New Delhi: India’s highest decision-making body on technical matters related to medicines ceased to exist in October after its three-year term came to an end, grinding to a halt all drugs-related policy activities in the country ever since.
The Union health ministry is now in the process of reconstituting the Drugs Technical Advisory Board (DTAB) after the lapse was highlighted during a meeting of the drugs consultative committee in January, according to three officials familiar with the matter.
The drugs consultative committee is constituted by the Union government to advise the Centre, the states, and DTAB on matters related to administering the Drugs and Cosmetics Act. DTAB, a statutory body, in turn advises the Union government on framing policies and rules related to the administration of the Act, including on key public health concerns such as antimicrobial resistance to drugs and spurious medicines.
“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,” one of the officials said. “Even an emergency DTAB meeting cannot be organised like it was done during the covid-19 pandemic.”
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Reconstituting the DTAB may take 2-3 months because it needs to have representatives from the industry as well as from Central and state governments, the official added.
India’ top drug regulator, the Drugs Controller General of India (DCGI), has asked the Union health ministry to expedite the process of reconstituting the Drugs Technical Advisory Board, according to the officials, who declined to be identified.
“The DCC organised its meeting last month. As part of its process, it sends its recommendation to DTAB… and (that’s when) they found out that DTAB’s tenure was over and a fresh board had to be constituted,” said the second of the three officials, adding that “we received an application from DCGI last week” about reconstituting the board.
“Without (DTAB’s) existence, no important decision can be taken,” said Harish Jain, president, Federation of Pharmaceuticals Entrepreneurs. “No government notification can be issued. No legal decisions can be taken. Right now, the most important decision pending is GMP (good manufacturing practice) compliance and its extension for MSME drug firms (micro, small and medium enterprises) as well as decision on manufacturing of nutraceutical products in the pharmaceutical factories.”
The health ministry didn’t reply to Mint’s queries.
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DTAB meeting due this month
The previous DTAB was a 17-member board chaired by Dr. Atul Goel, the chief of India’s Directorate General of Health Services (DGHS). In its last meeting on 14 August, the drug advisory body took up matters such as antimicrobial resistance to drugs, regulations related to medical devices, and using QR codes to trace cancer drugs.
DTAB holds a meeting every six months with about a dozen important agenda on the table, the second official said, adding that the process of reconstituting the body should have started ahead of its expiry. The advisory body’s next meeting was due this month.
“DTAB advises the Central and state governments on technical matters arising out of the administration of the Drugs and Cosmetics Act, 1940… (It) largely functions to bring uniformity throughout India in the implementation of the Act and its rules,” this official said. “DTAB meeting is due. DCGI has sent an application to the health ministry requesting to reconstitute DTAB to take the newer agendas forward.”
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