The ministry of health and family welfare has set up a three-member committee to examine validity of the scientific and statutory basis adopted for approval of new drugs without clinical trials. The committee has been asked to submit its report within two months
The ministry of health and family welfare has set up a three-member committee to examine the report of the parliamentary panel which had accused the regulatory body-Drugs Controller General of India (DCGI)-of favouring pharmaceutical companies by approving drugs without conducting mandatory clinical trials. The report had also pointed lapses in the approval procedure for new drugs.
Ghulam Nabi Azad, minister for health announced that the committee consisting of Dr VM Katoch, secretary and director general of Indian Council of Medical Research, Dr PN Tandon, president, National Brain Research Centre, (department of Biotechnology, Manesar) and Dr SS Aggarwal, former director, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow will examine the validity of the scientific and statutory basis adopted for approval of new drugs without clinical trials.
The committee has also been asked to outline appropriate measures to bring about systemic improvements in the processing and grant of statutory approvals and suggest steps to institutionalise improvements in other procedural aspects of the functioning of the Central Drugs Standard Control Organization (CDSCO). The committee has been asked to submit its report within two months.
The report tabled in the parliament on 8th May by the Standing Committee on Health and Family Welfare pointed the laxity in India's drugs regulation and stated that the DGCI is approving one drug every month without 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, "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 revealed that many such drugs which are banned in developed countries like the US, UK, Australia are sold in India. The panel, which investigated and reviewed the drug regulation in India for 18 months, randomly picked up 42 medicines for scrutinising its approval status. Apart from approving drugs without mandatory clinical trials, 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.
The report also mentioned that pharmaceutical majors like Ranbaxy, Cipla, USV and Lundbeck are advertising prescription drugs, falling under Schedule H, which is not permitted in India. (Advertising of prescription drugs by pharma companies shocks govt panel)
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Until 2004, the medicine was being sold in packs of 50s, with all retailers refusing to sell 30/60/90 caps to any user. In other words, a buyer was being forced to buy either 20 caps more, or 10 caps less or 40 caps more as reckoned with the prescribed 30/60/90 caps a month.
The matter was referred to the Dy. Drugs Controller of India, South Zone, Shastri Bhavan, Annexe (II Floor), 26 Haddows Road, Chennai-600006. By a letter No. 34/SZ/2004-921 dt. 11.05.2004, he referred the matter to the Commissioner, Food and Drugs Control Admn., Gujarat, with a copy to the Dy. Drugs Controller (India), West Zone, Mumbai (exact postal address NOT known).
Later, without any concern for the actual users, the company changed the packaging and started selling the drug in packs of 25 caps, with an increase in price. In other words, the actual users are now compelled to buy, at a time, either 5 less (one pack) or 20 more (two packs), 10 less (two packs) or 15 more (three packs), or 10 more than the prescribed dosage of 30/60/90 respectively.
This would clearly appear to be a restrictive trade practice and against the interests of actual users, since retailers refuse to sell as per prescriptions. The Drug Controller also does not appear to have acted on the reference made to him in May, 2004. This was also taken up with a few consumers’for a who also did not care to act!
Thus, while the Drug Controller’s office never bothered, the company also kept following its own business model as usual! What then can be expected of this committee?
It is thus no use blaming the drug manufacturers who will show thousands of reasons for their packaging and pricing strategies. But is the govt. really concerned?
May I refer to a very brilliant analysis in the Sakaal Times: http://epaper.sakaaltimes.com/SakaalTime... to all your readers in this context?