DTAB agrees to amend Rules for OTC drugs and license displaying in Medical Stores

The Board after detailed deliberation agreed for the necessary amendment in the Rules in this regard

Rules Law Act
Picture: Pixabay

Last Updated on January 9, 2022 by The Health Master

The Drugs Technical Advisory Board (DTAB) has approved a proposal to amend the Drugs Rules to include a provision for the display of the picture of the license holder in medical stores.

It has also been agreed to make the necessary amendments in the rules to add 16 drugs to the list of over-the-counter (OTC) products.

The Board, in its latest meeting held in November, 2021, has observed that the practice of medicine is changing rapidly, and with these rapidly changing ground realities, the practices of allied professionals such as druggists and chemists also need to change synchronously.

“Professionals associated with this complementary profession too need to adopt ‘Good Practices’ wholeheartedly,” observed the Board meeting chaired by Dr Sunil Kumar, Director General of Health Services (DGHS).

Several observations were received for improving the current practices at the retail outlets or medicine shops, one of which was to display the picture of the license holder in the shop.

A joint meeting was convened by the Central Drugs Standard Control Organization (CDSCO) and the Pharmacy Council of India (PCI) with various stakeholders, including the All India Organization of Chemists and Druggists (AIOCD), the All India Chemists’ and Distributors’ Federation (AICDF) and the South Chemists and Distributors Association (SDCA) wherein the observations which required elaborate deliberations were discussed, said the Board.

The proposal was deliberated in the 59th Drugs Consultative Committee (DCC) meeting held on March 2, 2021, and the committee recommended that the Drugs Rules may be amended to provide provision for display of the picture of the license holder in the shop.

“The Board, after detailed deliberation, agreed to the necessary amendment in the rules to have a provision for the display of the picture of the license holder in the shop,” said the DTAB.

Beside, it also considered the sub-committee report on OTC drugs in the meeting. The 57th meeting of the DCC held on August 8, 2019 recommended that the recommendations of the Sub-committee be considered for suitable amendment in Schedule K of the Drugs and Cosmetics Rules, 1945 to incorporate necessary provisions for such drugs to provide exemptions from requirements for sale license/prescription of RMP etc. subject to appropriate conditions.

Drug Consultative Committee (DCC): Minutes of meetings

Accordingly, the DCC further recommended that the sub-committee identify such a list along with conditions and frame a draft for amendments to the rules.

The sub-committee in its last meeting, held on October 20, 2021, the sub-committee deliberated issues with respect to certain drugs along with experts in the fields of pharmacology and medicine and recommended 16 drugs as OTC drugs.

A copy of the minutes of the sub-committee meeting, along with the list of 16 drugs, was placed before the DTAB.

The minutes of the last meeting said, “After detailed deliberation, we agreed to the necessary amendment in the rules in this regard,”

Further, the Board recommended that a proposal for adopting best practices with respect to the dispensing of drugs by various professionals should be prepared for further consideration.

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