One of the critical issues raised in the 59th report of the Parliamentary Standing Committee on Health was the issue of missing files at the CDSCO. The Committee had summoned several files pertaining to the drug approval process in India from the government. Three critical files, pertaining to the approvals of three specific drugs: pefloxacin, lomefloxacin and sparfloxacin, were however missing from the government’s records. As noted by the Standing Committee, all three drugs were controversial and had either not been approved or had been approved and withdrawn in developed countries with much better drugs regulatory systems. The exact observations of the Committee are reproduced as follows:
7.12 Out of 42 drugs picked up randomly for scrutiny, the Ministry could not provide any documents on three drugs (pefloxacin, lomefloxacin and sparfloxacin) on the grounds that files were non-traceable. All these drugs had been approved on different dates and different years creating doubt if disappearance was accidental. Strangely, all these cases also happened to be controversial drugs; one was never marketed in US, Canada, Britain, Australia and other countries with well-developed regulatory systems while the other two were discontinued later on. In India, all the three drugs are currently being sold.
Since the files were missing, the Committee was unable to examine the conditions of approval. It merely ordered the government to reconstruct the files.
For those of you familiar with the workings of government offices, the issue of missing files will not come as a particular surprise. In most cases, files go missing due to either corruption or inefficiency of the office in question. In 2011, the Trade Mark Registry had famously reported missing more than 44,000 files to the Delhi High Court. In the present case regarding the missing files at the CDSCO, the government quietly ‘reconstructed’ the files without investigating how exactly the files went missing in the first place. This is contrary to the guidelines put in place by the courts and the Central Information Commission (CIC).
Under the Public Records Act, 1993 each government office is required to maintain records in a prescribed format. Section 7 of this legislation requires the Records Officers in every department of government to take “appropriate action” in case files go missing. The Central Information Commission (CIC) which hears complaints and appeals under the Right to Information Act, 2005 had ruled in the case of Om Prakash v. Land & Building Dep. GNCTD, Delhi (CIC/DS/A/2013/001788SA) that all cases of missing files had to be thoroughly investigated and responsibility for the missing files had to be fixed on a public servant. The CIC’s judgment also cites a Delhi High Court judgment where the court held that even if the information was found through other means, responsibility had to be fixed for the missing files. If criminality, such as theft or corruption in suspected the missing files case, a FIR is required to be filed with the local police station that has the jurisdiction over the office.
In the case of these three missing files, the government never filed a FIR or conducted a criminal investigation to fix responsibility for the missing files. We filed a RTI application with the Ministry of Health to determine the status of the files and more specifically on the point of whether an investigation had been conducted into the cause that made these files go missing. The Ministry answered a couple of questions on the status of the files but transferred the main question of whether the investigation had been conducted to the CDSCO. The one line reply from the CDSCO is as follows: “No such formal complaint was conducted; however, continuous efforts were made by CDSCO to trace out these files at various locations where the old files were stored”. It reminds me of the time when the files related to allocation of coal blocks went missing and the people of India received similar responses from the government.
I had raised the issue of the missing files in the PIL to the Supreme Court; my concern is not about just these three files, but the lack of any proper mechanism within the CDSCO to maintain records. The PIL sought directions to be issued to the Comptroller & Auditor General (CAG) to conduct an audit of CDSCO’s file storage and archival system. It’s very likely that the three missing files are merely representative of a larger systemic issue at the CDSCO and we were hoping an external audit by an experienced agency like CAG would help identify the real issues. Unfortunately the Supreme Court dismissed the PILs on the grounds that we were raising mere academic issues. If the national regulator cannot do something as basic as maintain proper records, isn’t public health under jeopardy in India? I wonder how this is an academic issue.