In a statement issued here on Wednesday, the activists asked the Ministry to immediately put into action the remedial steps, as suggested in the report, and order an investigation by the Central Bureau of Investigation into the alleged connivance between doctors and pharma companies.
The activists strongly opposed the government’s decision to constitute a committee to look into the matter. Some of the proposed members have been named as condoning research-related violations — and thus have major conflicts of interest in this concern.
Further, this step once again centralised the regulatory authority, which the Parliamentary Standing Committee report had criticised in detail. The findings of the committee must be acted upon, not relegated to yet another committee of people uncomfortably close to the regulatory system under scrutiny, the statement said.
“We demand that any further investigation involve a wider representation from civil society. The Central Bureau of Investigation must follow up the committee’s findings with an investigation, and take action against those individuals and organisations — health professionals as well as regulatory officials and pharmaceutical companies — found guilty of violating the law and exposing people to harm. The action taken on this report must be made public,” the statement said.
The 59th report on the functioning of the CDSCO had “unanimously provided authoritative, clear and detailed evidence of a severely flawed system of medicine regulation in the country, whose ‘stated’ mandate is evidently to meet the aspiration, demands and requirements of the pharmaceutical industry.”
The committee’s findings are wide-ranging: severe shortage of qualified staff and resources; poor data collection and its maintenance; grossly insufficient monitoring of industry compliance to regulatory requirements; incomplete, missing or ‘untraceable’ files; flaws in the Drugs and Cosmetics Act and the Drugs and Magic Remedies Act and their implementation; bypassing of regulatory requirements in the interests of industry, including granting marketing approval to dozens of medicines without the mandatory phase 3 clinical trials in the guise of “the public interest”; approval of dangerous and irrational medicines, improper and unethical testing practices; nexus between regulators, medical experts and industry.
The signatories to the statement are: Jan Swasthya Abhiyan, Sama Resource Group for Women and Health, LOCOST Therapeutics, Prayas — Chittorgarh, Delhi Science Forum, Drug Action Forum, Centre for Trade & Development, All India People’s Science Network, The Ant (The Action Northeast Trust), Indian Journal of Medical Ethics, Indian Journal of Medical Ethics and Trustee, Anusandhan Trust, SAHAJ, Healing Fields Foundation and several scientists, researchers and professors.