Whether the pandemic is over or not isn’t a question we will ponder today. For most people and businesses in most of the world, the pandemic is definitely over. And it’s been a welcome return to the new normal for almost everyone, except a few healthcare professionals and epidemiologists.
Except.
The post-pandemic scenario hasn’t been all that rosy for Indian drugmakers.
Not because of reduced sales, except for some who stockpiled Covid therapeutics or those who held 500 million syringes as backup. And yes, the supply chain is not yet back to normal, mainly because China is still in Zero Covid mode.
During the pandemic, regulatory inspections of facilities were often deferred or even cancelled entirely. Earlier this year, the US FDA declared the resumption of inspections at domestic operations in the US. Weeks later, the agency stated its intent to continue overseas facilities. Statements that resulted in articles foreseeing the rise of quality concerns.
True to prediction, the return of inspections has seen a spike in issued warnings and notices. And Indian drugmakers have been at the receiving end of a fair few of them.
The first one covered in The Kable this year was Granules, whose subsidiary plant in Virginia received 3 observations from the agency.
And the trend continued.
The last day of February saw Aurobindo, and Sun Pharma issue recalls in the US.
Google Fonts-led rebrand notwithstanding, Zydus got 3 observations from the US FDA for its Vadodara unit in March.
In April, Aurobindo, Sun Pharma and Jubilant issued recalls for various reasons. And Lupin found itself in hot water with the US FDA. More than once.
In May, Sun Pharma recalled its antidepressant in the US and received a form 483 for its unit in Halol, while Aurobindo received a form 483 for its Hyderabad facility.
That’s not all that has gone wrong for Indian manufacturers this year. In June, a Biocon executive was arrested for trying to bribe a drugs controller. Covaxin, suspended from the WHO’s Covid immunisation protocol in late March, remains suspended for poor manufacturing practices, despite the Indian health ministry asking the company to shape up.
Even local authorities weren’t shy, slapping 16 units in Maharashtra with an order to cease production. Courts asked units in India’s pharma manufacturing hub Baddi to shut down for violating pollution control norms. Circulation of substandard and falsified medical products in India increased by 47%.
Gennova Biopharma, makers of India’s first mRNA Covid vaccine, saw parent Emcure sued in the US for violating trade secrets. Sun Pharma shelled out $485 million to resolve a long-standing antitrust case against its generics unit, Ranbaxy.
Nigeria had initially blocked all drug imports from India before ceding a little.
And quality concerns have ticked up dramatically in August. Cipla was censured by the US FDA. Glenmark received an OAI classification for its formulations facility in North Carolina. Glenmark, Strides, and Cipla issued recalls due to manufacturing issues. Aurobindo’s subsidiary got one more observation.
Considering India’s sheer number of manufacturers and manufacturing facilities, one can expect the odd red flag. But for a country that claims to be the world’s pharmacy, laxity on quality, long accepted in the industry when inspections are not due, needs to go. Forever.
Ending this piece with the news that Lupin has a tentative go-ahead from the US FDA for its generic cancer treatment. A tiny little ray of sunshine.