(Weekly Organ of the Communist Party of India (Marxist)
August 31 , 2008
CPI(M) Asks Govt To Tighten Procedures For Clinical Trials
THE CPI(M) has demanded from the UPA government to tighten the procedures for allowing conduct of clinical trials by MNC pharma companies on our people. This demand was made in the wake of reports about deaths of 49 infants in the AIIMS clinical trials since 2006.
In a letter written to union minister of health and family welfare Dr Anbumani Ramadoss, CPI(M) Polit Bureau member and MP Brinda Karat expressed shock over these deaths in AIIMS and felt that the inquiry ordered by the ministry was inadequate and skirted the main issue of liberalization of procedures for granting permission for the conduct of clinical trials. “This is putting at risk the lives and health of Indian citizens. You will recall that I have been repeatedly raising the issue in parliament of the use of poor Indian citizens as guinea pigs, by multinational pharma companies. I regret that the concerns I had expressed and which the government has been ignoring have been proved to be valid by the tragic loss of lives of babies in the AIIMS trials.
Brinda Karat reiterated the three issues she has been raising in this regard, (1) the liberalisation of Schedule Y of the Drugs and Cosmetics Act regarding the removal of the protective time-lag between the tests of foreign drugs in countries of their origin and India in Phase 3 trials. As a result of giving permission to pharma companies to make these trials “concurrent” the risks to Indian citizens increase. It is precisely for these phase 3 trials which have a much larger sample that India is now the favoured destination for trials by MNCs because it costs 60 per cent less than in their own countries where subject protection laws are much more stringent (2) There is no mandatory insurance or compensation for the subjects (3) The concept of “informed consent” is a mockery in India where the large majority of subjects are from poor families, most of whom have had no access to literacy and are therefore unable to give “informed” consent. More likely the consent is driven by vulnerability due to poverty or sometimes because they believe it is conditional for the treatment for which they went to the hospital in the first place. It is learnt that a new draft for 0 phase and Phase 1 trials are also in circulation which will give additional benefits to foreign pharma companies to conduct trials in India for foreign drugs, she stated.
She criticised the callous approach of the government on this issue, which was exemplified by the tax concessions given in Budget 2007 to MNCs to conduct clinical trials in India which was claimed to be a big incentive for another area of “outsourcing”. “I believe it is a matter of shame not pride that India is the favoured destination of MNCs to conduct trials on our citizens of foreign drugs most of which can never be used by our citizens because of the prohibitive prices at which these drugs are ultimately sold.
Karat requested the minister to reconsider the issues raised by her. She felt that the liberalised schedules and protocols, lack of mandatory insurance and compensation, as well as the poor implementation are triggers that create the tragedies as seen in AIIMS.