International regulators offer to help India build expertise

European regulators have joined the FDA in suggesting joint plant inspections and training with their Indian counterparts. The offers come as India's industry has lost status in recent years as the FDA and other countries have banned Indian plants from shipping to the U.S. and Europe over quality and data-integrity issues.

Mark Birse

Officials with the EU as well as the U.K. and other countries suggested closer ties during a meeting of regulators from 10 countries held in Hyderabad, India, Pharmabiz reports. "To bridge the gaps, and for better understanding of regulatory systems in both India and abroad, there should be regular exchange of information and regulators must take part in joint training programs and should also conduct joint inspections for better understanding of regulatory issues and at the same time help in harmonizing regulatory hindrances if any," Mark Birse, group manager inspectorate of MHRA in the U.K., said during a presentation, Pharmabiz reports. He said that while most Indian drugmakers are meeting international expectations, some plants have had lapses.

India's pharma manufacturing oversight has been called into question the last couple of years, as the FDA and other regulators have banned plants operated by some of its most prominent drugmakers, plants that Indian regulators never raised issues with.

Susanne Keitel, director, European Directorate for the Quality of Medicines and Healthcare (EDQM), mentioned an inspection in which regulators discovered that an Indian plant had started commercial production of a number of products without any safety or risk management systems in place. "Such instances not only raise suspicion but also create an impression of doubt and lack of confidence on the entire industry," Keitel said, as quoted by Pharmabiz.

But she also noted that drugmakers in all countries face regulatory challenges, and that while there are gaps and limited resources in India, its regulatory system has improved. She pointed out that countries set their standards uniformly for all drugmakers and that no one country is being singled out for action.

Indian regulators and industry officials have complained about exactly that, being targeted by regulators, but the government has also responded, pledging to invest about $500 million to hire and train more inspectors and see that regulators in each state are applying regulations uniformly.

Margaret Hamburg

FDA Commissioner Margaret Hamburg made many of the same offers and observations during her first visit to India last year, where she held meetings with government and industry leaders. She said the FDA was ready to offer assistance and training to Indian regulators and inspectors so they would understand exactly what the FDA expects of all manufacturers.

The FDA, meanwhile, has kept the pressure on Indian drugmakers to toe the line and issued a ban this month against a plant operated by generic drugmaker Ipca Laboratories. The facility had halted shipping to the U.S. last summer after an inspection by the FDA found that employees had been falsifying drug testing results and deleting failed tests. It is an issue that has been noted by the FDA, and in some cases European regulators, at plants operated by Ranbaxy Laboratories, Wockhardt and Sun Pharmaceuticals as well.

- read the Pharmabiz story