In our recent post we recorded Andrew Jack’s report that the European Medicines Agency (EMA) has been blocked from releasing clinical trial data generated by AbbVie and InterMune, by the EU’s General Court, until a final ruling is given by the Court.
We now read that India’s central government has informed the Supreme Court that as many as 2,644 people died during the clinical trials of 475 new drugs on human beings in last seven years, others suffering ‘serious adverse effects’. Only 17 of the medicines were approved for marketing in India.
The Union health and family welfare ministry said that of the 57,303 enrolled subjects, 39,022 completed the clinical trials.
An NGO, Swasthya Adhikar Manch, alleged in its Public Interest Litigation claim that Indians were used as guinea pigs by foreign pharmaceutical majors for human trial of their new drugs.
The Supreme Court was about to issue an order banning all fresh clinical trials of new drugs on humans but this was averted after central government promised a stringent regime on clinical trials on the recommendations of the Parliamentary Standing Committee; this had faulted the Drugs and Cosmetics (Amendment) Bill, 2007, in a stinging report pointing out the extent of the involvement of foreign pharmaceutical multinational companies in the clinical trial of new drugs and the need for a thorough review of the existing mechanism.
On January 3, Justices R M Lodha and A R Dave of the Supreme Court pulled up Central government for its insensitivity to scores of deaths and serious adverse effects to thousands during clinical trial of new drugs and asked the health secretary to monitor implementation of the supervisory and scrutiny mechanism for ‘human experiment of new drugs’.
The ministry will introduce Drugs and Cosmetic (Amendment) Bill, 2013 in Parliament during the Budget session.