India’s top drug advisory board revived, pharma policy impasse set to ease | Mint

The health ministry has reconstituted India’s apex drug advisory panel, paving the way for long-pending discussions on spurious drugs, OTC norms, antimicrobial resistance, and more.

Mint had reported on 5 February that the term of India’s Drug Technical Advisory Board (DTAB) expired in October last year, bringing a whole lot of drug related policies to a halt, the union health ministry has constituted a fresh DTAB.

The formation of DTAB holds significance as India’s pharmaceutical market for FY 2023-24 is valued at $50 billion with domestic consumption valued at $23.5 billion and exports at $26.5 billion.

India’s top drug regulator, the Drugs Controller General of India (DCGI) also wrote to the Union health ministry to expedite the process of reconstituting the DTAB.

The reconstituted panel of experts from pharma, and medtech, will meet in the last week of April to discuss matters related to manufacturing compliance, spurious drugs, anti-microbial resistance, OTC drugs etc.

“The first meeting is going to happen very soon and we are looking forward to take important drug policies related matter,” said Sudarshan Jain, general secretary, Indian Pharmaceuticals Alliance, one of the members at the freshly constituted DTAB.

Indian pharmaceutical industry is globally the largest supplier of generic drugs, accounting for about 20% of the global supply. More than half of the exports are to markets under stringent regulations such as the US, EU and Japan etc.

The apex body’s DTAB is a statutory body which provides recommendations to the union government on framing of new policies and rules related to the administration of Drugs & Cosmetics Act, 1945 which regulates medicines, drugs, and cosmetic items in India. DTAB holds a meeting every six months with about a dozen important agendas on pharmaceutical and medical devices on the table.

The fresh DTAB comprises 18 members. Dr Atul Goel, directorate general of health services (DGHS) is the chairman of the DTAB with the Drugs Controller General of India (DCGI) acting as the member secretary, including other members.

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“The formation of DTAB takes time. We need five nominations to select each member and then industry representatives also have to be part of DTAB, and the government has been working on this last many months,” an official aware of the matter said.

The last 91st DTAB meeting was held on 14 August last year, which considered important agendas such as AMR, medical device, track and tracing of cancer drugs among others.

“It is very likely that the DTAB will take the pending matters of the last DTAB meeting and recent recommendations of Drugs and Consultative Committee (DCC) which was held in January this year. The latest DTAB is to tentatively meet in the last week of April,” said the official.

The official said that the proposals on medical devices, in-vitro diagnostics, Good Manufacturing Practice (GMP), pharmacovigilance, misuse of antibiotics are some of the agenda may be discussed.

Queries sent to the health ministry spokesperson remained unanswered till press time.

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