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在2013年中，印度医疗卫生单位出台了一系列举措来加强对于药品和临床试验的管控，重新建立并选举了印度医学委员会，并在卫生部发展低价替代科技的工作中取得不错地进展。 Read More

Over the course of 2013, India's healthcare sector took several steps to strengthen drug and clinical trial regulations, re-established the elected Medical Council of India, and made progress in the Health Ministry's work to develop alternative and cheaper technologies like an indigenous... Read More

印度立法委员再次延缓关于一项已提交议案的讨论，此议案将在印度史上首次对于所有在印度境内生产或销售的医疗产品进行全面性的法规约束。2013药品和化妆品法案（修订案）要求为医疗器械建立单独的类别，并且创建医疗器械专家咨询委员会，为执法者提供咨询建议。 Read More

Indian legislators again delayed the discussion of a proposed bill that would, for the first time in the country's history, require comprehensive regulation of all medical devices manufactured in or sold in India. The Drugs and Cosmetics (Amendment) Bill 2013 calls for... Read More

India’s drug regulator will soon expand its inspections of foreign manufacturing facilities that supply active pharmaceutical ingredients (APIs) to Indian drug companies. According to the Drug Controller General of India (DCGI), the inspections will focus on China, which supplies nearly 60 percent... Read More

On August 30, 2013, India’s Ministry of Health proposed legislation that would — for the first time in the country’s history — require the comprehensive regulation of all medical devices manufactured in or sold in India. The Drugs and Cosmetics (Amendment) Bill... Read More

The US FDA will increase inspections of Indian drug and medical device manufacturing facilities in response to growing concerns about the quality of Indian medical device and pharmaceutical products. In mid-September, the agency issued the latest of many import alerts against Indian... Read More

In August 2013, India’s patent appeal board revoked patents on three drugs produced by Western firms, including Allergan’s glaucoma treatment Ganfort and GlaxoSmithKline’s breast cancer drug Tykerb. The drugs failed to meet the board’s “improved efficacy” test, which is being used with... Read More

A proposed bill from India’s Ministry of Health (MOH) would — for the first time ever — require the comprehensive regulation of all medical devices manufactured in or imported into India. On July 11, the Union Cabinet approved the Drugs and Cosmetics... Read More

Since India’s Supreme Court transferred the power to regulate clinical trials from the Drugs Controller General of India (DCGI) to the Ministry of Health (MOH) on January 3, 2013, just 12 clinical trials had been approved for the first six months of... Read More