-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 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...

-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...

-PTI Clinical drug trials in India led to the death of 1144 people in 2010 and 2011, the government today said. The number of people dying during such trials also include 1106 people whose death could be attributed to diseases like cancer, terminal illness or various unrelated causes which is also known as Serious Adverse Event (SAE) of death, Health and Family Welfare Minister Ghulam Nabi Azad told the Rajya Sabha. "The number...

Regulations covering public health should override personal rights and the country cannot wait any more for a good public health law. The health care industry, including institutions of medical education, hospitals and pharmaceutical businesses, have grown into behemoths that can do considerable harm in the absence of independent and effective regulatory systems. While there are no success stories in the regulation of any kind of industry in India, I will focus...