RTI Activist News

Will Mira-Bhayandar Municipal Corporation (MBMC) appoint distinguished citizens with a record of social service, members representing local NGO’s and social organizations on ward committee panels (Prabhaag Samithi) ?

The Answer is no !!! why ? Well out of all the Municipal Corporations Mira Bhayandar Municipal Corporation has been the worst performer and implementer of Government schemes and provisions, Despite recent reports that the civic administration has woken up from it’s slumber and has directed all ward committee chiefs to initiate process towards nominating active citizens on ward panels. Nothing concrete has been still done. It’s to be noted that Aimed at increasing the active participation of citizens in the transparent functioning of civic bodies, the state government authorities have made provisions to appoint distinguished citizens with a record of social service, members representing local NGO’s and social organizations on ward committee panels (Prabhaag Samithi) and under the relevant sections of the BPMC Act, it is the duty of the civic administration to ensure that real citizen activists be on board of the ward panels.

Why will it not be a fair selection even if it sees the light of the day ? Earlier Mira Bhayandar was a strong hold of the CONGRESS – NCP and most of the Ward Chiefs were those who favor their works and businesses, after the fall of the NCP CONGRESS combine in the elections and loss of the Mayor post till now held by either Congress or NCP it was believed that BJP Sena Combine might do a good job for Citizens but till now nothing concrete has been seen, BJP has triumphed and even holds the post of the Mayor, but has anything changed in terms of behavior of MBMC work culture ? No.

As of Today there is a Property tax outstanding amount of Rs.54 crores approximately due by Builders and Developers in Mira Bhayandar pending from past few years, surprisingly the list also includes “Seven eleven Construction Company” apparently a company allegedly owned by the BJP MLA Mr.Narendra Mehta. Despite of giving the list of Property tax defaulters to the MBMC Commissioner Mr.Achyut Hange no action is taken against such Builders and Developers. Its a vice-a-versa case when in it comes to common Citizens, Water connections of Societies have been disconnected by Property tax Department staff stating that Current Property Tax dues are outstanding, And when the Citizens oppose this they are threatened by the MBMC officials who visit for disconnecting the water connections. So a common Citizen has to suffer but Politicians, Builders and Developers go scot-free, the law is only for Common Citizens and not these people.

Why will MBMC not have a transparent and fair representation of distinguished citizens with a record of social service ? Well, there are lot of works which happen through the Prabhag Samitis which include raising of requests for works to be carried out in the wards after which process of tendering starts, if Citizens with a Clean record who are non corrupt will be part of these Prabhag Samitis it will be difficult for Corporator’s , MLA’s and MP’s who have their say in these works for their own benefit, as every 2nd Corporator or MLA has a conflict of interest, as they double up as Contractors aswell !!! most of them have companies doing construction or Infrastructure works so the requests for works in wards are raised by them, tenders are floated and allotted also to their companies only.If Citizens will be part of such committees these irregularities will come out in open… which will be disastrous for their business.

If you take out records of Gutter repair ,Road repair or even works of MLA or MP fund either they are themselves the contractors with tenders allotted to companies owned by either their immediate relatives or their sleuths owning them where indirectly they are the owners of such companies or if they do not win the tender these Contractors threaten the actual tender winner and become a subcontractor of them and take up these jobs, most of the times Road repair and Gutter works are repeatedly done in a shoddy manner to re do the same work within a years time thus profits shower on such Contractors even the PWD department is hand in glow with such Contractors as there is fixed percentage behind every tender which gets distributed among all concerned departments which handle the contract from tendering process to making of payments, as known by our sources the current percentage stands at 15% which goes in distribution by every contractor in MBMC, such issues will get highlighted which the MBMC officials would not like to come in open.

Thus the selection of distinguished citizens with a record of social service, members representing local NGO’s and social organizations on ward committee panels (Prabhaag Samithi) seems very difficult and even if few who are really good get selected in the nomination process they will be mere puppets who will not be allowed to participate and have a say in issues which really matter to the citizens.

Pravasi Bharat U.K based Organisation of the citizens of India held a Protest on 17th August 2013,against the Indian Government’s introduction of a bill in Parliament to amend the RTI law, as a reaction to the recent Central Information Commission order, which declared six political parties to be public authorities under the RTI Act.

