Over the past year India has begun to face up to the reality that its regulatory machinery is insufficient to enforce quality standards, leading authorities to commit to hiring more inspectors. Another piece of the plan has been unveiled, with the Central Drug Standard Control Organization (CDSCO) revealing Indian inspectors are tagging along on inspections run by their international peers.
CDSCO plans to double its headcount and add laboratory capacity by the end of 2017, but there is little benefit to having 1,000 inspectors unless they know how to assess if a plant is following good manufacturing practices. In the last financial year CDSCO ran 17 training programs for inspectors, Pharmabiz reports, and has worked with the FDA on four GMP workshops on topics including process validation and enforcements. To support these efforts, CDSCO is sending its inspectors into the field with their global peers.
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| Dr. K. Bangarurajan |
"The practice of deputing drug inspectors as observers through joint inspections has been able to help draw suggestions and feedback from our global regulatory counterparts on continuing good manufacturing practices. It will help manufacturers in adopting global practices followed in other countries where our medicines are consumed," Dr. K. Bangarurajan, deputy drugs controller at CDSCO, said.
Having 1,000 inspectors working in India to international GMP standards could have a major effect on the global regulatory community's ability to spot manufacturing problems, but such a scenario is still a distant prospect. CDSCO said it has hired 80 inspectors over the past year, but much more work on growing and training the workforce lies ahead.
- read Pharmabiz's article