The initiative by India's Central Drugs Standards Control Organization (CDSCO) seeks to upgrade the skills of employees working in pharmaceutical and biologic manufacturing in order to bring "substantial improvement in the quality of pharmaceutical products."
The Drug Controller General of India - Dr. G N Singh - has set a deadline of January 1, 2018, for all personnel in companies to complete the certification process, according to a notice posted on the CDSCO website.
"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," says Dr. Singh.
cGMP deviations
The move comes at a time when India's pharma industry has seen a number of disruptions as a result of regulatory actions for deviations from Good Manufacturing Practice (GMP), including warning letters, product recalls and bans on the import of drugs into the US.
The actions affected facilities making both finished dosage forms and active pharmaceutical ingredients (APIs), which were held up for deficiencies such as compromised sterility, data integrity failings and inadequate cleaning, testing and complaint handling, amongst others.
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 Wockhardt, Dr. Reddy's Laboratories, Cadila Healthcare and IPCA Laboratories have also been in the spotlight for quality failings since the start of 2015.
Growth slowdown
India is a massively important player in the international trade in pharmaceuticals, manufacturing around 30 to 40 per cent of the generic medicines prescribed in the US market. Latterly has seen a slowdown in growth, according to figures released last year by the Pharmaceutical Export Council of India (Pharmexcil).
Negative news flow has undermined the credibility of the sector and the Indian government has been trying to restore confidence. The certification scheme comes on the back of other initiatives such as the introduction of a traceability system for exported medicines.
Meanwhile, India's leading pharma companies recently set up a quality forum to tackle what has been described as an "ingrained cultural issue" that is leading to quality issues.