New Delhi, Aug 12 (PTI) The Drugs Technical Advisory Board (DTAB) considered the agenda to revise the Schedule H of the Drug Rules, 1945 at its 92nd meeting held in April, the government told Parliament on Tuesday.
In a written reply to a question in the Rajya Sabha, Minister of State for Health Anupriya Patel said the DTAB is a statutory body constituted under section 5 of the Drugs and Cosmetics Act, 1940 and the Rules thereunder to advise the Centre and state governments on technical matters arising out of the administration of the Act and to carry out the other functions assigned to it by the Act.
The minister was responding to a question on whether the Centre is planning an overhaul of the medicines listed under Schedule H of the Drugs and Cosmetics Act.
Patel said the sale and distribution of drugs, including Schedule H drugs, are regulated by state licensing authorities (SLAs) under the Drugs Rules, 1945.
Further, the sale of Schedule H drugs without the prescription of a registered medical practitioner is a punishable offence and the SLAs are empowered to take action for the same.
The minister said the state drugs controllers and other stakeholders have been sensitised about concerns regarding the sale of prescription drugs by retail without prescriptions of registered medical practitioners.
Various notices, advisories and letters have been issued to the state drugs controllers and other stakeholders for strict compliance with the requirements of the Drugs and Cosmetics Act and Rules.
Responding to a question on whether the government is considering implementing any digital tools to track the sale of Schedule H drugs, Patel said presently, there is no such proposal under consideration regarding this.
However, on November 17, 2022, the Drugs Rules, 1945 that came into force on August 1, 2023 were amended, providing that the manufacturers of the top 300 brands of drug-formulation products, as specified in Schedule H2, shall print or affix a bar code or quick response code on its primary packaging label or, in case of inadequate space on the primary package label, on the secondary package label that stores data or information legible with software application to facilitate authentication, she said. PTI PLB RC
Category: Breaking News
SEO Tags: #swadesi, #News, Agenda to revise Schedule H of Drug Rules considered: Govt