending that this reaction might turn into fatal condition. He was examined at the emergency department of NIMS, and due to his extremely critical condition, he got admitted there. The doctors gave him life saving drugs and steroid. Thus, the complainant No. 1 had to battle for his life during his stay in NIMS from 19.6.2001 to 27.6.2001.
3. The complainant No. 1 further alleged that his father about 75 years of age was staying at their home town in Rajasthan, went into shock by knowing the serious condition of his son. His father could not recover from the shock and finally expired on 27.6.2001. Despite his ailing condition, he was forced to seek discharge from NIMS to attend last rites of his father.
4. Regarding vaccine ‘Revac-B’ it was bearing batch No. RVV 009 manufactured in 1998 and its expiry was November 2001. The complainant No. 1 enquired about the details of the company and came to know that the drug control had issued notice to the opposite party and it accused of not having printed the proper generic name of the said product in accordance to the prescribed manner. It was alleged that the vaccine was released before the approval of the Central Research Institute, Kasauli. The complainant also alleged that the drug department had received complaints that some people who used the vaccine ‘Revac-B’ of batch No. RVV 009 developed pain at the place of injection. The complainant No. 1 was shocked and surprised when he came to know that even after the drug department had issued directives to stop the sale of ‘Revac-B’ vaccine, opposite party disobeyed the directives and doing unethical sale in the market. The complainant further submitted that during his hospitalization, two senior officers of opposite party-company, namely, Mr. K. S. Rao, Director and Mr. G. M. Krishna, General Manager visited him with a bouquet of flowers and offered the complainant to pay hospitalization charges and other expenses. However, the complainant politely declined their offer. Thus, it was a mala fide intention of the opposite party to buy his silence by coming forward to pay the hospitalization charges/expenses. The opposite party had manufactured the said dangerous vaccine in violation of license from drug controller with utter disregard to the value and importance of human life. The complainant further submitted that due to the said episode his entire family suffered mentally as well as financially.
5. The complainant No. 1 further submitted that, on 6.7.2001 Dr. P.M. Bhargava, the President of Society for Scientific Values had written a letter to the then Drugs Controller General of India stating that the opposite party had been licensed to produce Hepatitis-B vaccine using only “ Cervisiac ” as the vector but have been using “ Pischia Pastoris ” as the vector. Thus, complainant No. 1 requested for investigation and withholding of license to manufacture their vaccine using “Pischia Pastoris” pending the Drug Controller General’s investigation.
6. On 19.7.2001, the complainant served legal notice to the opposite party for supply of sub-standard vaccine which did not meet the standard of purification. Being aggrieved by the entirety, the complainant filed a complaint for recovery of damages due to the negligence of opposite party-company, with the following prayer:
1. Issue an appropriate order and direction thereby directing the respondent to pay sum of Rs. 12 crore as compensation/damages/expenses as stated in para 26 of the complaint.
2. Issue an appropriate order and direction thereby directing the respondent to pay sum of Rs. 50,000 as cost and expenses of the present complaint.
3. Issue any other appropriate orders or directions as this Hon’ble Commission may deem fit and proper in the circumstances of the case.
7. The opposite party filed its written version through its manager and denied entire allegations. According to the opposite party, complaint was based on wrong premise. There is no basis that the first dose of vaccine named ‘Engerix-B’ was uneventful, but after the second dose of vaccine with different trade name ‘Revac-B’, he got intolerable pain. He was hospitalized and took treatment for about one week for pain and inflammation caused due to administration of ‘Revac-B’ vaccine. The alleged grievance was untenable and the compensation of Rs. 12 crores prayed was highly exaggerated. The opposite party obeyed the direction/communication issued by Drugs Controller of Andhra Pradesh on 30.6.2001 calling upon the opposite party to withdraw batch No. 009 from the market. However, it was an administrative direction and not a conclusion about the quality of vaccine because the said batch No. 009 was already certified by the Central Drugs Laboratory, Kasauli on 22.3.1999, as being fit for human administration. One Dr. P.M. Bhargava addressed a letter dated 6.7.2001 to several persons alleging that the opposite party-company is using “ Pichia pastoris” as a vector without license from the owner of the Patent M/s. Research Technologies Corporation of USA. At the same time, complainant No. 1 got issued lawyer’s legal notice dated 19.7.2001 and 3.8.2001 claiming Rs. 12 crores as compensation by alleging “Pichia pastoris” is an inferior vector and demanded the stopping of manufacturing of the vaccine. After issuance of the lawyer’s notice dated 19.7.2001 and 3.8.2001, Mr. M. L. Kumawat and Dr. P. M. Bhargava had gone on a rampage by planting sponsored news in the Indian Express of Hyderabad Edition from 6 th to 9th August, 2001. Thus, the opposite party-company was victimized by the media trial. Dr. P. M. Bhargava had filed a writ petition No. 20565 of 2001 before the Hon’ble High Court of Andhra Pradesh at Hyderabad on 1.10.2001. The writ petition was dismissed vide order dated 21.11.2001 with their observation “inspecting team has pointed out certain deficiencies relating to documentation and maintenance” . There was no adverse remark about the quality of product and vector (Pichia-Pastoris) used in the production of vaccine. Thereafter, the sample of vaccine was sent to Central Drug Laboratory, Kasauli, who certified that the vaccine was safe and immunogenic responsive. According to the OP, the complainant No. 1 did not belong to high risk category of immunization of ‘Hepatitis-B’.
