Ranbaxy Laboratories, which is facing heat from the US Food and Drug Administration (FDA) over the quality of products from its Mohali plant, is still under the scanner of Indian regulatory authorities also and the Drug Control General of India (DCGI) said his office will look into the fresh complaints, if required.
“The investigation is still going on,” DCGI Dr G N Singh informed about the status of the review of GMP compliance of Ranbaxy facilities as ordered by the Health Ministry. “It is an ongoing process as we want to ensure the safety and efficacy of drugs marketed in the domestic market,” he added.
Union Health Minister some time back told the Parliament that the Ministry had asked the DCGI to review the GMP compliance of the manufacturing facilities of Ranbaxy in India in the wake of the situation arising out of the legal battle in the United States.
However, the DCGI remained non-committal about seeking a report from the company against which the US FDA issued an import alert reportedly after finding tablet containing some embedded black fibre that could have been a hair from an employee’s arm or tape fragments.
“It is a fully export-oriented plant. The US FDA is going as per its norms and rules in this regard. If required, we will also go into the recent instance for further inquiry,” Dr Singh told Pharmabiz.
Meanwhile, reports also cited that the drug regulators in other countries like Britain and Australia were also seeking information from the US regulatory to check the impact on Ranbaxy drugs marketed in their own countries. UK's drug regulator Medicines and Healthcare Products Regulatory Agency (MHRA) is reportedly in touch with US FDA and other European regulators to assess the situation. Likewise, Australia's Therapeutic Goods Administration (TGA) also initiated similar steps.
Ranbaxy's newest facility at Mohali was put under an import alert by US FDA earlier this month after the company had failed to correct violations from prescribed good manufacturing practices noted by US drug regulatory investigators in September 2012 and December 2012.
The Mohali facility is the fourth plant of Ranbaxy from which the US drug regulator has blocked products. The other three are at Dewas, Paonta Sahib and Batamandi which were put under import alert in 2008. These plants still remain under import alert, meaning drugs manufactured here are forbidden from entering the US market.
On the other hand, the Indian drug major said it was taking all steps required. "Ranbaxy would like to assure all stakeholders that we are taking stringent steps to address all (the FDA's) concerns," Ranbaxy chief executive Arun Sawhney told shareholders in a letter posted on the company's website.