Going by its plan and mandate to recruit 500 more drug inspectors to double the manpower by the end of 2017, the Central Drug Standards Control Organization (CDSCO) has concluded the modalities of hiring 147 drug inspectors to enhance inspections of manufacturing units in line with current Good Manufacturing Practices (cGMP).
A total of additional 1,195 posts were sanctioned for the upgradation of manpower and labs under the 12th five year plan. Central government has also allocated Rs. 900 crore for enhancing manpower and capacities of minilabs at port offices and mobile labs at CDSCO level.
To ensure quality of drugs supplied to over 200 countries from India, CDSCO is also 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 last two years.
CDSCO had in the past 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 was 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 2014.
Talking about the increasing global requirement for evolving regulatory compliance in regulated and unregulated markets, an official stressed on the need for uniformity of GMP inspections for supplying quality drugs globally. Countries globally are concerned about safety and efficacy of medicines to be supplied for the sake of patient safety. The practice of deputing drug inspectors as observers through joint inspections has been able to help draw suggestions from global regulatory counterparts on continuing good manufacturing practices.
The Union health ministry is also planning to frame and release a draft guideline towards constant upgradation of good manufacturing practices (GMP) to align India-specific standards with global regulations.
Meanwhile, the Drug Controller General of India (DCGI) has submitted a proposal to the Union health ministry to mandate upgradation of Schedule M units across the country to WHO-GMP level under the purview of drug rules towards good manufacturing practices adopted globally.
CDSCO also plans to bring about uniformity in inspections of Schedule M units across the country as a part of its programme to upgrade Schedule M units to WHO-GMP standards.
For the last two years, Indian Drug Manufacturers Association (IDMA) and Department of Pharmaceuticals (DoP) have jointly held a series of workshops for small and medium companies aimed at imparting technical skills and improving regulatory and quality standards of manufacturers. After successfully organising a workshop series themed 'GMP workshops for SMEs – schedule M and beyond' last year, this year the focus is on meeting quality challenges and achieving global compliance.