The Union health ministry has recently recruited around 31 assistant drug inspectors at Central Drugs Standard Control Organisation (CDSCO) and sanctioned another 470 technical staff posts as a part of manpower upgradation programme. An amount of Rs. 1,750 crore has already been sanctioned for upgradation of manpower at the CDSCO and state level. As a part of the plan, drug testing infrastructure in the country will also be upgraded.
According to a senior CDSCO official, ” Around 80 drug inspectors were recruited at the CDSCO last year as a part of the process.” While State drug control departments have been allocated Rs. 850 crore, CDSCO has been allocated Rs. 900 crore for enhancing manpower and capacities of minilabs at port offices and mobile labs. A total of additional 1195 posts were sanctioned for the upgradation of manpower and labs under the 12th Five Year Plan, as per official sources.
In order to monitor manufacturing plants on GMPs and equip drug inspectors on enforcing its compliance across the country, CDSCO had also started the exercise of deputing drug inspectors as observers to carry out joint inspections in an event of inspection from an international regulator.
An official said that the manpower is expected to double both at the centre and states by the end of 2017. Talking about the increasing global requirement for evolving regulatory compliance in regulated and unregulated markets, deputing drug inspectors as observers through joint inspections has been able to help augment our knowledge on continuing good manufacturing practices. It will also be helpful for manufacturers in adopting global practices followed in other countries where our medicines are consumed.
A total of 100 drug inspectors with equal representation from CDSCO and state drug regulatory bodies from across the country are also participating in workshops on GMP and data integrity to be held in Bengaluru and Ahmedabad between November 16 and 19, 2015. Workshops on GMP and cGMP compliance conducted by CDSCO and US FDA’s jointly for the first time in four cities of India last year in May was well received as over 60 pharma companies participated in the workshop.
The US FDA CDSCO workshops were held in Hyderabad, Goa, Chandigarh and Ahmedabad covered relevant topics for regulatory requirements like process validation, enforcements and computer system validation based on specific information.