The central drug regulator, along with various state drug regulators, have carried out inspections at 76 pharmaceutical manufacturing units in last six months as per the new “risk-based inspection criteria”, which was issued in May this year.
While the probe reports, which points out various deficiencies at these manufacturing facilities, have been shared with respective pharmaceutical companies, the regulators have already planned a re-inspection of these units from January next year to check what improvements have they done.
“While no feedback has so far been received from the state regulators about the action taken to rectify deficiencies, it is planned to carry out follow up inspections by different teams to gauge the extent of improvements made by the manufacturers. The process will begin in the month of January, 2017. The details of the programme will be sent to the individual (manufacturing) units in due course of time. Accordingly, all units are requested to ensure that the deficiencies noticed may be removed at the earliest possible,” said G N Singh, Drug Controller General of India (DCGI), in a notice dated November 9, 2016.
In May this year, the Central Drug Control Standard Organisation (CDSCO), which is headed by DCGI, had issued a new risk-based evaluation criteria so as to “improve the quality of medicines manufactured in the country and ensure their safety and efficacy”. All 76 inspections were carried out jointly by the officials of CDSCO and respective state drug regulators. While the first round was done on the basis of evaluation criteria issued in May, the CDSCO had then said that it is open to suggestions from various “stakeholders” to upgrade its evaluation criteria for second and subsequent round of such inspections.