With a view to further streamlining clinical trials and minimizing the irregularities in the sector, some States have suggested restricting the trials only to the Government-run hospitals in the country.
However, the general opinion among the States was that restricting the trials to government hospitals would not be a solution and instead the Government should create a 'robust system for regulating the conduct of trials,' it is learnt.
The suggestion came up during a meeting of the Chief Secretaries, Health Secretaries of the State Governments and the Administrators of the Union Territories, convened by the Union Health Ministry some time back, as per the directions by the Supreme Court to consider the views of all the States.
Sources said diverse issues were deliberated at the meeting and all States gave their view points.
The views expressed by the States of Madhya Pradesh, Rajasthan, West Bengal, Punjab, Andhra Pradesh, Karnataka and Gujarat were particularly noted.
Even though the concerns have been raised about the conduct of clinical trials in the country, clinical trials are necessary for the development of new drugs in the country. India has the capacity and knowhow for drug discovery research. However, there should be a robust system for conducting clinical trials in the country to ensure that trials are conducted in a scientific and ethical manner and in compliance to the regulatory provisions, the meeting felt.
One of the concerns raised by many States was the money part in trials which can act as the inducement to the investigator for conducting trials. “Sometimes such inducement may lead to bias in enrollment of subjects in the trials,” the meeting reportedly pointed out.
The States also pointed out some concerns about certain clauses of the amendment of Drugs & Cosmetics Rules made on 30.1.2013 regarding compensation in clinical trials. Some amendments in these clauses may be required, they said.
The Union Health Ministry assured the States that their views would be considered for further strengthening the regulation of the clinical trials. The meeting was held after the Supreme Court, which is hearing a petition on clinical trials filed by the NGOs, asked the Centre to consult the States and take note of their views on the matter.