Tag: Whistleblowers Protection Act

Chief Labour Commissioner’s Office Has No Data on Stranded Migrant Workers, RTI Reveals

The move comes despite a circular on April 8 asking regional heads to collect data about every stranded migrant worker in every district and state.

The lockdown imposed by governments since March 25, 2020, to contain the spread of COVID-19 epidemic across India, now in its third phase, has hit migrant workers, among others, the hardest. Not a day goes by without stories of their travails being highlighted in the print, electronic, digital and social media.

What is the magnitude of migrant workers under distress due to the lockdown? Is it four million, or forty million or much more?  The office of the Chief Labour Commissioner (CLC) under the Union Ministry of Labour and Employment claims, it does not have state-wise and district-wise data despite the CLC directing the regional heads based in 20 centres across the country to enumerate every migrant worker stranded due to the lockdown within three days during the second week of April, 2020.

The problem leading to the RTI intervention

Hundreds of thousands of men, women and their children who had migrated out of their home states to other cities, towns and villages in search of gainful employment, suddenly found themselves jobless and penniless as the economy came to a grinding halt due to the lockdown. With inter-state borders sealed during the first two phases of the lockdown, they had few options for keeping body and soul together and the coronavirus at bay. They were forced into government-run relief camps or shelters or compelled to remain at the worksites of their employers or simply remain bundled up in clusters near highways and other open spaces.

Reports of hundreds of thousands of migrant workers protesting their forcible incarceration and demanding they be allowed to return to their hometowns have come from Kerala, Bengaluru, Hyderabad, Surat, Mumbai and other places. Some tried to find their way back home travelling inside water and milk tankers and concrete putty mixers paying hefty sums of money to owners who sought to profit from their suffering. Even more heartbreaking are stories of migrant workers, walking alone or in groups, hundreds to thousands of kilometres under the blazing sun to get back to their families and some perishing within reach of their homes. Meanwhile, many of us saluted other frontline workers combatting the virus with sound and light shows, flypasts and fireworks on the seas.

Also read: The Lockdown is a Dangerous Experiment, India’s Democracy Will Not Emerge Unscathed

Amidst this humanitarian crisis of gargantuan proportions, on April 8, 2020, the office of the chief labour commissioner issued a circular to his regional heads based in 20 centres across the country to collect data about every stranded migrant worker in every district and state. Templates were issued for data capture during the enumeration process. Both blue and white collared workers were to be enumerated in this manner. The regional heads were given three days to collect this data and send it to the CLC.

After waiting in vain for almost two weeks for the official announcement of the results of the enumeration exercise, on April 21, 2020, I submitted an RTI application with the office of the CLC through the RTI Online Facility, seeking the following information under the RTI Act:

“Apropos the D.O. dated 08 April, 2020 issued by the Chief Labour Commissioner to all Regional Heads regarding urgent collection of data about migrant workers who are stranded and placed in various temporary shelters/relief camps arranged by:

a) the State Government authorities,

b) employers IN-SITU/at workplace itself, and

c) where they are generally clustered in some localities:-

 I am seeking access to the following information available in your office, as on date, under the RTI Act, 2005:

1) the State-wise names of districts from which data about the stranded migrant workers has been received,

2) the district-wise numbers of male and female migrant workers belonging to each of the three categories mentioned above as reported from each State,

3) the occupation-wise number of male and female migrant workers reported from each State as per the List of Occupations mentioned in Annexure-I of the said D.O.,

4) the Sector-wise number of male and female migrant workers reported from each State as per the List of Sectors mentioned in Annexure-II of the said D.O., and

5) the Native State-wise cumulative figures for male and female migrant workers according to each Occupation and Sector mentioned in Annexure-I and Annexure-II, respectively of the said D.O., reported from each State.”

Being aware of the possibility that the CLC’s office would not be fully functional, I did not seek copies of official records. Instead, I requested the CLC’s office to upload all the information described in my RTI application and inform me the URL of the database on the official website. Given the widespread debate about the plight of migrant workers and the yeomen service provided by several government agencies, hundreds of NGOs and thousands concerned citizens to ensure that many of them were served food, water and other essentials, this information I believed has an enormous public interest dimension attached to it.

Also read: Migrant Workers in Punjab Continue Long Walk Home, Ask for Government Support

The CPIO’s reply 

On May 5, 2020, a day after the third phase of the lockdown began, the RTI online facility sent me an automated email stating that my RTI application had been disposed of. When I checked the status of my RTI application on the website, instead of a proper response under his name and signature, the CPIO has entered the following reply:

“As per the stat section is concerned, no such details are available based on requisite information.”

