Clinical trials lawyer Gene Matthews has welcomed a push from the Federal Drug Agency (FDA) to promote safety and quality in clinical trials that are carried out in India.
The blog describes the programme of engagement that the FDA is carrying out to promote the safety and efficacy of imported drugs.
The programme includes inspections, targeted engagements including training, and the collection and use of data to inform decision-making by the FDA.
A trip by FDA personnel in May 2017 was taken to participate in a joint training workshop for Indian regulators, academic representatives and the drug industry on scientific and ethical standards for clinical trials. Representative from the FDA, the European Medicines Agency (EMA), the Indian Central Drugs Standard Control Organization, and the Drug Information Association were all involved.
While recent changes in the regulation of clinical trials in India seems to have led to a decline in the number of registered drug clinical trials between 2010 and 2015, there has been a sharp increase in the number of bioavailability or bioequivalence studies taking place in the country.
The collaborative workshop looked at:
- Identifying general concepts in inspections of clinical investigators, clinical trial sites, ethics committees, and bioanalytical study sites;
- Identifying techniques for maintaining data integrity in clinical trials; and
- Reviewing inspections to develop evidence and determining appropriate observations to include in inspection reports.
“I welcome moves by the FDA and the EMA to support the clinical trials regime in India. Greater harmonisation of standards by different regulatory authorities around the world should result in greater levels of protection for those participating in clinical trials. After all, that will help to ensure that Good Clinical Practice (GCP), the international ethical, scientific and practical standard to which all clinical research is conducted, is properly adhered to around the world.
"It is critically important that drug trials conducted in Mumbai (or anywhere else in India) are equally as safe as those conducted in Minneapolis or Manchester.”
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