In a bid to emphasise on the quality of the product as well as the process, the Drug Controller General of India (DCGI) has kicked off a “risk-based inspection” of pharma companies in the country with its inspectors assessing the compliance of manufacturing facilities with the specified good manufacturing and laboratory practices.
However, shortage of drug inspectors remains a challenge for the DCGI to smoothly implement the inspection.
The DCGI, under the Union Health Ministry, has recently released a voluminous new draft checklist and evaluation tool for pharmaceutical inspectors of manufacturing sites in the country and has already undertaken assessment in over 36 pharma companies including the MNCs so far.
This year, the DCGI’s target is to inspect at least 200 drug companies, said a senior official from the Ministry. There are over 10,000 drug manufacturers in the country and the Government wants them to voluntary risk assess their practices and correct the gaps.
The official said that till now the emphasis was on product quality but the checklist aims to cover process of manufacturing also.
Among the items on the checklist are questions on the location and surroundings, building and premises, water and waste system and other pertinent details on warehousing, production, quality control and manufacturing operations and controls.
“The inspections will assess the compliance of manufacturing facilities with the specified GMP (god manufacturing practices) and GlP (good laboratory practices) requirements and also seek to harmonise the procedures for conduct of inspections throughout the country, identify gaps in such compliance and communicate the same to the manufacturers,” the drug controller GN Singh said in a public notice released last week. He further said the DCGI will take suggestions and amend the checklist and tool after stakeholders weigh in.