There was no indication whether my RTI application would be transferred to any other section or public authority, or if any effort would be made to collate the information from the enumeration exercise and make it publicly available.

Migrant workers walk towards a bus station along a highway with their families as they return to their villages, during a 21-day nationwide lockdown to limit the spreading of coronavirus disease (COVID-19), in Ghaziabad, on the outskirts of New Delhi, March 29, 2020. Photo: Reuters/Adnan Abidi

What is wrong with the CPIO’s reply?

Under the RTI Act the CPIO has only three options available while dealing with an RTI application:

  1. if the information sought is not available with one’s public authority, it must be transferred to another public authority which may have custody of such information; or
  2. supply the information after collecting copying charges (which would not apply in my case as I did not ask for copies, but requested proactive disclosure on the website); or
  3. reject the RTI application if it is covered by one or more of the exemptions provided in Sections 8, 9 or 24.

The CLC’s CPIO resorted to none of these actions. He did not even send a signed reply. Most other CPIOs upload a scanned copy of their reply on the RTI online facility in addition to emailing it to the RTI applicant under their name and signature. So the CLC CPIO’s cryptic one-liner reply raises serious doubts about the availability of data about migrant workers despite the launching of the enumeration exercise. Does the CLC or any other public authority in government have accurate data about the number of stranded migrant workers or is there any reason why it does not want to make such information public?

I have already filed a complaint before the central information commission in this case requesting an early hearing. if this case is put at the end of the queue of nearly 36,000 cases currently pending before the CIC the matter may come up for hearing in 2021 when the information would be devoid of any value. As it is the enumeration figures are becoming irrelevant with the public authorities making arrangements to return migrant workers to their states of domicile by road or rail transport.

RTI activists suggest measures for more transparent and accountable implementation of the COVID relief package

Two days after the CLC issued its circular seeking enumeration of migrant workers, CHRI organised a webinar of RTI activists and advocates of transparency to take stock of the effect of the lockdown on people in general and the vulnerable and disadvantaged communities in particular.

Participants from across 12 states and UTs came identified several problems with the manner of implementation of the PM Garib Kalyan Yojana Relief Package. They also identified some practical solutions for relieving hardships people have faced due to the lockdown.

These suggestions continue to have relevance for most parts of the country during lockdown 3.0:

1) RBI must issue a circular for hassle-free reactivation of the inoperative PMJDY bank accounts (23% of the total) particularly, for beneficiaries eligible for ex gratia at their doorstep through post office employees and turning fixed location Banking Correspondents into itinerant Bank Mitras for the period of ex-gratia distribution. They may be directed to strictly adhere to COVID-19 related precautionary measures while moving about;

2) The government of India must issue circular clarifying how the free gas cylinders benefit may be availed by beneficiaries. Itinerant Bank Mitras may be roped in to disburse DBT benefit to beneficiaries at their doorstep, with due regard to COVID-19 related precautionary measures;

3) Oil marketing companies must issue strict instructions to their supplier agencies to deliver gas cylinders at the doorstep upon receiving bookings, with due regard to COVID-19 related precautionary measures;

4) District administration must be directed to make PDS supply and distribution related information available to beneficiaries on a weekly basis through the various methods of dissemination mentioned under the “Explanation” to Section 4 of the RTI Act, 2005 (disclosure through internet, radio, TV, newspapers, notice boards, other kinds of announcements using public address system and beat of drums etc.) Doordarshan’s country-wide outreach must be used for disseminating information about the manner and status of implementation of the PM Garib Kalyan Yojana package;

Also read: Understanding the Implications of the COVID-19 Lockdown on Migrant Workers’ Children

5) Department of Personnel and Training (DoPT) must issue advisories to all State Governments to urge the respective State Information Commissions to restart work along the modalities adopted by the Central Information Commission;

6) DoPT must issue advisories to the state governments to urge the respective Lokayuktas and Anti-Corruption Bureaus to restart accepting and inquiring into complaints of corruption from the general public. A toll-free helpline may be established in every State to receive and forward complaints of corruption from the public to the respective anti-corruption bodies. These numbers must be advertised widely;

