For patients confronting cancer, the physical pain and mental anguish caused by the illness and treatment, along with the significant financial burden, are aches all too familiar. Compounding this distress is the potential that the cancer medication administered could be ineffective—an allegation highlighted by the International Consortium of Investigative Journalists (ICIJ) in collaboration with 47 media partners, focusing specifically on Merck & Co’s (known as MSD outside the United States and Canada) cancer drug, Keytruda.
The investigative report concerning Keytruda in India has sparked concerns regarding the integrity of the supply chain, the safe disposal of medical waste (such as vials), and accountability in potential misconduct. Critical questions arise: Who maintains comprehensive visibility across the supply chain for essential medications, and who is accountable when this chain is compromised or manipulated?
R. Uday Bhaskar, Honorary Director General of the All India Drugs Control Officers’ Confederation, emphasizes the need for a standardized operating procedure for managing the journey of drugs—from manufacturers to distributors, pharmacies, hospitals, healthcare providers, patients, and waste management agencies. He advocates for criminal penalties for those engaging in diversion, repackaging, and other unethical practices.
Cancer patients are often advised by healthcare professionals to procure their costly medications from hospital-affiliated chemists or recommended distributors in order to alleviate financial burdens, say multiple voices from the healthcare sector. Faced with escalating expenses, patients commonly comply, and the sealed packaging of these drugs leads them to trust that their medicines are legitimate.
The high cost of cancer medications makes the supply chain vulnerable to exploitation by unscrupulous individuals looking to take advantage of desperate patients and their families. KM Gopakumar, Co-convenor of the Working Group on Access to Medicines and Treatment, notes that the price of a 4 ml vial of Keytruda is approximately ₹1.8 lakh, based on industry estimates.
Industry insiders assert that companies must implement a track-and-trace system for their products. Such a system would allow for a thorough stock check on the number of vials supplied, used, and disposed of, helping to reveal discrepancies within the supply chain.
Approved in India for over 14 indications across eight different types of tumors, MSD’s pembrolizumab (brand name Keytruda) enhances the body’s immune response to identify and combat cancer cells, distinguishing it from traditional chemotherapy or radiation therapies, according to company information. MSD also operates a patient assistance program for this medication.
An inquiry was sent via email to MSD regarding the reported misuse of Keytruda vials in India, and a response is currently awaited.
