- India’s government has launched a certification programme aimed at tightening up quality standards in its domestic drug industry.
- Drug manufacture have comply their manufacturing facility for GMP/GLP
- Pharma employee must be certified and trained for the area they are deployed
To increase the quality of all products manufactured by India’s $ 30 billion pharmaceutical industry, the regulator DCGI has made it compulsory for all employees in pharma manufacturing facilities to get a skill certification.
In first of its kind government directive, the Drug Controller General of India(DCGI) has made it compulsory for all employees in pharmaceutical manufacturing units to get a skill upgradation certificate from the government’s Life Sciences Skill Development Council (LSDDC) from 1st January 2018.
The notification, called “Upgradation of skill sets of persons employed in pharma manufacturing units” was issued by DCGI, Dr G N Singh on 28th August 2016. The notification is available with ABLE. Biotech manufacturing units are also covered under the pharma industry classification.
“Keeping in view the objective of bringing substantial improvement in the quality of pharmaceutical products, it has become imperative that all personnel employed in pharmaceutical manufacturing units shall undergo the certification programmes developed by LSSDC,” the notification said, adding “and with effect from 1st January 2018.”
The DCGI notification said: “All pharma manufacturing units in the country, are accordingly requested to take steps for ensuring that persons employed by them are duly trained and certified.” This notice is posted on CDSO website.
According to the government, the objective of the certification is to enhance the skills of the workforce engaged in pharmaceutical and biotechnology industry and enable organizations to effectively meet quality standards.
The government had earlier entrusted the work relating to development of qualification pakcs (National Occupational Standards) to the Life Sciences Skill Development Council to upgrade the skills of persons employed in the life sciences sector.
LSSDC evolved the following modes for certification:
1. Post fresh skilling and assessment of eligible youth; and
2. Post assessment under “Recognition of Prior Learning (RPL)’ for existing workforce in the industry
From last few years Indian pharmaceutical products are facing problem US and other regulatory markets due to product quality, improper documentation and data integrity.
Most recently Pfizer was forced to halt production at Hospira plant in Chennai that drew fire from regulators in the US and Europe, while facilities run by Wochardt, Dr, Reddy’s Laboratories, IPCA Laboratories and Cadila Healthcare have also been in the spotlight for quality failings since the start of 2015.
CDSCO also ordered the companies to do their self assessment for the compliance of the good manufacturing practices ﴾cGMP﴿ and good laboratory practices ﴾GLP﴿. They have provided a compliance checklist to perform the GMP/GLP evaluation. Checklist is prepared to fulfil the GMP requirements of Schedule M, Schedule L‐1, WHO and PIC/s standards. GMP/GLP checklist must be complied, filled and submitted to office of DCGI by November 15, 2016 by all drug manufacturers as per the notice.