Chennai: Apollo Pharmacy, part of the Apollo Hospitals chain, will resume the sale of products manufactured by Ranbaxy Laboratories Ltd, after resolving concerns that arose from the settlement the drug maker reached with the US Food and Drug Administration last month for falsifying data and selling substandard drugs.
“We have been working with Ranbaxy over the past week to validate the necessary documentation in line with quality standards followed by international quality certifying authorities,” the drug store chain said in a statement on Thursday.
“Ranbaxy has provided us batch quality certification for all their products certified by the government approved third-party certifying laboratories,” the statement said.
The reports showed the drugs complied with the quality norms stipulated by the department of pharmaceuticals, as well as the Drug and Cosmetics Act, the company said.
Last week, Business Standard newspaper reported that Apollo Pharmacy, the largest branded pharmaceutical store chain, had temporarily suspended the sale of medicines produced by Ranbaxy and also stopped procurement of its products because of quality concerns.
Ranbaxy said last month that it agreed to pay $500 million to resolve fraud allegations and charges that the company sold adulterated drugs and lied about it to US regulators.
“We have also understood the stance of the Directorate General of Health Service of India in this regard and received confirmation from them that there are no quality issues in the Ranbaxy products currently marketed in India,” said Apollo Pharmacy.
“We will continue to stock and dispense Ranbaxy products across all our pharmacies and continue to provide the best patient care without missing a beat,” the company statement added.
Ranbaxy, India’s No. 1 drugmaker by sales, plans to file three to four generic drug applications every year that can earn it a six-month marketing exclusivity in the US, the company’s chief executive said on Thursday, Reuters reported.
The first company that seeks approval from the US Food and Drug Administration for a generic version of a patented medicine gets exclusive rights to sell it for 180 days after patent expiry.
“We have a very ambitious growth plan for our US business,” Ranbaxy CEO Arun Sawhney told Reuters in an interview. “We will be strengthening our dermatology business in the US with a good slew of products in the future,” he said.
Ranbaxy is controlled by Japan’s Daiichi Sankyo Co. Ltd