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 government is coming around to the view that the state Lokayukta be kept out of the Lokpal Bill and a model law be passed by Parliament to enable states to create their own Lokayukta
New Delhi: In a bid to evolve consensus on the anti-corruption Lokpal Bill before it is brought to the upper house of the Parliament, Rajya Sabha, the UPA government on Thursday reached out to the Opposition and other parties to thrash out differences and ensure smooth passage of the proposed legislation, reports PTI.
Union Ministers Kapil Sibal, Salman Kurshid, Pawan Kumar Bansal and V Narayansamy met Leader of Opposition in Rajya Sabha Arun Jaitley in Parliament House to discuss the Lokpal Bill.
The Bharatiya Janata Party (BJP), the main opposition party, is adamant on two main issues, namely, that the process of appointment and removal of the Lokpal or the proposed ombudsman be made more democratic and the investigation agency CBI be kept out of government control.
Sources said government is coming around to the view that the state Lokayukta be kept out of the Lokpal Bill and a model law be passed by Parliament to enable states to create their own Lokayukta.
Opposition ruled states as well as east Indian West Bengal state, where ally TMC is in power, are against the Lokayukta clause in the Bill.
These Union Ministers are also likely to meet CPI-M leader Sitaram Yechury and leaders from other parties to discuss their views.
Other than the issues of appointment and removal of the ombudsman and keeping CBI out of government control, the Left wants foreign-funded non-governmental organisations to be brought under the Lokpal.
"We would like the Bill to come to Rajya Sabha only after there is a consensus. If the Bill is brought and then consensus is sought in the House, it would lead to certain problems," Law Minister Salman Khurshid told reporters.
On activist Anna Hazare's demand for appointing Lokayukta in states, Khurshid said Hazare's supporters in Delhi are accusing the government of trying to keep it out of Lokpal Bill.
Prime Minister Manmohan Singh had held an all-party meeting on 23rd March to resolve the issues regarding the Bill.
Though the meeting failed to evolve a consensus, it was decided that parties will continue negotiations on the Bill.
The Bill could not be passed in the Rajya Sabha in the Winter Session last year. The House was adjourned sine die amid high drama with the opposition accusing the government of running away from a vote because it was in a minority.
The Bill, which was earlier passed in the lower house -- the Lok Sabha -- in the same session, was brought in the Upper House on the last day of the Winter session and key constituent of the ruling coalition UPA, Trinamool Congress refused to bail out the government there.
Even in the all-party meeting this year, opposition parties and key allies like Trinamool Congress and DMK had opposed the provision for setting up Lokayuktas in states along with Lokpal and wanted that states be given the freedom to decide on it
With over 200 pilots owing allegiance to the Indian Pilots Guild refusing to join duty, Air India has suspended its international operations to the US, Canada and Europe
New Delhi/Mumbai: Crisis-hit Air India on Thursday stopped bookings for the US, Canada and Europe-bound flights till 15th May 15 as it sacked nine more pilots on day three of their agitation which led to cancellation of over 20 flights and left hundreds of passengers fuming, reports PTI.
With over 200 pilots owing allegiance to the Indian Pilots Guild (IPG) refusing to join duty, Air India said it was suspending its international operations to New York, New Jersey, Chicago, Toronto, London, Paris and Frankfurt. Some other foreign destinations are also likely to be affected.
Air India sacked nine more pilots taking the number of pilots whose services have been terminated to 45. While 10 pilots, mostly office bearers of the IPG, were dismissed on Tuesday, another 26 were shown the door yesterday. Air India management has also derecognised IPG.
Showing no signs of relenting, the IPG asserted that the AI management must withdraw the sack orders and till then there was no question of resuming work.
The agitating pilots sought the intervention of Congress chief Sonia Gandhi and Prime Minister Manmohan Singh to resolve the impasse.
"It is a matter of life and death and career for the pilots. Talks were held by IPG with AI management which did not honour its commitments. The management is having a non-serious attitude towards our grievances,'" Jitendra Awhad, IPG president, told reporters.
Over 20 Air India flights were cancelled today from Delhi and Mumbai. From Delhi flights to Frankfurt, Shanghai, Toronto, New Jersey, Chicago and Seoul were cancelled while Air India flights to New York, Riyadh and Shanghai were not operating from Mumbai.
Air India daily operates about 50 international flights and 400 domestic flights.
Civil Aviation Minister Ajit Singh said, "If they (pilots) are not willing to follow the court order, why would they listen to me. They have to decide to follow the High Court order. That's the law but they are not willing to do so. What can we do."