Supreme Court: Public Servant's Complaint Revives Vaccine Labeling Case Against Panacea Biotec

Summary: The Supreme Court of India, led by Judge Ahsanuddin Amanullah, made a decision on a case about incorrect labels on vaccines made by Panacea Biotec Ltd. The case was about mistakes in vaccine labels, which led to accusations of false labeling under the Drugs and Cosmetics Act, 1940.

The Initial Complaint

On October 21, 2005, Mr. Joy Mandi found a labeling problem with a vaccine from Panacea Biotec Ltd. He reported this to the Primary Health Centre in Thrissur, Kerala. The box said the vaccine was "Easy Five Pentavalent," but the bottle inside was labeled "Tetravalent Vaccine Easy Four."

Legal Proceedings Begin

• January 5, 2006: Mr. Mandi made a formal complaint to the Drug Inspector.
• January 16, 2006: The Drug Inspector started looking into the issue.
• January 20, 2009: A complaint was filed in the Chief Judicial Magistrate's Court in Thrissur against Panacea Biotec Ltd. for false labeling under the Drugs and Cosmetics Act, 1940.

Discrepancies in Labeling

The complaint pointed out that the box said the vaccine had five ingredients, including a Hepatitis vaccine, but the bottle inside said it only had four ingredients, leaving out the Hepatitis vaccine. This mistake led to accusations of false labeling.

"According to the label on the box, the drug is Easy Five pentavalent vaccine... But according to the label on the bottle Easy Four tetravalent vaccine... does not contain HbSAg 10 mcg." - Complaint Document

Court's Initial Decisions

• July 10, 2012: The Chief Judicial Magistrate excused the delay in filing the complaint and called Panacea Biotec Ltd. to court.
• July 14, 2022: The Kerala High Court dismissed the complaint due to mistakes in the procedure, especially the failure to do a required check under Section 202 of the Criminal Procedure Code.

Supreme Court's Ruling

Judge Ahsanuddin Amanullah, along with Judge R. Mahadevan, reversed the High Court's decision, stressing that the steps were followed correctly because the complaint was made by a government worker. The Supreme Court brought back the complaint, allowing the trial to continue.

Key Legal Points

• Time Limit: The Supreme Court explained that the time limit started when they knew who was responsible, not when the first complaint was made.
• Government Worker Exception: The Court noted that complaints by government workers do not need the same initial check as private complaints, referring to a similar past case in Cheminova India Limited v State of Punjab.

Verdict Summary

The Supreme Court decided that the trial against Panacea Biotec Ltd. should continue, emphasizing that the complaint was valid because it was filed by a public servant. This ruling highlights the need for accurate vaccine labeling and the importance of following legal procedures in such cases.