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Darshan Kulkarni is part of the limited club of lawyers working on US Food and Drug Administration (FDA) regulatory and compliance. A member of the New Jersey and Pennsylvania State Bar Associations, Darshan Kulkarni has also worked as a pharmacist for more than a decade, and has even participated as a clinician in clinical trials.
In this interview with Bar & Bench’s Varun Marwah, among other things, Darshan Kulkarni speaks about the Indian legal landscape for pharmaceutical companies, investor confidence, and the limits of pharma regulation.
Varun Marwah: Tell us more about your educational background.
Darshan Kulkarni: We are at least six generations of pharmacists. I learned from my father that all businesses run along three major concerns: the technical aspects, the legal aspects of the business, and the business aspects. Given my education and experience, I have covered all these three aspects.
I completed my junior college at St. Xaviers in Mumbai and went to the US for further education. After completing the Doctor of Pharmacy degree, I went back to get a Doctor of Law (Juris Doctor) degree which I completed at the age of 25. I also went back to pharmacy school, to get a Masters in Quality Assurance/Regulatory Affairs. Additionally, I completed a one year clerkship in the Eastern District of Pennsylvania for the Hon. Clifford Scott Green. After the clerkship, I finally completed my fellowship in Inter-professional Geriatric Care. So, I’m actually a fully qualified pharmacist, and still maintain my license – which helps my clients since my knowledge is not based on a vacuum of information.
Varun Marwah: How does your education complement your practice, given your niche area of practice?
Darshan Kulkarni: Turns out about 1% of all lawyers are Intellectual Property lawyers, but there are very few lawyers in the entire country who do US FDA regulatory work. After working as an Intellectual Property lawyer for a short stint, I went on to become corporate counsel for a multi-national pharmaceutical company that had connections in Singapore, India and the US.
While I was in this company, I ended up in Kansas City, where the FDA happened to be inspecting our manufacturing facility. I quickly realized that there was no FDA regulatory counsel around. So I ended up talking to the FDA. Soon after the recession I went solo and focused on FDA regulatory and compliance law.
Varun Marwah: So what does your work entail?
Darshan Kulkarni: I mainly do legal compliance and regulatory work for the FDA. Of course, I also represent these companies in whistleblowing matters brought against them. In terms of regulatory advice, I have a range of clients. I may be called to help clients bring a new product to the market, or help keep an existing product on the market.
In terms of more traditional clients, I also do work with pharmacies. This has become especially interesting due to the rising importance of compounding pharmacies.
Varun Marwah: You mentioned compounding pharmacy – could you explain what that is?
Darshan Kulkarni: Compounding is the preparation of personalized medications for patients in response to a practitioners prescription in which individual ingredients are mixed together in the exact strength and dosage form required by the patient.
Between 2008-2010 the US FDA became overly aggressive with the enforcement of Good Manufacturing Practices (GMPs). Suddenly, pharmaceutical companies that were functioning in a “business as usual” way were required to reconfigure. This resulted in critical drugs not being available.
At one point there were over 240 essential drugs not available in the market and patients were significantly affected and dying due to the lack of these products. So, compounding pharmacists, who used compound personalized medications for their patients, came to the rescue. They started doing large scale compounding to fill in the void.
The problem with this was that a compounding pharmacist, whether or not he knows it, typically doesn’t meet the high standards of GMPs. This problem came to the forefront in 2012-13. A compounding pharmacy (NECC), was making tens of millions of dollars in turnover by essentially manufacturing pharmaceuticals under the guise of large scale compounding and without following GMP requirements. Around 800 people were affected, and 64 people died from the contaminated product. Murder charges are currently being pursued.
It was soon realized that compounding pharmacy is a largely unregulated world and a new law, called the Drug Quality and Security Act (DQSA), was thus passed. The law prescribes appropriate guidelines for people doing large scale compounding, such as registering with the US FDA, and following GMPs.
