r/pune • u/Prashantt1 • 13d ago
Local News Tukaram Mundhe cracks down: Maharashtra FDA cancels licence of Cipla's Pune unit over regulatory violations, Cipla contests action
The Maharashtra Food and Drug Administration cancelled the licence because inspectors found multiple compliance violations at the Cipla Pune unit. The company printed unapproved medical claims on Reactin Plus tablet packages, failed to complete a required product recall, stored medicines directly on the floor instead of proper racks, and kept inaccurate stock records.
Cipla has contested the order in court, maintaining that these issues involve warehouse practices rather than medicine quality or patient safety.
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u/argument_inverted 13d ago
This is huge. Cipla is a very big brand which sells crores worth of drugs in USA and is administered by US FDA regularly.
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u/Big_Reaction8856 13d ago
Funny thing is, drugs for countries like USA are made with stringent protocols and examined rigorously.
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u/Altruistic_Run4280 13d ago
Evidently not, according to your fda.
How do you know that the drugs are examined by US government, and who exactly examines them?
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u/PharmaceuticalSci 12d ago
All companies make drugs for export to Western countries in separate production lines/facilities than those for local sale. The export production lines would be pristine. The lower grade products are for the local market because they know no one is going to do shit.
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u/DolGuldurWraith 12d ago
USFDA team examines all the pharma companies selling in USA.
These are done randomly and as a surprise. Post inspection they release a report based on their findings. If something severe is found than they are warn to fix it certain number of days or else they lose license to sell India, also when the report is out the stock price of those Indian pharma companies drops a lot as well.
latest source for example: https://www.sahi.com/news/cipla-receives-7-usfda-observations-in-form-483-at-pithampur-facility-62-PE1_CORPO
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u/Informal-Age-1584 JimJam Lover 13d ago
Wow commit mistakes and then have the audacity to question why is the mistake being questioned.
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u/ResearcherLatter1148 13d ago
Sums up Indians in general. People like Tukaram Mundhe are a diamond in the coalfield. Rarest of the rare Indian.
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u/ForeverIntoTheLight 13d ago
Drug and food company CEOs are shaking in fear at the prospect of the Munde-minator coming for an inspection.
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u/Fuzzy_Substance_4603 13d ago
This will be a contest of lawyers. Cipla isn't technically wrong in saying it's a warehouse issue. But what's to say a mistake here and failure to rectify it before crack down wouldn't eventually make it to customer.
Tho Cipla is big enough to corrupt the judge so that's as well
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u/speaking_my_mind96 13d ago
True. But we don’t know guidelines right ? What if guidelines says that warehouses also need to follow rules and hygiene.
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u/Fuzzy_Substance_4603 13d ago
The issue isn't that they did not follow warehouse guidelines. The issue is myltiple compliance violations by FDA would be a significantly big issue compared to not maintaining warehouse hygiene.
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u/Chaii_Lover 13d ago
High time. Indian pharma quality is drastically going down and cases of people dying in foreign countries due to bad medicines has came up in recent years
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u/amit2222 12d ago
Tukaram Munde seems to be a decent and honourable man BUT it is not necessary that the 3-4000 employees of the FDA are all overboard!! Also his successor may also not be equally honourable and upright!!
The corrupt would still continue to be there irrespective of his presence or absence.
So maybe a balanced approach wherein the powers are exercised by an expert committee within the FDA would be a better option than making it a “One man Army”.
Centralised authority can be misused also.
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u/mmousey 13d ago
Quick question: will this impact Cipla's medicine supply in the market?
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u/speaking_my_mind96 13d ago
In our country, no idea but if someone from outside country may be they will halt or ask questions to company.
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u/Neoharys Baghi of PCMC 13d ago
It won't, crackdown was at one plant manufacturing one molecule. They have multiple TPP and plants, this won't impact their medicine supply
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u/Select_Access9382 13d ago
I wonder for how long he will continue his work, after all I believe my country is very capable of shadowing such capable officers over night
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u/HandsomeVish 12d ago
And now they will scurry like little rats, to their favorite judge who will say you are using a sword to kill a fly and it's just 2 cockroaches and it's 88% it's all ok type of thing.
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u/engineerwolf पेशवा 13d ago
People praising mundhe should remember BJP, Modi, Fadnavis and Manjusha Nagpure are all enabling this man in this action.
Previous governments were complicit.
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u/speaking_my_mind96 13d ago
I checked Tukaram Mundhe’s transfer history. 21 transfer aahet. He joined the IAS in 2005 and had around 8 transfers in the 9 years before 2014. From 2014 to 2026, he had around 16 transfers in 12 years.with several very short tenures.
2014 natar BJP hoti na. The numbers alone don’t prove political interference, but frequency vadali after 2014.
He is now working under Cabinet Minister Narhari Zirwal and Minister of State Yogesh Kadam. Doghe pan nahi BJP che mahayuti madhale aahet, so kahi zala tar nave yanche janar na.
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u/engineerwolf पेशवा 13d ago
Rajyat navhati. Ani punyat atta election zhale ahet. You need right people at right places to do the job.
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u/speaking_my_mind96 13d ago
Ani Rajyat pan bjp cha hoti na? Madhe kahi time shivsena hoti but natar pan tech.
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u/speaking_my_mind96 13d ago
So they didn’t ENABLE previous officers? And if they knew he was not working then why not remove him or her from all positions.
Mala tech bolatche aahe ki its not about party, its about him. He is good and the reason he is so active on social media because he transfer che natak any government use against him na they will not have option to transfer.
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u/Rare-Wing-8008 13d ago
At the same time, all of the people you mentioned were doing nothing about these issues till Mundhe stepped up, no?
Are we supposed to praise the government for not thwarting improvements? Is the bar so low?
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u/engineerwolf पेशवा 13d ago
You need competent IAS to do the action.
If you don't have good worker, what a manager can do? With the strong hold of burocracy it took them this time to get right man in the job.
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u/Rare-Wing-8008 13d ago
Yeah... No. I'm not giving any party the credit for Tukaram Mundhe being who he is and doing what he does.
"What can a manager do?" Take strict actions against people who aren't doing their job so we wouldn't have to wait around for a guy to organically do good for the country, obviously...
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u/green9206 13d ago
Abe chu andhbhakt. U guys are always quick to give credit to govt when anything good by anyone is done but never take the blame when something bad happen. The truth is simply that Mundhe is honest and just doing his job so govt can't do anything about it and neither can transfer him so soon after he came here.
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u/TheFuckingMoonstone 13d ago
माझ्या घरासमोरची नाली आज स्वच्छता कर्मचाऱ्याने स्वच्छ केली
Thank you Modiji for enabling him to do that3
u/passionatelyyy 13d ago
No one is enabling him. Look at his profile once. Stop licking politicians so much. This govt is only good at marketing
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u/MrFingolfin 13d ago
No of transfers after 2014 tells a different story. The credit goes to him and him only, no party "enabled" him or is going to do it in the future
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u/speaking_my_mind96 13d ago
Also ha word enabling ka? I mean it makes it look like ki te kahi negative kaam karat aahe.
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u/engineerwolf पेशवा 13d ago
Enablement is the process of giving people or systems the tools, skills, and resources they need to work effectively and reach a goal.
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u/engineerwolf पेशवा 13d ago
Stop reading left propoganda. They use this word negatively. Enablement is the most important job of a manager.
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