"I am not against generic drugs that can be made available at cheaper rates. My fight is against poor or bad quality drugs that are being manufactured and sold in India. Add to this, poor public healthcare system, data manipulation by pharmaceutical companies and lack of regulation, and the entire issue become very complex. There are no easy solutions; but we need to have our own efficient systems and regulators," says Dinesh Thakur, the Ranbaxy whistleblower. He was speaking in Mumbai on "How Pharma Companies Fudge Data" organised by Moneylife Foundation.
While explaining the role played by the US Food and Drug Administrator (US FDA) in curtailing data fudging and malpractices in Indian pharma sector, Mr Thakur, feels it is not right to compare what happens in the US and what is happening in India.
Mr Thakur, who blew the whistle on Ranbaxy and exposed the myth of cheap generic drugs, spoke with examples about how pharmaceuticals companies from across the globe fudge data. According to him, the issue of pharmaceuticals companies fudging data is not about protecting intellectual property (IP), trade issues and certainly not about the share price of individual companies. He stressed that the consequence of pharmaceuticals companies manipulating data is felt by the patients.
In order to explain how companies in all industries fudge data, Mr Thakur provided an example of the baggage carousel at airports. The TV screen at airports notify passengers about the time the baggage will arrive on the carousel and the carousel itself will be running, but no baggage is being offloaded and transferred across the belt. Even though the screen is showing that your luggage is being transferred and provides an estimated time, the actual time in receiving your baggage is incorrect.
Connecting this example back to pharma companies, Mr Thakur questioned why companies intentionally try to cover up data and misguide the consumer. This misrepresentation starts with the inherent culture of the company and in order to bring about substantial change, such 'bad practices' will have to be reformed through regulatory agencies, he added.
He explained how the public health system in India is not on par with the West and how sanitation, hygiene and attitudes toward general wellness leave a lot to be desired. There is an over reliance on antibiotics to control the disease burden in India which. in turn is assisting the prevalence of substandard or adulterated drugs in the supply chain.
The message throughout his presentation was about putting public health before everything else.
Mr Thakur, is at the center of the explosive new book, Bottle of Lies, written by Katherine Eban, has triggered a global discussion on the quality of generic drugs and their implication for users.
He insisted that not all generic drugs are to be treated with immediate disdain. “Although most of them are manufactured under unhygienic conditions or are not bio-equivalent to the brand name drug, there is no way for the consumer to determine whether the cheaper generic is just as effective as the branded drug. Unlike the US FDA, India’s Central Drugs Standard Control Organisation (CDSCO) does not make publicly available its testing data on drugs and consumers are essentially in the dark about the efficacy of the drugs that they are consuming.”
The central message of Mr Thakur’s talk seemed to be that regulatory authorities do not have the necessary powers to effectively and thoroughly investigate drug manufacturing plants and processes. Such regulatory lapses are allowing pharma companies with the necessary loopholes to circumvent standard processes, fudge testing data, and use substandard ingredients all at the cost of the health of a patient.
Mr Thakur, a public health activist, focused on improving the quality of affordable medicines across the globe and improving health policies in the US and India. At the same time, he says, there is no point comparing what happens in the US and what takes place in India, in healthcare or patient care.
“Why we need to compare with some other country for anything when there is a vast difference in our environment, social life and public systems? Especially, in food and drug segment, we need to have our own and effective regulatory system,” he added.
Generics, FDCs and the End Users
Debashis Basu, editor of Moneylife and the moderator for the panel discussion raised issues like quality of processes in Indian companies, processes adopted by big pharmaceutical companies and the US and Indian system of public health. "We also need to think about the role of alternatives, traditional knowledge and mainly using food as medicine as being advocated by several practising MDs from across the globe. After all, all the research, manufacturing, hospitals, medicines, doctors, regulations are all designed for patient welfare, that is, us," he added.
Participating in the discussion, Dr Sanjay Nagral, who is a practising general surgeon and gastroenterologist with over 31 years of experience, says lack of access to healthcare is the biggest issue in India. "Cost of medicines is one of the components in entire healthcare system. However, we found drugs, including lifesaving ones, were being sold in India at whopping prices. Therefore, we advocated generic drugs. Generic drugs indeed brought down cost of medicines and this cost effectiveness helped several patients, including poor ones."
In genetic drugs too, there are two types of medicines sold in India, one is generics and other branded generics. Explaining this, Dr Nagral says, "Branded generics are produced by bigger companies and sold as their own brand, while other generics are manufactured by smaller companies. But in simple terms, we can says generics are drugs that are not manufactured by the innovator company."
Mr Thakur, however, has a different view on branded generics. According to him, branded generics are nothing but marketing comparing or concept. "In India companies were allowed to create brands out of generics," he added.
The Ranbaxy whistleblower also raised serious questions on fixed dose combination (FDC) drugs where India is the world leader.
A combination drug is a fixed-dose combination (FDC) that includes two or more active pharmaceutical ingredients (APIs) combined in a single dosage form which is manufactured and distributed in fixed doses.
Mr Thakur says, “FDC, to be frank, is non-sense according to me. While the CDSCO issues approval for FDCs, it is the state FDA, which given permission for manufacturing and marketing. Due to this liberal licensing system, we have large number of FDCs whose efficacy, safety and rationality is questionable. Majority of these FDCs are formulated with marketing as primary interest and add no value to its therapeutic usage. This is why we need an effective and centralised regulator who will time and again verify authenticity of the data submitted by the pharmaceutical companies and act swiftly in case of any fudging with data.”