However, the rules and expectations make all the difference between being regulated by the FDA, versus meeting the seemingly lower standards of a state board of pharmacy. These are the kind of questions I could be involved in.
Varun Marwah: Are there specialized law firms like yours, existing in India?
Darshan Kulkarni: Not that I’m aware of. There are general practice firms who do try to get into this, but none specialize. Although, I do know of people who do food and drug law. My father used to work with a Supreme Court lawyer Dadasaheb Kharmate, who was phenomenal. He did food and drug law.
Varun Marwah: How are the food and drug laws in India vis-à-vis the USA?
Darshan Kulkarni: India is trying to catch up with the rest of the world in the pharmaceutical sector. This is good thing. However, there are outstanding questions on how to achieve these goals. One of the key elements of any business, is to have a certain amount of consistency.
A government is essentially saying, “If you play by these established rules, you we won’t prevent you from making a return on your investment”. But that consistency is often lacking since the rules are either applied inconsistently or change inconstantly.
In my limited experience, India is very eager to pass laws, but not very eager to enforce them. When the laws are enforced, they are seemingly enforced in an arbitrary manner. If person X and person Y both did the same crime, there may be significantly different results depending on who each person knows, their ability to bribe, their position in society, etc.
In my limited experience, India is very eager to pass laws, but not very eager to enforce them. When the laws are enforced, they are seemingly enforced in an arbitrary manner.
Additionally, for example, the judiciary often interprets the law in a more equitable manner as opposed to a more legalistic manner. I’ve read certain Indian Supreme Court judgments and compared them to judgments written by US courts. Indian judges often grant something neither parties have asked for because it is a “fair” result. However, what is fair may not be what is just.
Whether this is a good thing is dependent on your perspective on the role of the court. In the US, it is typically rather cut and dry: You ask for something and either will get what you ask for, or wont. It’s unusual to get something other than what was requested. On the other hand, I have seen some Indian courts seemingly compromise so that they will cut the pie in half so that neither party walks away empty handed. Obviously, both versions have value – it merely comes down to the role people expect the courts to play.
Additionally, administrative bureaucracy does not help the system. For example, in the US, the US FDA that handles most issues as they apply to drugs. On the other hand, in India, you have state and national level food and drug authorities and numerous committees. This confusing mass of authorities with varying interpretations and expectations has resulted in problems before and this seems unlikely to stop anytime soon.
Varun Marwah: Thoughts on the Uniform Code for Pharmaceutical Marketing Practices? Is it enough to account for the malpractices?
Darshan Kulkarni: In the US, several pharmaceutical companies have come together to create an organization called PhRMA. PhRMA represents the collective interests of these companies and often promulgates guidelines and codes for their members to follow. These codes are, by definition, non-binding and non-enforceable. No court can require a company to follow these rules.
But one of the reasons PhRMA creates these codes and guidelines is to enable Congress or the FDA to not have to worry about the issue since it is possible that the Government will put its own code (via law or regulation) which will be harsher than anything the pharmaceutical companies may have wanted. Essentially, it’s easier for a company or group of companies to self police than meet heightened requirements imposed by the government. So, in my world, codes can work.
However, a voluntary code is by definition unenforceable. This is, by itself, a rather significant limitation since it depends on the desire of a company to adhere to a common standard.
On the other hand, if the question is whether a voluntary code is better than a law, I might argue that it may not matter if neither is going to enforce it. I have been involved in court cases in India. These cases drag on for many years and I quickly learned that justice delayed is justice denied. If voluntary codes can help enable quicker justice and the imposition of good standards, Codes seem like a respectable way to proceed.
Varun Marwah: Thoughts on the Indian legal landscape for pharma companies?
Darshan Kulkarni: The legal landscape for pharma companies coming to India is very concerning for multiple reasons. From an IP perspective, 2005 was a watershed moment. That’s when the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement impacted India directly.
