Public Interest   Exclusive
Advertising of prescription drugs by pharma companies shocks govt panel

A parliamentary panel on heath found that pharma companies are advertising prescription drugs, which is not permitted in India. The Standing Committee also made a shocking revelation that the DCGI is favouring drug manufacturers by approving drugs without conducting mandatory clinical trials

A parliamentary panel which made a shocking revelation that on an average Drug Controller General of India (DGCI) is approving one drug every month without trials has also pointed out that pharmaceutical majors like Ranbaxy, Cipla, USV and Lundbeck are advertising prescription drugs, falling under Schedule H, which is not permitted in India.

The report tabled in the parliament on 8th May by the Standing Committee on Health and Family Welfare said that it has noticed the advertisements of prescription drugs such anti-depressant Deanxit of Lundbeck, USV's cholesterol lowering Coltro, and also ads of anti-epileptic agent C-Toin (USV), Desval (Ranbaxy) and Lametec DT (Cipla).

The committee, in its report, has recommended to the ministry (health and family welfare) to take action against these companies.

Pointing to the laxity in India's drugs regulation, the Standing Committee also made a shocking revelation that the DCGI is favouring drug manufacturers by approving drugs without conducting mandatory clinical trials.

Based on information provided by the ministry, the panel said that 31 new drugs were approved in the period between January 2008 and October 2010 without conducting clinical trials on Indian patients. It also said that, "There is sufficient evidence on record to conclude that there is collusive nexus between drug manufacturers, some functionaries of CDSCO (Central Drugs Standard Control Organization) and some medical experts." The CDSCO is headed by DCGI.

The panel, which investigated and reviewed the drug regulation in India for 18 months, randomly picked up 42 medicines for scrutinising its approval status.

However the ministry could not provide any approval document on three drugs-pefloxacin, lomefloxacin and sparfloxacin, stating that the "files were non-traceable".  According to the report, "Strangely, all  these  cases  also  happened  to  be  controversial  drugs;  one was  never marketed in the US, Canada, Britain, Australia and other countries which have well developed regulatory systems while the other two were discontinued  later on. In India, all the three drugs are currently being sold."

On scrutinising 39 drugs, the Committee found that for 11 drugs, mandatory Phase III clinical trials were not conducted. These drugs includes Switzerland-based Novartis' Everolimus and Aliskiren; Cipla's Colistimethate and Pirfenidone, UCB's Buclizine and GlaxoSmithKline's Ambrisentan among others.

 The report reveals that for two among these drugs, Sanofi's Dronedarone and
Novartis's and  Aliskiren clinical trials were conducted on just 21 and 46 patients respectively as against the statutory requirement of at least 100 patients; for one drug Irsogladine (Macleods) trials  were  conducted  at  just  two hospitals as against legal requirement of three to four sites.

The panel found that in case of Novartis' Everolimus, UCB's Buclizine, Eli Lilly's  
Pemetexid and Theon's fixed dose combination of Pregabalin, no expert opinion was sought and they were approved by the non-medical staff of CDSCO. While in case of case of 25 drugs opinion of medically qualified experts was not obtained before approval.

According to the report of the total scunitized drugs, 13, like UCB's Buclizine for appetite stimulation, fixed dose combination of Tolperisone with Paracetamol (Themis), Nimesulide injection (Panacea), etc, do not have specific relevance to the medical needs of India. Sale of these drugs is banned in countries like the United States, Canada, Britain, etc

The panel also mentioned that in 14 out of 39 drugs, the number of experts consulted was generally three to four, though in isolated cases the number was more. Citing the example of  the United States  Food and Drug Administration (USFDA) which constituted a panel of 37 experts drawn from all over the country to review just the dose of the popular  pain-killer paracetamol and also uploaded the expert opinion on its website, the report remarked that, "In  India, every discussion and document  is confidential away from public scrutiny. This matter needs to be reviewed to ensure safety of patients, fair play, transparency and accountability."

Like this story? Get our top stories by email.

User

COMMENTS

Paul Davidson

4 years ago

Just in case anyone need to fill out a Schedule H form, I found a blank form in this link http://pdf.ac/6LEQI. This site PDFfiller also has several related forms that you might find useful.

Ratanlal Purohit

7 years ago

Zindagi ki dar se Mafia se darna.
Marz ka marna ya mariz ka marna
Roz roz ke marne se achchha ek bar Marna.
Dusron ke kafan se sir pe kafan rakhna
Anna ka isme kya kehna?

Shibaji Dash

7 years ago

Readers/viewers, kindly do go through the news item on equally damaging part of the report of the Parliamentary Committee published in TOI of May 10 ( Kolkata/Bhubaneswar edition.)The abject surrender of top icons of the medical fraternity to the ever greedy and unethical pharma industry as reported.

