Page 155 - PENARIKAN PRODUK RANITIDIN YANG TERKONTAMINASI N-NITROSODIMETHYLAMINE (NDMA)

Pharmalab with its Rinadin syrup and PT Indofarma with its Indoran and Ranitidine
injections, the agency said.

“As a form of responsibility by the pharmaceutical industry in ensuring the quality and
safety of the medicines it produces and distributes, the industry is required to
independently conduct tests on whether its products have been contaminated with
NDMA and to voluntarily recall its products if the amount exceeds the permitted limit,"
the BPOM said in its statement.

Lucia said the agency had previously found that NDMA had also contaminated some
antihypertension products in the angiotensin receptor blocker (ARB) group, namely
Losartan and Valsartan. The agency then recalled the products, she said, but they
could be used again after the producers had resorted to using other ingredients proven
to be safe. She added that the agency routinely conducted risk-based post-market
assessments on impurities under international pharmacopoeia standards.

"For the NDMA impurities, the assessment method was just discovered, so all drug
regulatory bodies in the world only recently adopted it, including the FDA and EMA,"
she said. Indonesian Doctors Association (IDI) chairman-elect Mohammed Adib
Khumaidi said ranitidine was widely used in Indonesia and was commonly found at
first-level health facilities, such as clinics and community health centers (Puskesmas)
as it was more affordable than other products meant to decrease the production of
gastric acid. Adib said there were alternatives that were more effective for treating the
same diseases, although at a higher price, noting however that they could still be
covered under the National Health Insurance (JKN) scheme. "The cause of cancer
can depend on multiple factors. NDMA consumption doesn't necessarily and certainly
lead to cancer.

However, it's better to avoid it," he said on Wednesday. He went on to say the recall
should also act as an input for the BPOM to be more proactive in conducting post-
market research to ensure the quality and safety of products sold, although he
acknowledged that the findings of the FDA and EMA should act as the basis for
BPOM's decisions. “The FDA's post-marketing survey and research is even more
active [than the BPOM] because there is better research support there," he said.

Indonesian Consumers Foundation (YLKI) chairman Tulus Abadi urged the BPOM,
industry and the health and pharmacy professionals to keep themselves updated with
knowledge, research and inventions, given that both fields were dynamic with rapidly
advancing research and development, to ensure consumer safety.”What has always
been allowed can turn the other way with new research findings. The BPOM should
be more proactive in monitoring and running lab tests on products in the market, so
that the drugs that we consume won't cause side effects due to slow research and
development from the government or the BPOM and the pharmacy industry." he said.