Even as a comprehensive amendment to the Drugs and Cosmetics Act is awaited with a separate chapter on the rules to streamline the clinical trials sector, the industry is reportedly facing increased heat due to the new guidelines and requirements already imposed by the Central Drugs Standard Control Organisation (CDSCO).

Apart from mounting criticism on the new guidelines and resultant slow-down in the approvals, many have reportedly suspended enrollment of participants too. Union Health Ministry has confirmed that the National Institutes of Health (NIH) under the US Government raised concerns about how these new requirements will be implemented, particularly the specific provision related to compensation.

“NIH has suspended enrollment of participants in 35 interventional trials in India,” Union Health Minister Ghulam Nabi Azad informed the Parliament recently. But he went on to claim that it would not affect the country’s health programmes and domestic pharma industry.

It was being pointed out that many foreign private companies have also stopped trials in India after the new guidelines, especially on the compensation part, were issued and claimed that such provisions could lead to unreasonable claims by subject-patients.

There were already wide-spread concerns about the new guidelines which reportedly affected the approval process of trials in the country. Indian Society for Clinical Research (ISCR), an association of clinical trials professionals, had pointed out this recently.

In order to strengthen the regulatory provisions and the monitoring mechanism of clinical trials in the country, Drugs and Cosmetics Rules, 1945 have been amended through three notifications this year. One amendment laid down procedures to analyse the reports of Serious Adverse Events occurring during clinical trials and procedures for payment of compensation in case of trial related injury or death as per prescribed timelines. Another one was made on various conditions for conduct of clinical trials, authority for conducting clinical trial inspections and actions in case of non-compliance. Government also made mandatory the registration of ethics committees, through another amendment.

Following concerns by the industry, the DTAB has already suggested some changes to the guidelines to relax the norms on compensation in the case of injury or death during the clinical trials. The timeline for reporting the serious adverse events also will be modified in line with the international practices. This was done in accordance with the recommendations by a technical committee set up by the Ministry of Health and in the wake of apprehensions raised by different stakeholders.