The Central Drug Standards Control Organization (CDSCO) has started deputing drug inspectors as observers to carry out joint inspections on an event of inspection from an international regulator. The exercise done in coordination with state drug regulators is meant to monitor manufacturing plants on GMPs and equip drug inspectors on enforcing its compliance across the country. Following which, around 80 drug inspectors have been recruited at the CDSCO in the past one year.
A total of additional 1195 posts have been sanctioned for the upgradation of manpower and labs under the 12th five year plan. Central Government has allocated Rs. 900 crore for enhancing manpower and capacities of minilabs at port offices and mobile labs at CDSCO level.
Informs Dr K Bangarurajan, deputy drugs controller, DDC(I), CDSCO, "We expect to double the manpower and enhance the lab infrastructure both at the centre and states by the end of 2017. CDSCO has also conducted 17 training programmes to train drug inspectors on carrying out GMP inspections in the year 2013-14 to ensure quality of drugs supplied to over 200 countries from India." Talking about the increasing global requirement for evolving regulatory compliance in regulated and unregulated markets, he stressed on the need for uniformity of GMP inspections for supplying quality drugs globally.
"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. Similar kind of inspections have also been carried from India to other importing countries for the sake of ensuring quality and consistency. Countries globally are concerned about safe and efficacious medicines to be supplied for the sake of patient safety," he added.
He further said that US FDA's workshops on GMP and CGMP compliance for the first time in four cities of India in partnership with Central Drugs Standard Control Organisation (CDSCO) earlier this year has been well received as over 60 pharma companies participated in the workshop.
The US FDA CDSCO workshops held in Hyderabad, Goa, Chandigarh and Ahmedabad four months ago covered relevant topics for USFDA regulatory requirements like process validation, enforcements and computer system validation based on specific information.
Considering the fact that certain Indian companies have got critical global attention due to certain evasions, violations and avoidances during international inspections, compliance is required for development of closed systems which captures electronic signatures, audit trials and any changes made in the system or content and also simultaneously offer, track, record and report at the same time. This is in accordance to 21 CFR Chapter 11 compliance of US FDA guidelines.