New Delhi: A Parliamentary panel today dubbed as "skewed" the priorities and perceptions of the Central Drugs Standard Control Organisation and held them responsible for most ills besetting the drugs regulation in the country.
Slamming the Drugs Control Organisation (CDSCO) for failing to serve the interests of the consumer, the Parliamentary Committee on Health and Family Welfare held that it was taking care of the drugs industry instead.
"The Committee is of the firm opinion that most of the ills besetting the system of drugs regulation in India are mainly due to the skewed priorities and perceptions of CDSCO.
"For decades together, it has been according primacy to the propagation and facilitation of the drugs industry, due to which, unfortunately, the interest of the biggest stakeholder i.e. The consumer has never been ensured.
"Taking strong exception to the continued neglect of the poor and hapless patient, the Committee recommends that the Mission Statement of CDSCO be formulated forthwith to convey in very unambiguous terms that the organisation is solely meant for public health," the Committee held.
The panel also raised strong objections to the qualifications and powers of the Drugs Controller General of India (DCGI) and asked the government to take immediate measures to esnure that the CDSCO is headed by an eminent and professionally qualified person.
With rapid progress in pharmaceutical industry, the Committee held "there is urgent need to revise the qualifications and experience as minimum eligibility criteria for appointment as DCGI".
"The Committee is of the view that it is not very rational to give powers to a graduate in pharmacy who does not have any clinical or research experience to decide the kinds of drugs that can be prescribed by super specialists in clinical medicine such as those holding DM and PhD qualifications and vast experience in the practice of medicine and even research," the panel said.
The Parliamentary Standing Committee on Health on the functioning of the CDSCO expressed concern over alleged collusion between drug manufacturers and CDSCO functionaries.
"There is sufficient evidence on record to conclude that there is collusive nexus between drug manufacturers, some functionaries of CDSCO and some medical experts," it held.
It also raised concerns over safety of patients, fair play, transparency and accountability during clinical trials of drugs and sought expert opinions on new drugs be made public.
It noted with concern that 33 new drugs were approved between January 2008 and October 2010 without conducting clinical trials on Indian patients. "There is no scientific evidence to show that these 33 drugs are really effective and safe in Indian patients."
The panel also recommended that while approving Phase III clinical trials, the DCGI should ensure that such trials are spread across the country to cover patients from major ethnic backgrounds and increase the number of subjects for trials.
Inadequacies and shortage of manpower in CDSCO were also pointed out by the panel, which resulted in shortcomings in respect of coordination with and between states as also implementation of applicable legislations in states.
The panel asked the Ministry of Health and Family Welfare to work out a fully centrally-sponsored scheme for developing infrastructure and increase in manpower so that the State Drug Regulatory authorities do not continue to suffer.
The Committee also expressed grave concern over serious shortcomings in the Centre-State coordination in implementation of Drugs and Cosmetics Act and asked for its uniform implementation in all states. It also sought strengthening of both central and state drug testing laboratories.
It recommended that the Health Ministry takes the initiative to address the shortcomings in coordination with Civil Aviation ministry at all seaports/airports handling import and export of pharmaceutical products.