-TheWire.in The US drug regulator says Lupin Limited's response to tackling genotoxic impurities was not adequate. New Delhi: The US Food and Drug Administration (FDA) has sent a warning letter to the Indian pharmaceutical company Lupin Limited after deeming its efforts to address violations of various Good Manufacturing Practices at its facility in Tarapur, Maharashtra “inadequate”. The FDA sends a ‘warning letter’ to a manufacturer if it has “significantly violated” the agency’s regulations....
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Most small drug makers aren’t WHO-GMP certified -Priyanka Sharma
-Livemint.com The Centre has started an outreach programme for such SMEs operating in 10 locations Considering that only one-fifth of the small and medium manufacturers of bulk and API (active pharmaceutical ingredient) drugs have been certified under the World Health Organization’s Good Manufacturing Practices, the Centre has launched an outreach programme to establish India as a best-in-class pharma hub, said an official in the know. “As of now, India has around 6,790 SMEs...
More »Expired pill: Editorial on new drugs and cosmetics bill
-The Telegraph There is no mention of compliance with ‘Good Manufacturing Practices’ or the need to make inspection reports public, leaving the process of regulation vague and dependent on whims of drug inspectors This month, the Union ministry of health published the draft new drugs, medical devices and cosmetics bill to replace the antiquated Drugs and Cosmetics Act, 1940. Yet, most of the draft bill appears to be a copy of the...
More »Is the govt. doing enough for the Jan Aushadhi scheme?
On Janaushadhi Diwas this year (i.e., March 7th, 2022), Prime Minister Shri Narendra Modi stated that the poor and the middle-class benefited from the 'Jan Aushadhi Kendras' that were set up to provide generic drugs at affordable prices. He said that the poor and the middle class saved around Rs.13,000 crore through these stores during the COVID-19 pandemic. In the wake of COVID 19 crisis, the 'Bureau of Pharma PSUs of India'...
More »We need a Nutrition Mission -Vinita Bali
-The Hindu India must convert its young population to a competitive advantage, and nutrition and health are foundational to that outcome. The “Global Nutrition Report 2016” once again demonstrates India’s slow overall progress in addressing chronic malnutrition, manifest in stunting (low weight for age), wasting (low weight for height), micronutrient deficiencies and over-weight. Our track record in reducing the proportion of undernourished children over the past decade has been modest at best,...
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