Clinical research in India has gone through Dickensian times in the past two years. Alishan Naqvee, Partner and Abhijeet Das, Associate, LexCounsel opine that if 2015 sees the resolution of the Swasthya Adhikar Manch PIL, it could lend some stability to the clinical research scenario in the country as well as allow regulators to address other areas of oversight in the modified regulations
The past two years have been difficult for clinical research in India, akin to the grim dreams out of the pages of Dickens. With introduction of regulations with no parallels in the world, the stakeholders have been left baffled in their attempts to come to terms with this new regime. The genesis of the transformation can be traced to the sub judice (since early 2012) proceedings of ‘Swasthya Adhikar Manch, Indore & Anr. vs. Union of India & Ors.’ (Swasthya Adhikar Manch Case).
In the aforementioned proceedings the petitioners (including Swasthya Adhikar Manch, Indore) have alleged glaring and shocking irregularities in the whole process and administration of clinical research in India. While going into the details of the peti