Meftal: A Painkiller under Scrutiny – Navigating the Legal Landscape of Potential Adverse Reactions

Introduction:

Meftal, a popular painkiller, is the subject of a recent drug safety alert from the Indian Pharmacopoeia Commission (IPC). The usage and control of this medication have become the subject of legal and ethical challenges due to the concerns highlighted by this alert regarding potential adverse drug reactions (ADRs). Meftal and other prescription drugs with the chemical mefenamic acid as the active ingredient are widely used to treat pain and inflammation. But a recent warning from the Indian Pharmacopoeia Commission (IPC) has clouded this widely used pain reliever raising questions about possible negative responses. The Pharmacovigilance Programme of India (PvPI) database’s early examination of adverse drug reactions found drug responses associated with eosinophilia and systemic symptoms (DRESS) syndrome, according to the commission’s alert.

Evaluating Meftal’s Possible Dangers:

Meftal is a member of the non-steroidal anti-inflammatory drug (NSAID) class of medications that are frequently used to reduce pain brought on by a variety of ailments. Mefenamic acid has been related to a number of adverse responses, including gastrointestinal problems, hepatic and renal disorders, and even cardiovascular hazards while being generally safe when used as directed. The IPC specifically notes that the possibility of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome is concerning. This uncommon but dangerous ADR can be fatal if left undiagnosed and untreated. It causes a broad rash on the skin, fever, enlarged lymph nodes, and problems with internal organs.

 Meftal and its Constituent:  

Mefenamic acid, a non-steroidal anti-inflammatory medicine (NSAID) that is frequently used to treat pain and inflammation brought on by a number of illnesses, including rheumatoid arthritis and menstrual cramps, is the active ingredient in Meftal. Mefenamic acid is usually regarded as safe when used as prescribed, yet it has been connected to a number of possible adverse drug reactions, such as Gastrointestinal problems including ulcers, perforations, and bleeding, Liver and kidney disease is one of the hepatic and renal issues, Cardiovascular concerns include an elevated chance of stroke and heart attack, Red blood cell production is decreased due to bone marrow suppression, Skin rashes, Stevens-Johnson syndrome, and DRESS syndrome are examples of hypersensitivity reactions.

 The IPC Drug Safety Alert:

The IPC alerted readers to the possible danger of mefenamic acid-related Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome. A rare but dangerous ADR known as “DRESS syndrome” is characterised by an extensive skin rash, fever, enlarged lymph nodes, and involvement of internal organs. If not quickly identified and treated, it may be fatal.

Legal Frameworks and Regulations:

Drugs and Cosmetics Act of 1940: This Act creates quality standards, regulates drug registration and licensing, and forces manufacturers to report adverse drug reactions.

Drugs and Cosmetics Regulations of 1945: These regulations set forth particular guidelines for the production, marketing, and distribution of drugs, as well as how ADRs should be reported.

Programme for Pharmacovigilance in India (PvPI): The PvPI was created under the Drugs and Cosmetics Act and tracks and evaluates adverse drug reactions (ADRs) that manufacturers and medical practitioners report.

The regulations of the Medical Council of India (MCI): These rules require physicians to practise ethics, which includes reporting serious adverse drug reactions (ADRs) to the relevant authorities.

 Section 26B of Drugs and Cosmetics Act of 1940: Central Government’s authority to control or restrict the manufacture, sale, or distribution of drugs in the public interest.—In addition to any other provisions in this Chapter, the Central Government may, by notification in the Official Gazette, control or restrict the manufacture, sale, or distribution of any drug if it is satisfied that the drug is necessary to meet the needs of an emergency resulting from an epidemic or natural disaster and that doing so is necessary or expedient.]

Legal Repercussions for Organisations Involved:

Significant legal ramifications follow from the IPC’s alert for different parties involved in the use and handling of Meftal:

Manufacturers: They are required by law to guarantee the security of their goods and notify the PvPI of any suspected ADRs. Infractions may result in regulatory action, such as the suspension or revocation of drug licences.

Health Care Workers: Physicians and other health care workers have to report any significant adverse drug reactions (ADRs), including those that may be present in patients who are using Meftal. If you don’t, it could be viewed as a professional conduct violation and you could be subject to disciplinary action.

Patients: It is the right of patients to know about any possible dangers associated with the medications they are taking. This includes having access to precise and lucid data regarding possible ADRs associated with Meftal.

Government Agencies: Section 26A of the Drugs and Cosmetics Act of 1940 guarantees the security and effectiveness of pharmaceuticals, and the government is obligated to safeguard the public’s health. This includes keeping an eye on ADRs, enacting the necessary regulations, and launching public awareness initiatives.

The recommendations for Future Action:

Several recommendations can be put into practice to solve the issues brought up by the IPC’s alert and guarantee the safe use of Meftal:

Boosting ADR Reporting Systems: The PvPI ought to enhance reporting mechanisms and motivate medical personnel and patients to proactively report suspected ADRs.

Enhanced Pharmacovigilance Activities: Meftal safety must be actively monitored by manufacturers through post-marketing surveillance and thorough Pharmacovigilance investigations.

Public Awareness Campaigns: In order to inform patients and medical professionals about the possible hazards associated with Meftal, particularly DRESS syndrome, public awareness campaigns are essential.

Examining Prescription Practices: Physicians should thoroughly consider the benefits and hazards of Meftal before writing a prescription.

Improving the Law Enforcement System: The Indian government ought to consider reviewing and updating the nation’s drug laws to handle emerging safety concerns and enhance Pharmacovigilance practices.

Conclusion:

Although Meftal helps a lot of people, caution and a multifaceted strategy are required due to the possibility of severe side effects, meftal and other medications can be used safely and effectively in India by embracing a cooperative effort that includes improved Pharmacovigilance, robust public awareness campaigns, and strengthened reporting systems. This will protect public health and encourage informed decision-making within the healthcare system.

Aditya Pratap is a lawyer and founder of Aditya Pratap Law Offices. He practices in the realm of real estate, corporate, and criminal law. His website is Aditya Pratap.in and his media interviews can be accessed at http://www.youtube.com/@AdityaPratap/featured. Views expressed are personal.

This article has been assisted by Umang Pandey, a 3rd year law student pursuing B.A.LL.B. From Lloyd Law College, Greater Noida.