Vineeth

7 years ago

You are exposing MLM companies some with evidence or some without evidence, controversy sells. Any report without proper evidence in hand is as good as murder of "Aam Admi". With evidence, I will be in front with you to ensure justice. Chalo...leave it..

Drugs are essential commodities and UOI should ensure its availability at the most economical MRP to the patients. Are they doing it? Have you ever thought: a lipid lowering agent like Atorvastatin 10 mg there a dime a dozen companies marketing it...with MRP ranging from Rs. 1.60/tab to Rs. 6.00/tab...can give numerous example. Can give you the list of manufacturing cost and MRP. The Profit is 200 %. Companies are royally cheating people and everybody is quite. I can provide you with evidence...do you have the guts to pursue the matter to its logical solution. If you are ready, I can help you identify the unholy NEXUS between Pharmaceutical Companies-Doctors-Hospital Pharmacy. Unless DGCI is in SLUMBER these kind of loot of the poor patients are not possible.

Don't think you will take it up, everybody has fear for his/her life.

Writing articles without any concrete evidence is in poor taste.

Public Interest   Exclusive
President Pratibha Patil’s luxurious home continues to be built

The 2,42,000 sq ft of land in Pune returned by President Patil is to be ‘suitably’ used for an alternative purpose. Communication from the ministry of defence is awaited, said Southern Command officials

Although President Pratibha Patil has returned the 2,42,000 sq ft of land in Pune on which she was building her palatial post-retirement home, construction continues on the site.

Senior officials at the Southern Command headquarters said since the construction is half done, it is being allowed to be completed. Assuring that it would be used 'suitably' as per the stringent norms of A1 defence land, they also clarified that A1 land 'can' be used for residential accommodation of jawans. However, they failed to answer how the same construction meant for a palatial personalised home could be converted for accommodation of jawans, which would obviously comprise a series of small tenements.

So far, Rs5 crore have been spent by the Southern Command. The construction work comes directly under the Army Commander with MES having given the contract to private contractors (allegedly not registered with the MES). However, senior officials of the Southern Command said they are waiting for orders from the ministry of defence (MoD), for the nature of the re-use of the sprawling construction site.

When asked as to how, in the first place, the Southern Command gave permission for a civilian home on A1 land, Maj Gen SK Yadav stated that they were merely following the orders of the ministry of defence. When told that the MoD had questioned 'precedence' of such an allocation, the Defence Estate Office was mum in its reply, the officers stated that they had "raised objections" but refused to spell out anything further.

In an unprecedented and curious move, the Southern Command, after coming under storm for bending backwards to construct President Patil's palatial post-retirement home on 2,42,000 sq ft of A1 defence land, decided to hold a press conference on Tuesday to "put the records straight" on land issues including official accommodation for serving officers and jawans not only in the Pune station but the entire command comprising 10 states and three Union Territories.
 
Pune is an important military station but officers are made to wait for between six months and one year to get an official accommodation and there is a woeful lack of homes for jawans in particular. It is against this background that President Patil's retirement home came under sharp criticism, as besides the legal aspect, the question of the propriety and precedence was questioned.

Maj Gen C P Singh, in charge of logistics and operations, stated that, "to make up the overall deficiency of married accommodation with an outlay of Rs56 crore-84 officers, 27 junior commissioned officers (JCOs) and 250 other ranks (OR) houses were constructed in 2011 and with an approximate projection of Rs.95 crore, 188 officers, 60 JCOs and 300 ORs houses are in various stages of completion in Married Accommodation Project Phase II. Satisfactory levels of accommodation will increase to above 90% for all ranks on completion of second phase."

Compilation and digitalisation of land records in Southern Command is underway but they had no answer to the number of encroachments on defence land and what specific action they have taken on the 2009 Pune Defence Estate Office report of such encroachments.

Like this story? Get our top stories by email.

User

COMMENTS

mike rana

7 years ago

no one should think that they can stop what the government is bent on doing ... thank god they are doing only this. Read history

Ghoda

7 years ago

The house may be alloted to the kin of the President ! In India any thing can happen.

Ashok Malkani

7 years ago

It is really heartbreaking to read of the loot that is taking place in every government organisation, be it Civil or Military.
The order of the day is " Take what you can and the Devil take the hindmost "

The incompetence and inability to govern displayed by the UPA , has created a lawless state of the nation.
The time has come to vote the UPA/Congress out, at every level.

Ravi Saraogi

7 years ago

Maj Gen SK Yadav is certainly hiding the facts and continuation of construction of the house is only raising suspicion in mind. GOC-In-C and MOD both should let people know the facts.