Protests were held and petition copies were given to Government of India through Indian High Commission in London.

The Act has enabled the making of informed choices and strengthened participatory democracy; by enabling the citizens of India to monitor and access services throughout the country. Any amendment to the RTI Act would undermine and weaken the process of realizing various constitutional promises.” We would, therefore, expect the government to hold wide ranging public discussions before they think of amending the law in any way”

The Key Highlights:

They have tied their mouths with black cloth – To condemn: As government of India trying to suppress people’s voice by amending RTI.
Some of them painted their faces with India flag and RTI Words – To show that the citizens of living abroad too were concerned about their mother land and the historical RTI act, which had given our citizens power through transparency and accountability.
Submitted the petition to Honorable Prime Minister of India and the Honorable Speaker of Loksabha, requesting to ‘Not Amend RTI – without wider consultations from NGO’s and Social Activists’ through High Commission of India.
The actual event as it un-folded as below.
Event Information & Back Ground:- As we all are aware that RTI act is one of the best tool
available for common man in our nation; it increased both the transparency and accountability in most of the public sectors.We the Indians living in abroad felt happy with the order of Central Information Commission (CIC)
declaring that political parties are public authorities under the RTI Act. We believe the transparency and accountability through RTI in the political parties of India will definitely enhance our democracy. We have come across the news through electronic and online media on the plans in amendment of RTI Act. It is reported that the Government is in process to amend the RTI law, as a reaction to the recent Central Information Commission order. We, as the citizens of India request that it not to be amended. The Act has enabled accountability and strengthened our democracy through citizen’s active participation. In 2009, when amendments were being proposed to the RTI
Act, the concerned minister of the government had assured Parliament, in response to a question, that “Non- Governmental Organisations and social activists will be consulted on the proposed amendments.” We would, therefore, expect the government to hold wide ranging public discussions and also include its abroad citizens and concerned organizations before amending the RTI Act.

Protests in London against RTI Amendment by Pravasi Bharat

Protest Process they followed:-

1. Mrs. Arti Gujare, Core Member started the event with the National Anthem.

2. Mr. Srujan Chada, Core Member lead the event; He requested everyone to be silent for 2 Minutes- All the participants stood silence and paid homage to all those RTI Actvists who laid down their valuable lives for being whistle blowers and for fighting for the right cause.

3- Mr. Srujan addressed the gathering by giving background information on RTI and about the initiation for this peaceful demonstration.

4. Mr Ceeka ChandraShekar, Core Member: Requested Government of India to not amend the RTI Act.

5. Mr. Nagender Chindam, Chairman of this campaign group appealed the Government of India to not amend RTI Act with out wider consultations, He said, we the citizens residing abroad heartily welcomed the CIC decision of including 6 major political parties under RTI Act and said very unfortunate to know that government is trying to amend the RTI Act without wider consultations from the stake holders i.e. Citizens of the largest democracy, which was in fact promised in the year 2009. He also appealed government to involve/invite Indian citizens/organizations in abroad for RTI consultation process (if any). He said when the political parties build their infrastructure based on tax-payers money – then how come they can be excluded from being transparent and being accountable for public? It is not just the matter of NGOs and the people like us, It’s the matter for genuine honest political parties to do a protest and demand government to not amend RTI Act.

6. Dr Naresh Hanchate: Reasearch Scholor and Citizen of India, US based member of Pravasi Bharat, appealed to not amend RTI Act by reminding the importance of RTI Act by addressing it over telephone.

7. Dr Amit Mukerjee, Core Member: Requested Government of India to not amend the RTI Act.

8. Many from the audience shared their feelings regarding the RTI amendment and demanded government to stall the amendment process immediately.

9. All the participants including the members of Pravasi Bharat Arti Gujare, Srujan Chada, Feroz Khan, Roopa Nagaraju, Dr Amit Mukerjee, Chandra Ceeka, Nagender Chindam submitted the petitions on RTI addressed to Prime Minister of India, Speaker of the Loksabha through High Commission Office in London.

