Delhi High Court pulls DCGI for violating RTI Norms

Delhi High Court pulls DCGI for violating RTI Norms

The plaintiff had sought the report of Dr T.M. Mohapatra Committee under the RTI Act but was not successful. The aggrieved plaintiff filed a writ petition before the Delhi High Court for a copy of the complete report and contended for the digitization of all the records of DCGI for clinical trials.

The Delhi High Court in the latest move took a serious note concerning the blatant violation of the RTI Act by the Drug Controller General of India (DCGI) imposing the cost of Rs 25,000.

In the recent order of Prashant Reddy vs. DCGI, the Court took the notice of violation of the Right to Information Act by the Drug Regulator of India, DCGI. The Single Judge court of Justice Pratibha Singh gave the order against the DCGI.

A committee was constituted by the Drugs Controller General of India with regards to the criticism in the 59th Parliamentary Standing Committee Report. The criticism pertains to the mechanism being adopted for the approval of drugs in India by DCGI. The committee was named as Dr T.M. Mohapatra Committee.

The Parliamentary Standing Committee reiterated some of the findings such as (i) the absence of local clinical trials for new drugs (since the response levels of people of different ethnicities vary, local clinical trials are relevant for evaluating the effects of new drugs); (ii) files regarding certain controversial drugs were missing from the Central Drug Standards Control Organization (CDSCO); and (iii) certain drugs were cleared based on dubious expert medical opinions. The weak approach of the regulatory system was opined for incompetency and ineptitude.

The plaintiff sought the report of Dr T.M. Mohapatra Committee under the RTI Act but was not successful even after making various attempts. Due to the unsuccessful attempts, the plaintiff approached the Central Information Commission (CIC) seeking the said copy of the Committee's finding. After attempts, an incomplete copy of the report was made available to the plaintiff. Aggrieved by this, the plaintiff filed a writ petition before the Delhi High Court for a copy of the complete report. In the same writ petition, the plaintiff contended for the digitization of all the records of DCGI for clinical trials.

On 29 September 2020, a notice was sent to the DCGI but no filing of the counter affidavit was done. Taking note of all the activity, High Court coming down heavily imposed the cost of Rs 25,000 on DCGI. On not filing of counter-affidavit and cost, a senior official of DCGI needs to be present and also to file a status report for the digitization of its record.

Questioning the function of the DCGI, the Court's decision, and putting it heavily on the defendant, is a welcome move. Moreover, the findings of the committee are indispensable for analyzing the function of DCGI, and having not available for the same, will affect its evaluation.