8. The opposite party further submitted that there was no prescription with the complainant No. 1 for ‘Hepatitis-B’ vaccination. The complainant No. 1 neither produced bill showing his name and details of purchase of Engerix-B (1st dose) and the Revac-B (2nd dose). The vaccine was administered by Dr. Indeevar Reddy, the doctor of police department which might have administered with lack of due care and caution. Another objection was that the complaint was barred by limitation as the alleged cause of action was from 19th to 26th June, 2001 when the alleged vaccination and hospitalization occurred, however, the complaint was filed on 7.8.2003. The complainant No. 1 had misused his official capacity and got enlisted the services of his subordinate officer Mr. Alok Srivastava, IPS (1977 batch), who was the Inspector General of Drugs Control Administration and got initiated proceedings by the Drugs Inspector against the chemist who sold ‘Revac-B’ vaccine of batch No. 009 on 19.06.2001 without prescription or bill. However, the investigation showed that the chemist had six vials of 0.5 ml each of Pediatric dose of batch No. 011. He did not possess any stock of batch No. 009.
9. Learned Counsel of both the sides argued the matter. They reiterated their respective affidavits of evidence.
10. We have perused the affidavits of evidence and the medical record of NIMS; gave our thoughtful consideration to the arguments from both the sides.
* According to the complainant No. 1, he suffered severe pain after injection of ‘Revac B’. There are several reasons which could be due to faulty administration or storage / refrigeration at the pharmacy. Therefore, how opposite party-company made liable.
* It is surprising that, how Dr. Indeveer Reddy suggest the complainant No. 1 to take ‘Revac B’ when already 1st dose of Engerix-B was given. Thus in our view it was fault of the doctor for choosing the different brand of 2 nd dose.
* We are not impressed about the contention raised by the complainant No. 1 with respect to the use of vector ‘Pichia Pastoris’ for manufacture of the vaccine. As per record the drug authorities have certified the product fit for human use and in the instant case, Central Drugs Laboratory certified the vaccine as being fit for human use and for release in the market on 23.2.1999. Moreover, M/s, Research Technologies Cor-poration of U.S.A. has not chosen to initiate any proceedings against the opposite party in India for its patent. Therefore,Dr. P. M. Bhargava has no locus to arrogate himself about what would be ethical in manufacture of vaccine by the opposite party.
* In the instant case, when the vaccine caused allegedproblem, the complainant should have preserved the product literature and the vial of the vaccine as an evidence before this commission.
11. We have perused the medical literature ‘Martinale: The Complete Drug Reference, a reference book published by Pharmaceutical Press consisting the adverse effects of vaccines. The extracts are reproduced below:
Adverse effects of vaccines
“Injection of a vaccine may be followed by the local reaction possibly if inflammation and lymphangitis and Induration or sterile abscess may develop at the site of injected vaccine. Fever, headache and malaise may start a few hours after injection and last for one or two days. Hyper sensitivity reaction may occur and anaphylaxis has been reported rarely.
In addition, Hapatitis-B vaccines have been reported to cause abdominal pain and gastro intestinal disturbance, and musculo-skeletal and joint pain inflammation. There may also be dizziness and sleep disturbance. Cardiovascular effects include occasional hypotension and rarely, tachy cardia. Other rare adverse effect dysuria, visual disturbance and earache.”
Adverse effects of Revac-B
Inflammation at the site of injection or a febrile reaction may be obsorved in some subjects. In rare cases of post vaccinal hyper sensitivity, the common symptoms that are quickly recognized by the physician are dizziness, headache, nausea, abdominal pain, rash, pruritis, urticria, arthralgia, myalgias, and similar associated symptoms and side effects.
Observations of NIMS hospital
There were no suggestive features of drug reaction or respiratory distress or bronchospasm or urticarial. The discharge report dated 27.6.2001 mentions the clinical diagnosis as post injectional soft tissue injury. The investigation with MRI of right arm showed oedema of deltoid muscle with subcutaneous tissue oedema.
12. The provisions of the Consumer Protection Act are in addition to and not in derogation of other laws in force. In our considered view, the vaccine manufactured by opposite party was not hazardous. Opposite Party complied with the World Health Organisation (WHO) standards and the manufacturing norms under Drugs and Cosmetic Act, 1940. The action under Section 32(2) of the Drugs and Cosmetics Act is entirely different. However, in this case, the drug authorities have certified the product fit for human use and it was fit for release in the market on 23.2.1999. Even the Hon’ble High Court left the matter to decide by the statutory authorities.