HCI Official has received petitions on behalf of HCI, London
Letter to Honourable Prime Minister of India on RTI – Draft

Letter to Honourable Speaker (Loksabha) of India on RTI – Draft

The constitution of India under Article 19(1A) declares that all citizens have the right to freedom of speech and expression, But Shiv Sena thinks it otherwise, if the constitution of INDIA has given every individual the right to freedom of speech , how can a Privilege motion be justified against Shobha De ? Its to be noted that De had only expressed her dissent on the diktat by the Maharashtra Government . Ms. De, reacting to Maharashtra government’s controversial move to make it mandatory for multiplexes to screen Marathi films in the prime time slot, had earlier tweeted: “I love Marathi movies. Let me decide when and where to watch them, Devendra Fadnavis.

It’s true that the Marathi film Industry has not prospered to the level of Hindi Film industry and Marathi Film industry has given best Actors in the Industry but will putting them on prime slots in Multiplexes change things, No doubt as a proud Maharashtrian even we feel that Marathi Movies are fantastic, and different from Hindi Movies and are definitely mind boggling but are all Marathi movies hit ? Movies of actors like Neelu Fule, Dr.Shree ram Lagu ,Dada Kondke have given various tastes of serious and comic movies what we still cherish, even the recent movie of Riteish Deshmukh “Lai Bhari ” was a crowd puller , why ? because people enjoyed it and mouth publicity made it a hit it moreover it was the highest grossing Marathi movie, did any diktat make it a hit ?

The delicacies of Maharashtra Dahi Misal and Vada pav are eaten and enjoyed by all and few of the Multiplexes do sell Vadas too.Does by saying that that popcorns will now be replaced by (Marathi delicacies) ‘dahi misal’ and ‘vada pav’ in multiplexes insult a community ? it was again just a outburst of emotions not directed to any community nor derogatory which deserved a Privilege motion to be moved against her !!! Maharashtra is not known because of its Delicacies but because of the Maharashtrians like Shivaji Maharaj and Dr.Babasaheb Ambedkar who are a few of the renowned figures of the Great Maharashtra History.

If section 66A of the IT Act violated freedom of speech and was thrown out by Supreme Court , Isn’t the Privilege Motion against Shobha De not the same, Does the Maharashtra CM Mr.Devendra Fadnavis approve and support this if he is impartial and a real Maharashtrian he should take in stride the Criticism as he takes pride in his praises.

New Delhi: Bharatiya Janata Party (BJP) and Indian National Congress (INC) are the only two National Parties which have not yet submitted details of the expenditure incurred by the parties ​during the Lok Sabha 2014 elections ​to the Election Commission of India (ECI). Among the recognised regional parties, only 24 parties out of a total of 49 parties have submitted their Lok Sabha election expenditure statements at the time of this release.

 Supreme Court Judgement regarding submission of Election Expenditure Statements by Political Parties

The Supreme Court of India, in its judgement of Common Cause Vs. Union of India, dated 4^th April, 1996, had stated “…the political parties shall submit to the Election Commission, for its scrutiny, the details of the expenditure incurred or authorized by the parties in connection with the election of their respective candidates.” The Supreme Court also stated that the ECI would be justified in asking political parties to file an account of their expenditure incurred or authorised by the parties in connection with the election of its candidates during the course of elections.

Time Period within which Election Expenditure details should be submitted to the ECI​

​Hence, the ECI stipulated a time period of 90 days within which all National and Recognised parties need to submit the expenditure the parties incurred during Lok Sabha elections. As the results of the Lok Sabha elections were declared on 16^th May, 2014, the parties should have filed their expenditure statements on or before

​ 14th of August 2014.​

​​​ECI issues Notices to defaulting Parties

According to a note on the website of the ECI, as of 8^th September, 2014, INC, BJP and CPI were the three defaulting National Parties along with 46 regional parties which had not filed their statements of election expenditure to the Commission.

​Contents of Expenditure Statement

The expenditure statement contains details of the total amount received as funds in the form of cash, cheques and demand drafts and the total amount spent under the following heads at the central, state, district and constituency levels by the party:

·               Party propaganda

• Travel expenses
• Publicity expenses
• Other expenses

·               Expenses on candidates

Political parties are required to submit these statements providing information of funds collected and spent between announcement and completion of elections.

