CDSCO told to streamline the process of digitizing records as crucial drug report go missing
New Delhi: The Central Information Commission (CIC) recently flagged a "serious concern" and reprimanded the Directorate General of Health Services (DCGI) for allegedly misplacing the file containing a crucial report related to clinical trials and the approval processes of four new drugs Aceclofenac and Drotaverine, Buclizine, Letrozole, and Placenta extract; which were adopted by the Central Drugs Standard Control Organisation (CDSCO).
The report, called the Dr T N Mahapatra Committee Report, was a development to the comments made by the Parliamentary Standing Committee on Health and Family Welfare, early in 2013, on glaring "irregularities" adopted by DCGI and CDSCO while giving approvals to new drugs, allegedly without proper research and clinical trials.
Over a year ago, an RTI was filed by an applicant Prashant Reddy seeking a copy of the reports and recommendations of the office order issued by the DCGI on 26 March 2013 and review processes adopted by CDSCO in granting approval for new drugs and clinical trials.
At first, the response was denied but later Reddy reiterated that he had sought under RTI, a copy of the Mohapatra Committee Report which was denied to him. Reddy alleged the document was "malafidely" withheld as it detailed "shocking lapses" by the DCGI's office in granting drug approvals. "Many of these lapses border on criminal negligence," he had submitted to the CIC.
Reddy worked closely with a health activist Dinesh Thakur, who recently tweeted on the process in a thread that reads;
So here is the backstory on this excellent piece from @PrabhaRaghavan. This is a long thread, so please bear with me. @CDSCO_INDIA_INF stonewalled us for over two years before they gave us an unsigned copy of this report (sans annexures) 15 hrs before the CIC hearing 1/n https://t.co/BPtXRjRYFR— Dinesh S. Thakur (@d_s_thakur) June 2, 2020
Deliberating the matter, CIC has now asked CDSCO to not only digitize its records fast but also make its reports and the reports on it public. In its order dated May 26 CIC noted;
"Keeping in view the facts of the case and the submissions made by both the parties, it was noted by the Commission that on its intervention, a reply was furnished to the appellant. The commission, however, expressed its serious concern over the record-keeping methodology in the office of DCGI / CDSCO due to the fact that an important report relating to the review of procedures and practices followed by CDSCO for granting approval and clinical trials on certain drugs went missing from their office that had to be procured from the author after the receipt of the notice of hearing from the Commission."
"This is despite the fact that the parliamentary standing committee had also taken cognizance of the lapses by the public authority. The intent and the conduct of the public authority should always be above board in matters relating to the grant of approvals through a transparent and objective mechanism. The commission advises the secretary, m/o health and family welfare, govt. of India to examine this matter appropriately for further necessary action at its end, " CIC added.
The Commission further added;
The Commission instructs the Respondent (CDSCO) to provide a certified copy of the information provided to the Appellant vide letter dated 11.05.2020 within a period of 30 days from the date of receipt of this order depending upon the condition for containment of the Corona Virus Pandemic in the Country or through email, as agreed. Moreover, taking into consideration the observations made in the preceding paragraphs, the Commission without commenting on the merits of the case, advises the Respondent to urgently initiate steps to streamline the process of digitization of records within the Public Authority so that the RTI applications/ First Appeals are dealt with in a time-bound manner. The Commission also instructs the Public Authority officials to suo moto disclose its reports and other associated documents in the Public Domain for the benefit of public at large.
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