7) The Whistleblowers Protection Act, 2014 must be enforced immediately across all states by notifying competent authorities to receive and inquire into complaints of attacks and harassment of whistleblowers. The state police must be issued advisories to lodge FIRs in all such cases of attacks without delay and conduct speedy investigations to book the culprits;

8) Empowered groups of officers must be set up at the state, district and sub-district level to coordinate relief and rehabilitation efforts to between the public sector and private sector players;

9) Government agencies must not insist on production of identity proof for migrant workers for accessing benefits under the relief and rehabilitation measures. Mere self-declaration of identity and domicile status should be treated as adequate for accessing such benefits. Circulars may be issued to all State and district level authorities for this purpose;

10) Lockdown passes must be issued on a priority basis to caregivers for PwDs to provide services to them on a daily basis. Audio-visual training modules must be developed and disseminated for them to explain the social distancing and other precautionary measures to ensure that PwDs do not contract the coronavirus. All telecasts of important speeches including that of the Hon’ble PM and daily press conferences that are televised must be accompanied in real time by sign language interpretation visible adequately on the TV screens;

11) Alternative arrangements must be made for ensuring that people living in areas without mobile phones or internet connectivity are able to access their entitlements under the PM Garib Kalyan Yojana without any delay;

12) Households in remote hamlets and settlements not covered by PM Ujjwala Yojana must be supplied with adequate fuel sources including firewood for daily use at their doorstep. Officials of the concerned departments including the forest department may be engaged to supply fuel to such households at least twice a week at their doorstep with due regard to COVID-19 related precautionary measures

13) There is an urgent need to reactivate lower courts in order to provide justice delivery services to the people. The statutory Legal Services Authorities at the national, state, district and tehsil levels must also be reactivated. Their contact numbers, as well as those of lawyers, empanelled to provide legal aid must be widely advertised through various mass media and other offline methods so that people may contact them for getting redress for their grievances against the administration’s actions and omissions; and

14) Governments must increase budgetary allocation for the health and education sectors. Increasing public spending on the welfare of women, children and vulnerable groups like migrant workers must become a priority.

Whether the governments will pay attention to these practical suggestions coming from the grassroots level, remains to be seen.

Venkatesh Nayak is programme head of the Access to Information Programme of the Commonwealth Human Rights Initiative.

With Attack on Himachal Man, Number of Murdered RTI Activists Rises to 73

Family members of slain Kedar Singh Jindan, along with several locals and activists, have demanded a CBI probe into the matter.

New Delhi: Even as the Centre dithers on implementing the Whistleblowers Protection Act, which was passed four years ago to protect anyone who exposes alleged wrongdoing in government bodies, another name has been added to the growing list of RTI activists who have been killed for raising disturbing questions.

The 73rd person to be killed for raising a voice against corruption is Kedar Singh Jindan, who according to agency reports from Himachal Pradesh was first allegedly beaten up and then run over by a vehicle near Bakras village in Sirmaur district on the afternoon of September 8. Jindan was a social activist and an SC/ST rights leader who had also contested the 2017 assembly election in the state on a Bahujan Samaj Party ticket.

In June, Jindan had claimed at a press conference in Shimla that an RTI application filed by him had revealed that six affluent families in the Bakras panchayat with assets running into crores were wrongfully registered under the below poverty line category.

Reporting this, a local website had also stated that he had alleged forging of records by one Jai Prakash for securing government jobs for his family members. The website stated that Jai Prakash along with another person, Gopal, were among those accused in the case.

Though the police initially thought it be an accident, they later registered a case of murder. Jindan’s family protested with his body and has demanded that the case be probed by the Central Bureau of Investigation. They were joined in the protest by a large number of locals as well as RTI and social activists.

The protesters charged that there were five people who were involved in the attack on the slain activist and demanded that they all be proceeded against. They also sought security for the family, which has lost its sole earning member, and a job for the victim’s wife, Hem Lata.

Jindan’s wife also claimed that he had “already asked for security as he was threatened for life” but insisted that “police did not take any action”. She said the RTI activist had been “attacked by these people earlier also.”

According to the Commonwealth Human Rights Initiative which maps cases of attacks on RTI users, there had been 419 cases of such attacks till August 20 in which 72 people had lost their lives. As such, the attack on Jindan marks 420th such recorded case and takes the toll up to 73.

It is in view of such attacks on RTI workers that there has been a constant demand for implementing the Whistleblowers Protection Act.