J Sharotri

7 years ago

South comd specially GOC-In-C can't get away by saying "we were following MOD Ordrs" He is not L/NK Bhup Singh to say like dat, he is an Army Cdr- in my openion unfit to hold dat rank n appntmnt wd suchc conduct and statemnent. He is spending govt(Army) money on construction of dat house. He must reveal tod public every proof of wt were his reaction/observation/orders when he received "ordrs of MOD to first give thastlasnd and subsequently construct dat house for dat women-head of Indn State, which puts my head to shame :-((((

P V Nair

7 years ago

There is a stench in the air. Clearly some foul work is afoot. It ill behoves the army to waste the taxpayers' money on building a luxurious mansion without knowing to what perpose it would be put. Vinita Deshmukh and her band of tenacious watchdogs need to be doubly vigilant to thwart any misconceived plot to use
defencse land for any purpose other than to house defence personnel.

Gaurav Garg

7 years ago

Really Shame On Our Indian Leaders :(

Rajnish Raj

7 years ago

Yeh Hamara India hai ! Yahan Koi Kitney Badi post per kuy na ho parntu Sarkari Suvidha ka beza istemal karney me nahi peechey rahta hai. Niyam kanoon to Janta- Janardan ke Liyey hotey hai maha mahim - manniyo ke liyey nahi. UP ke Ex CM apney sarkari Banglow me without permission Construction karati hai .Aur Vikas Pradhikaran Set back area me Construction ke liyey Public ko notice deta hai? Hai na India Gzab ka !

Caroline

7 years ago

Looking at the picture of the building, I am sure Mrs. Pratibha Patil Sekhawat may end up occupying the palatial house along with her entrie khandaan of children, grand-children & niece & nephews as well.

The point here is that how can the President of a country run up a bill of Rs.65 crore and above for foreign trips as well as grap land meant for the Defence. She & her family should be impeached and put behind bars for embezzlement and using her position for personal gain.

God save the nation from any future Presidents who might turn out to be like her!

Dr. A.P.J Abdul Kalam is the best President we ever have in the last few decades. Not only is he perfect for the post, he is down-to-earth as well as not corrupted like Mr.s Patil.

Come on Mrs. S Gandhi, act fast before the entire country will blame you for every ills in the nation.

Ratanlal Purohit

7 years ago

I agree with previous comments supporting the author.
The RIT route takes long.
Mr Antony should clarify.
A multi story tower should take care of all pending list. The palace can be used for the mess and market for the resdency. More than 1000 accomdation can be create in this hub which may be named after the Supreme Commander to live after for ever.

B V KRISHNAN

7 years ago

I do not think this is the end of this story. I am prepared to bet that Ms Pratibha Patil will find a way to occuppy the palatial residence once it is completed, on some pretext or the other. Utmost vigil is required from all of us to ensure that she does not outsmart us!!

Shibaji Dash

7 years ago

Defence Minister Mr. Antony whose integrity and probity is taken as unimpeachable ought to make a statement on the issue in public interest.The President's name getting embroiled in controversy certainly does not augur well for the country.

R Srinivasan

7 years ago

What a shame that we have people at the very top flouting all norms of decency and spending public money for personal good. Rs.5 crores spent so far for a partially-built palace. Don't people have a conscience that should dictate dharmic behaviour

Public Interest   Exclusive
Probe former CJI KG Balakrishnan: Supreme Court

The apex court has asked a competent authority to look into allegations of misconduct against the former CJI even though it has refused to direct the government to recommend a presidential reference to remove justice Balakrishnan as NHRC chairman

New Delhi: The Supreme Court on Thursday asked the competent authority of the Centre to look into the allegation of judicial misconduct against the former chief justice of India and current National Human Rights Commission (NHRC) chairman Konakuppakatil Gopinathan Balakrishnan (KG Balakrishnan) for his alleged misconduct during his tenure as a judge in the apex court.

The court passed the order on a PIL (public interest litigation) by non-government organisation (NGO) Common Cause, which had sought directions from the court to the government to make a presidential reference to the apex court for removal of former CJI Balakrishnan as the chairman of NHRC.

The NGO had alleged that the ex-CJI and his relatives amassed wealth far exceeding their legal income during Justice Balakrishnan's tenure as an apex court judge.

According to a PTI report, a bench of justices BS Chauhan and JS Khehar said if there is any truth in the allegations, then it is for the president to make a reference to the Supreme Court, on the advice of council of ministers, for inquiry against the former CJI.

The Supreme Court, however, refused to direct the Centre to recommend a presidential reference to remove him from NHRC.