​

ECI: Unrecognised parties would be required to submit election expenses details

For the first time since the above quoted judgement of the Supreme Court, the ECI has asked the unrecognised parties, which contested in the Lok Sabha elections, 2014, to file their expenditure statements. Out of a total of 419 unrecognised parties which contested, 17 parties have submitted details of expenditure so far.

Recommendations of ADR

While it is crucial for political parties to submit their expenditure statements for greater financial transparency, it is equally important to file the same within the time limit set by the ECI and endorsed by the Supreme Court of India. The National and Regional Parties should, ideally, lead by example by filing complete and correct statements of expenditure to the ECI well in time for public scrutiny so as to encourage financial transparency.

Health hazard warning Toxic Johnson & Johnson’s Baby Powder

Bombay High Court today stayed the order of the Maharashtra Food & Drug Administration (Maharashtra FDA) suspending the license of Johnson & Johnson to manufacture cosmetic products at its Mulund plant. Justice S J Vazifdar and Justice M S Sonak ordered Maharashtra FDA to hear the matter afresh. However, while declining to quash FDA’s order, the bench left it open for whistleblower Dr Ajit Telang to intervene in the matter before FDA, or to approach high court with a PIL.

“Johnson is manufacturing the cosmetic products on a loaned licence,” Justice Vazifdar explained to Dr Telang’s advocate. “If manufacturing is not allowed to resume, the suffering of the other party i.e. the licence owner, will be needlessly prolonged,” he said.

Dr Ajit Telang, who had worked for 14 years at Johnson’s Mulund plant, complained to Johnson’s headquarters in 2008 regarding the contamination of the 1.6 lakh containers of Baby Powder with carcinogenic Ethylene Oxide. Later, in 2011, he alerted FDA and pursued the matter doggedly until the permission to manufacture cosmetic products at its Mulund plant was finally suspended in June 2013.  

Brief outline of the case:

• Dr. Ajit Telang, aged 51 years, holding Doctorate in Polymer Science from University Department of Chemical Technology, was a Technical Services Officer and later, Technical Services Manager.  He helped to develop many products over the decades, and received four global awards between 1996 and 2003, and the Asia Pacific Award in 2005 for Neutrogena Mask design. He came to hold nine international patents/patent applications during his tenure with Johnson & Johnson.

• In 2006, Dr Telang worked on a Process Excellence (PE) project for elimination of sterilization processes with Ethylene Oxide (commonly called ETO or EO) for Band-Aid range of products, and became well-versed with the harmful effects of ETO.

• Around December 2008, he got information that 15 batches of Johnson Baby powder had been recently sterilized using ETO, which was not as per the procedure allowed by Maharashtra Food and Drugs Administration (FDA). Knowing the propensity of dangerous amounts of ETO residues to linger in powder and plastic containers, he brought it to the knowledge of his immediate superior, and asked him to recall these batches. As no further action was taken by his superior, he filed an online complaint on the website of the headquarters of Johnson & Johnson USA, in December 2008. Still, the 15 batches were not recalled.

• On 15th October 2010, Dr Ajit Telang was sacked without any prior notice.

• In February 2011, Dr Telang approached the FDA and made a full disclosure. In March 2013, FDA conducted a thorough investigation of the incident and the cover-up. Read FDA’s investigation report procured under Right to Information by Dr Telang:  http://tinyurl.com/FDA-Report-on-J-J-Baby-Powder

• Page 8 of FDA’s report says: “The unfortunate babies who were repeatedly exposed to the talcum powder of these Ethylene Oxide treated batches, which was highly advertised and claimed as “mild and clinically proven” product (actually this claim was developed for baby talcum powder in which steam sterilization was used) may develop slowly and silently disease of cancer… there are sometimes years between exposure to a carcinogen and development of cancer. Further, some of these victims may pass on the genetic mutations to next generations if they live longer.”

• The manufacturing license of the Mulund Plant was suspended on 29th June 2013.

• Johnson approached the FDA minister Manohar Naik to have FDA’s order overturned. However, Dr Telang approached the minister and impressed on him the gravity of the multinational’s crime. In the end, the FDA order was upheld by the minister.

