With the Indian pharma industry facing huge shortage of skilled human resources, the regulator, Drug Controller-General of India (DCGI) has made it compulsory for all employees of drug manufacturing firms to get a certificate from the Government’s life Sciences Skill Development Council (lSSSDC) by January 1, 2018.
Those without certificate or proper qualification will not be allowed to join the industry, the DCGI has made it clear in its notification, “Upgradation of skill sets of persons employed in pharma manufacturing units” which was issued by DCGI, GN Singh recently.
This is the first of its kind government initiative aimed to provide quality services in the rapidly growing USD 30 billion pharmaceutical industry in the country. The move has also come in the background of some domestic pharma companies facing problems abroad such as the US and other regulatory markets due to product quality, poor manufacturing facilities and improper documentation.
“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,” says the notification.
It adds, “...and with effect from 1st January 2018, no person shall be employed in any pharmaceuticals/biopharmaceutical manufacturing units unless he has obtained a formal diploma or degree in the relevant area, or has been certified by the lSSSDC or equivalent organisation in the area in which he has been deployed.”
The DCGI has asked all the pharma manufacturing units in the country to take steps for ensuring that persons employed by them are duly trained and certified. A senior official in the Union Health Ministry, which oversees the working of the DCGI said that the pharmaceutical sector is poised to contribute significantly to India's GDP growth in the coming years. Hence, it is must for the Government to create a strong foundation of highly skilled resources to effectively meet quality standards to support the industry growth.
Welcoming the move, Sachin Choudhary, a pharmaceutical expert said in his blog that 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.