One of the key portions of TRIPs compliance includes the ability to engage in compulsory licensing.
India was one of the first few countries start using those provisions, and that is concerning because global pharma companies (MNCs) have spent billions of dollars and decades of time risking for a potential drug. For a country to then say we’re going to just start using your process, and potentially sell the product not only in your country, but also in places in Africa, for a profit that you deem insufficient is, from a company’s point of view, very concerning. It doesn’t make sense for them to put their money there anymore.
From a clinical trials perspective, there is less dependability on the laws. Just a few years ago, clinical trials were routine. However, it was determined that the laws and enforceability in India is so lax that over 370 people died in only 2 years from clinical trials. The Supreme Court then asked for a record of these deaths and the records were not forthcoming. The clinical trials industry was quickly shut down to reorganize, and the industry has not yet recovered. If you want to work at a global level, you need to meet basic expectations; you can’t have global companies who are spending billions here, shutting down one day, telling them we are going to ‘reorganize’.
Then there is the issue of fraud and enforcement. There are numerous instances of Indian companies engaging in fraudulent and deceitful behavior. Examples of such behavior has been discovered by the US FDA and has resulted in bans against these companies.
However what is worse is that examples of such behavior keeps getting found. This shows that it isn’t a “one- off” problem found once in one problematic company. It is hence, more likely, a result of a systemic failure caused by the lack of appropriate enforcement.
What is worse is that examples of such behavior keeps getting found. This shows that it isn’t a “one- off” problem found once in one problematic company. It is hence, more likely, a result of a systemic failure caused by the lack of appropriate enforcement.
Varun Marwah: What are your views on the Physician Payments Sunshine Act? Is it required in India?
Darshan Kulkarni: In the US, this law was passed with an intent of shining a ‘light’ on any transfers of value, between a pharma company and a physician. It was a waste of money. The idea was – if you shine the light on physician–pharma company relations, drug prices will go down.
The inherent argument was that pharma-physician relations are bad, and doctors prescribe drugs because they are bribed. I believe those arguments are flawed. Not only did drug prices not go down, prices may have increased. According to the GAO (Government Accountability Organization), the implementation of this law cost a billion dollars in the first year, and hundreds of millions of dollars every year thereafter. Obviously, these costs will be eventually borne by patients. So, who really benefitted?
Lets get some differences in mind, there are some very obvious bribes which are not ok- in the US there was something called the ‘gas and dash’ which was when a doctor’s car would go up to a gas station, and the pharmaceutical sales rep would take the pump, put it into the doctor’s car, and then quickly talk to the doctor. So the rep pays for the gas but in exchange he gets to talk to the doctor. That is obviously unacceptable behavior.
However, if a company wants to tell a doctor about the latest drugs, that is not necessarily a bad thing. People say you shouldn’t be allowed to advertise drugs. But, someone just put upto 4 billion dollars and decades getting a product to the market, why shouldn’t they be allowed to advertise their product to get a return on their risky investment?
But, someone just put upto 4 billion dollars and decades getting a product to the market, why shouldn’t they be allowed to advertise their product to get a return on their risky investment?
I think the pendulum has swung too far, where everything seemingly needs to be stopped. However, I believe that these ideas as often ill considered and people have not adequately considered the repercussions of their statements.
If there is an Indian version of the Physician Payment Sunshine Act, there needs to be a clear clarity of purpose. Is the goal that patients make more informed decisions about which doctor to go to? If so, is there an assessment about will these patients actually review the site? For example, how many people in India go online to look at the doctor’s information?
If you’re saying I simply want disclosure, then fine do it, but then you need to recognize that there is a cost of such disclosure – costs that are passed on to the patients and the poor. So, unless there is a more specific, well thought out purpose, I don’t see the value of such a law.
(Views expressed in this interview are of Darshan Kulkarni. Bar & Bench neither endorses nor is responsible for the same)