• Dr Telang became aware from news reports that Johnson had approached Bombay High Court. He believed that FDA, being aware of the matter, would adequately defend the case. In August, he learned from news reports that Johnson had successfully played down the criminal nature of its offense. For reasons best known to itself and its lawyers, Maharashtra FDA was keeping quiet, instead of drawing attention to the many lies that Johnson was relying on in its petition.

• The implications of Johnson’s lapses for the lives of an estimated 1,61,000 infants (and their mothers) exposed to the baby powder with ETO residues are grim. Based on risk-assessment statistics, it may be inferred that as of date, more than 16 persons have actually died as a result of Johnson’s negligence. This makes it an act of culpable homicide. Risk-assessment statistical analysis indicate that deaths due to cancer, and also genetic mutations, will continue for years and decades. However, any connections drawn between actual deaths, mutations etc, to the baby powder would necessarily have to be probabilistic.

12 Flaws in Johnson’s High Court Petition:

1. To give a clean chit to Johnson, PCP Lab in Thane assumed that the Permissible Exposure Level (PEL) for babies is the same as for adults i.e. 1 ppm. The tests conducted by Johnson at PCP Lab say that residual ETO of 1 ppm was “not detected”. Baby skin being  three times thinner than adult skin, it is globally accepted that human babies are 100 times more sensitive to a carcinogen than adults, and therefore, the PEL for babies should be 0.01 ppm.

2. Residual ETO levels of, say, 0.9 ppm may very well be present in that same sample, in which 1 ppm was “not detected”. In other words, the test parameters are faulty.
   

3. PCP Lab did not draw the test samples. Samples were supplied by Johnson, and hence the test results are not reliable and unacceptable by a court of law. (An authorized person from PCP lab person should have independently collected the samples from the market and brought it to the lab in a sealed envelope.)

4. Johnson conducted the test to determine residual ETO at PCP lab about 17 months after the product was released to market. This is not acceptable as per ISO standards.
   

5. PCP is a non-FDA approved lab, and it did not have validated test method to conduct this test. PCP Lab modified the ISO test and carried out the test for carcinogenic residual ETO contents in the Baby Powder container without a previous ‘validation of test’ procedure.

6. PCP did not have a blank unsterilized sample from J&J which is the ISO test method requirement (ISO 10993-7, 2008, section 4.4.3) and hence J&J India got their samples tested without a blank. The FDA report confirms this discrepancy. The PCP lab used 1 ppm ETO as standard as per their report and reported the residual carcinogen results as “not detected”.

7. In its petition, Johnson has relied on a report by Gary Mitchel, who, while being a world-renowned expert, is an employee of Johnson & Johnson, USA. To give his company a clean chit, Gary Mitchel has referred to residual ETO in Shower-to-Shower powder and ear buds to arrive at the detection limit of 0.1 ppm. These products are for adults and hence, these references are irrelevant and misleading.

8. Another set of “simulation tests” done at Bee Pharmo, submitted as evidence by Johnson, were also done with 1 ppm as ETO standard. The test samples at this lab were from aimulation test done at Microtrol’s sterilization facility at Gurgaon, Haryana, which is an advanced facility certified by regulatory agencies as per the Microtrol website. However, the original ETO sterilization of the 1.51 lakh boxes of baby powder were carried out at the Microtrol unit at , which is a very old non-certified facility of Microtrol built in 1983. The decision of Johnson to carry out a “simulation test “at a sophisticated facility in Haryana is dubious.

9. The simulation protocol was not shared with FDA in advance, before conducting the test. The simulation test was not approved by FDA in advance. As per proper protocol, a representative from FDA should have been present during the “simulation test” at Gurgaon to see that the test is done as per approved protocol. This was not done. An FDA person should have drawn the test samples of Baby Powder containers from the sterilizer and should have sent those samples for testing at Bee Pharmo laboratory in a sealed envelope. This also was not done. The results submitted by J&J themselves, in the absence of monitoring by any third party during the trial and drawing of samples, cannot be acceptable to any court of law.

10. Bringing down the residual values of ETO is notoriously difficult and time consuming. Scientific research has shown that aeration time of as many as 17 hours may be needed to get bring residuals of a “medical device” below 1 ppm after ETO sterilization. Even after 96 hours of aeration, some researchers found that polythene samples had 40 ppm of residual ETO in them.