In July, RTI activists had taken to the streets in Delhi and held a rally to protest against the Centre’s attempts to dilute the transparency laws. With respect to the Whistleblowers Protection Act, they had demanded that the government implement it in its present form.

Speaking to The Wire, co-convener of NCPRI and organiser of the event, Anjali Bharadwaj, had stated that while the original Act was passed four years ago, instead of implementing it, the Narendra Modi government had brought in amendments to dilute it and got these passed in the Lok Sabha. The activists had claimed that amendments to this Act sought to dilute the law as they provided for punishing RTI users under the Official Secrets Act.

Changes to Anti-Graft Law Will Stick Only If the Centre Acts with Renewed Vigour

While the changes will unshackle India’s civil servants, if a perception arises once again that corrupt persons are flourishing, it will result in the amendments being rolled back.

In emerging economies like India, the most crucial factors that the impact the well-being of a country’s citizens are their incomes, the quality of infrastructure, healthcare and education support provided by the State.

While India is the third largest economy in terms of purchasing power parity, our per capita income is extremely low. We are categorised as a low middle income country by the World Bank. Poverty and extensive malnutrition are present in vast swathes of the country and it’s clear that we will need to grow at a sustained level of 8%+ for the next two decades just to get a respectable middle income level.

This requires a forward-looking governance system. Our civil service officers must innovate, plan and take decisions. They must not be unduly worried that due to deficient anti-corruption laws, their bonafide actions will be questioned later, where one will land up in jail, lose her lifelong reputation and spend her pension on lawyers defending cases launched by the government of the day.

On the other hand, probity in public life is extremely important. Corruption results in gross abuse of public funds, which slows down growth. It also undermines the development of an ethical society, which is the foundation of a developed nation. In the global polities, India is ranked 81, much lower than China, Malaysia, South Africa, Singapore, Sri Lanka, and Bhutan, and most Western and European economies.

Why we get corrupt civil service officers

A lot of corruption can be traced to three factors. First, our laws and procedures are complex. This gives opportunities to civil services to indulge in corrupt acts and force users of services to pay bribes to expedite decisions or get favourable decisions. Second, politicians require a lot of money to fight elections. They use government resources and the governance system to collect money by abusing their authority. Many weak and corrupt civil servant acquiesce in this and in fact willingly take part in it.

Third, the opening up of the economy has led to large investments by the private sector. In the total investment in our economy, the share of private investments has grown rapidly and is more than 80%. The induction of these funds requires a lot of government approvals, policies to incentivise these investments and interaction of ministers and civil servants with big business. This provides an opportunity to collect illegal money by them.

The recent amendments to India’s anti-corruption law have to be considered in the context of issues mentioned in the above two paragraphs.

We must consider its impact on efficient decision taking on governance without fear of questioning of bonafide decisions. We must also consider whether these promote probity in public life so that our resources are not misused leading to slowdown of growth and people’s income.

Amending anti-graft laws

The amendments in the Prevention of Corruption Act, 1988, broadly cover three areas.

First, under Section 8 of the Act, the bribe giver is now liable for punishment up to seven years. However, if one is being coerced to pay such bribes, she can approach anti-corruption agencies within a prescribed period. This amendment has brought our law in full compliance of the UN Convention against Anti- Corruption, of which India is a signatory. It has also made bribe givers criminally responsible. Unless there are people willing to stand up, we cannot limit the supply side of corruption. Many private sector business houses who thrive on bribing the bureaucracy are now equally liable.

Second, an amendment in Section 13(1) has done away with the draconian provision of Section 13(1)(d)(iii) under which public servants could be punished even for bonafide acts. Under the new law, a public servant is liable for criminal misconduct if he has intentionally enriched himself illicitly during the period of his office or of he dishonestly or fraudulently misappropriates (or converts) for his own use any property entrusted to him or any property under his control. This introduces responsibility on public servants for corruption where his actions are dishonest. This implies that for bonafide acts, public servants are not liable and only manifestly corrupt dishonest acts where he enriches himself, action under this provision can be taken.

Credit: Reuters/Files

Third, under Section 17A of the Act, police officers have been barred from conducting an inquiry or enquiry or investigation without the previous approval of the Central or state government where the said offence relates to any recommendation made or decision taken by such public servant in discharge of his official function or duties. This protection is available to retired public servants and officials too. Such decision of the government or concerned authority for permitting inquiry etc. has to be given within four months after the request is made to it.

