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Policy Matters

Experts feel Ayush dept in undue hurry on introduction of sale licenses & GCP guidelines

Bengaluru (PB): Ayush Drug Technical Board Advisory Board (ASUDTAB) is now in the process of evaluating Guidelines for Licenses of P&P (proprietary and prescription) medicines and their categories. It is also looking for an Amendment in Rule 161 for inclusion of Anupan/Dose /Indication, besides introduce sale licenses in the Ayush sector and Good Clinical Practices (GCP) Guidelines. In a meeting held on January 12, the ASUDTAB is keen to pass many of the resolutions.

Meanwhile, the industry is surprised at the meeting organized by ASUDTAB as it feels there seems to be some kind of a hurry by the department of Ayush to get the approvals without adequately consulting the stakeholders and the scientists. This move would be detrimental for the growth of the industry, industry sources said.

“The way the ASU DTAB met is questionable. It is chaired by the new DG (health), without gazette notification, and the practice of dept of Ayush to issue Government Orders  under power vested in department of Ayush – 33N are now being mis-utilized circumventing the role of Board, sources said.

“In fact the right way would be to consider the stakeholders views adequately before taking any proposal to DTAB, to achieve implementable decisions” Moreover “all ASUDTAB meeting agendas and resolutions should be  transparently put on a dedicated website or section on the Dept. of Ayush website”, stated a regulatory expert.

It is not understood why the proposal to make Sale licensing for Ayurvedic medicines sale on the agenda when the same has been “rejected on two occasions earlier by the Board”. “Even if the same is approved, the department of Ayush does not have adequate manpower to inspect and supervise sale of Ayurvedic medicines, nor such a process is warranted,” says an industry expert. The impact of Sale Licenses for Ayush Classical medicine and P&P medicine will be immense in widespread distribution and availability. The classical segment of the Ayush sciences has taken a back seat in light of the over-the-counter and personal care products and thereby as such this requirement of Sale Licenses for the retail trade will be a further blow in the availability and distribution of medicines. In fact, all drugs dispensed by a physician, clinic, hospital should be exempt from such a requirement, stated the experts.

The draft Good Clinical Practices (GCP) guidelines put up to ASUDTAB is  mixed up with sciences and regulations. Instead of sticking to things that need to be regulated for any ASU product being taken up for Human Clinical Trials, the draft talks too much of design and scientific aspects of such trials. More than 50 comments given by the Industry does not seem to be considered by the Board. “To thrust such guidelines, which in many ways are suited for assessment and evaluation of new chemical entities is not a correct method,” stated the expert who did not wish to be identified.

Efforts to contact officials at the department of Ayush were in vain as none were available for comment.

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