-The Business Standard USFDA's zero tolerance policy requires our drug firms to reorient not just processes but organisational cultures to serve that market credibly The following two quotes from the United States Food and Drug Administration (FDA) news releases may help put the Ranbaxy controversy in perspective. The first sums up what it is that drives the FDA and the second is typical of the challenge the pharmaceutical industry faces. (1) "The consent...

-The Times of India The new Central Drug Standards Control Organisation (CDSCO) guidelines meant to help calculate compensation in case of clinical trial related injury or death in a fair and equitable manner seem to be loaded against the very people it is meant to help. The guidelines suggest a formula based on the income of the injured or dead person along with age and severity of disease. Such a formula raises...

-The Hindu In a major boost to the country’s private vaccine manufacturing pharmaceutical companies, the World Health Organisation (WHO) has said that India’s national regulatory authority — Central Drugs Standard Control Organisation (CDSCO) — and its affiliated institutions meet the prescribed international standards. India is a major vaccine producer with 12 major vaccine manufacturing facilities. These vaccines are used for the national and international market, reaching nearly 150 countries. Every second child...

-Deccan Herald The Supreme Court on Monday expressed concern over the lives of people who, without their knowledge, were subjected to drug clinical trials by pharma companies and sought details of the number of such trials and the deaths and adverse reactions caused by them over the last seven years. “We are concerned with the lives of those who become subjects of clinical trials unknowingly and helplessly,” ta bench of Justices R...

-Frontline Health activists say the health chapter of the Twelfth Plan document exaggerates the role of the private sector in providing health care. The draft chapter on health for the Twelfth Five Year Plan document not only is grossly inadequate in its approach but exaggerates to unrealistic levels the role of the private sector in providing health care. It invokes the concept of universal health care (UHC), but, critics say, it...