- Indian regulator to approve in a timely manner generics and biosimilars to cure, vaccines to prevent, diagnostics to identify early. Clinical trials are necessary to be conducted in India for pharma and biotech industry to bring to Indian and global market these medicines, vaccines and diagnostics. Last three years, the sector has been paralysed in the name of safety of participants in clinical trials. While maintaining all measures to ensure global standards of participant safety, remove all hurdles for clinical research which are not in line with global practice. AIIMS-Harvard University recommendations to be adopted within 90 days.
- Empower Drug Controller General (India) (DCGI) by making the position an independent regulator of the level of Secretary to Central Govt. Amend Drugs & Cosmetics Act to the effect. Like DBT has done, attract highly qualified persons and offer sensible terms and conditions.
- Responsible medical research requires MD’s Super Specialists who have deep understanding of disease and treatment. Double the capacity of PG seats in all Government Medical, pharmacy and biotech institutions to have double the number of MD, M Pharm, PhD’s to become available within five years. Overcome clinical investigator shortage. MCI and UGC have come in the way of capacity creation in the last decade and prevent repetition of this mistake.
- Invest in public health. Disease prevention will get a big boost if solid waste removal is brought to global standards to improve sanitation. Adopt Surat experiment.
- Globally pharma industry is transforming from a chemical industry to a biologics industry. Incentivise Indian pharma to transform and build a significant biologics portfolio.
These are ACRO’s top five recommendations for clinical research.
– DA Prasanna, Chairman, Association of Clinical Research Organizations