Following the US Food and Drug Administration (USFDA) alert to patients and health care professionals, Hyderabad-based drugmaker Dr Reddy’s Laboratories (DRL) suspended worldwide supply of ranitidine as a precautionary measure. According to industry insiders, this is probably because DRL was selling the drug as an over-the-counter (OTC) medicine in the US, where it clocks $7 million in annual sales from the drug. European player Sandoz, too, had stopped distribution of the drug after regulators raised concerns.
“The other Indian formulation players who supply the generic version of Sanofi’s Zantac or ranitidine are prescription players. DRL was supplying the drug also as OTC and in that case monitoring and control can become difficult. Therefore, the suspension of supplies happened as a precautionary measure,” said a senior official of a drug firm that too supplies the drug to the US. He said all firms are in touch with the USFDA
for updates on the agency’s decision. “This is an old molecule and does not constitute a significant portion of our US sales. If the USFDA
issues any recall notice, drugmakers would comply immediately,” he added.
In mid-September, the USFDA
issued a statement saying, “The USFDA has learned that some ranitidine medicines, including some products commonly known as the brand name Zantac, contain a nitrosamine impurity called NDMA at low levels. NDMA is classified as a probable human carcinogen, based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.”
It says that it is working with international regulators and industry partners to determine the source of this impurity in ranitidine. “The agency is examining levels of NDMA in ranitidine and evaluating any possible risk to patients. The FDA will take appropriate measures based on the results of the ongoing investigation,” it says. The USFDA, however, has not asked patients to stop taking ranitidine at this time.
Major Indian drug firms that supply the drug to the US include Aurobindo, Wockhardt, Glenmark, Cadila Healthcare, Strides, Granules India, Ajanta Pharma, etc, says Deepak Malik, analyst with Edelweiss. “Most of the players do not have exposure beyond $1-2 million annually for ranitidine supplies. We do not foresee any major impact,” he adds. The market size for the drug in the US is estimated to be around $50 million.
Global market size for the drug is estimated to be $400 million. After slipping over 3 per cent on Monday, DRL’s stock had closed day’s trade on the BSE down 1.6 per cent. The stock, however, recovered on Tuesday, closing at Rs 2,784.6, flat from previous close. Nifty Pharma index also remained flat on Tuesday, up 0.4 per cent.
Analysts feel the crisis is deeper for bulk drug players like Strides (it fell 2.8 per cent on Tuesday) that supply raw materials for ranitidine. Ranjit Kapadia, an independent pharma consultant, points out the NDMA is a water related impurity that can get into the bulk drug during the process of manufacturing. “The FDA needs to issue a directive on what is the permissible level of NDMA for daily intake. Manufacturers can take necessary action on sourcing only after that,” he said.