Today, On 30th January, The Supreme Court criticized the lower court’s decision to issue summons in a case against a company accused of making poor-quality drugs. The court dismissed the case, saying there was not enough evidence to support the claims. The company was accused of producing substandard medicines, but the Supreme Court found no proof.
New Delhi: The Supreme Court on Thursday cancelled proceedings against a firm accused of producing substandard drugs, stating that the trial court’s summoning order lacked any justification, even superficially.
A bench consisting of Justices B R Gavai and Augustine George Masih described “the summoning order as completely a non-speaking one.”
This ruling followed an appeal by the firm against an October 2023 judgment from the Andhra Pradesh High Court, which had rejected its request to quash the proceedings in a Kurnool trial court.
Also Read: Supreme Court Upholds Centre’s Decision to Classify Medical Devices as ‘Drugs’
The bench noted,
“However, we do not find it necessary to consider the submissions made by the appellants on various grounds inasmuch as the present appeal is liable to be allowed on the short ground that the magistrate has issued the process without assigning any reasons.”
It emphasized that “no reasons even for the namesake have been assigned by the magistrate.”
In its decision, the court set aside the high court’s order, quashing the trial court’s summoning order from July 2023 and the associated proceedings.
It recalled that in May 2019, the drugs inspector of Kurnool Urban filed a complaint under Section 32 of the Drugs and Cosmetics Act, 1940, against the company, its managing partner, and others. The complaint stated that a drug sample collected from the firm in September 2018 was subsequently reported as “not of standard quality.”
The appellants faced accusations of violating the 1940 Act by manufacturing, selling, and distributing these inferior quality drugs, which led to the trial court summoning them.
The dispute centered on a pharmaceutical company accused of producing and distributing poor-quality drugs in violation of drug safety regulations. If the allegations were proven, the company could have faced serious consequences, including large fines, the cancellation of its business license, and harm to its reputation.
The case was filed after some consumers and health authorities raised concerns about the quality of the company’s products. These complaints were sent to the appropriate regulatory bodies, which decided to take legal action.
When a firm is accused of manufacturing poor-quality drugs, several legal provisions come into play, depending on the jurisdiction:
- Drugs and Cosmetics Act, 1940 (India): Under this Act, the manufacture, sale, and distribution of drugs are regulated. If a firm is found guilty of producing substandard or misbranded drugs, it can face penalties under Section 18, including fines, imprisonment, or both. Section 27 of the Act also allows for legal action against individuals involved in the production or sale of harmful or substandard drugs.
- The Federal Food, Drug, and Cosmetic Act (FDCA) (USA): In the United States, the FDCA regulates drug manufacturing. Section 501 of the FDCA outlines that drugs must meet certain standards of identity, strength, quality, and purity. If a firm manufactures poor-quality drugs, it may face sanctions from the FDA, which can include product recalls, fines, and even criminal charges against company executives or responsible individuals.
- Consumer Protection Laws: In both India and the U.S., firms can also be held liable under consumer protection laws for causing harm through substandard drugs. Affected consumers may file lawsuits for damages under these laws.
- International Regulations: Firms operating globally may also be subject to international regulations, such as those set by the World Health Organization (WHO) and other international bodies that ensure drug safety and quality standards are met.
Legal action against such firms can involve regulatory authorities conducting inspections, legal proceedings in court, and civil claims from consumers or patients who have suffered harm due to poor-quality drugs.
The Supreme Court’s ruling sets an important example, emphasizing the need for proper legal processes when handling cases involving poor-quality products. It also reminds lower courts to carefully check the evidence before taking actions that could seriously affect businesses and individuals. This decision will likely impact how similar cases are handled in the future, especially in the pharmaceutical and healthcare industries.