This provision has provided added protection to honest civil servants particularly those who are pensioners and have limited income. It also would result in unnecessary mudslinging where inquiries are initiated and leaked to the press by interested parties. Even when nothing comes out of inquiry, the mudslinging besmirches the reputation of officers earned over a lifetime. This provision will provide protection against this.

Fourth, there are other provisions relating to the time bound disposal of such cases and a fuller exposition defining ‘advantage’ which can be gained by corrupt public servants.

The amendments were needed for several reasons. First, the law on corruption was enacted in the late 1980s when the nature of challenges before the governance system were different from those when the economy opened up in 1991 and private investment became the driving force for economy. Amendments were needed to take account of this. Second, the concept of the bribe giver being equally liable was needed to be introduced specifically to focus on responsibility of supply side of corruption. The earlier law did not do so.

Third, the concept of corruption had to include an ingredient of ‘quid pro quo’ for performing a corrupt act or promising to do so. Cases where no advantage was gained or promised could not be considered part of corruption. The need for making ‘mens rea’ as a necessary ingredient of corruption was necessary. This gap had to be rectified. Fourth, bonafide mistakes or action of civil servants needed protection to encourage them to take risks and not just shuffle papers from one desk to the other without taking any out of the box decision.

The amendments have provided clarity in the corruption law and will help curb growth of a group of public servants who are all the while looking behind and are afraid to take decisions for fear of making mistakes (which was being treated a criminal act under the earlier law).

What still needs to be done

There are, however, several issues which will need to be addressed to punish the corrupt expeditiously, improve probity in public life and ensure faster economic growth.

First, it has to be recognized that amongst civil servants, the level of adherence to value systems has grown weaker over the period of years. They are handling large finances and surfeit of new goods coming in the market are an attraction. It will be therefore necessary to monitor the assets of public servants very closely and watch how these are growing. Somewhat in the nature of US law called Ethics in Government Act 1978 and creation of an institution to promote ethical values, we should evolve our own system. Any infraction must result in departmental action including dismissal from office.

Second, expansion of digital systems in all activities relating to government, availability of online services in practically all services being provided by government, award of contracts of large value through e tendering are all issues which must be adopted across the nation and public funds use must be subject to these restrictions. Third, the decision on funding of elections (or political parties if that is considered more practicable) must be taken quickly. Elections are the biggest cause of corruption. We must make them clean.

There is a worry which was articulated by several civil servants and investigating officers in police that often officials do not take a stand and follow the illegal directions of the minister. During this they may not take bribes, but do not show a mettle to oppose the corrupt acts of ministers. Such officials will go scot free under the current amended law as they do not derive any benefit from government decision. We must ensure that officials, if they have acted against rules, must be preceded against (unless the decision was bonafide) under departmental proceedings. In such cases we could make procedure simple and award punishment quickly.

Also, officials could be repeatedly reminded of this policy especially in economic ministries and warned to avoid weak governance. This will be far more effective in preventing corrupt acts than trying to proceed against them under the old law.

To punish the corrupt quickly, rules under the amended law need to be notified quickly. It has to be realised that government permission is now required to initiate an inquiry, or enquiry or investigation under the PC Act. This permission is required to be given in three months and for special reasons in four months. Since there are a large number of such cases, government will have to make rules to ensure that the system of giving such permissions works smoothly and fairly. The government will have to also provide greater clarity on role of Lokpal in the entire process. Past experience where such permissions were required for a class of civil servants before filing of charge sheets, was that a lot of time was taken. The institutional mechanism to provide for such approvals and the nature of people deciding it will have to be decided quickly, but with quick public consultation. Since Lokpal act has already been notified, this could be sent to them for such approvals. The government will also have to provide that if such permissions are not available in time prescribed, it will be deemed to have been given.

Unless the government acts quickly, arguments will be advanced that corrupt persons are flourishing since anti-corruption agencies like the CBI have become toothless as they cannot inquire against anyone suo moto. This will result in a clamour for amending the law again. That process will again vitiate the atmosphere.

Probity in public life is dependent upon the level of economic well-being of the people, the simplicity of our rules providing public services, our ability to control corruption in the electoral process and how quickly we punish corrupt ministers and senior civil servants who amass illicit wealth.

The amended law is a good opportunity to improve governance, encourage honest civil servants to take risks and decisions for faster growth. But we would need to act simultaneously on several fronts to enable the development of a more ethical society. Unless we do that, we cannot have a modern nation meeting the needs of the 21st century.