13. The complainant No. 1 was hospitalized for 8 days from 19.6.2001 to 26.6.2001, it was not due to any grievous hurt or injury. We do not find any justification, why complainant No. 1 remained away from work for 21 days. It is also transpired that the complainant continued to be in the hospital and while being inpatient he went out of the hospital from 11.00 a.m. to 2.00 p.m. on 23.6.2001 and 24.6.2001 on his own volition, when he was allegedly under life threatening condition. He was discharged on 26.6.2001.
The NIMS medical record revealed that it was a case of local induration reaction due to inflammatory changes in the deltoid muscles. Medically in few persons induration or sterile abscess may develop at the site of injected vaccine. Fever, headache and malaise may start a few hours after injection and last for one or two days.
14. It is also transpired from the NIMS record that the duty doctor recorded that there were no suggestive features of drug reaction or respiratory distress or bronchospasm or urticarial rash.
15. We note the conduct of the complainant No. 1 in collusion with Dr. P. M. Bhargava and he made several allegations against the opposite party about the violation of manufacturing norms, the licence, about the illegal release of vaccine in the market without any authorisation by the department of drugs under Drugs and Cosmetics Act. We also note that the complainant No. 1 initiated action through Mr. Alok Srivastava, the Inspector General of Drugs Control Administration against the chemist who sold the said vaccine and against the opposite party-Co., however, nothing was proved. It seems that the complainant No. 1 has misused his official position by taking advantage of being senior to Mr. Alok Srivastava who belonged to 1997 Batch of IPS.
16. In our view, there is nothing on record to prove that the vaccine was either defective or of sub-standard quality. It was within the expiry date. It was administered by Dr. Indeveer Reddy, who was a doctor of their own police department. A person develops pain at the point of injection mainly due to injury and inflammation in the muscle tissue. Nothing is attributed to medical negligence. Thus complainant No. 1’s own statement about his life threatening condition is totally false.
17. The complainant No. 1 neither suffered any anaphylactic reaction nor had any signs of allergic reaction to the vaccine. Thus, in our view, the entire allegations and the complaint itself have multiple rings of untruth. It was just harassment by the complainant No. 1 in collusion with Dr. P. M. Bhargava, who was ex-staff of opposite party-Co. Both have indulged in publishing news in the newspaper from 6th to 9th August, 2001
18. Thus, in our considered view, the allegations are imaginary and the claim was irrational. Considering the entirety, the complainant No. 1 filed the instant complaint to harass the opposite party-co. by one way or the other. We do not find any merit in the complaint. The complaint is dismissed with cost of Rs. 10,000 to be deposited in the Consumer Legal Aid Account of this Commission within 8 weeks from today.
Registry shall report the compliance accordingly.
Mr. Dinesh Singh, Member:
19. It is noted that:
(a) A second dose of Hepatitis-B vaccine, ‘Revac-B (Recombinant)’, manufactured by opposite party Bharat Biotech International Ltd., was averred to have been taken by the complainant No. 1 on 19.6.2001. The said vaccine in the said second dose was different from the first dose of Hepatitis-B vaccine, ‘Engerix-B’, manufactured by one Smith Kline Beecham, averred to have been taken earlier. The averred batch No. of the Hepatitis-B vaccine, ‘Revac-B (Recombinant)’, in question was RVB 009. The report dated 22.3.1999 of Central Drugs Laboratory,
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Central Research Institute, Kasauli, Himachal Pradesh, India, inter alia states that batch No. RVB 009 manufactured on 22.11.1998 with expiry date of 21.11.2001 was found to be of “Standard Quality” and “be released”. (b) No steps were taken by the complainants to get the vaccine in question analysed or tested through an appropriate laboratory as per the provisions of Section 13(1)(c) of the Act 1986. (c) No steps were taken by the complainants for class action under Section 12(1)(c) of the Act 1986. (d) On the face of it, the compensation claimed (Rs. 12 crore plus, in 2003) was not commensurate with the averred loss and injury due to ‘reaction’ to the vaccine in question, which, admittedly, did not cause any continuing or permanent bodily ill-effect to the complainant No. 1. (e) The complaint, ex facie, is frivolous and vexatious within the meaning of Section 26 of the Act 1986. 20. The complaint is dismissed with cost of Rs. 10,000 to be deposited by the complainant No. 1 with the Consumer Legal Aid Account of this Commission within eight weeks of the pronouncement of this Order. 21. It is, but, unequivocally and explicitly added that it is for the regulatory authorities, both of Government of India and of the State Government concerned, to regulate the import, manufacture, distribution and sale of vaccines. This Commission has no role therein. The dismissal of the complaint by this Commission shall in no way be construed to imply that the role and responsibility and accountability of the regulatory authorities or of the opposite party Bharat Biotech International Ltd. are in any manner affected or diluted. This inter alia includes any action that the regulatory authorities may have taken or may take in respect of the said batch No. RVB 009 or any other batch of the said vaccine in question or any other vaccine or drug manufactured by the one Bharat Biotech International Ltd. Complaint dismissed.