Earlier, former chief justice JS Verma, former apex court Judge VR Krishna Iyer, noted jurist Fali S Nariman, former member of NHRC Sudarshan Agrawal and prominent activist-lawyer Prashant Bhushan had called for justice Balakrishnan to step down from the chairmanship of the NHRC pending an inquiry into the matter.

Justice HL Gokhale of the Supreme Court also had accused justice Balakrishnan of misrepresenting facts to conceal sacked telecom minister A Raja's attempt to influence Justice R Reghupathy of the Madras High Court, on behalf of two murder accused known to the DMK leader.

Justice Balakrishnan had been elevated as a Supreme Court judge in June 2000 and was appointed the Chief Justice of India on 14 January 2007. He retired on 12 May 2010 after which he was appointed NHRC chairman.

The NGO had also sought directions to the ministry of home affairs (MHA) for making a reference to the apex court under the Human Rights Act to look into the allegations of 'misbehaviour' against justice Balakrishnan. The court had reserved its verdict on the NGO's plea on 7th May.

A provision under the Human Rights Act says the NHRC chairperson or its members cannot be removed from their offices unless the President of India orders it on the ground of proved misbehaviour, ascertained by the Supreme Court after an inquiry on the president's reference for the probe.

Common Cause, in its petition, had annexed media reports as documents to buttress its allegations that 'benami' properties were acquired by justice Balakrishnan's kin during his tenure in the Supreme Court.

On an earlier date of hearing, the Centre had informed the apex court that it is probing into the allegations that justice Balakrishnan and his relatives had amassed disproportionate assets during his tenure as a judge and had submitted a probe status report to it in a sealed envelop.

The court after going through the report had asked the government to tell it as to what further action it intended to take on the allegations against the former CJI and appraise it about it.

According to media reports, justice Balakrishnan's son-in-law and Indian Youth Congress leader PV Srinijan, who did not have any land four years ago, is now the owner of property worth hundreds of thousands of rupees.

During his tenure as Chief Justice of India, he also tried to exempt the Office of the chief justice of India from the purview of the Right to Information (RTI) Act. Justice Balakrishnan ordered the Supreme Court registry to file an appeal before the Supreme Court against the Delhi High Court judgement making the office of the CJI amenable to the RTI act. He has also spoken about the need for amending the RTI act in the interests of the right to privacy.

Like this story? Get our top stories by email.

User

COMMENTS

Nagesh Kini FCA

7 years ago

Mr. Balakrishnan, he no longer deserves to be called "justice" ought to have gracefully stepped down from the NHRC.
Possibly he thinks he can get away with blue murder just like his equally dishonourable predecessors Ramaswamy and Sen.
The charges are very serious from blatant corrupt practices to tampering with Raja's case and most unbecoming of the position of CJI.
There is absolutely no case for wasting nation's money on the fruitless exercises of Presidential Reference and Impeachment by Parliament, we all know what happened in the two cases - ended as damp squibs.
That he was, and not is a sitting CJI, should not make any difference in the eyes of law. He has been given enough opportunity to defend himself. The CBI should straight away charge him.We are not living in Orwel's land of 'some being more equal than others'. Gone are days of Gandhi/Annagiri.
This is a fit case for Team Anna's IAC to pursue to its logical end to bring about conviction.Otherwise they are not worth the Anti-corruption crusade they crow about.

REPLY

Gopinath Prabhu

In Reply to Nagesh Kini FCA 7 years ago

The biggest irony is that he can only be removed on a reference by the President :)

anil bhatia

7 years ago

the EX- chief justice of india is under the suspicion of graft charges . the justice sen was tried in to the joint session of parliament for impeachment but nothing happened .In india the judiaciary and administerative quasi judicial officials are not worried about the wrong and illogical orders and judgements in various courts after getting bribed . becuase none has been tried since independece to today so who is going to afraid of being caught .even the administerative and revenue officials on quasi judicial position do deliberatly defy and made disobedience to various court orders as everyone knows that nothing is going to happen and the officials will transfer and refuse to accept the court's notices !

We are listening!

Solve the equation and enter in the Captcha field.
  Loading...
Close

To continue


Please
Sign Up or Sign In
with

Email
Close

To continue


Please
Sign Up or Sign In
with

Email

BUY NOW

online financial advisory
Pathbreakers
Pathbreakers 1 & Pathbreakers 2 contain deep insights, unknown facts and captivating events in the life of 51 top achievers, in their own words.
online financia advisory
The Scam
24 Year Of The Scam: The Perennial Bestseller, reads like a Thriller!
Moneylife Online Magazine
Fiercely independent and pro-consumer information on personal finance
financial magazines online
Stockletters in 3 Flavours
Outstanding research that beats mutual funds year after year
financial magazines in india
MAS: Complete Online Financial Advisory
(Includes Moneylife Online Magazine)