Regulation of psychotropic fixed dose combination drugs in India: a retrospective longitudinal study (Regulation of psychotropic FDCs in India)

Study identification

• EU PAS number:
  EUPAS45738
• Study ID:
  46707
• Official title and acronym:
  Regulation of psychotropic fixed dose combination drugs in India: a retrospective longitudinal study (Regulation of psychotropic FDCs in India)
• DARWIN EU® study:
  No
• Study countries:
  India

  United Kingdom
• Study description:
  Fixed dose combination (FDC) products contain two or more drugs. Few clinical studies have considered the use of FDCs in psychiatry. FDCs containing psychotropic drugs, including combinations not approved by the Indian central regulator, are widely available in India. The Indian government has been attempting to ban the sale of FDCs lacking central approval since 2007. This study aims to assess the impact of the efforts to regulate psychotropic FDC sales.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Newcastle University

Population Health Sciences Institute

Public Health Foundation of India Delhi, India, The William Harvey Research Institute, Queen Mary University of London London, UK

Study timelines

Date when funding contract was signed

Planned:11/02/2022

Actual:11/02/2022

Study start date

Planned:07/02/2022

Actual:07/02/2022

Data analysis start date

Planned:21/02/2022

Date of final study report

Planned:31/08/2022

Sources of funding

Other

More details on funding

No funding

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable