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To ensure quality of drugs supplied to over 200 countries from India, Central Drug Standards Control Organization (CDSCO) is in the process of training its drug inspectors on Good Manufacturing Practices (GMP) and risk based assessment. Around 5 such training programmes have already concluded in the past one year, according to a senior CDSCO official.
CDSCO had conducted 17 training programmes to train drug inspectors on carrying out GMP inspections in the year 2013-14.
This comes at a time when 7 drug companies in India with substantial exposure to the US market, have also disclosed over the last few weeks that some of their manufacturing facility inspections had reached successful closure, signaling resumption of supplies and new product filings to the US.
In line with the training imparted to US FDA inspectors through a collaboration with US-based global safety consulting and certification company Underwriters Laboratories (UL), The Gujarat Food and Drug Control Authority (FDCA) has also recently shortlisted 50 drug control officers to help get them training on GMP for medical devices and drugs. Training also includes Good Distribution Practices (GDP) and Good Laboratory Practices (GLP).
Gujarat FDCA has already trained 45 drug inspectors on 22 online courses through this initiative based on an MoU signed with UL during Vibrant Gujarat Summit in January, 2015. UL EduNeering, the compliance education and training services business division of UL, is leading this initiative.
Other state drug controllers have also shown interest to roll out the same training programme that has been extended to Gujarat FDCA.
It is learnt that US FDA's workshops on GMP and CGMP compliance for the first time in four cities of India in partnership with CDSCO in 2015 was well received as over 60 pharma companies participated in the workshop. The US FDA-CDSCO workshops held in Hyderabad, Goa, Chandigarh and Ahmedabad in May 2014 covered relevant topics for US FDA regulatory requirements like process validation, enforcements and computer system validation based on specific information.
India accounts for about 40 per cent of generic and over-the-counter products and 10 per cent of finished dosages used in the US. India also has the most number of US FDA approved manufacturing facilities outside the US.
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