In a sweeping decision, the Department of Drug Administration (DDA) has revoked the manufacturing licenses and registration certificates of 47 immunosuppressants brands at once. The department cited concerns over drug quality and safety, including the risk of cross-contamination at manufacturing facilities that lack dedicated production units for the medicines.
Of the 47 brands, 33 are manufactured in Nepal, 13 in India, and one in Bangladesh.
The move has raised concerns among doctors about the future availability of medicines essential for kidney transplant patients with chronic illnesses. The department has since clarified that medicines already imported into the country or available in the market can still be sold and distributed.
Kidney transplant recipients must take immunosuppressants twice a day for the rest of their lives to prevent their immune systems from rejecting the transplanted organ. The drugs are also used to treat autoimmune diseases such as rheumatoid arthritis and lupus, certain inflammatory disorders, severe asthma, and serious allergic reactions.
It is estimated that there are over 4,000 people in the country who have undergone kidney transplantation and thousands of others rely on immunosuppressants to manage their chronic illnesses.
The decision has left some patients who have already bought the medicines unsure whether they should continue taking them. Doctors say patients should not stop or change their treatment without consulting physicians as interrupting immunosuppressive therapy can put transplant recipients at risk of organ rejection.
“Nearly half a dozen transplant patients came to the hospital on Wednesday alone, asking which medicines they should take now,” said Arun Sedhain, a professor and nephrologist at Bir Hospital, one of Nepal’s oldest and largest hospitals. “People who have undergone kidney transplants must take these medicines every morning and evening for the rest of their lives.”
When transplant recipients stop taking immunosuppressants, their immune systems may recognise the transplanted kidney as foreign and attack it. This process, known as organ rejection, can damage the transplanted organ and, in severe cases, lead to graft failure. Patients may then need dialysis or another transplant.
Doctors stress that even patients who feel well must continue taking these medicines as prescribed because rejection can occur without visible symptoms in its early stages.
Doctors have questioned whether the concerns cited by the department justify action that has affected so many brands at once.
“Most of the medicines banned by the department are effective,” said a nephrologist at Tribhuvan University Teaching Hospital, requesting anonymity. “Some of these medicines were included in the health insurance scheme until recently. The alternatives available in the market are not as effective.”
Senior nephrologist Rishi Kumar Kafle questioned the rationale for the decision.
“How can medicines that were considered safe until yesterday suddenly become unsafe overnight?” he asked. “Even if there is a problem with a medicine, it could be limited to a particular batch. How can all products manufactured by a company be problematic at once?”
The department said it had removed the manufacturing licenses and registration certificates of the affected brands after their manufacturers failed to submit the risk assessment documents by the deadline.
In a statement issued on Thursday following concerns raised by patients, their relatives and doctors, the department clarified that the action did not prohibit the sale and distribution of medicines already imported into the country or available in the market.
“Only certificates of those companies have been revoked,” reads the statement.
The department said it was committed to preventing shortages of medicines that organ transplant recipients and patients with chronic illnesses need to take regularly, and maintaining a balanced supply chain.
However, Kafle said the decision had been made without consulting specialists.
“Such a major decision, which directly affects thousands of patients, was made without consulting a single concerned doctor, specialist, or member of the transplantation society [of Nepal],” Kafle said. “The department may have the authority to make the decision, but it did not consider the impact on patients. They have now been forced to go abroad to obtain their medicines.”
The Department of Drug Administration authorises the manufacture and import of medicines, monitors compliance with quality standards, inspects pharmacies, and tests drug samples collected from the market.
It routinely suspends the sale and distribution of substandard medicines and orders their recall. Officials say several medicines have been suspended or recalled in the past, but a move affecting so many brands within the same drug category is believed to be unprecedented.