11. American college of chest physicians opines that the aeration time to reduce residual carcinogenic ETO from a very low weight 5g talc pouch took 24 hours of aeration time. A 100 gram container of baby powder (which is much denser than 5g talc) may take 20 days to several months for residual carcinogenic ETO to be extracted. And yet, Johnson had used only 30 minutes of aeration time. Experts can state with absolute certainty that if the simulation test at Gurgaon, Haryana is carried out with aeration time of 30 minutes, there is no possibility of removing the residual ETO from 100 g baby powder container.

12. Johnson has relied on a self-serving and unscientific report by Gary Mitchel of J&J USA, written without conducting a single actual test as per ISO 10993-7 (2008). This ISO standard requires determination of residual ETO in a medical device by conducting an actual extraction test. Gary Mitchel has made up a full report by making only theoretical assumptions and mathematical calculations, which USFDA would never accept. Mr Mitchel has computed quantity of ETO concentration in the container as 145 mg/ litre when the Batch record sheet of Microtrol shows it as 750 mg/ litre and hence the calculation has used 750/145 mg/litre = 5.17 times less quantity. Further, Mr Mitchel uses on page 152 of his report an equation that is not mentioned anywhere in ISO standard to “theoretically” calculate the residuals of the whole baby powder container post ETO sterilization. Surprisingly this equation does not have any factor for material of the packaging (HDPE baby powder containers, which adsorb a lot of ETO) nor for the material like talc.  In the absence of such factors, it is theoretically possible to pack 100 g of baby talcum powder in a PVC or glass container (instead of J&J’s HDPE container) of the same volume (188 ml), and the same reading of 21.9 mg /litre will be derived. Alternatively, if, instead of 100 g talc, one were to pack 100 g of mud or sand or iron shavings inside baby powder containers, the result would be the same the equation does not have a factor for material packed inside the container and hence does not recognise the type of material. Hence, this equation does not have any scientific basis. And as if this were not enough, Mr Michel has relied on an outdated ISO tolerable limit of daily exposure of 20 mg of ETO residue in 1995, instead of the more stringent limit of 4 mg imposed in 2008. But even this is only applicable for adults, and not for babies, who are their target customers.

Johnson thus tried to confuse the court by using contradicting information as per their convenience, averred Dr Ajit Telang in his petition.

Dr Ajit Telang’s Petition: http://tinyurl.com/Johnson-Baby-powder-CS

An earlier press release: Lies of Johnson & Johnson’s Petition for Restoration of its Manufacturing License !!!

FOR DETAILS & DOCUMENTS, CONTACT Dr Ajit Telang 9323227247, atelang1@gmail.com

Bombay High Court is expected to give a judgement in WPL 1714 of 2013, possibly quashing or staying the cancellation of the licence of Johnson & Johnson for manufacturing cosmetics and Baby Powder at its Mulund Plant. On Monday, they will also give a hearing to whistleblower Dr Ajit Telang — formerly a scientist working for J&J – who has alleged in his Chamber Summons CHSWL/240/2013 that Johnson has blatantly lied and misled the court.

 Brief outline of the case:

• Dr. Ajit Telang was a Technical Services Officer, who helped to develop many products and received four global awards between 1996 and 2003, and the Asia Pacific Award in 2005 for Neutrogena Mask design. He came to hold nine international patents/patent applications during his tenure with Johnson & Johnson. In 2006, Dr Telang worked on a project for elimination of sterilization processes with Ethylene Oxide (commonly called ETO or EO) for Band-Aid range of products, and became well-versed with its harmful effects.

• Around December 2008, he came across information that 15 batches (about 1.61 lakh containers) of Johnson Baby powder had been recently sterilized using ETO, which was not as per the procedure allowed by Maharashtra Food and Drugs Administration (FDA). He brought it to the knowledge of his immediate superior, and asked him to recall these batches. Later, he filed an online complaint on the website of the headquarters of Johnson & Johnson USA. Still, the 15 batches were not recalled.

• On 15th October 2010, Dr Ajit Telang was sacked without any prior notice.

