Delhi

Delhi HC Reprimands DCGI After Portions Of CDSCO Drug Approval Process Report Found Missing

• byDoctor News Daily Team
• 18 February, 2025
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New Delhi: The Delhi High Court on Wednesday pulled up the Drugs Controller General of India (DCGI) over portions of a report going missing with regard to procedures and practices followed by the Central Drugs Standard Control Organisation (CDSCO) while granting approvals to clinical trials of certain drugs, saying it was "really shocking" and "not a laughing matter".
"This is not a laughing matter. It is a very serious matter. I cannot allow this to go so easily. It is really really shocking. How can you say that annexures of a committee report placed before Parliament is not available with you," Justice Prathiba M Singh asked the DCGI.
The court was hearing a plea by an RTI applicant -- Prashant Reddy T -- who had made several attempts to obtain a copy of the report by the Dr T N Mahapatra Committee, which was constituted to review the procedures and practices followed by CDSCO for granting approval to clinical trials of certain drugs, and when the same was not provided in entirety to him, he had moved the High Court for production of the same.
Reddy has also sought digitisation of all the records of DCGI which pertain to clinical trials.
Besides the issue of portions of the report having gone missing, the court was also displeased that DCGI has not yet filed a reply to Reddy's plea till date despite issuance of notice in the matter in September last year.
Central government senior panel counsel Rahul Sharma, appearing for DCGI, told the court that the reply was filed on February 12, but Justice Singh said it was not yet on record.
Even the lawyers for the petitioner said that they have not received a copy of the reply.
Subsequently, the court directed that the reply would be taken on record only on deposit of cost of Rs 10,000.
It further said that the amount would be in addition to the cost of Rs 15,000 imposed on DCGI earlier in December last year.
The court had on December 21, 2020 said that if DCGI does not file a reply within four weeks, the cost of Rs 15,000 would have to be paid by it.
Justice Singh said if the total costs of Rs 25,000 is not deposited and the reply is not on record before the next date of hearing on March 19, the DCGI will depute a senior official to be present in the court.
The court also directed DCGI to file a status report with regard to the steps taken by it to digitise its records, saying "there is no reason why DCGI should not digitise its records".