Journalist - Indian pharma & healthcare industry; views own, no noise. vikas.dandekar@timesinternet.in
Jun 29, 2022 • 12 tweets • 4 min read
#Thread
Last week, a top official from CDSCO, India's drug regulatory agency, was hauled up by CBI for allegedly taking a bribe to waive off Ph 3 clinical trials on a type of insulin. Four others were taken into custody including a senior executive from Biocon Biologics (1/12)
Biocon Biologics has however strongly denied those allegations and said all the norms for approvals were followed.
Anyways, this however is not the first time that the central drug agency is hit for breach of ethics.
Let's go back to 1998 (2/12).
May 15, 2020 • 4 tweets • 2 min read
#Thread Gilead's remdesivir is the latest in a volley of potent leads explored in severely ill Covid-19 patients. Indian firms signed supply deals, similar to sofosbuvir a few years ago. But it is not as similar as many think. Key points: 1. Remdesivir is an infusion drug (1)
It has a complex process and a supply chain that takes no less than six months to make. China makes some critical inputs. 2. That being the case, how will it be viable? A study showed probable price range of $10 to $4500 in US for a treatment course. That's some gap to fix (2)
Dec 10, 2019 • 14 tweets • 3 min read
#Thread: As @Novartis’ vildagliptin (#Galvus) goes off-patent in #India today and a scramble is expected, some tidbits about this hugely successful drug.
-Vildagliptin, from a class of drugs called DPP-4, was launched in India in 2008 with a licensing arrangement with USV (1)
-This was one of the first few drugs launched post-2005, the starting of India's product patent era
-Novartis’ drug is Galvus and USV took the brand name Jalra; Novartis marketed Galvus in top cities while USV sold in smaller cities as Jalra (2)
Oct 11, 2019 • 15 tweets • 4 min read
Long #Thread - My #Ranbaxy Musings:
1997: I was happily set in the textile industry writing news stories for Indian Express business publications division and enjoyed regular rounds of the textile trade unions in the Parel area. But that changed abruptly.
My Editor PA Francis said I have to move to the pharma beat. Fret and fume, but there was no option.
Even as I was settling down, there came a big bold Page 1 lead headline in @EconomicTimes from @shankarsview, a low-key, soft-spoken gentleman and an ace journalist, I admire.
Sep 25, 2019 • 9 tweets • 3 min read
Thread #valsartan#ranitidine NDMA impurity.....
Last year when the US FDA sent out a warning letter to China's Zhejiang Huahai (ZHP) for NDMA impurities, a known carcinogen, a few large Indian drug makers may have felt the chill...one of them is Hyderabad-based Hetero Drugs.
Following ZHL, Hetero is learnt to have changed the manufacturing process for valsartan API. Since it meant fewer stages of manufacturing, it more or less became an industry norm to adapt to a new way to cut costs; being ahead in the market competition was a priority