• In February 2011, Dr Telang approached the FDA and made a full disclosure, and followed it up for the next two years, until FDA conducted its own investigation in March 2013, and finally cancelled the manufacturing license of the Mulund Plant on 29th June 2013. FDA’s investigation report was procured under Right to Information by Dr Telang:  http://tinyurl.com/FDA-Report-on-J-J-Baby-Powder

• Page 8 of FDA’s report says: “The unfortunate babies who were repeatedly exposed to the talcum powder of these Ethylene Oxide treated batches, which was highly advertised and claimed as ‘mild and clinically proven’ product (actually this claim was developed for baby talcum powder in which steam sterilization was used) may develop slowly and silently disease of cancer… there are sometimes years between exposure to a carcinogen and development of cancer. Further, some of these victims may pass on the genetic mutations to next generations if they live longer.”

• Johnson approached the State Health Minister Manohar Naik, to have the FDA order overturned and have their license restored. However, Dr Telang came to know about this, and personally deposed before the minister and impressed on him the gravity of the crime committed by the multinational. As a result, the FDA order was upheld by the minister.

• After this, Dr Telang became aware from news reports that Johnson had approached Bombay High Court to have the FDA order overturned. He believed that FDA, being aware of the matter, would adequately defend the case. However, in August, he learned from news reports that Johnson had misled the court as to the criminal nature of its offense, and misrepresented the matter before Bombay High Court. For reasons best known to itself and its lawyers, Maharashtra FDA was keeping quiet, instead of drawing attention to the many lies that Johnson was relying on in its petition.

• The implications of Johnson’s lapses for the lives of an estimated 1,61,000 infants (and their mothers) exposed to the baby powder with ETO residues are grim. Based on risk-assessment statistics, it may be conservatively inferred that as of date, more than 16 adult persons would actually have contracted cancer as a result of Johnson’s act of negligence. (Babies who are 100 times more sensitive to carcinogen may have contracted cancer in numbers significantly larger!) This makes it an act of culpable homicide in the eyes of law, and is a ground for not only cancellation of license, but further of imprisonment of all those who were responsible for this act.

• Internationally acceptable toxicity models suggest that several infants and children exposed to suspected residual levels of ethylene oxide stand a positive life-time risk of contracting cancerous tumours. How many have actually contracted is difficult to speculate unless tested. Out of those who have contracted malignant tumours, survival depends upon early detection and treatment. Hence, the first priority of FDA should be to highlight the risk to Indian parents through public notice and focus on: (a) Mass-screening of children suspected to have been exposed to residual levels of ethylene oxide (b) Treatment of children tested positive for malignant tumourous growth. As is well known, every day’s delay in detection and treatment will lead to more fatalities. Hence, litigation will need to be urgently separated from relief activities which needs to be immediately initiated by the ministry of health and family welfare on a national scale.
  

• Standard risk-assessment statistical analysis would indicate that many more deaths due to cancer, and also genetic mutations, are inevitable in the years and decades to come. However, any connections drawn between actual deaths, mutations etc. to this incident would be at best probabilistic.

One Dozen Lies in Johnson’s High Court Petition:

1. To give a clean chit to Johnson, PCP Lab in Thane has assumed that the Permissible Exposure Level (PEL) for babies is the same as for adults i.e. 1 ppm. The tests conducted by Johnson at PCP Lab have shown that residual ETO of 1 ppm was “not detected”. Baby skin being three times thinner than the adult skin, easily allows penetration toxic materials and babies are vulnerable to very low quantities of toxic materials. It is globally accepted that human babies are 100 times more sensitive to a carcinogen than human adults, and therefore, the PEL for babies should be 0.01 ppm as against 1 ppm for adults.

2. Residual ETO levels of, say, 0.9 ppm may very well be present in that same sample, in which 1 ppm was “not detected”. In other words, the test parameters are faulty.
3. PCP Lab did not draw the test samples. They were supplied by Johnson, and hence again the test results are not reliable and are unacceptable by any court of law. (To be acceptable, an authorized person from PCP lab person should have independently collected the samples from the market and brought to the lab in a sealed envelope.)

4. Johnson conducted the test to determine residual ETO at PCP lab about 17 months after the product was released to market. This is not acceptable as per ISO standards.
   

