Horrific GMP standards @ PAN Drugs, India: Warning Letter - How FDA had approved this facility???

Linkedin Post - Horrific GMP standards: If you read this warning letter to PAN Drugs, India, in first place, you wonder how FDA had approved this facility!!! https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm518540.htm

Pan Drugs Limited 8/25/16 <!— END Social buttons—> Managing Director and Chairman 192 G I D C Makarpura Industrial Estate The U.S. Food and Drug Administration (FDA) inspected your pharmaceutical

Response by C. Chantzis:

Folks, I don't know why some of you are SURPRISED by the Pan Drug FDA findings? India’s pharma regulator, the Drug Controller General of India (DCGI) G N Singh has said: “If I have to follow US standards in inspecting facilities supplying to the Indian market, we will have to shut almost all of those.” So, this horrific unsafe, inefficacious state of the various pharma and/or medical device companies is KNOWN both to the Indian and US FDA authorities plus top management of Indian companies. Paul Hargreaves, chair of Pharmaceutical Inspection Co-operation Scheme (PIC/S) has said "... India’s pharmaceutical industry is “very much against joining PIC/S” as it’s too expensive. India would have to raise standards significantly to meet PIC/S requirements."

While I agree with the above statement of India’s pharma regulator, the Drug Controller General of India (DCGI) G N Singh, I can prove to interested parties that India CAN manufacture/market raw materials, APIs, generic drugs ONLY and medical devices to the US/Europe/Japan/Canada at a "REASONABLE" profit. In addition, I agree with the above statement made by Paul Hargreaves, chair of Pharmaceutical Inspection Co-operation Scheme (PIC/S). requirements."

* My Definition of "Reasonable" Profit: 8-20% after taxes.

The article's author "India, China not joining PIC/S: A global pharma quality setback or increased access to affordable medicines? @ https://www.pharmacompass.com/radio-compass-blog/india-china-absent-as-countries-align-on-global-pharma-quality-standards " wrote in part "... The absence of India and China from PIC/S and ICH is a cause of concern, in view of the rising instances of FDA (and other regulators’) warnings, Form 483s, banned products and import alerts against manufacturers from these two countries" and "...While there may be a cost attached to improving quality, the cost of neglecting quality maybe even higher in the long run. And, there are no short cuts to adhering to GMPs."

The core root cause of found significant violations is the "get quickly rich without any concern with the sale to the public of inferior/defective/dangerous products (e.g. raw materials, APIs, drugs, medical devices) short-sighted, self-defeating - and typically even criminal - strategy. There is no lack of knowledge in the industry on how to produce a raw material, intermediate, API or end product in compliance with the US/European regulations. Also, a company in China, India, Vietnam or elsewhere where labor is relatively low can still be reasonably profitable if it were to build and operate a medical device, pharma facility in regulatory compliance. That is exactly what I have been helping my clients achieve throughout my career for 35+ years. I am ready to provide bonafide parties with proper evidence inclusive of a plan to either cost-effectively remediate an existing regulatory non-compliant facility or design and build a new one.

The various regulatory agencies such as the FDA are the protectors of the public. So, those regulatory authorities have set specific regulations which each company manufacturing/marketing products that are being regulated must comply with. Evil people exist and will continue to exist. That is why we have laws, rules, regulations, courts, police, jails, lock our homes/cars/property, etc. We just can not assume that everyone will ALWAYS do the right thing and act like Jesus did :-)!

I find one group member's prospective VERY interesting indeed in light of a) the admission of India’s pharma regulator, the Drug Controller General of India (DCGI) G N Singh - please see above - ; b) Paul Hargreaves, chair of Pharmaceutical Inspection Co-operation Scheme (PIC/S) - please see above -; c) the numerous, significant up to-date violations in India found by FDA over the last several years and d) the first hand knowledge of numerous people who have posted in Linkedin vs ONLY one group member post with a contrary view alleging "I have seen many facilities in India which have higher standards then many I have seen in [Western Europe - let's not muddy more the waters with this inclusion for now] or US" without any evidence to prove their position.

Therefore, it is important to summarize a few critical points:

1. Each one of us can have our own opinions BUT we can NOT create our own facts. That is, are the FDA's findings in India true - many times of criminal nature - or not? I answer: True.

The denial, "sugar-coating', deflection strategies continue to prove these pharma/medical device industries in India and the rest of the world will not/can NOT recover until they admit their VERY serious problems and seek help urgently and/or the regulatory agencies shutdown permanently EVERY criminal operation and then bring to justice the involved parties.

2. What are the root causes? Top companies' greed and determination to profit by knowingly manufacturing/marketing harmful products. What is your opinion? BUT, please be an Object Fact Trier; use only the facts, logical reasoning, NOT your self-interests. A small percentage of companies found in significant non-compliance might not know what they are doing. Yet, even so, then the responsibility rests with the respective regulatory authorities that gave them the approval to "open shop." Action: Shut them down until either they regain proper regulatory compliance or create an opportunity for someone else to do so properly. What is your position?

