India’s Regulator Talks Improvements
India’s drug regulator has struggled with criticism from inside and outside the country in recent years, but the agency wants the public to know it is taking steps to improve its performance.
CDSCO’s Efforts
In a post to its website today, the Central Drugs Standard Control Organization (CDSCO) lists nine areas it has worked on during the previous month.
To combat the present outbreak of H1N1, also known as swine flu, CDSCO has taken measures to make sure drugs used to treat the virus are readily available. The agency says it has worked with companies to guarantee the supply of vaccines and diagnostics and has made exemptions to import restrictions for certain vaccines to increase supply. The agency has also requested that regional drug offices monitor the availability of drugs used to treat H1N1 on a daily basis.
CDSCO is also looking to modernize certain systems, and says it is developing an electronic clinical trial application and monitoring system. The agency also says an e-governance system to host electronic marketing authorization applications is being developed by the Centre for Development of Advanced Computing.
Internal Measures
Some of CDSCO’s efforts to improve accountability have been focused inward. The agency says it will be part of the pilot for a new human resource management system being developed by the Department of Personnel and Training.
A proposed amendment to India’s Drugs and Cosmetics Act could bring medical devices in CDSCO’s domain. To prepare for the possibility, the agency held a five-day workshop on medical device regulations for 48 of its staff.
India’s Drug Controller General Dr. G.N. Singh promises 2015 will be a year of change for CDSCO. In a message to the agency, Singh says the focus for the year will be on “streamlining regulatory procedures without compromising patient safety.”