B.K. Chaturvedi is a former Cabinet Secretary and Member of the Planning Commission.

Opposition Parties Unite to Oppose Amendments to RTI Act

In agreement that the Modi government wants to control salaries and tenures of information commissioners through these changes, at least six parties declared their intent to oppose the amendments when they are moved.

New Delhi: Leaders of a large number of opposition parties today came together to denounce the proposed amendments to the RTI Act that have been moved by the Narendra Modi government and to demand the immediate operationalisation of anti-corruption laws.

Speaking at a people’s convention or ‘jan manch’ organised by the National Campaign for People’s Right to Information, senior leaders of the Congress, Communist Party of India (Marxist), CPI, Rashtriya Janata Dal and Trinamool Congress declared that they would oppose any amendments to the RTI Act, 2005.

At the Jan Manch, a resolution was also passed to demand that the RTI Act not be diluted through amendments which seek to place in the hands of the Centre the powers of determining the tenure and salaries of all the information commissioners, including the chiefs, in both the Central Information Commission and the State Information Commissions. The resolution had also demanded immediate operationalisation of the Whistleblowers Protection Act and the Lokpal law, introduction of the Grievance Redressal Bill and opposed the lack of transparency in electoral funding due to introduction of electoral bonds.

Speaking at the meet, Rajeev Gowda of the Congress said his party would oppose any amendment to the RTI Act. He also accused the BJP government at the Centre of destroying every institution and legislation of transparency and accountability. Gowda said the Congress would also support the demand for implementation and passage of the other anti-corruption laws.

General secretary of CPI(M) Sitaram Yechury said the RTI Act came about after a long and hard struggle of the people. He said his party would support the demand to not dilute the RTI Act and assured that it would work both within and outside parliament to ensure that the RTI Act was not amended.

Another Communist leader, D. Raja of the CPI said his party was very clear in its position and would not allow any dilution of the RTI Act. His colleague and party national secretary Atul Kumar Anjaan said the BJP government wanted to weaken the RTI Act as it is a tool in the hands of the ordinary citizens for fighting corruption. “Who are the people who are opposed to this RTI Act? They are those who are involved in the loot of public money,” he said.

Anjaan said any tinkering with the RTI Act would be worse than rape as it would directly impact those who are poor and socially marginalised. He also charged that the Modi government has not got a Lokpal appointed in its four year rule thus far. “Now,” he quipped, “they are talking about it when its term is about to come to an end and the elections are only a few months away.”

Manoj Kumar Jha of the RJD said the government was trying to destroy the RTI Act as they have no answers to people’s questions. Trinamool leader Dinesh Trivedi too said his party would oppose the amendments to the RTI Act.

Later, Aam Aadmi Party leader and Rajya Sabha MP Sanjay Singh said that his party would block all attempts to get the amendments to the RTI Act introduced in parliament. He said it was clear that by controlling the purse-strings of the information commissioner, the Modi government wanted to curb their independence and freedom of deliver orders fearlessly.

The leaders of all these opposition parties were in unison that the failure of the Modi government in enacting or implementing the anti-corruption laws showed its real intent and face.

Senior advocate Prashant Bhushan, who was part of the Lokpal movement, said the government was also trying to undermine the independence of the judiciary and that it was crucial that people campaign against all these attempts to dilute these important institutions.

Anjali Bhardwaj and Nikhil Dey of NCPRI declared that a follow up to today’s protests, which were also held in Gujarat and Rajasthan, similar demonstrations would be held all over the country to oppose the amendments to the RTI Act.

The gathering was also attended and addressed among others by former chief information commissioner Wajahat Habibullah, Harsh Mander of Centre for Equity Studies and former major general Anil Verma of Association for Democratic Rights.

There’s No Romance in this Story of Fudged Clinical Trials

How systemic problems at a drug testing lab, GVK Bio, morphed into the story of an illicit affair.

How systemic problems at a drug testing lab, GVK Bio, morphed into the story of an illicit affair

The headquarters of GVK Bio. Credit: gvkbio.com

The headquarters of GVK Bio. Credit: gvkbio.com

In October this year, a national newspaper in India ran a front page news item with the headline “A love story that cost GVK its international reputation”.

