The Drugs Technical Advisory Board (DTAB) has approved its Action Taken Report covering slew of initiatives. These included taking a scientific rationale of fixed dose combinations (FDCs), restricting pack size of diclofenac injection for human and suspend manufacture and sale letrozole for induction of ovulation.

In its 75th meeting held early this month, DTAB in its 12 point agenda also agreed to amend rule 96 of the Drugs and Cosmetics Rules, to provide the proper name of the drug larger than the trade name. It agreed to amend the rule to have a generic drug name in a font size which is two font sizes more than the trade name.

With regards to FDCs, the drug technical board has called for the constitution of the committee under Dr. Parija, Department of Microbiology, JIPMER, Puducherry, Dr. Samantary, AIIMS, Prof. and Head of Department of Surgery, CMC, Vellore, Madras Medical College, PGI, Chandigarh and Head of Department of Medicine, KEM Hospital, along with Dr V G Somani, Joint Drugs Controller (India), CDSCO to look into the issue.

It also agreed that the Rule 96 of the D&C Rules may be amended to label certain categories of drug formulations with a band not less than 5 mm width in which words ‘Prescription Drug’ overprinted in black colour.

In consideration of the proposal for making separate rules under the D&C Act, for new drugs and clinical trials including stem cell and cell based products, DTAB agreed to the various provisions.

It has recommended for ‘accelerated approval process’ for new drugs, even before completion of phase III trial in certain cases, where report of the phase II clinical trial has been received and at least three institutions have given the certificate that there is unmet need of the drug.

DTAB further suggested that earlier decisions taken by it on clinical trials should be expedited for notification and not clubbed with the present notification. A decision on stem cell and cell based products would be decided during its next meeting.

While DTAB recommended to withdraw suspension cancer drug dextropropoxyphene and its formulations, it called for package insert, promotional literature, labelling of the drug with mention of ‘use for cancer pain only and dosage not over 300mg per day.

Regarding packing of patent and proprietary medicines or pharmacopoeial medicine, ready for internal or external use, DTAB agreed to the proposed amendment of Rule 37 D&C Rule.

On the amendment of schedule D of the D&C Rules to permit import of medicines for charity purposes or humanitarian aid without taking any cost of drugs DTAB recommended that the term NGOs may be deleted from the proposed amendment.

Delving on to agenda No. S-1, related to the proposal to replace gelatin capsules with cellulose based capsules, DTAB said that it pertained not only to drugs but to other products also, Hence, Ministry of Health needs to be consulted to take a policy decision.

Under agenda No. S-3, DTAB agreed to include waiving of local clinical trials for new drugs approved by major ICH countries. Under its agenda, No.S-3, DTAB agreed to have separate rules to regulate manufacture, import, clinical investigation, sale and distribution of cosmetics in the country It has now called for the publication of the draft rules.

Other agendas included change of name of Central Drugs Standards Control Organisation (CDSCO) to Indian Drugs Administration (IDA) to make it simple and befitting to its activities.