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

PT Jyothi Datta Mumbai | Updated on April 03, 2020 Published 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

A letter from the Editor

Dear Readers,

The coronavirus crisis has changed the world completely in the last few months. All of us have been locked into our homes, economic activity has come to a near standstill. Everyone has been impacted.

Including your favourite business and financial newspaper. Our printing and distribution chains have been severely disrupted across the country, leaving readers without access to newspapers. Newspaper delivery agents have also been unable to service their customers because of multiple restrictions.

In these difficult times, we, at BusinessLine have been working continuously every day so that you are informed about all the developments – whether on the pandemic, on policy responses, or the impact on the world of business and finance. Our team has been working round the clock to keep track of developments so that you – the reader – gets accurate information and actionable insights so that you can protect your jobs, businesses, finances and investments.

We are trying our best to ensure the newspaper reaches your hands every day. We have also ensured that even if your paper is not delivered, you can access BusinessLine in the e-paper format – just as it appears in print. Our website and apps too, are updated every minute, so that you can access the information you want anywhere, anytime.

But all this comes at a heavy cost. As you are aware, the lockdowns have wiped out almost all our entire revenue stream. Sustaining our quality journalism has become extremely challenging. That we have managed so far is thanks to your support. I thank all our subscribers – print and digital – for your support.

I appeal to all or readers to help us navigate these challenging times and help sustain one of the truly independent and credible voices in the world of Indian journalism. Doing so is easy. You can help us enormously simply by subscribing to our digital or e-paper editions. We offer several affordable subscription plans for our website, which includes Portfolio, our investment advisory section that offers rich investment advice from our highly qualified, in-house Research Bureau, the only such team in the Indian newspaper industry.

A little help from you can make a huge difference to the cause of quality journalism!

Support Quality Journalism
This article is closed for comments.
Please Email the Editor
You have read 1 out of 3 free articles for this week. For full access, please subscribe and get unlimited access to all sections.