This document discusses various forms of corruption in the Indian pharmaceutical industry, including bribery, theft and fraud, falsification of information, and undue influencing. It provides examples of companies like Biocon and Merck being involved in bribery and falsifying drug trial information. Whistleblowers like Dinesh Thakur have helped expose instances of Ranbaxy falsifying drug data submitted to regulators. However, positive results from drug trials are more likely to be published than negative results, creating a biased view of drug effectiveness. Corruption in the pharmaceutical sector puts patients' health at risk, and reducing such practices can help achieve better health outcomes.

1. Cancer in the Indian Pharma
industry
 Bribery
 Theft and Fraud
 Falsification of
information
 Undue Influencing
Ritupurna Biswas, President,
Corruption Free India

2. Purpose
 How corruption in the Pharma industry and the
drugs regulatory mechanism works
 To achieve genuine change in the pharmaceutical and health care sector
through the awareness of reducing corruption
 Promoting transparency, integrity and accountability
 Better outcomes for patients all across the country

3. Bribery :
CBI officials say Biocon had agreed to pay an Indian drug regulator
about $11,500 to waive a phase 3 clinical trial of Insulin Aspart Injection,
which treats of Type 1 and Type 2 diabetes, .
CBI arrested a senior official of the
rank of joint drug controller of the
Central Drugs Standard Control
Organization (CDSCO) as well as
executives of a Delhi-based agency,
allegedly while they were in the
process of handing over a bribe of ₹4
lakh to the CDSCO official

4. Theft and Fraud :
Delhi Police files fresh FIR against Malvinder and
Shivinder for Rs 400 crore 'fraud’
Shivinder Singh and Malvinder Singh, former promoters of
the pharmaceutical giant Ranbaxy . The pharmaceutical
company was sold to Japanese firm Daiichi Sankyo in
2008, and the brothers continued to run a family-owned
hospital chain called Fortis Healthcare.
Over the years they lost control of the hospital chain over
allegations of fraud and problems of mounting debt.

5. "The main reason we take so many drugs is that drug
companies don't sell drugs, they sell lies about drugs. ” -
Peter C Gotzsche
Merck had been involved in fraudulently representing the mumps component of its
MMR vaccine. The company was blamed for fraudulently informing the public that
the MMR II, used to replace the MMR vaccine Pluserix, is an effective vaccine.
However over a period of time, studies had proved that the vaccines'
effectiveness are said to be falsified. Reports further pointed out that the Mumps
component of the vaccination was ineffective and that the results of the tests
carried out on the vaccine have been altered.

6. Clinical Trial :
Industry trials with positive results are over-
represented in the medical journals, and those
with negative results are under-represented,
resulting in significant publication biases
In antidepressant trials submitted to regulatory
agencies such as the United States Food and
Drug Administration or the Swedish regulatory
agency and thus all industry trials—positive
results are much more likely to be published.
The positive trials are often multiply published
by lumping and splitting, than are those with
negative results.
This has produced an impression in the medical
literature that the evidence for the effectiveness of
antidepressants is much stronger than it actually is.

7. Business Standard of Delhi front-paged a story that
pharmaceutical multinationals Novartis, Pfizer, Bayer, Bristol
Myers Squibb were involved in clinical trials in India that killed
438 people in 2011.

8. Falsification of
information
Those are just a few of the
hyperbolic responses from
government health officials and Big
Pharma cheerleaders to preliminary
COVID vaccine trial data released
by Pfizer and Moderna .
 The vaccine is being tested on people who are at incredibly low risk of COVID-19 -- not only the
vaccinated enrollees but also the unvaccinated.
 The BMJ author, associate editor Peter Doshi, pointed out that none of the trials underway "are
designed to detect a reduction in any serious outcome such as hospital admissions, use of
intensive care, or deaths. Nor are the vaccines being studied to determine whether they can
interrupt transmission of the virus." This is in stark contrast to how the trials have been marketed to
the public as assessing the vaccine's impact on preventing severe COVID-19 illness,
hospitalizations and deaths.

9. Voice of
Protests:
Dinesh Thakur, a former director of project and information management at Ranbaxy, has
pulled off what very few corporate executives dare to do. He gave evidence to the US
authorities about the company falsifying drug data and violating good management
practices, triggering a massive investigation that resulted in the drugmaker pleading guilty
to felony charges related to the manufacture and distribution of certain adulterated drugs
made at two of its plants in India. The company has agreed to pay $500 .
Thakur was tasked to scrutinize the data that Ranbaxy submitted for approvals to the US
and other foreign markets. He found that test results were being falsified for HIV anti-
retroviral and other drugs; he also came across sloppy manufacturing processes.
Two years later Thakur made a complaint in the US under the False Claims Act (FCA),
also known as a ‘whistleblower’s law’. This enables private individuals to file cases
against government contractors if they have information that the contractor knowingly
submitted fraudulent claims to the government.

11.  When a cheque landed on the desk of 63-year-old doctor Himmatrao Saluba
Bawaskar, from a diagnostic centre under the guise of “professional fee”,
Bawaskar not only returned it, but he also filed a complaint against the centre
with the Medical Council of India (MCI), the national watchdog for medical
education and doctors. His case is currently being heard by the state medical
council of Maharashtra.
 Prime Minister Narendra Modi has warned India’s top
pharmaceutical companies to strictly adhere to
marketing ethics, and not to bribe doctors with women,
foreign trips and gadgets ( Jan 2 , 2020 )
 The Supreme Court has sought the Centre’s response on a
petition to make pharmaceutical companies equally liable for
openly bribing doctors with free gifts, travel packages and
hospitality in exchange for prescribing their drugs.

12. MCI (Medical Council of India )chairman
Ketan Desai was arrested and
dismissed from the organization in
2010 on charges of accepting a bribe.

13. OUR
MOTIVE
 corruption in the pharmaceutical sector endangers positive health outcomes and
puts patients’ health at risk.
 Selecting motivated leaders in the key areas like health and education service
 appointing a public service based on merit and competitive recruitment
 Accelerate the pressure on government to take steps against corruption .
 Fund – raising for treatment of the poor