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."

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.

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.