JB Chemicals braces for twin challenges of lockdown hurdles and ranitidine concerns

PT Jyothi Datta Mumbai | Updated on April 03, 2020

The USFDA has asked manufacturers to withdraw prescription and over-the-counter versions of ranitidine

Drugmaker to continue marketing Rantac in India

Drugmaker JB Chemicals’ cup of woe seems to run over. Just as it grapples with keeping medicine supplies uninterrupted in the lockdown period, another challenge has come its way due to the US Food and Drug Administration’s move on heartburn drug ranitidine.

The USFDA has asked manufacturers to withdraw prescription and over-the-counter versions of ranitidine, following ongoing investigation into a contaminant known as N-nitrosodimethylamine (NDMA), a probable human carcinogen.

JB Chemicals is a key ranitidine producer in India, though it has not yet launched this in the US. And while an advisory is awaited from the Indian drug regulator, the development has cast a shadow on ranitidine producers, with JB Chemicals’ stock price plunging close to 12 per cent to ₹446 on the BSE (at 3.10 pm) on Friday.

To continue marketing Rantac

“There are no easy answers,” Pranabh D Mody, Executive Director, JB Chemicals, told BusinessLine, responding to how the company was dealing with the twin troubles of supply hurdles due to the lockdown, and the ranitidine announcement.

“There are already challenges in getting the factories working and all our effort is spent on getting permissions to get products and raw materials across State borders due to the lockdown,” he said. On ranitidine, Pranabh, who is part of the promoter Mody family, pointed to the company’s response to the stock exchanges.

Following the USFDA caution on the presence of this contaminant in September 2019, the company said its vendors of ranitidine’s Active Pharmaceutical Ingredient (API) had ensured that they met international guidelines on the presence of NDMA and kept it within prescribed limits.

JB Chemicals would continue to market Rantac, its brand of ranitidine, in India, it said, adding that the company had taken steps to ensure that the NDMA in the finished product was also within acceptable limits. The company was “continuing to evaluate the data obtained from the analysis of the product and results obtained have been satisfactory,” it said.

“Rantac is being marketed by the company in India for over three decades and so far no serious adverse event has ever been reported. As a responsible manufacturer, the company continues to manufacture Rantac that complies with all the standards set by the Drugs Controller General of India (DCGI),” the ₹1,501-crore JB Chemicals said, adding that it would follow the DCGI’s guidance.

Lockdown challenges

Outlining the problems faced by pharmaceutical companies like his during the shutdown, Pranabh said the movement of labour is not easy, as some factory employees may live just across a State border. For this reason, the attendance at the Daman plant was at 20 per cent, he said, though the Gujarat plant fared better, at about 50 per cent.

Though medicines come under essential supplies, societies were preventing people from coming to work. About 20 people are brought to work in a 50-seater bus and lunch hours are staggered to ensure that work continues and employees are kept safe.

“We are using up the existing inventory of two months, but we need to get fresh raw materials, packaging, etc, from other regions,” he said, expressing concern about medicine supplies in the coming months. Responding to how this would impact the financial performance of companies, he said lockdowns across the world — depending on how long they continued and created delays and medicine stock-outs — could impact the June quarter.

Published on April 03, 2020

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