Emerging Markets Regulatory Tracker: India Plans Regulatory Overhaul
This article was originally published in PharmAsia News
Executive Summary
India’s health ministry has laid out basic steps towards an overhaul of drug regulation at the local level, identifying a number of areas of concern.
For the previous article in the series, see: (Also see "Emerging Markets Regulatory Tracker: China Self-Audit Results Released" - Scrip, 14 Sep, 2015.).
India Issues MOU For Drug Regulatory Reform
India’s Ministry of Health has established a Memorandum of Understanding (MOU
) with state governments designed to strengthen the regulation of drugs at the local level through subsidies provided by the central government.
The preamble to the MOU underscores the importance of the pharmaceutical sector to India’s economy, and identifies the following six concerns about drug regulation at the local level:
- Inadequate or weak drug control infrastructure at the State level
- Inadequate drug testing facilities
- Non-uniformity of enforcement of law and rules
- Lack of training to regulatory officials
- Lack of database
- Inadequate IT services.
The MOU took effect on Sept.1, 2015 and will remain in force until March 31, 2018.
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