Clinical trials: Health Minister feels need for balance between innovation and regulation

Noting that the industry has voiced concerns regarding regulations on clinical trials in the country, Union Health Minister Ghulam Nabi Azad said there is need to strike a balance on the issue.

'...industry feels that regulations we have made are too difficult; ...I think, what we need to do is strike a balance...,' Azad told reporters. Speaking on the sidelines after inaugurating Baxter Global Research Center at Syngene here, he said '...what we are hearing from the industry is that earlier the number of clinical trials which was taking place has dropped to half, more than half.'

'While we are happy that the new dispensation is in the interest of the country and is in the interest of the patient on whom the trials were taking place, at the same time we should also see that new innovations should come up and whole industry should not fall short of holding clinical trial...,' he said. Stating that we have done our best having gone through observations made by the Supreme Court, NGOs and Parliamentarians, Azad said, 'At the same time, we will have to accommodate the view point of the industry as well.' To a question whether any 'tinkering' was going on in the government about the same, he said 'no, not at the moment'.

Earlier Biocon Chairperson Kiram Mazumdar-Shaw said the industry hoped that the regulatory regime for clinical trials would allow innovation to proceed 'unhindered and unhampered.' Pointing out that there were 'challenging aspects to drug discovery and innovation,' she said 'The regulatory system needs both reform and reinforcement.'

The Clinical Trial issue

2013 started with the shocking news that a US-based NGO called PATH (Programme for Appropriate Technology) tested cervical cancer vaccines on tribal girls, illegally. The subsequent petition filed in the Supreme Court named various renowned companies including Glaxo Smithkline and MSD Pharmaceuticals, and alleged that they had tested two unproven HPV vaccines gardasil and cervarix on almost 24,000 tribal girls in Andhra Pradesh and Gujarat, including 44 people at the Maharaja Yeshwantrao Hospital (MYH). Of these 44, ten were males! The trials were eventually suspended, following the deaths of five girls in Andhra Pradesh, and two deaths in Gujarat in 2009-10 after being administered the said HPV vaccines.

This lead to the passing of the Drugs and Cosmetics Act 2013 that promised tobolster the country's drug regulatory system by setting up a Central Drugs Authority an overarching body to regulate the drugs and cosmetics sector that will be headed by the secretary of the health ministry. Whether this act will hold good in the new year and the years to come, is still a mystery. (Read: '436 died during clinical trials last year')

With inputs from PTI