 "Make plant inspection reports public, Indian Pharmaceutical Alliance tells government")
The Indian Pharmaceutical Alliance (IPA) wants the central government to make plant inspection reports public to bring about transparency in the sector.
The recommendation comes in the backdrop of inspections at 76 manufacturing units carried out by Central Drug Standard Control Organisation (CDSCO) and state drug regulators.
At present, the CDSCO does not put up inspection reports of manufacturing units on its website. " We have had a discussion with the government on the issue and we have given recommendations. We feel the inspector should not be given powers to initiate action against the plant. Evaluation of the inspection report and action should be decided by the head office in four days and the report should be put on the website. This will help bring transparency. We have suggested this measure in public interest," said IPA's secretary general D G Shah.
While domestic drug companies have come under the glare of overseas drug regulators, inspections and audits by local agencies have been far and few.
Shah said training and capacity building workshops have been carried out by drug inspectors. Recruitment too is being carried out to increase the strength of inspectors.
In May CDSCO 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."
Based on this criteria inspections were carried out at 76 drug manufacturing units. From January, the CDSCO plans to reinspect plants which were found deficient in the earlier round of inspection.