Court confirms prima facie case against directors and officials for alleged violations under Drugs and Cosmetics Act
In a significant ruling, the Allahabad High Court has upheld the summoning order against M/S Marion Biotech Pvt Ltd and its directors in connection with the manufacture and sale of drugs deemed "not of standard quality." The court dismissed the criminal revisions filed by the company's directors and officials, confirming that a prima facie case exists under various sections of the Drugs and Cosmetics Act, 1940.
The proceedings stemmed from a complaint filed by the Drugs Inspector, alleging violations including the use of prohibited substances, such as Ethylene Glycol and Diethylene Glycol, in their products. These substances, found in samples of the company's cough syrup, were declared toxic and harmful, leading to the initiation of legal action.
Counsel for the revisionists argued that the magistrate's order lacked judicial application, noting procedural irregularities and the absence of specific averments linking the directors to the alleged misconduct. However, the court found that the complaint and accompanying test reports provided adequate evidence for the case to proceed.
The court emphasized the responsibility of company officials, noting their accountability for operational compliance. It rejected the defense's claims of procedural missteps, stating that such technical objections could not override public health considerations.
The judgment also highlighted the serious implications of non-compliance with drug safety regulations, particularly in light of international concerns and reported fatalities linked to the company's products. The court concluded that the directors and officials could not evade liability merely by virtue of their titles, stressing the importance of ensuring adherence to safety standards.
The ruling affirms the validity of the summoning order, allowing the trial to proceed, where the accused will have the opportunity to defend themselves. This decision underscores the judiciary's commitment to upholding drug safety regulations, reinforcing the accountability of pharmaceutical companies in maintaining public health standards.
Bottom Line:
Drugs and Cosmetics Act, 1940 - Summoning order for alleged violations under Sections 18(a)(i), 16, 17-A, 17-B, 18-A, 18-B, and related penal provisions upheld - Prima facie case made out against revisionists, including directors and officials of the company, for the manufacture and sale of drugs found to be "not of standard quality," and alleged use of prohibited substances in violation of regulatory norms.
Statutory provision(s): Sections 18(a)(i), 16, 17-A, 17-B, 18-A, 18-B, 27(a), 27(b)(i), 27(b)(ii), 27(c), 27(d), 28, 28-A, 28-B of the Drugs and Cosmetics Act, 1940; Section 482 of the Criminal Procedure Code, 1973; Section 34 of the Drugs and Cosmetics Act, 1940.
M/S Marion Biotech Pvt Ltd. v. Union of India, (Allahabad) : Law Finder Doc Id # 2838076
