India is poised to revamp its 75-year-old drugs law, a move that the country hopes will allow better regulation of the latest generation of treatments, improve oversight of clinical trials and boost quality in domestic manufacturing.
Lawmakers had been planning to push through an amendment to the Drug and Cosmetics Act of 1940, but decided to withdraw that approach and rewrite the law entirely, the government's press office said in a statement.
“[N]ewer areas of biological, stem cells and regenerative medicines, medical devices and clinical trial[s] … cannot be effectively regulated under the existing law,” the statement said.
Along with the new regulatory framework for drugs, officials are planning to write rules governing the medical devices business separately. Now, devices are overseen as drugs, and the industry has been lobbying for a different set of regulations better tailored to devices development and production.
G.N. Singh, who heads up the country’s Central Drug Standard Control Organization, said the health ministry is in contact with regulators in the U.S. and Europe, asking them for suggestions for the new law. "We want to know what their expectations are in terms of compliance,” Singh told Reuters.
Compliance has been an issue in India as stepped-up enforcement by international regulators has led to shutdowns at some plants and import bans affecting a variety of Indian drugmakers. Clinical trials in the country have been under scrutiny as well; earlier this year, the FDA and World Health Organization refused to accept approval applications citing trial data collected by an Indian CRO, Semler Research Center. India’s own Supreme Court criticized the country’s drug regulators for failing to provide adequate oversight in certain vaccine trials.
Multinational pharmas operating in the country have also been caught up in enforcement actions. Last year, for instance, the FDA slapped U.S.-based generics giant Mylan for failing to follow up on problems at three sterile injectables plants in Bangalore, which it had acquired in its 2013 Agila Specialties buyout.
More recently, the U.S. agency banned products from Megafine Pharma, and later sent a warning letter citing the India-based company for faking batch-test data. As of last fall, 44 Indian drugmaking facilities were banned from shipping products into the U.S. The bans have cut export significantly, prompting the government to promise to step up its own oversight of its domestic industry. The plans to revamp its regulatory framework are part of that effort.
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