The court order comes after more than a year of wrangling and new proposals from CDSCO (Central Drugs Standards Control Organization) to beef up trial regulations, impose new standards on patient compensation, establish ethics committees to review trial proposals and other committees to inspect trial sites.
The call from the Supreme Court to convene a meeting between the various regulatory bodies comes as Vibha Dutta Makhija, counsel for the state of Madhya Pradesh, said that “no consultation with regard to the measures that are necessary for strengthening regulation of clinical trials has taken place with the State Government.”
Lalit Pai, co-founder of Cytespace Research in India, told Outsourcing-Pharma.com, “The Supreme Court wants to make sure that the CDSCO has input from the State Government Health Ministries because the new proposal requires that compliance is a joint responsibility of the [CDSCO] and states. These meetings would probably seek opinion from the state health ministries to ensure that they build infrastructure and bandwidth to ensure compliance.”
The country’s top court is calling on those who petitioned it for better trial regulations – including the National Human Rights Commission, NGOs and others that intervened – to submit suggestions to the Secretary of the Ministry of Health by mid-August. The Secretary of the Ministry of Health will then have to file a report with the court within six weeks from July 26.
Scepticism
But some experts are sceptical of the deadlines set by the top court and how these new regulations will help to speed the approval of trials and bring the country back on track to where it was two years ago.
Chinu Srinivasan of the All India Drugs Action Network told us, “I do not think the meeting with the states can take place within a month.”
An ISCR (Indian Society of Clinical Research) spokesman told us that the society is supportive of the efforts to strengthen regulations and facilitating a discussion regarding “all the facets and aspects concerning the legal framework for strengthening the regulation of clinical trials and other incidental matters.”
But the society takes issue with “the slowdown in granting approvals for clinical trials in the country which has the greatest impact on patients for many of whom clinical trial provides early access to a new treatment and for others, the last option or hope of a cure.”
John Lewis, VP of public affairs for ACRO (Association of Contract Research Organizations), also expressed even more concern when he told us last month that India is “shrouded in regulatory uncertainty, especially around the issue of compensation for serious adverse events or injuries in clinical trials.”
Regardless of what has happened in years past, some sort of consensus will be formed in the relatively near future.
"The next hearing is slated for September and the Court has asked for a time bound schedule of events to be followed," Pai added. "We understand that the Apex Committee and the DTAB [Drugs Technical Advisory Board] are meeting sometime in the next few days to move forward these steps."