NCDRC | Hepatitis-B vaccine ‘Revac-B’ manufactured by Bharat Biotech held not hazardous, no proof of defect or sub-standard quality found

National Consumer Disputes Redressal Commission (NCDRC): The Coram of Dr S.M. Kantikar (Presiding Member) and Dinesh Singh (Member), while deciding the present matter stated that,

“The provisions of the Consumer Protection Act are in addition to and not in derogation of other laws in force.”

In the present case, Complainant 1, an IPS officer filed a complaint against the opposite party – Bharat Biotech International Limited, a pharmaceutical company.

19-06-2001: For Hepatitis–B prophylaxis; Complainant 1 took the first dose of Hepatitis- vaccine ‘Energix-B’ manufactured by Smith Kline Beecham and on taking the same he did not experience any adverse reaction.

Complainant took the second dose of the vaccine with the trade name ‘Revac-B’ vaccine manufactured by Bharat Biotech Ltd. The vaccine was administered at the complainant’s residence and in a matter of 5 minutes of administering the same, the complainant started getting pain on the right deltoid region which went on increasing and inflammation started in that area. He also started feeling breathless with severe intolerable pain and thereafter he was rushed to a nearby hospital.

Complainant then approached Nizam Institute of Medical Sciences (NIMS), wherein the doctor gave him life-saving drugs and steroids. Thus the Complainant 1 had to battle for his life during his stay in NIMS from 19-06-2001 to 27-06-2001.

Complainant 1’s investigation about the vaccine

Complainant 1 enquired about the details of the company and came to know that drug control had issued a notice to the OP and it accused of not having printed the proper generic name of the said product in accordance with the prescribed manner. It was alleged that, the vaccine was released before the approval of the Central Research Institute, Kasauli.

Further, the allegation added to the list of allegations was that the drug department had received complaints that some people who used the vaccine ‘Revac-B’ of the same batch number as complainants developed pain at the place of injection. Complainant 1 was shocked and surprised on knowing that even after the drug department had issued directives, OP was doing unethical sales in the market.

OP manufactured the said dangerous vaccine in violation of license from drug controller with utter disregard to the value and importance of human life. Complainant further submitted that due to the said episode, his entire family suffered mentally as well as financially.

Thus in view of the above, Complainant 1 requested investigation and withholding of license to manufacture their vaccine using “Pischia Pastoris” pending the Drug Controller General’s investigation.

19-07-2001: OP was served legal notice due to the supply of sub-standard vaccines which did not meet the standard of purification. Aggrieved by the entirety, the complainant filed a complaint about the recovery of damages due to negligence of OP-Company.

OP’s Defence

Denying the entire set of allegations by Complainant 1 stated that, the complaint was based on the wrong premise. OP stated that it had obeyed the direction/ communication issued by Drugs Controller of Andhra Pradesh calling upon the OP to withdraw batch no. 009 from the market.  However, it was an administrative direction and not a conclusion about the quality of the vaccine because of the said batch no. 009 was already certified by the Central Drugs Laboratory, Kasauli, as being fit for human administration.

According to the OP, Complainant 1 did not belong to the high-risk category of immunization of ‘Hepatitis-B’. OP further submitted that there was no prescription with the Complainant 1 for ‘Hepatitis-B’ vaccination. The Complainant 1 neither produced bill showing his name and details of the purchase of Engerix-B (1 st dose) and the Revac-B (2 nd dose). The vaccine was administered by Dr Indeevar Reddy, the doctor of the police department which might have administered with lack of due care and caution.

Conclusion

On perusal of the affidavits of evidence and the medical record of NIMS, following were the observations:

  • Complainant 1 suffered severe pain after injections of ‘Revac B’, there are several reasons which could be due to faulty administration or storage/ refrigeration at the pharmacy. Therefore, how OP – Company made liable.
  • It is surprising that, how Dr Indeveer Reddy suggests the Complainant 1 to take ‘Revac B’ when already 1st dose of Energix-B was given.
  • NCDRC being impressed by the contention raised by Complainant 1 with respect to the use of vector ‘Pischia Pastoris’ for the manufacture of the vaccine. Drug authorities 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.
  • When the vaccine caused the alleged problem, the complainant should have preserved the product literature and the vial of the vaccine as evidence before this commission.

Thus in view of the above-stated observations, a vaccine manufactured by OP was not hazardous. OP complied with WHO standards and manufacturing norms under Drugs and Cosmetic Act, 1940. In the present case, drug authorities have certified the product fit for human use and it was fit for release in the market.

According to the Commission, there is nothing on record to prove that the vaccine was either defective or of sub-standard quality. Complainant’s own statement about his life-threatening condition is totally false and the complainant’s motive in the present case was only to harass the OP in one way or the other. [M.L. Kumawat  v. Bharat Bio-Tech International Ltd., 2019 SCC OnLine NCDRC 325 , decided on 09-10-2019]

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