Govt to amend Rule 123 w.r.t. Schedule K: D&C Rules 1945

Rule 123 read with Schedule K of the D&C Rules 1945 provides exemption from certain rules for certain drugs and Schedule K specifies the extent of exemptions.

Govt India
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Last Updated on January 26, 2021 by The Health Master

The Union health ministry will soon amend Rule 123 of the Drugs & Cosmetics Rules 1945, and will add and delete certain drugs coming under the Schedule K of the Drugs and Cosmetics Rules.

The move comes in the wake of the fact that the Karnataka State Registered Pharmacists Association (KSRPA) had earlier raised objections over Rule 123 and called for its amendment in a time bound manner. 

Rule 123 read with Schedule K of the D&C Rules 1945 provides exemption from certain rules for certain drugs and Schedule K specifies the extent of exemptions.

In a communication, Somnath Basu, Assistant Drugs Controller, CDSCO stated that after the KSRPA’s complaint was examined, the effort to direct a proposal to create a separate provision for the over the counter (OTC) drugs has been deliberated in various Drugs Consultative Committee (DCC) meetings to create a separate provision for the OTC drugs.

This was made at the 52nd meeting held on September 18, 2017, 55th meeting on January 31, 2019 and February 1, 2019 besides at the 57th meeting on August 20, 2019.

To read about DCC meetings, click here

“The sub-committee constituted by the DCC had given recommendations on various aspects of the OTC drugs. These are to include definition of OTC, its basic characteristics and classification.

It also included the preparation of an initial list of OTC, regulation of prescription (Rx) drugs to OTC drug switch process, regulation of new OTC drug approval, manufacturing and labeling of OTC drugs, advertisement of these over-the-counter drugs and its pricing,” Basu noted in his communication to the KSRPA president, Ashokswamy Heroor.

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Further the letter also noted that the DCC in its 57th meeting held in mid August 2019, after considering the recommendations of the sub-committee, suggested for suitable amendment in the Schedule K of the Drugs & Cosmetics Rules to incorporate necessary provisions for such drugs to be exempted from requirements of seeking sale license, and prescription of a registered medical practitioner (RMP).

Now subjected to appropriate conditions, the sub-committee should identify such a list along with the conditions and frame a draft for amendments in the Rules.

The communication also stated that further action in this regard would be under consideration by the sub-committee.

This order is also being issued with the approval of the competent authority, he said.

“This is a major development for us as the Union government’s Directorate General of Health Services and the CDSCO have comprehended our objection. We are confident that the government will make the necessary amendments and bring in more clarity on both OTC and the drugs under the Schedule K ambit,” Heroor told.

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