Pharma manufacturing cGMP has lately become an unbelievable drumbeat of Enforcement Reports and FDA and EMA Import Bans, even repeatedly, at several generic manufacturers.
But is non-compliance convulsing so much in the ground beneath our industry that we now have the “Big Pharma Offshoring cGMP Tsunami” racing toward us?
On the subcontinent of India, starting in 2005, whistleblower Dinesh Thakur, former R&D executive at Ranbaxy, precipitated the eventual $500 million agreement in cGMP fines and settlements with FDA. Thakur’s brave revelations surfaced egregious cGMP violations for numerous US-bound pharma products and a massive, conscious fraud which was intentionally concealed by Ranbaxy senior management. Mr. Thakur received $49 million from the US Department of Justice, after he boldly came forward with evidence to help settle this unbelievable cGMP catastrophe in America’s everyday pharmaceutical consumption.
In 2008, the clinical medical world could not avoid noticing the most horrific violation of deficient cGMP… in the doctors’ own hands at their patients’ bedside. Baxter had imported Chinese-sourced heparin into the US, but it was laced with 50% over-sulfated chondroitin sulfate (OSCS), which mimics the heparin HPLC profile, but provides no anticoagulant activity. Over 103 deaths were linked to this abhorrent and criminal Drug Product contamination, and tens of thousands more suffered from the resulting Import Ban and severe drug shortage and subsequent rationing of scare supplies of real heparin for several years.
In 2012 and 2014, FDA Commissioner Margaret Hamburg visited India and China, respectively, in the midst of three import bans on Ranbaxy Pharmaceuticals products, including the incredible 2011-12 crisis over non-cGMP manufacturing of atorvastatin. But her visits appears to have had no real impact on the deeply-entrenched cultural and business practices of overtly and routinely ignoring full compliance with cGMP, as Ranbaxy was slapped with additional FDA Import Bans for esomeprazole and valsartan in 2013.
In April 2014, an investigative study by Consumer Reports substantiated 80% of the active ingredients in all U.S. drugs, both generic and branded, were made in foreign countries.
In fact, most brand-name drugs are produced in the same countries and often in the same facilities as their generic counterparts. There is only one reason: improved profitability from cheaper foreign manufacturing costs. Increased Pharma profits, however, may often come at the cost of patient health.
While some Pharma companies work hard to produce safe and compliant products, we know from experience that many do not. The list of alleged cGMP infractions, product recalls and Import Bans grows, and even repeats, as the years go on: Baxter, Ranbaxy, Sun Pharma, Apotex, GVK, Cipla, Wockhardt and now Emcure . All occurring despite the watchful (but under-staffed) eyes of the FDA, EMA, DCGI and SFDA.
In May 2015, the Indian Government issued an initial report entitled “Recommendations of the Task Force on Enabling Private Sector to Lead the Growth of the Pharmaceutical Industry.” The sparsely listed regulatory issues and recommendations show India currently has 846 drug inspectors, while 1,349 positions are approved and 3,200 are actually needed to enforce cGMP compliance in India’s 10,500 Pharma manufacturing sites.
Instead of singularly focusing on assuring product quality and safety, the Indian government is instead aggressively offering Pharmas a 15-year tax holiday, low-cost space at industrial parks and subsidies on interest owed to banks. It appears that India is more interested in taking Pharma manufacturing business away from China than assuring patient safety and full drug potency for Indians and Americans.
Alarmingly, the most recent major recalls and FDA Enforcement Actions involve significant deviations of DS potency in finished Drug Product: Dr. Reddy’s divalproex sodium ER and amlodipine besylate/atorvastatin in June 2015, and metoprolol succinate XL in June 2014.
Very recently in July 2015, Emcure was cited by FDA with yet unrevealed 483s and a massive US Import Ban by for an undisclosed majority of its products from their Hinjawadi plant. Teva had previously recalled numerous generic drugs in May 2014 that had been manufactured by Emcure.
Of greatest concern, Emcure is a CMO partner for US and Western branded big Pharmas including Pfizer, Roche, Novartis and Sanofi. See the full reports: http://www.reuters.com/article/2015/07/14/us-india-drug-regulator-idUSKCN0PO16P20150714
Is this Import Ban the rising of the “Big Pharma cGMP Offshoring Tsunami” many have long suspected? Is the non-compliance swell about to wash over all of our industry?
Which brings us to the ultimate question: WHEN do we finally understand the depth of potency deficiencies in DP arising from off-shore cGMP manufacturing violations across America’s Pharmaceutical supply? Do we wait for a DCGI Task Force, do we wait for FDA who haven’t obtained sufficient visas or personnel for India and China inspections, or is there a disruptive, but highly-ethical and faster, path to simply stop and correct the flow of contaminated and sub- and super-potent drugs flowing to American patients ?
We offer an answer. The U.S. Department of Justice is authorized to pay whistleblowers – pharma workers and executives with inside knowledge of cGMP violations – an award of up to 30% of whatever the government collects from wrongdoers. We know that most pharma employees are hard-working, conscientious people that truly care about the industry and patient safety. We also know that receiving a large cash award potentially in the tens of millions of dollars is necessary to help those workers who do come forward to get a fresh start.
If you or your colleagues, anywhere in the world, have evidence of significant cGMP deviations in the last 6 years for American-bound DS or DP, contact us confidentially by emailing us at: [hidden email] or call us in the US on +001-202-780-9957. We help match would-be whistleblowers with CM&C experts and qualified lawyers to ensure they receive the highest awards possible and protection from retaliation. There is no fee for our services.
The Pharmaceutical Integrity Coalition (PIC) is an independent Advocacy Group, with no ties to the Pharma industry. Our non-government organization was founded as a Safe Harbor by highly-concerned professionals who are focused on ending this public-health tragedy of ignorance and neglect as soon as possible. Our goals are simple: stop contaminated and questionable potency pharmaceuticals from entering the US commerce stream and reaching patients, and restore integrity to our profession and industry.
We want to precipitate “the beginning of the end” of cGMP violations from manufacturing of America’s Pharmaceutical products anywhere in the world, and move to a future of sustained dependability and full trust in pharmaceuticals for health and healing. It’s all about why and how we grew our careers in the Pharma industry, to help people, and the only way we know how to practice our CM&C craft.