The story spoke of a former GVK Biosciences employee turned whistle-blower, and of a chain of unintended consequences that resulted in the European Medical Agency (EMA) cancelling the marketing authorisation of 700 drugs previously approved for sale in the EU on the basis of data generated at GVK Bio. This in turn caused India to cancel scheduled talks on the Indo-EU Free Trade Agreement (FTA).

I saw stark similarities with the Ranbaxy case of 2004, where I was the whistle-blower. I had informed the US FDA about how Ranbaxy falsified data to seek approval of their drugs. My effort to hold Ranbaxy accountable had a positive outcome; however in the GVK Bio case, the reported facts didn’t seem to add up.

The story suggested that the Europeans had cancelled the drug approvals based on a complaint by a former employee who had cheated on his wife with a younger woman – in other words, the story fixes the problem on a disgruntled employee and an illicit affair gone wrong.

Given the international interest in the disproportionate reaction of the Indian government, my acquaintances and others in foreign media outlets attempted to establish the veracity of the claims made in the report of the newspaper, The Hindu.  They however failed to get a response from the whistle-blower, who had sent 12 extensive emails to regulators and others in Europe and the US between September 5, 2014 and July 31, 2015 and then gone silent.

I was one of the recipients, and I have based my own limited investigation on the information in those messages, and on the inspection reports I procured from the French regulator. I now am in a position to establish that parts of The Hindu story, and comments by industry spokespersons, the Drug Controller General of India (DCGI) and the concerned minister in the Indian government accusing the French Regulator ANSM of bias are unfair and in some cases, blatantly false.

I have turned over the results of my investigations to three national media outlets in India, none of whom wished to pursue this story for reasons best known to them.

The GVK Bio scandal

It is necessary, first, to understand that GVK Bio does not manufacture medicines sold in Europe. It is a clinical research organisation (CRO), which conducts bioequivalence studies – tests on patients intended to establish that generic drugs work as well as their branded counterparts. The results of such studies, carried out by GVK Bio in its clinic, are used by manufacturers to secure marketing approvals in Europe, the US and presumably even in India.

The whistle-blower, a former employee at GVK Bio, sent an anonymous email on May 6, 2012 to international regulators at USFDA, ANSM (France), MHRA (UK), WHO, Inspectie voor de Gezondheidszorg (Holland), and Saglik (Turkey) alleging large scale violation of good clinical practices (GCP) at GVK Bio during its conduct of bioequivalence studies.

The email contained specific allegations of data manipulation and fabrication by GVK Bio to ensure the successful outcome of a bioequivalence study, and detailed how such fabrication was carried out. For instance, the message pointed out how concentration profiles of 14 patients had been replaced with other patients in a trial sponsored by a major Indian company seeking approval for a generic version of Felodipine, a drug used to treat hypertension.

A concentration profile is the rate at which a drug dissolves in the bloodstream – one of the key measures to prove bio-equivalence. According to the whistle-blower, the concentration profiles of these 14 patients, as recorded, would mean that the bioequivalence trial for the sponsoring Indian company would fail, and the failure would in turn delay its entry for this product into the American market.

On May 16, 2012, ten days after the original email, the whistle-blower sent a copy of the same mail to GVK Bio’s management.

The original email triggered a joint inspection of GVK Bio, and set in motion events that led to the cancellation of 700 drug approvals in Europe.

Inaccuracies in the ‘love affair’ story

Contrary to what The Hindu reported, the whistle-blower’s identity and his emails were not discovered by the Hyderabad police when they seized his computer during an investigation based on a complaint by the parents of the girl with whom he had allegedly eloped.

I applied for and received copies of the inspection reports by French regulator ANSM, which along with other regulators conducted an inspection of GVK Bio’s facilities. ANSM’s preliminary report, dated April 30, 2013, details how the identity of the whistleblower was established.

GVK Bio representatives told ANSM that when they received the anonymous email from the whistle-blower, they found his name in the ‘properties’ of a PDF file that was attached to the mail as attachment. GVK Bio then filed police complaints against the whistle-blower,  and traced the cyber-café from which the email was sent.

GVK Bio then traced the IP address of the anonymous email account through Google. The company managed to triangulate the position of the whistle-blower’s mobile phone to the general location of the cyber-café. As an aside, it is disturbing that a private entity could access such sensitive personal information, and it is worth investigating how GVK Bio actually accessed these details.