3. Can companies in relatively inexpensive labor countries make a reasonable profit - as I have defined it above - by manufacturing/marketing Safe and Efficacious products? If, Yes, then How?

A company fundamentally must have: a) properly built facilities with layout that minimizes/ eliminates cross contamination (internal and external air, floor/wall/ceiling, piping and ducts, wardrobes, transfer equipment), b) WFI, HVAC and stable electrical/gas utilities, c) manufacturing/testing laboratories with validated equipment for consistently producing valid data/materials/intermediates/products and audit trail, d) a Lean Six Sigma (LSS), unified, regulatory compliant Quality System based on Quality-by-Design (QbD) and e) personnel inclusive of top management empowered to work diligently for developing/ producing safe and effective raw materials, intermediates, APIs and end products. That is exactly what I have been helping my clients achieve throughout my career for 35+ years. I am ready to provide bonafide parties with proper evidence inclusive of a plan to either cost-effectively remediate an existing regulatory non-compliant facility or design and build a new one. What is your position?

A prerequisite to a smoker who wants to stop but after MANY tries still can NOT do it is???? Admit YOU got a problem :-)! "Sugar-coating, deflection, yes we got a problem but we do not have a problem, dilution, not here - look elsewhere, total denial" strategies will NEVER work. FDA violations like this one @ PAN Drugs or MANY others from the recent years continue to validate what we already know ...

In any event, let's have the public and the Indian/US Regulatory Authorities - that are watching this discussion on the sidelines per my evidence - judge what are the facts, truth, root causes and PROPER remediation actions. At the end, the public's safety is in the hands of our politically appointed "Gate-keepers" in India, US and elsewhere in the world. If the police either gives licenses and/or refuses to take those licenses away/jail drivers speeding recklessly/causing harm after documented repeated, serious harmful offenses, then the only action we - the people - can take is: to unite against such unacceptable policing behavior and DEMAND swift action from their replacements!!!

Finally, it is VERY unfortunate that FDA's public domain data on global inspections from 2006 to date is unsuitable for proper statistical analysis per specific variables, e.g: country, company location ID, original license date, categories of materials/products manufactured on location ID, volume of materials/products produced annually per company location ID, onsite inspection dates, onsite inspection type, inspection outcome code, list of found violations by specific regulatory code, summary of company's response/action per each found violation, etc, etc.

I am SURE there might be legal obstacles to making such data public BUT the public and companies themselves - eventually - stand to gain enormously if the above data were to become available. Let's pray for that outcome - I know the regulatory authorities are watching this discussion.

@One Poster's Comment: It appears you are on the side of a small percentage of people that continue to be "Denial" ... I respect that but the facts on the record speak louder than words.

In response to your statement "It is mere opinion in Pharma Compass, ..." implying that if a conclusion or assessment does NOT come out of the mouth of India's or USA's President, then we - wise people - must reject it as nonsense. I respectfully disagree.

Wise people ALWAYS evaluate a person's actions and then make a proper decision about the merit of those actions ignoring their title. Why? Because titles tend to be VERY misleading. Having said that, I can tell you that even though I have never met Mr. Bharat Mehta, I believe he is not only wise but also he wants to make the world - inclusive of India- a better place for all of us. Thx to Bharat we can debate such important topics as this one on his "FDA Inspections" forum or read informative articles on PharmaCompass.com. So, instead of knowing how to criticize, maybe it would be better to encourage and empower others to continue doing "good deeds" for the benefits of all of us.

The FDA is comprised of people like each one of us: They are imperfect humans. UNFORTUNATELY, one has also to factor in the possible effect of Corruption, Bribe or the equivalent. In this case, I don't think lack of knowledge by the regulatory inspector was the core root cause ...

If any of you have done business in South East Asia like I have, then you should NOT be surprised ... I point out again what one of our knowledgeable group members - R. Gupta - wrote previously here "... The sole cause of gross noncompliance in India is lethargy, culture and habits. The management seems to be always short of funds for upgrading the systems and documentation." Let's add China along with a few other countries located nearby to the above statement for fairness ...

The FDA records document that it issued 63 Letters and with the following Subject to Indian pharmaceutical related companies from 2008-09-16 to 2016-08-25:

1. GMP/Finished Pharmaceuticals/Adulterated --- 35/63 or 55%

2. Labeling/Promotional Claims False & Misleading/New Drug --- 15/63 or 24%

3. CGMP/Active Pharmaceutical Ingredient (API)/Adulterated --- 13/63 or 21%

I believe an Objective Fact Trier will conclude the above compelling evidence proves Beyond a Reasonable Doubt that such practices are in regulatory non-compliance and obviously must not be used as emulation examples by others. If anyone has evidence to disprove the above, please do so.