5. PCP is a non-FDA approved lab, did not have validated method to conduct this test, container without a ‘validated test’ before it was used to test J&J’s baby powder.

6. In its petition, Johnson has relied on a report by Gary Mitchel, who, while being a world-renowned expert, is an employee of Johnson & Johnson, USA. In order to give his company a clean chit, Gary Mitchel has referred to residual ETO in Shower-to-Shower powder and ear buds to arrive at the detection limit of 0.1 ppm for residual carcinogenic ETO. As these products are for adults and not for babies, these references are irrelevant and misleading. Secondly if 0.1 ppm was used as detection limit for adult products why it was not used for baby powder test mentioned above.

7. Another set of “simulation tests” done at Bee Pharmo, submitted as evidence by Johnson, were also done with 1 ppm as ETO standard. J&J’s carcinogenic baby powder samples tested at this lab were from Simulation test done at Microtrol’s sterilization facility at Gurgaon, Haryana, which is an advanced facility certified by regulatory agencies as per the Microtrol website. However, the original ETO sterilization of the 1.51 lakh boxes of baby powder were carried out at the Microtrol unit at Sakinaka , Mumbai, which is a very old non-certified facility of Microtrol built in 1983. The decision of Johnson to carry out a “simulation test “at a sophisticated facility in Haryana is dubious.

8. Further, the simulation test itself is dubious, as the simulation protocol was not shared with FDA in advance, before conducting the test. The simulation test was not approved by FDA in advance. As per proper protocol, a representative from FDA should have been present during the “simulation test” at Gurgaon to see that the test is done by J&J as per approved protocol. This was not done. An FDA person should have drawn the test samples of Baby Powder containers from the sterilizer and should have sent those samples for testing at Bee Pharmo laboratory in a sealed envelope. This also was not done. The results submitted by J&J themselves, in the absence of monitoring by any third party during the trial and drawing of samples, cannot be acceptable to any court of law.

9. Bringing down the residual values of ETO is notoriously difficult and time consuming. Scientific research has shown that aeration time of as many as 17 hours may be needed to get bring residuals of a “medical device” below 1 ppm after ETO sterilization. Even after 96 hours of aeration, some researchers found that polythene samples had 40 ppm of residual ETO in them.

10. American college of chest physicians opines that the aeration time to reduce residual carcinogenic ETO from a very low weight 5g talc pouch took 24 hours of aeration time. A 100 gram container of baby powder (which is much denser than 5g talc) may take 20 days to several months for residual carcinogenic ETO to be extracted. And yet, Johnson had used only 30 minutes of aeration time. Experts can state with absolute certainty that if the simulation test at Gurgaon, Haryana is carried out with aeration time of 30 minutes, there is no possibility of removing the residual ETO from 100 g baby powder container.

11. Johnson has heavily relied on a self-serving and patently unscientific report by Gary Mitchel of J&J USA. This report has been written without a single actual test result done as per ISO 10993-7 (2008). J&J has made up a full report by making only theoretical assumptions and mathematical calculations, which USFDA would never accept. Mr Mitchel has computed quantity of ETO concentration in the container as 145 mg/ litre when the Batch record sheet of Microtrol shows it as 750 mg/ litre and hence the calculation has used 750/145 mg/litre = 5.17 times less quantity. And as if this were not enough, Mr Michel has relied on an outdated ISO tolerable limit of daily exposure of 20 mg of ETO residue in 1995, instead of the more stringent limit of 4 mg imposed in 2008. However, even this is only applicable for adults, and not for babies, who are their target customers. For babies as per ISO standard, the Tolerable Exposure Limit is computed as 0.2 mg, which can be rounded off to 0 mg. Gary Mitchel who is the member of ISO standards for sterilization has not mentioned this value anywhere. This is a criminal act of omission.

Johnson has thus tried to deliberately confuse the court by using contradicting information as per their convenience, says Dr Ajit Telang in his petition to the court. “Gary is aware of these facts since he is employed in J&J Medical division. Hence, the cover up act by Gary Mitchel is a criminal act,” says Dr Telang.

Will the hon’ble Bombay High Court will take these facts into account ? Or will they simply ignore this petition? We must wait and see.

Health hazard warning Toxic Johnson & Johnson’s Baby Powder