India’s key drug advisory body ceases to exist, policy decisions on hold: Report

The Drugs Controller General of India (DCGI) has urged the health ministry to expedite the reconstitution, as without DTAB, no crucial decisions can be made.

India’s key drug policy body, the Drugs Technical Advisory Board (DTAB), ceased to exist in October after its three-year term ended, leading to a halt in all drug-related policy activities in the country, according to a report by Mint.  The lapse came to light during a January meeting of the Drugs Consultative Committee (DCC), which advises the Centre, states, and DTAB on matters related to the Drugs and Cosmetics Act, the report added,

The Union health ministry is now in the process of reconstituting DTAB, according to three officials familiar with the matter, who spoke to Mint. This delay in reconstituting the board has raised concerns, as DTAB plays a critical role in advising the Union government on drug policies, including pressing public health issues such as antimicrobial resistance and spurious medicines.

An official told Mint, “Whatever agenda was discussed in the last DCC should be placed before the DTAB... If any existing policy or rule requires any amendment or improvement, that may not be implemented now.” The official also noted that even an emergency DTAB meeting, such as those held during the COVID-19 pandemic, cannot be convened in the absence of the body.

Reconstituting the DTAB is expected to take 2-3 months, as the board requires representation from the industry, as well as from central and state governments. The Drugs Controller General of India (DCGI) has urged the health ministry to expedite the reconstitution, as without DTAB, no crucial decisions can be made.

Harish Jain, president of the Federation of Pharmaceuticals Entrepreneurs, highlighted the significance of DTAB, stating, “Without (DTAB’s) existence, no important decision can be taken... No government notification can be issued. No legal decisions can be taken." He pointed out that the most pressing decision at hand is the extension of Good Manufacturing Practice (GMP) compliance for MSME drug firms, as well as a decision on the manufacturing of nutraceutical products in pharmaceutical factories.

The previous DTAB, a 17-member board chaired by Dr. Atul Goel, head of India’s Directorate General of Health Services (DGHS), addressed various matters, including antimicrobial resistance, medical device regulations, and QR code-based tracing of cancer drugs, in its last meeting on August 14. The advisory body typically holds meetings every six months, but the process of reconstituting the board should have been initiated before its term ended. The next DTAB meeting was expected this month.

The health ministry did not respond to Mint's queries. Moneycontrol could not independently verify the report.