{"id":220754,"date":"2019-10-11T18:22:57","date_gmt":"2019-10-11T12:52:57","guid":{"rendered":"https:\/\/www.scconline.com\/blog\/?p=220754"},"modified":"2019-11-01T16:51:10","modified_gmt":"2019-11-01T11:21:10","slug":"ncdrc-hepatitis-b-vaccine-revac-b-manufactured-by-bharat-biotech-held-not-hazardous-no-proof-of-defect-or-sub-standard-quality-found","status":"publish","type":"post","link":"https:\/\/www.scconline.com\/blog\/post\/2019\/10\/11\/ncdrc-hepatitis-b-vaccine-revac-b-manufactured-by-bharat-biotech-held-not-hazardous-no-proof-of-defect-or-sub-standard-quality-found\/","title":{"rendered":"NCDRC | Hepatitis-B vaccine ‘Revac-B’ manufactured by Bharat Biotech held not hazardous, no proof of defect or sub-standard quality found"},"content":{"rendered":"

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

\u201cThe provisions of the Consumer Protection Act are in addition to and not in derogation of other laws in force.\u201d<\/strong><\/p>\n

In the present case, Complainant 1, an IPS officer filed a complaint against the opposite party \u2013 Bharat Biotech International Limited, a pharmaceutical company.<\/p>\n

19-06-2001: For Hepatitis\u2013B prophylaxis; Complainant 1 took the first dose of Hepatitis- vaccine \u2018Energix-B\u2019 manufactured by Smith Kline Beecham and on taking the same he did not experience any adverse reaction.<\/p>\n

Complainant took the second dose of the vaccine with the trade name \u2018Revac-B\u2019 vaccine manufactured by Bharat Biotech Ltd. The vaccine was administered at the complainant\u2019s 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.<\/p>\n

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.<\/p>\n

Complainant 1\u2019s investigation about the vaccine<\/strong><\/p>\n

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.<\/p>\n

Further, the allegation added to the list of allegations was that the drug department had received complaints that some people who used the vaccine \u2018Revac-B\u2019 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.<\/p>\n

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.<\/p>\n

Thus in view of the above, Complainant 1 requested investigation and withholding of license to manufacture their vaccine using \u201cPischia Pastoris\u201d<\/em> pending the Drug Controller General\u2019s investigation.<\/p>\n

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 <\/strong>of OP-Company.<\/p>\n

OP\u2019s Defence<\/strong><\/p>\n

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.\u00a0 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.<\/p>\n

According to the OP, Complainant 1 did not belong to the high-risk category of immunization of \u2018Hepatitis-B\u2019. OP further submitted that there was no prescription with the Complainant 1 for \u2018Hepatitis-B\u2019 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.<\/p>\n

Conclusion<\/strong><\/p>\n

On perusal of the affidavits of evidence and the medical record of NIMS, following were the observations:<\/p>\n