The second inconsistency in The Hindu story is the whistle-blower’s reported motive. The story suggests that the whistle-blower was dismissed by GVK Bio after his affair with a colleague was discovered. GVK Bio however has denied this claim in a subsequent clarification to The Hindu. The whistle-blower had attached a copy of his resignation letter,  along with a letter from GVK Bio accepting his resignation, in one of the emails in the series. Further, the ANSM preliminary inspection report states that GVK Bio informed them, during the inspection on June 25, 2012, that the whistle-blower had left on cordial terms, after which he allegedly eloped with the former employee.

There are many versions for why the whistle-blower approached the regulators. The Hindu gives one version, the ANSM preliminary inspection report gives a different version and GVK Bio’s police complaint gives yet another reason. All relevant documents are being made available here for anyone to examine and draw their own conclusions.

The third problem with The Hindu report is that it fails to expressly mention that the French regulator ANSM, in its final inspection report dated July 11, 2013, found the allegations regarding falsification of data in the Felodipine trial to be highly credible.

Additionally, ANSM discovered other serious compliance failures at GVK Bio, some of them based on leads provided by the whistle-blower. The bioequivalence study for Felodopine was for the US market, not for Europe. Therefore, there was little that ANSM could do, despite validating the whistle-blower’s allegations.

The final inspection report by ANSM ends with a recommendation to all regulators to “systematically check” data from GVK Bio with “the utmost vigilance for possible suspicious trends, patterns or similarities”.

The missing link and doubtful sources

The Hindu story traces a direct link between the whistle-blower’s emails and the suspension of EMA approvals for 700 drugs. However, the ANSM report, which was a result of the whistle-blower’s complaint, did not lead to the suspension of the approvals.

The EMA action happened three years later, in 2015. The suspension came about because ANSM, in a second inspection of GVK Bio, discovered more instances of data falsifications and violations of GCPs.

This second ANSM inspection was conducted on May 19, 2014 at GVK Bio’s facilities, and found systematic fabrication of ECGs in 9 clinical trials. This second inspection report is the most vital link in the story on GVK Bio, since it establishes that the extreme action taken by the European Union was based on not one, but two inspections of this contract research organisation (CRO) where they detected similar compliance violations.

Also, clearly, the two inspection reports document that GVK Bio’s international reputation was not hurt because of an illicit love affair, as The Hindu story suggests, but because of documented evidence of systematic falsification of data and other irregularities.

Speaking from personal experience as one who routinely audits compliance at pharmaceutical companies, when the integrity of clinical data, which is sacrosanct to establish the safety and clinical efficacy of drugs, is compromised on two successive occasions, it calls into question all the data that the CRO has supplied for marketing approval.

The intent here is not to question the integrity of the reporter who worked on The Hindu story. However, as I have established above, all the facts of the case could have been determined by securing inspection reports from relevant regulators – as I did.

This leads to the conclusion that the report was based on selective leaks by interested parties – leaks that appear to have led the Indian media astray.

These selective leaks have led to a false impression: that there was nothing behind the EMA’s ‘harsh’ action other than the anonymous emails of a disgruntled employee. From that basis flows the perception that Commerce Minister Nirmala Sitharaman’s decision to suspend the Indo-EU Free Trade Agreement (FTA) was valid.

Interestingly, Sitharaman has recently reversed the decision to suspend the FTA, and has said talks with the EU will resume shortly.

Why this matters

The reason I felt the need to tell this story is because it shows how little has changed in India after more than a decade since that first WHO inspection at Vimta Labs, which was the starting point of the Ranbaxy scandal.

Regulatory oversight over CROs has not been strengthened in the interim; the country still lacks a robust whistleblower protection law for uncovering fraud in the pharmaceutical industry. The Whistleblowers Protection Act, 2014 is meant primarily for exposing corruption in the government. The whistle-blower scheme announced by the DCGI several years ago inspires little faith, as the institutional response of the Indian establishment has been to deny any allegations against the pharmaceutical industry.

“In a worrying trend,” reads a newspaper report dated February 11, 2013, “there has been an increase in cases of fake drugs in last three years, and efforts by authorities to encourage whistleblowers to report such illegal activity too have failed to elicit the desired response.” This report appeared, incidentally, in The Hindu.

Postscript: In a follow-up piece, I will explain how the Indian Pharmaceutical Alliance, the DCGI and the Commerce Ministry unfairly questioned the competence, integrity and motives of the French inspector and, in the process, compromised public health in India and among those patients who consume India-sourced medicines abroad.

The author is the Executive Chairman of Medassure Global Compliance Corporation