|
The Gujarat Food and Drug Control Administration (FDCA) is planning to conduct surprise inspections on units which are non-compliant out of around 4000 schedule M units in the state based on the good manufacturing practices (GMP) guidelines.
The inspections would be based on the assessment of critical units as per GMP criteria and analysis done through a specialised software. Even the drug inspectors will be delegated the job of inspections randomly to come out with unbiased reporting of the manufacturing units.
GMP is based on a criteria involving factors such as sanitation and hygiene, qualification and validation, self-inspection, quality audits, suppliers’ audits, prevention of cross-contamination and bacterial contamination during production, training employees and personnel.
Four GMP compliance reports were issued to Indian companies in 2015 compared to an average of around eight in 2011 to 2014. Thirty per cent of quality related warning letters and less than five per cent drug recalls have also been attributed to Indian companies, according to official sources.
Says Gujarat FDCA Commissioner Dr H G Koshia, “This comes at time when the state has also witnessed grant of 160 new licenses to pharmaceutical companies for investments into direct manufacturing and contract manufacturing. Gujarat government has recently revised its timeline for grant of manufacturing licenses to 60 days from the earlier stipulated timeline of 120 days.”
The state regulator recently approved layout designs of 160 pharmaceutical companies including the major ones being of American medical technology provider Abbott, Israel based Teva, Japanese company Otsuka Pharmaceutical and Baxter among others. The manufacturing units include APIs, formulations and medical device units.
Gujarat has witnessed an upswing in foreign and domestic players taking interest in setting up manufacturing bases in the country and accelerate Make in India. A favourable policy on bulk drugs and medical devices is also awaited as the Centre is mulling over to frame an exclusive policy on the same.
|